COMPARATIVE DISEASE BURDEN IN PATIENTS WITH RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS OR ANKYLOSING SPONDYLITIS: DATA FROM COVAD PATIENT-REPORTED E-SURVEY

BackgroundRheumatoid arthritis (RA) and spondyloarthritis, including either Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS), are some of the most diagnosed autoimmune rheumatic diseases (AIRDs) in rheumatologists' routine clinical practice [1]. Understanding patients' health and functional status is crucial to provide personalized management strategies to optimize disease control and enhance the quality of life.ObjectivesWe aimed to compare disease burden in patients with RA, PsA or AS by assessing Patient-Reported Outcome Measurement Information System (PROMIS) Physical Health, Global Mental Health, Physical Function and Fatigue 4a together with VAS Pain.MethodsData were obtained in the international COVID vaccination in autoimmune rheumatic diseases study second e-survey (COVAD study). Demographics, AIRD diagnosis, disease activity, PROMIS Global Physical health, PROMIS Global Mental Health, PROMIS Physical Function SF10 and PROMIS Fatigue 4a score were extracted from the COVAD study database. For this study, we only included patients with self-reported RA or spondyloarthritis (either PsA or AS) undergoing active treatment with conventional synthetic disease-modifying drugs (DMARDs) and/or biologic DMARDs, who answered all the survey questions. Active disease was defined as the patient's perception of their disease as active in the four weeks before their first COVID-19 vaccine shot. Analysis of Variance with Bartlett's and Tukey's test was used to compare continuous variables between groups.ResultsFrom January to June 2022, n.1907 patients with RA, female 87.62% (1671/1907), with mean age (±SD) 50.95 ±13.67, n.311 patients with PsA, female 67.20% (209/311), with a mean age of 50.42 ±12.70, and n.336 patients with AS, male 51.31% (209/311), with a mean age of 43.13 ±12.75 years, responded to the COVAD e-survey.In those with active disease, neither physical health, global mental health, physical function, fatigue, nor pain were different among groups (Table 1, Figure 1). Patients with inactive AS had higher mean global physical health scores than RA patients (13.13 ±2.93 VS RA 12.48 ±2.90, p=0.01, Table 1). Those with inactive RA or PsA showed more severe fatigue (PsA 10.58 ±2.22, RA 10.45 ±4.08 VS 9.4 ±4.13, p =0.01 for both). Patients with inactive RA also reported poorer physical function and more residual pain than those with AS (37.79 ±8.86 VS 41.13 ±7.79, p<0.001;3.87 ±2.45 VS 3.34 ±2.39, p=0.01, respectively). Similarly, residual pain was perceived as higher in patients with inactive PsA than those with AS (4.04 ±2.50 VS 3.34 ±2.39, p=0.01)ConclusionDisease burden is roughly comparable in patients with active RA, PsA or AS. Patients with inactive RA and PsA suffer higher disease burden than those with inactive AS.Reference[1]Mease PJ, Liu M, Rebello S, Kang H, Yi E, Park Y, Greenberg JD. Comparative Disease Burden in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis: Data from Two Corrona Registries. Rheumatol Ther. 2019 Dec;6(4):529-542.Table 1.Patient-Reported Outcome Measures between groups.Inactive diseaseAS (n.185)PsA (n.179)RA (n.1167)MeanSDMeanSDMeanSDPROMIS Global Physical Health13.13*2.9512.433.2712.482.90p=0.01, VS RAPROMIS Global Mental Health13.313.3612.973.3312.843.17PROMIS Fatigue 4a9.44.1310.58*4.2210.45*4.08p=0.01, bothPROMIS Physical Function SF10 Score41.137.3939.279.0137.79*8.86p<0.001, VS ASVAS Pain3.342.394.04*2.503.87*2.45p=0.01, bothActive DiseaseAS (n.35)PsA (n.38)RA (n.189)MeanSDMeanSDMeanSDPROMIS Global Physical Health11.053.1910.102.7611.243.41PROMIS Global Mental Health11.313.2610.843.6311.893.30PROMIS Fatigue 4a12.944.8712.844.4211.754.68PROMIS Physical Function SF10 Score35.829.6233.528.7634.909.80VAS Pain4.682.775.02.544.682.61Figure 1.Violin plots showing kernel densities, quartiles and median for Patient-Reported Outcome Measures for patients with RA, PsA and AS, stratified by disease activity status.[Figure omitted. See PDF]Acknowledgements:NIL.Disclosure of InterestsVincenzo Venerito: None declared, Marc Fornaro: None declared, Florenzo Iannone: None declared, Lorenzo Cavagna: None declared, Masataka Kuwana: None declared, Vishwesh Agarwal: None declared, Naveen Ravichandran: None declared, Jessica Day Grant/research support from: JD has received research funding from CSL Limited., Mrudula Joshi: None declared, Sreoshy Saha: None declared, Syahrul Sazliyana Shaharir: None declared, Wanruchada Katchamart: None declared, Phonpen Akarawatcharangura Goo: None declared, Lisa Traboco: None declared, Yi-Ming Chen: None declared, Parikshit Sen: None declared, James B. Lilleker Speakers bureau: JBL has received speaker honoraria/participated in advisory boards for Sanofi Genzyme, Roche, and Biogen. None is related to this manuscript., Consultant of: JBL has received speaker honoraria/participated in advisory boards for Sanofi Genzyme, Roche, and Biogen. None is related to this manuscript., Arvind Nune: None declared, John Pauling: None declared, Chris Wincup: None declared, Ai Lyn Tan Speakers bureau: ALT has received honoraria for advisory boards and speaking for Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB., Nelly Ziade Speakers bureau: NZ has received speaker fees, advisory board fees, and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre;none are related to this manuscript, Grant/research support from: NZ has received speaker fees, advisory board fees, and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre;none are related to this manuscript, Marcin Milchert: None declared, Abraham Edgar Gracia-Ramos: None declared, Carlo Vinicio Caballero: None declared, COVAD Study: None declared, Vikas Agarwal: None declared, Rohit Aggarwal Speakers bureau: RA has a consultancy relationship with and/or has received research funding from the following companies: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, and Roivant., Grant/research support from: RA has a consultancy relationship with and/or has received research funding from the following companies: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, and Roivant., Latika Gupta: None declared.

PLACEBO-CONTROLLED EFFICACY AND SAFETY OF UPADACITINIB THROUGH ONE YEAR IN PATIENTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS

BackgroundUpadacitinib (UPA), a Janus kinase inhibitor, was effective and well tolerated in patients (pts) with non-radiographic axial spondyloarthritis (nr-axSpA) through 14 weeks (wks) of treatment.[1]ObjectivesThis analysis assessed the efficacy and safety of UPA vs placebo (PBO) through 1 year.MethodsThe SELECT-AXIS 2 nr-axSpA study included a 52-wk randomized, double-blind, PBO-controlled period. Enrolled adults had a clinical diagnosis of active nr-axSpA fulfilling the 2009 ASAS classification criteria, objective signs of inflammation based on MRI sacroiliitis and/or elevated C-reactive protein, and an inadequate response to NSAIDs. One-third of pts had an inadequate response to biologic DMARDs. Pts were randomized 1:1 to UPA 15 mg once daily or PBO. Concomitant medications, including NSAIDs, had to be kept stable through wk 52. The study protocol outlined that pts who did not achieve ASAS20 at any two consecutive study visits between wks 24 to 52 should receive rescue therapy with NSAIDs, corticosteroids, conventional synthetic/biologic DMARDs, or analgesics. Cochran-Mantel-Haenszel (CMH) test with non-responder imputation incorporating multiple imputation (NRI-MI) was used to handle missing data and intercurrent events for binary efficacy endpoints. Mixed-effect model repeated measures (MMRM) was used to assess continuous efficacy endpoints. NRI was used for binary endpoints after rescue and as observed analysis excluding data after rescue for continuous endpoints. Treatment-emergent adverse events (TEAEs) are reported through wk 52.ResultsOf the 314 pts randomized, 259 (82%;UPA, n=130;PBO, n=129) completed wk 52 on study drug. More pts achieved an ASAS40 response with UPA vs PBO from wks 14 to 52 with a 20% treatment difference at wk 52 (63% vs 43%;nominal P <.001;Figure 1). The proportion of pts achieving ASDAS inactive disease with UPA remained higher than PBO at wk 52 (33% vs 11%;nominal P <.0001;Figure 1). Consistent improvements and maintenance of efficacy were also seen across other disease activity measures. Between wks 24 and 52, fewer pts on UPA (9%) than PBO (17%) received rescue therapy. A similar proportion of pts in each treatment group had a TEAE (Table 1). Infections were the most common TEAE;the rates of serious infections and herpes zoster were higher with UPA vs PBO, although no new serious infections were reported from wks 14 to 52. COVID-19 events were balanced between treatment groups. No opportunistic infections, malignancy excluding non-melanoma skin cancer, adjudicated major adverse cardiovascular events, inflammatory bowel disease, or deaths were reported. Two pts (1.3%) on PBO had adjudicated venous thromboembolic events.ConclusionUPA showed consistent improvement and maintenance of efficacy vs PBO through 1 year across multiple disease activity measures. No new safety risks were identified with longer-term UPA exposure. These results continue to support the benefit of UPA in pts with active nr-axSpA.Reference[1]Deodhar A, et al. Lancet. 2022;400(10349):369–379.Table 1.Safety through week 52Event, n (%)PBO (n = 157)UPA 15 mg QD (n = 156)Any AE103 (66%)107 (69%)Serious AE6 (3.8%)6 (3.8%)AE leading to D/C4 (2.5%)6 (3.8%)COVID-19-related AE22 (14%)24 (15%)Deaths00Infection60 (38%)68 (44%) Serious infection1 (0.6%)2 (1.3%) Herpes zoster1 (0.6%)5 (3.2%)Malignancy other than NMSC00NMSC1 (0.6%)0Hepatic disorder7 (4.5%)6 (3.8%)Neutropenia1 (0.6%)8 (5.1%)MACE (adjudicated)00VTE (adjudicated)2 (1.3%)a0Uveitisb3 (1.9%)2 (1.3%)Inflammatory bowel disease00aBoth patients had non-serious events of deep vein thrombosis in the lower limb with risk factors including obesity and prior deep vein thrombosis in one patient and concomitant COVID-19 infection in the other patient.bThree events of uveitis occurred in each treatment group (among n = 3 patients in the PBO group and n = 2 patients in the UPA group);two events in the PBO group and one in the UPA group occurred in patients with a history of uveitis.AcknowledgementsAbbVie funded this study and participated in the study design, res arch, analysis, data collection, interpretation of data, review, and approval of the . All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Julia Zolotarjova, MSc, MWC, of AbbVie.Disclosure of InterestsFilip van den Bosch Speakers bureau: AbbVie, Amgen, Galapagos, Janssen, Lilly, Merck, MoonLake, Novartis, Pfizer, and UCB., Consultant of: AbbVie, Amgen, Galapagos, Janssen, Lilly, Merck, MoonLake, Novartis, Pfizer, and UCB., Atul Deodhar Consultant of: AbbVie, Amgen, Aurinia, BMS, Celgene, GSK, Janssen, Lilly, MoonLake, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Bristol Myers Squibb, Celgene, GSK, Lilly, Novartis, Pfizer, and UCB, Denis Poddubnyy Speakers bureau: AbbVie, Biocad, BMS, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, MSD, Medscape, MoonLake, Novartis, Peervoice, Pfizer, Roche, Samsung Bioepis, and UCB, Consultant of: AbbVie, Biocad, BMS, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, MSD, Medscape, MoonLake, Novartis, Peervoice, Pfizer, Roche, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, Lilly, MSD, Novartis, and Pfizer., Walter P Maksymowych Consultant of: AbbVie, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Novartis, Pfizer, and UCB, Employee of: Chief Medical Officer of CARE Arthritis Limited, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, and UCB, Employee of: Director of Imaging Rheumatology BV, Tae-Hwan Kim Speakers bureau: AbbVie, Celltrion, Kirin, Lilly, and Novartis., Mitsumasa Kishimoto Consultant of: AbbVie, Amgen, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Chugai, Daiichi Sankyo, Eisai, Gilead, Janssen, Lilly, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, and UCB., Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, and UCB, Consultant of: AbbVie, BMS, Chugai, MSD, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie and Novartis, Yuanyuan Duan Shareholder of: AbbVie, Employee of: AbbVie, Kristin D'Silva Shareholder of: AbbVie, Employee of: AbbVie, Peter Wung Shareholder of: AbbVie, Employee of: AbbVie, In-Ho Song Shareholder of: AbbVie, Employee of: AbbVie.

BERTOLOTTI SYNDROME: AN UNDER RECOGNIZED CAUSE OF INFLAMMATORY BACK PAIN?

BackgroundBertolotti syndrome describes a lumbosacral transitional vertebra (LSTV) which causes symptoms, usually low back pain. LATV is a congenital anomaly where the L5 vertebra has an unusual morphology. Bertolotti syndrome is an under-recognised condition by clinicians.ObjectivesTo clarify the presentation of Bertolotti syndrome, whether there are features of inflammatory back pain (IBP) and the effect on quality of life.MethodsIn this pilot study, 62 patients with LSTV were identified on imaging (plain x-ray). Imaging was performed for a variety of indications, predominently for back pain. In total, 34 patients agreed to take part, with 18 returning questionnaires. Questionnaires were selected for face vailidity and included: Calin IBP Questionnaire, EQ-5D Questionnaire, Visual analogue pain scale (VAS-P). In view of Covid restrictions all contact was by phone and questionnaires were completed online or returned via post.Plain X-rays visualising the lumbar spine were assessed for radiological features of LSTV.ResultsSeventeen (94%) of the participants (n=18) recorded a VAS-P score >3, indicating a clinically significant level of pain. The mean VAS-P score was 6 (range of 2-9). 89% of respondents scored at least 3/5 in the Calin questionnaire. Of the 5 features of inflammatory back pain in the Calin questionnaire, 4 out of the 5 were reported by most respondents. The exception was ‘improvement on exercise', which was only reported by 18% of respondents. Quality of life was impaired-EQ-5D (mean: 0.503, range -0.074 to 0.796).The commonest radiological abnormality was enlarged transverse process (100%) followed by pseudoarticulation with the sacrum (83%) and scoliosis (33%). Presence of sclerosis and/or osteoarthritis at the pseudoarticulation was associated with worse pain scores. Female respondents reported worse pain.ConclusionThese results suggest Bertolotti syndrome is associated with pain in the majority of patients and affects quality of life,. The character and site of the pain suggests that Bertollotti syndrome should be considered in the differential diagnosis of spondyloarthritis.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsSimon Stebbings Consultant of: Abbvie.Janssen, Ciara White: None declared, Terence Doyle: None declared.

CHALLENGES FOR PATIENTS WITH RMD'S IN BULGARIA DURING THE COVID-19 PANDEMIC

BackgroundThe Covid-19 pandemic has put patients with rheumatic diseases in front of a number of obstacles that had to be solved together with Bulgarian rheumatologists. The lockdowns and restrictive measures have made it difficult for people with rheumatic diseases to have access to timely hospital and pre-hospital care. A number of digital solutions have been implemented to address these issues.ObjectivesTo highlight the problems that patients with rheumatic diseases had during the Covid-19 pandemic;access to rheumatologists and the effectiveness of hospital and pre-hospital care during the pandemic, access to treatment, changes of treatment;communication between physicians and patients, the impact of the pandemic on work, social contacts, hobbies.MethodsAn anonymous survey was conducted online and by telephone. The survey was developed by Medical university, Plovdiv, University hospital "Kaspela”:, Plovdiv, Bulgarian Association for Musculoskeletal Ultrasound, Bulgarian organization for people with rheumatic diseases;Association for patients with autoimmune diseases.Number of participants: 1205 patients with RMD's.Age range: 18-82ResultsFace to face meetings with doctors have been limited during the pandemic.Visits to the rheumatologist's office are significantly reduced and phone, email, text messaging, online consultations were preferred as communication channels.Before the pandemic, 76% of respondents most often communicated with their physicians by visiting their practice, during the pandemic their relative share decreased to 46%, with a significant difference of 30%Phone consultations: patients using this type of communication increasing from 38% before the pandemic to 56% during the pandemic, a significant difference of 18%The percentage of patients who communicated via text or email rises from 10% to 17 %.It has become apparent that Digital transformation is needed and patients and physicians should work together to achieve it and to be established in Bulgaria.245 patients reported a change in their treatment. Of these: (30%) reduced the dose of their medications, 119 (49%) increased the dose and the remaining 55 (21%) stopped their therapy.From the responses of the respondents, it is clear that 71% have not experienced a change in their work during the COVID-19 pandemic, 17% have worked from home.From the responses of the respondents, it is clear that 71% have not experienced a change in their work during the COVID-19 pandemic, 17% have worked from home, 4% have been fired, 3% have left their jobs due to the risk of their health and 5% left their jobs for other reasons.ConclusionThe Covid-19 pandemic has shown that the digital transformation in rheumatology care can be an efficient alternative to some of the services offered to patients with rheumatic diseases in Bulgaria (especially secondary examinations and therapy monitoring examinations). The results of the conducted survey could be used to support digitization in healthcare in Bulgaria.Very important was the collaboration between the patient organizations and the Bulgarian Association for Musculoskeletal Ultrasound, Medical University, Plovdiv and the rheumatologists from University hospital "Kaspela” Plovdiv.References[1]Gianfrancesco M, Hyrich KL, Al-Adely S, et al. Characteristics associated with hospitalisation for COVID-19 in people with rheumatic disease: data from the COVID-19 Global Rheumatology Alliance physician-reported registry. Ann Rheum Dis 2020;79: 859–66.[2]Monti S, Balduzzi S, Delvino P, Bellis E, Quadrelli VS, Montecucco C. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies. Ann Rheum Dis 2020;79: 667–68.[3]Dejaco, C.;Alunno, A.;Bijlsma, J.W.;Boonen, A.;Combe, B.;Finckh, A.;Machado, P.M.;Padjen, I.;Sivera, F.;Stamm, T.A.;et al. Influence of COVID-19 pandemic on decisions for the management of people with inflammatory rheumatic and musculoskeletal diseases: A survey among EULAR countries. Ann. Rheum. Dis. 2020AcknowledgementsBul arian organization for people with rheumatic diseases.Association for patients with autoimmune diseases.Bulgarian Association for Musculoskeletal Ultrasound.Disclosure of InterestsNone Declared.

IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES AMONG PATIENTS WITH RESOLUTION OF ENTHESITIS AND/OR DACTYLITIS: POST HOC ANALYSES FROM THE KEEPSAKE 1 AND 2 TRIALS OF RISANKIZUMAB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

BackgroundEnthesitis and dactylitis are associated with greater disease activity and reduced quality of life. Results from the phase 3 randomized, placebo-controlled KEEPsAKE 1 and 2 studies (NCT03675308;NCT03671148) of risankizumab in active PsA showed greater resolution of enthesitis and dactylitis with risankizumab 150 mg vs placebo at week 24.ObjectivesThis post hoc analysis evaluated improvements in patient-reported outcomes (PROs) among patients who had enthesitis (n=444), dactylitis (n=188), or both (n=128) at baseline and achieved resolution of enthesitis, dactylitis, or both with blinded risankizumab at weeks 0, 4, 16, and open-label risankizumab every 12 weeks thereafter.MethodsAssessments included achievement of minimal clinically important differences (MCID) in pain (≥10-mm decrease on visual analog scale), Health Assessment Questionnaire-Disability Index (HAQ-DI;≥0.35-unit decrease), and Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue;≥4-point increase). Nonresponder imputation (with multiple imputation for COVID-19–related missing data at week 24) was used.ResultsMany patients who achieved resolution of enthesitis at week 24;week 52 also achieved MCID in pain (66.4%;71.4%), HAQ-DI (58.2%;63.4%), and FACIT-Fatigue (59.0%;72.1%). Many patients who achieved resolution of dactylitis at week 24;week 52 also achieved MCID in pain, (72.2%;81.7%), HAQ-DI (56.3%;66.2%), and FACIT-Fatigue (67.7%;69.9%). Many patients who achieved resolution of both enthesitis and dactylitis at week 24;week 52 also achieved MCID in pain (82.1%;86.4%) HAQ-DI (66.7%;69.2%), and FACIT-Fatigue (71.4%;74.6%). PRO results for patients for who did not achieve resolution of enthesitis and/or dactylitis will be presented.ConclusionMajority of patients who achieved resolution of enthesitis and/or dactylitis with risankizumab also reported improvements in pain, disability, and fatigue.AcknowledgementsAbbVie and the authors thank the patients who participated in the study and all study investigators for their contributions. Medical writing assistance, funded by AbbVie, was provided by Lisa M Pitchford, PhD, of JB Ashtin.Disclosure of InterestsShawn Kwatra Consultant of: AbbVie, Aslan Pharmaceuticals, Arcutis, Celldex, Galderma, Genzada Pharmaceuticals, Incyte, Johnson & Johnson, Novartis, Pfizer, Regeneron, and Sanofi., Grant/research support from: Galderma, Incyte, Pfizer, and Sanofi., Saakshi Khattri Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, and UCB, Grant/research support from: Bristol Myers Squibb, LEO Pharma, Novartis, and Pfizer, Ahmad Amin Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, LEO Pharma, Regeneron, Sanofi/Genzyme, Pfizer, and UCB, Ran Liu Shareholder of: AbbVie, Employee of: AbbVie, Byron Padilla Shareholder of: AbbVie, Employee of: AbbVie, Ahmed M. Soliman Shareholder of: AbbVie, Employee of: AbbVie, Blair Kaplan Shareholder of: AbbVie, Employee of: AbbVie, Dennis McGonagle Speakers bureau: AbbVie, Janssen, Novartis, and Pfizer., Grant/research support from: AbbVie, Janssen, Novartis, and Pfizer, UCB, BMS, Celgene.

IMPROVING THE UPTAKE OF ELECTRONIC PATIENT REPORTED OUTCOME MEASURES IN A SPECIALISED AXIAL SPONDYLOARTHROPATHY CLINIC

BackgroundSheffield Teaching Hospitals (STH), UK, has a specialised axial spondyloarthropathy (axSpa) clinic run by a rheumatology consultant and physiotherapist with special interest in this area. BASDAI and BASFI patient reported outcome measures are used to assess disease activity and response to treatment, in line with national guidelines. STH has invested in MyPathway (MP), an electronic patient messaging system used for patient information, appointments and electronic patient reported outcome measures (ePROMs). The data can also be viewed at a system level on a clinician dashboard. Prior to 2020 the uptake of ePROMs was low in the axSpa clinic. The move primarily to telephone consultations in March 2020, due to the COVID-19 pandemic, created an opportunity for increasing the use of MP for ePROMs collection to enable improved remote monitoring of patients with axSpa.ObjectivesThis quality improvement project aimed to increase the use of electronic BASDAI and BASFI (ePROMs) in the axSpa clinic.MethodsA multi-pronged approach has been taken since March 2020 to increase ePROMs completion and improve their use. Each appointment was used as an opportunity to discuss and recruit patients to MP. Clinicians invited each patient to join MP and sent them a link after their appointment. QR codes were then added to all rheumatology patient letters encouraging patients to register. A pathway was set up that automatically sent a prompt to patients registered on MP to complete their BASDAI and BASFI questionnaires prior to clinic appointments. Clinicians began logging into MP to view scores during appointments to provide patients with real-time feedback.A mixed methods approach was used to assess the uptake of ePROMs over time. We tracked MP registration rates and BASDAI completion rates as the key outcome measures, using a run chart to assess special cause variation. We undertook a patient focus group to explore attitudes towards ePROMs, key barriers and opportunities for further improvement.ResultsThe total number of axSpa patients seen in the specialised clinic (named LADAS) who have registered with MP has increased from 56 (35.9%) in January 2019 to 200 (58.9%) in September 2022. There has been an improvement in the BASDAI completion rate, with 80% of patients completing more than one BASDAI in 2022, compared to 24% in 2019, as illustrated on a run chart (Figure 1). Patients can complete BASDAI forms sent to them in a previous month, therefore the completion rate some months exceeds 100%.In a dedicated focus group, patients reported that ePROMs were generally more convenient, and provided a useful record to refer back to. This could be further improved by development of a graph function to view scores over-time and the ability for patients to complete a questionnaire between appointments when they feel their disease is more active. A key theme for improving the use of ePROMs was the need for more discussion about their utility and around individual patient's scores. There is concern that the BASDAI and BASFI scores are arbitrary and lack nuance, and that the importance of these scores at an individual patient level is not clear. This may be rectified by more discussion with clinicians in appointments, to add meaning to these scores. There was also concern that sleep and other generic health measures are not covered in the BASDAI or BASFI. The EQ-5D, a generic questionnaire, is also sent to axSpa patients, but there seems to be a lack of patient awareness regarding it. There is an appetite to improve and standardise the amount of patient information accessible on MP, for example disease information and links to patient support groups.ConclusionThere has been a clear improvement in the completion of ePROMs in the dedicated axSpa clinic at STH, over the last three years. Patient feedback has highlighted key areas for further improvement to maximise the potential of ePROMs, including more discussion around PROM scores to increase understanding and add individual patient meaning and nuance.Figure 1.AcknowledgementsI have no acknowledgements to declare.Disclosure of InterestsJudith Jade: None declared, Zoe Cox: None declared, Emily Fox: None declared, Rachel Tattersall Speakers bureau: honoraria as speaker for Abbvie, Lisa Dunkley Speakers bureau: honoraria as speaker/ teaching for UCB/ Abbvie/ Pfizer.

ASYNCHRONOUS TELECONSULTATION BY WHATSAPP CHATBOT IN CONTROLLED AXIAL SPONDYLOARTHRITIS PATIENTS UNDER BIOLOGICAL THERAPY: PATIENTS' PERSPECTIVE

BackgroundBefore COVID pandemic, rheumatologists were not confident with telehealth for the need to adquire new technology, need of specific training and poorer reimbursement [1]. Two groups of rheumatoid arthritis (RA) patients have been identified in a study of PROMS-based telehealth use (2): the keen and the reluctant. We proposed teleconsultation followup with a whatsapp platform chatbot to our axial spondyloarthritis (AxSPA) patients with controlled disease and we asked them for preferences at the end of the study.ObjectivesTo explore the degree of acceptance of asynchronous telehealth followup with whatsapp platform chatbot among our controlled AxSPA patients under biological therapy, and to search for a patient profile more prone to telehealth consultation.MethodsA prospective study with retrospective control was performed, chosing AxSPA patients under biological therapy with stable disease, visited in our centre from 01/01 to 30/11/2021. We recruited 62 patients, but finally include 60 (2 quit for home moving or personal reasons). We offered them two teleconsultation visits (using their personal mobile), every four months, and a presential final visit one year after inclusion. The chatbot sends PROMS (BASDAI, VAS for patient global disease assessment, ASDAS, and 3 questions for extraarticular disease), and feedback and schedule for the following visits. In the case of lab test or PROMs deviation or when the patient asks for contact, he/she is phoned by nurse/doctor who solves the question and/or arranges an additional presential visit. We collect patient and disease characteristics (age, gender, educational level, employment, disease activity, duration and treatments), and patient´s satisfation and preferences in the final visit.ResultsWe included 60 patients (83,3% men), mean aged 48,22 years (SD 12,128), 36% under 45 years at inclusion. 27% had received primary, 33.9% secondary and 39% tertiary education. 83.3% were active working and only 10 patients were jobless or retired. They were Ankylosing Spondylitis (AS) (90%), HLA B27 positive (85%) with longstanding disease (mean 23 years, SD 12,8), and were receiving the first (71%), or the second (23%) biological therapy (51,7% tapered anti-TNF). 50% were never smokers and 70% presented no remarkable comorbidity;25% presented peripheral impairment, and over 40% extraarticular manifestations.At inclusion 93,3% were at remission/LDA by ASDAS/BASDAI-RCP and 4 patients were considered clinically controlled in spite of higher scores. At followup 3 patients with reduced dose needed to increase to standard dose of biological drug, with no other need of treatment change. There was no worsening from basal to final visits according BASDAI, BASFI, ASDAS-RCP or AsQOL.Patients final VAS score (1-10) assessment of telehealth consultation was very high: mean 9,14 (DS 1,498);91.7% ≥ 8 and 76.7% ≥ 9.83,3% preferred telehealth followup. There was a trend towards telehealth preferences in higher educational levels, and active working (86% vs 70%) but not statistically significant. We found no correlation with gender, age and disease characteristics tested.ConclusionAsynchronous teleconsultation seems promising, not inferior to presential consultation and preferred for follow-up by our AxSpa patients with stable disease with biological drugs. We met some "reluctant patients”, that were more inactive working and with lower educational levels, but the differences were not significant. Further reserarch is needed with this telehealth model in other age and disease populations (RA), in order to characterize the reluctant and keen patients.References[1]Muehlensiepen F, et al. Acceptance of Telerheumatology by Rheumatologists and General Practitioners in Germany: Nationwide Cross-sectional Survey Study. J Med Internet Res. 2021 Mar 29;23(3):e23742.[2]Knudsen LR, et al. Experiences With Telehealth Followup in Patients With Rheumatoid Arthritis: A Qualitative Interview Study. Arthritis Care Res (Hoboken). 2018 Sep;70(9):1366-1372.AcknowledgementsGrupo INNOBIDE.Disclosure of I terestsNone Declared.

IMPACT OF CHRONIC KIDNEY DISEASE IN PATIENTS WITH AS USING BIOLOGIC AGENTS

BackgroundAlthough renal involvement is an rare extra-articular involvement in patients with ankylosing spondylitis (AS), medications and accopamyning comorbidities may adversly affect renal functions [1].ObjectivesTo determine the frequency and impact of CKD in patients with AS using biologic disease modyfying anti-rheumatic drugs (bDMARDs).MethodsBetween 2005 and November 2021, 3207 patients diagnosed with AS according to the modified New York criteria were enrolled in the Hacettepe University biological database (HUR-BIO). The 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guideline was used for the definition of CKD to evaluate the renal function of patients. Glomerular filtration rate (GFR) was calculated with the MDRD (modified Modification of Diet in Renal Disease) formula, taking into account the creatinine value, age and gender parameters of the patients [2]. CKD was detected in 39 (1,2%) patients. Age-sex matched 41 non-CKD AS patients were selected as the control group. Demographic and clinical characteristics and mortality rates of AS patients with and without CKD were compared.ResultsOf 39 AS-CKD patients, 25 (64.1%) had CKD before the initation of bDMARD and and 14 (35.8%) developed CKD during follow-up after treatment was started. Patients with AS-CKD had longer duration of symptoms and disease (Table 1). Comorbidities such as hypertension, coronary artery disease and amyloidosis were more prevalent in patients with AS-CKD. At a median follow-up of 2.48(0.1-20.1) years, mortality was observed in 11(28.2%) patients in the AS-CKD group, while no mortality was observed in the age-sex matched AS-nonCKD group (p<0.001, Figure 1). The mortality rate in patients with AS-CKD was 12.6 per 1000 patient-years, and 4 (10.2%) of deaths were during the COVID-19 pandemia.Figure 1.Table 1.AS-CKD group (n=39)AS-nonCKD group (n=41)PTotal AS patients, (n=3207)Age, mean(SD), years68.2 (12.0)58.8(12.6)-47.9±(11.2)Male, n(%)27 (69.2)27(65.9)-1716(53.5)53.1)Symptom duration, years median (min-max)20 (5-42)11(2-30)0.0110(1-44)Disease duration, years median (min-max)14,5(5-42)7(1-29)0.046(1-37)HLA-B27 positivity, n(%)13(33.3)12(29.2)0.5826/2014(41.0)Uveitis, n(%)6/354/360.2339/2946(11.5)Inflammatory bowel disease, n(%)4/353/360.4135/2946(4.58)Smoking, ever, n(%)22/34 (64.7)20/36(55.5)0.31781/2942(60.5)BMI (kg/m2), mean(SD)28 (6.08)28.2(5.01)0.828.1(5.5)Amiloidosis, n(%)14/36(38.9)1(2.4)<0.00133/2949(1.11)Comotbidities n(%)• Diabetes Mellitus,7/34(20.6)4/36(11.1)0.2199/2949(6.7)• Hypertension27/34(79.4)9/36(25)<0.001442/2949(14.9)• CAD8/21(38.1)1/25(4)0.005110/1882(5.8)• COPD5/21(23.8)0/240.004117/1774(6.59)CRP, med(min-max)1.6(0.4-12.4)1.77(0.1-23.6)0.81.07(0.1-45)• at the initiation of bDMARDs, at the last visit,0.7(0.16-14)0.55(0.1-7.5)0.30.5(0.1-14)ESR, med(min-max)• at the initiation of bDMARDs,48(12-140)30(2-96)0.119(1-140)• at the last visit, med(min-max)25(3-93)15(2-70)0.113(1-110)BASDAI, mean (SD)• At the initiation of bDMARDs4.5(±2.1) 5.46(±2.07) 0.5 5.7(±2.04) • At the last vizit3.94(±2.35)2.95(±2.33)0.093.69(±2.5)CAD: Coronary artery disease, COPD: Chronic Obstructive pulmonary disease, BMI: Body mass index, BASDAI: Bath AS Disease Activity IndexConclusionBoth comorbid disease burden and mortality seem to be increased in patients with AS-CKD. Increased mortality was more pronounced during the COVID-19 pandemia.References[1]Coşkun, B.N., et al., Anti-TNF treatment in ankylosing spondylitis patients with chronic kidney disease: Is it effective and safe? Eur J Rheumatol, 2022. 9(2): p. 68-74.[2]Stevens, P.E. and A. Levin, Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med, 2013. 158(11): p. 825-30.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

ADHERENCE TO BIOLOGIC THERAPIES IN INFLAMMATORY RHEUMATIC DISEASES: INFLUENCE OF ROUTE OF ADMINISTRATION

BackgroundInflammatory rheumatic diseases are a debilitating disease affecting the joints and periarticular structures and leading, more or less rapidly, to cartilage and bone destruction. It is a major source of chronic pain and physical, psychological, and social disability, it affect approximately 1% of the world's population [1]. For more than 20 years, biotherapies have revolutionized the treatment of these inflammatory diseases and have largely contributed to the improvement of their prognosis [2]. Adherence to biologic therapies conditions the effectiveness of the treatments then the improvement of patients' quality of life [3].ObjectivesTo evaluate and compare adherence to biologic disease-modifying antirheumatic drugs (bDMARDs) according to the route of administration and the molecule used (Infliximab, Tocilizumab, Etanercept, Adalimumab, Certolizumab, and Golimumab) in patients with inflammatory rheumatic diseases.MethodsThis is a descriptive cross-sectional study with repeated data collection, bi-centric carried out in the rheumatology departments and outpatient clinics at Charles Nicolle Hospital and Rabta Hospital in Tunis and conducted over a period of 01 year and 02 months between 02/02/2021 and 30/04/2022. 71 adult patients with rheumatoid arthritis, spondyloarthritis or juvenile idiopathic arthritis were recruited, their adherence rate in the last 3 months before inclusion should be ≥80%. The collection of socio-demographic, clinical and therapeutic data was established with the help of a pre-established form, from medical files completed by questioning the patients during a direct interview or through a telephone communication. Adherence rate was calculated by determining the ratio of treatments cures (number of biologic injections taken during a year divided by the number of annual biologic injections prescribed).ResultsWithin the study population, adherence was estimated at 85.9%;in the group of patients using intravenous biotherapy was 82.1% (Infliximab 86%, Tocilizumab 75% p=0.04) and in the group of patients using subcutaneous treatment was 89.9% (Golimumab 94%, Etanercept 92%, Certolizumab 89%, Adalimumab 87% p=0.3). Adherence to biologic therapy was significantly higher in the subcutaneous group than in the intravenous group (p=0.01). The causes of poor adherence presented by the patients in this study were: stock-outs of biological treatment and delay in renewal by the national health insurance (CNAM) in thirty-eight cases (54%p<0.001), intercurrent infections in thirty-three cases (46% p=0.005) and the COVID 19 pandemic and its consequences in thirty patients (42%,p=0.28).ConclusionAdherence to biologic treatment is influenced by the route of administration, drugs type, intercurrent infections and drugs availability. All this factors must be treated to improve therapeutic adherence then the efficiency of the biologic therapy which conditions the preservation of physical capacities and an improvement in the quality of life.References[1]Adhésion médicamenteuse et représentations des patients atteints de rhumatisme inflammatoire chronique sous biothérapie: étude ADREP'RI.: 84. Betegnie AL.[2]2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. Singh JA, Saag KG, Bridges SL, Akl EA et al. janv 2016;68(1):1‑26.[3]Adherence to biologic DMARD therapies in rheumatoid arthritis. Expert Opin Biol Ther. Koncz T, Pentek M, Brodszky V, Ersek K, Orlewska E, Gulacsi L. sept 2010;10(9):1367‑78.[4]Adherence of rheumatoid arthritis patients to biologic disease-modifying antirheumatic drugs: a cross-sectional study. Mena-Vazquez N, Manrique-Arija S, Yunquera-Romero L, Ureña-Garnica I, Rojas-Gimenez et al.. Rheumatol Int [Internet]. oct 2017 [cité 30 oct 2022];37(10):1709‑18.[5]Adherence to Anti-Tumor Necrosis Factor Therapy Administered Subcutaneously and Associated Factors in Patients with Rheumatoid Arthritis. Salaffi F, Carotti M, Di Carlo M, Farah S, Gutierrez M. J Clin Rheumatol. déc 2015;21(8):419‑25.Acknowledgements:N L.Disclosure of InterestsNone Declared.

ASYNCHRONOUS TELECONSULTATION BY WHATSAPP CHATBOT IN CONTROLLED AXIAL SPONDYLOARTHRITIS (SPA) PATIENTS UNDER BIOLOGICAL THERAPY: CLINICAL RESULTS OF A SINGLE CENTER

BackgroundThe use of telehealth in the control of rheumatic diseases had been scarce, but COVID pandemic forced to try alternatives to classic face-to-face consultation, and an overflow of telehealth consultations appeared, mainly synchronous (phone, video calls), and finally asynchronous. We try to demonstrate that asynchronous WhatsApp teleconsultation is a good alternative, at least for followup of patients that find it difficult to attend face-to-face visits. We chose axial spondyloarthritis (AxSPA) patients under biological therapy with controlled disease and we proposed teleconsultation with a WhatsApp platform chatbot created for this purpose. The chatbot sends PROMS (BASDAI, VAS for patient global disease assessment, ASDAs, and 3 questions for extraarticular disease), and receive feedback and schedule for the following visits.ObjectivesTo prove that teleconsultation through WhatsApp platform is not inferior to face-to-face consultation in terms of maintaining axial SPA patients disease controlled.MethodsProspective study with retrospective control of patients diagnosed of Axial SPA, fulfilling ASAS criteria and with stable disease under biological therapy for the previous year, recruited from 01 jan to 30 nov 2021. We recruited 62 patients, but two of them gave up (personal reasons, one moved to other region), so we finally include 60 patients. We offer them two teleconsultation visits with their personal mobile device, every four months, and a face-to-face final visit one year after inclusion. In the case of lab test or PROMs deviation or when the patient asks for contact (possible via WhatsApp) he/she is called up by the person in charge (nurse/doctor) that solves the question and arranges an additional presential visit if needed. We consider disease controlled if BASDAI <4, ASDAS < 2,1 or if in rheumatologist´s opinion there is no need to change treatment. We collect patient and disease information (age, gender, employment, characteristics of the disease, previous and actual treatment), activity (BASDAI, PCR, ASDAS), physical function (BASFI), and Quality of life (AsQol).Results60 patients (50 men, 83,3%) were included, mean aged 48,22 years (SD 12,128), 36% were under 45 years at the time of inclusion. They were mostly Ankylosing Spondylitis (AS) (90%;only 6 non radiographic SPA), positive HLA B27 (85%) and with longstanding disease (mean 23 years, SD 12,8), and only 6 patients less than five years. 25% had peripheral impairment (arthritis/dactylitis/enthesitis), and more than 40% presented extraarticular manifestations, mainly psoriasis (26,7%) and uveitis (21%)71,7% were under their first biological (TNF inhibitor, mostly adalimumab), 23,3% were refractory to the first, and 3 patients to at least two biologicals. 51,7% of patients were treated with tapered dose of TNF inhibitors. At inclusion 93,3 % presented remission/LDA by ASDAS/BASDAI-RCP. Only 4 patients included presented higher activity scores but were considered clinically controlled.Table 1.We did not find meaningful clinical differences between basal to final visits in BASDAI, BASFI, ASDAS-RCP or AsQOL.3 patients with reduced dose of biological drug needed to increase to standard dose with no other need to treatment adjustment.ConclusionWe consider asynchronous teleconsultation is promising, and not inferior to face to face consultation in terms of keeping disease control and quality of life, especially for follow-up in patients with stable rheumatic disease, The clinical results presented here are consistent with this considerations.AcknowledgementsGrupo INNOBIDE.Disclosure of InterestsNone Declared.

PERSISTENCE OF SYMPTOMS AFTER SARS-CoV-2 INFECTION IN PATIENTS WITH INFLAMMATORY ARTHRITIS: A RETROSPECTIVE STUDY

BackgroundThe World Health Organization defined long-COVID or post-COVID-19 condition as "the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation” [1]. Data on long-COVID in patients with inflammatory arthritis are very limited. The prevalence of this condition is 45% in the general population affected by COVID-19 who still experience symptoms after 4 months from the infection [2].ObjectivesTo investigate the persistence of symptoms after SARS-CoV-2 infection in a cohort of patients with inflammatory arthritis and the most common clinical manifestations.MethodsWe enrolled adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) classified according to standard criteria that received a diagnosis of COVID-19 through molecular, rapid or quantitative antigen swab tests between September 2020 and September 2022. Demographic and clinical data including age, body mass index (BMI), smoking habit, comorbidities, rheumatic treatment at diagnosis of COVID-19, date of COVID-19 diagnosis and clinical manifestations were collected through a questionnaire and recorded in a database.ResultsThirty-eight (40%) patients with RA, 49 (51.6%) with PsA, and 8 (8.4%) with AS [total: 95 patients;F:M=65:30, median age 56 years (IQR 15), median BMI 25.54 kg/m2 (IQR 5.58), active smokers 21 (22.1%), median rheumatic disease duration 96 months (IQR 120), median COVID-19 duration 13 days (IQR 7)] were recruited. Eighteen (19%) were only treated with csDMARDs, 38 (40%) only with bDMARDs, 29 (30.5%) with csDMARDs and bDMARDs, 8 (8.4%) were not taking any treatment and 2 (1%) were only taking glucocorticoids.Six (6.3%) patients were hospitalized (either in Day Hospital facilities for monoclonal antibodies infusion or in the emergency room). Twenty-six (27.3%) and 7 (7.3%) patients reported pre-existing cardiovascular or respiratory comorbidities, respectively. Ninety patients (94.7%) had a symptomatic SARS-CoV-2 infection. Seventy-five (79%) patients reported the persistence of symptoms after the end of the infection (negative swab), while 20 (21%) patients reported no symptoms. Among the former, 38 (50.7%) patients were symptomatic for ≤3 months and 37 (49.3%) were symptomatic for >3 months. In the hospitalized subgroup, 6 (100%) patients reported the persistence of COVID-19 symptoms, while this was reported by 69 (77.5%) patients in the non-hospitalized subgroup (p=ns).The clinical manifestations and their persistence after the infection are reported inFigure 1. The most common were cough and fatigue, which both lasted ≤3 months in 38 (42.2%) patients and >3 months in 3 (3.33%) and 21 (23.3%) patients, respectively. Headache (32 patients - 35.5%), arthralgias (28 patients - 31.1%), myalgias (27 patients - 30%) and shortness of breath (25 patients - 27.7%) were the most common symptoms that persisted in the first 3 months after the infection. Symptoms that persisted for >3 months in more than 20% of the patients were arthralgias (24 patients - 26.6%) and sleep disturbances (19 patients - 21.1%). However, it is difficult to assess whether arthralgias and myalgias were consequences of COVID-19 or secondary to the rheumatic disease. No COVID-19-related deaths were recorded.ConclusionOur data show the persistence of symptoms of COVID-19 after recovery in 79% of patients with chronic inflammatory arthritis. 49.3% of patients were symptomatic for >3 months. Cough, fatigue, headache, arthralgias, myalgias and shortness of breath were the most represented symptoms in the first 3 months after the infection, while arthralgias, fatigue, and sleep disturbances were the most reported after 3 months from SARS-CoV-2 infection.References[1]https://www.who.int/europe/news-room/fact-sheets/item/post-covid-19-condition updated: 7 Dec 2022[2]O'Mahoney LL et al. Lancet 2022Figure 1.Persistence of symptoms and signs after the end of SARS-CoV-2 infection.Data are represented as percentagesAcknowl dgements:NIL.Disclosure of InterestsNone Declared.

PATIENTS WITH AXIAL SPONDYLOARTHRITIS HAVE BETTER SARS-CoV-2 OUTCOMES COMPARED WITH PATIENTS WITH RHEUMATOID ARTHRITIS: DATA FROM THE NATIONAL SAR-COVID REGISTRY

BackgroundPatients with rheumatic diseases may present more severe SARS-CoV-2 infection compared to the general population. However, in some studies, hospitalization and mortality due COVID-19 were lower in patients with axial spondyloarthritis (axSpA) compared to other rheumatic diseases.ObjectivesTo assess the severity of SARS-CoV-2 infection in patients with axSpA from the SAR-COVID registry, comparing them with patients with rheumatoid arthritis (RA), and to determine the factors associated with poor outcomes and death.MethodsPatients ≥18 years old from the SAR-COVID national registry with diagnosis of AxSpA (ASAS criteria 2009) and RA (ACR/EULAR criteria 2010) who had confirmed SARS-CoV-2 infection (RT-PCR or positive serology), recruited from August 2020 to June 2022 were included. Sociodemographic and clinical data, comorbidities, treatments and outcomes of the infection were collected. Infection severity was assessed using the WHO-ordinal scale (WHO-OS)[1]: ambulatory [1], mild hospitalizations (2.3 y 4), severe hospitalizations (5.6 y 7) and death [8].Statistical analysisDescriptive statistics. Chi[2] or Fischer test and Student T or Mann-Whitney as appropriate. Poisson generalized linear model.ResultsA total of 1226 patients were included, 59 (4.8%) with axSpA and 1167 (95.2%) with RA. RA patients were significantly older, more frequently female, and had a longer disease duration. More than a third of the patients were in remission. 43.9 % presented comorbidities, arterial hypertension being the most frequent. At the time of SARS-Cov-2 diagnosis, patients with RA used glucocorticoids and conventional DMARDs more frequently than those with axSpA, while 74.6% of the latter were under treatment with biological DMARDs being anti-TNF the most used (61%).94.9 % of the patients in both groups reported symptoms related to SARS-CoV-2 infection. Although the differences were not significant, patients with RA presented more frequently cough, dyspnea, and gastrointestinal symptoms, while those with axSpA reported more frequently odynophagia, anosmia, and dysgeusia. During the SARS-CoV-2 infection, 6.8% and 23.5% of the patients with axSpA and RA were hospitalized, respectively. All of the patients with axSpA were admitted to the general ward, while 26.6% of those with RA to intensive care units. No patient with axSpA had complications or severe COVID-19 (WHO-OS>=5) or died as a result of the infection while mortality in the RA group was 3.3% (Figure 1).In the multivariate analysis adjusted to poor prognosis factors, no association was found between the diagnosis of axSpA and severity of SARS-CoV-2 infection assessed with the WHO-OS (OR -0.18, IC 95%(-0.38, 0.01, p=0.074).ConclusionPatients with EspAax did not present complications from SARS-CoV-2 infections and none of them died due COVID-19.Reference[1]World Health Organization coronavirus disease (COVID-19) Therapeutic Trial Synopsis Draft 2020.Figure 1.Outcomes and severity of SARS-CoV-2 infection in patients with axSpA and RA.[Figure omitted. See PDF]Acknowledgements:NIL.Disclosure of InterestsAndrea Bravo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Tatiana Barbich Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Carolina Isnardi Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretati n, or writing the report. They do not have access to the information collected in the database., Gustavo Citera Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Emilce Edith Schneeberger Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Rosana Quintana Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Cecilia Pisoni Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Mariana Pera Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Edson Velozo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Dora Aida Pereira Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Paula Alba Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Juan A Albiero Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Jaime Villafañe Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Hernan Maldonado Ficco Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Veronica Sa io Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Santiago Eduardo Aguero Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Romina Rojas Tessel Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Maria Isabel Quaglia Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., María Soledad Gálvez Elkin Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access tothe information collected in the database., Gisela Paola Pendon Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Carolina Aeschlimann Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Gustavo Fabian Rodriguez Gil Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Malena Viola Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Cecilia Romeo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Carla Maldini Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Silvana Mariela Conti Grant/research support from: SAR-COVID is a multi-sponsor re istry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Rosana Gallo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Leticia Ibañez Zurlo Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Maria Natalia Tamborenea Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Susana Isabel Pineda Vidal Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Debora Guaglianone Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Jonatan Marcos Mareco Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Cecilia Goizueta Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Elisa Novatti Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Fernanda Guzzanti Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Gimena Gómez Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Karen Roberts Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of t em participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database., Guillermo Pons-Estel Grant/research support from: SAR-COVID is a multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or influenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database.

EFFECT OF UPADACITINIB ON REDUCING PAIN IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO BIOLOGIC THERAPY

BackgroundPain is a debilitating symptom of ankylosing spondylitis (AS) that negatively affects patients' lives. Upadacitinib (UPA), a Janus kinase inhibitor approved for the treatment of AS and other inflammatory diseases, showed significant efficacy vs placebo (PBO) in the phase 2/3 SELECT-AXIS 1 study in patients with AS who were biologic-naive and in the phase 3 SELECT-AXIS 2 study in patients with active AS who had an inadequate response (IR) to biological therapy [1,2]. Improvement in pain outcomes with UPA was also previously demonstrated in the SELECT-AXIS 1 study [3].ObjectivesThe objective of this post-hoc analysis of SELECT-AXIS 2 was to evaluate the efficacy of UPA vs PBO on multiple pain assessments through 14 weeks in patients with IR to a biologic disease-modifying antirheumatic drug (bDMARD-IR).MethodsSELECT-AXIS 2 (NCT04169373) enrolled adults with active AS with IR to biological therapy, including patients who discontinued biologics due to lack of efficacy or intolerance [1]. Patients were randomized 1:1 to UPA 15 mg once daily (QD) or PBO for 14 weeks. Pain endpoints evaluated here included the proportion of patients achieving ≥30%, ≥50%, and ≥70% reduction from baseline, minimal clinically important difference (MCID, defined as ≥1 point reduction or ≥15% reduction from baseline), and much better improvement (MBI, defined as ≥2 point reduction and ≥33% reduction from baseline) in Patient's Global Assessment (PGA) of pain, total back pain, and nocturnal back pain on a 0–10 numeric rating scale [3,4]. Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 was used.ResultsA total of 211 patients received UPA 15 mg QD and 209 patients received PBO. Higher proportions of patients receiving UPA vs PBO achieved ≥30% and ≥50% reductions in PGA of pain, total back pain, and nocturnal back pain as early as week 2 that were sustained at all time points through 14 weeks (nominal P<0.05;Figure 1a-c). Achievement of ≥70% reductions in PGA of pain and nocturnal back pain were higher at week 4 and sustained thereafter (Figures 1a and 1c), and achievement of ≥70% reduction in total back pain was higher at week 2 and week 8, but not week 4, and sustained thereafter (Figure 1b). Results were similar for the proportion of patients achieving MCID and MBI, with improvements in PGA of pain, total back pain, and nocturnal back pain for UPA vs PBO as early as week 1 (MCID) or week 2 (MBI) that were sustained through week 14 (all nominal P<0.001;Table 1).Table 1.Achievement of MCID and MBI in Pain Outcomes at Week 14 (NRI-MI)Responder Rate (95% CI), %Pain OutcomesUPA 15 mgPBONominal P ValuePGA of painMCID81.0 (75.8–86.3)62.7 (56.1–69.2)<0.0001MBI60.7 (54.1–67.3)24.9 (19.0–30.7)<0.0001Total back painMCID80.1 (74.7–85.5)65.1 (58.6–71.5)0.0005MBI58.3 (51.6–64.9)25.4 (19.5–31.3)<0.0001Nocturnal back painMCID82.9 (77.9–88.0)61.3 (54.7–67.9)<0.0001MBI61.6 (55.0–68.2)32.1 (25.7–38.4)<0.0001MBI, much better improvement;MCID, minimal clinically important difference;NRI-MI, non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19;PBO, placebo;PGA, Patient's Global Assessment;UPA, upadacitinib.ConclusionIn patients with active AS who were bDMARD-IR, greater proportions of patients treated with UPA achieved rapid and clinically meaningful reductions in pain vs PBO as early as week 2 that were sustained through 14 weeks across multiple pain assessments.References[1]van der Heijde D, et al. Ann Rheum Dis. 2022;81(11):1515-1523.[2]van der Heijde D, et al. Lancet. 2019;394(10214):2108-2117.[3]McInnes IB, et al. RMD Open. 2022;8(1):doi:10.1136/rmdopen-2021-002049.[4]Salaffi F, et al. Eur J Pain. 2004;8(4):283-291.AcknowledgementsAbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this p blication. No honoraria or payments were made for authorship. Medical writing support was provided by M. Hovenden and J. Matsuura of ICON plc (Blue Bell, PA, USA) and was funded by AbbVie.Disclosure of InterestsXenofon Baraliakos Consultant of: Novartis, Pfizer, AbbVie, Eli Lilly, UCB Pharma, Galapagos, Janssen, Celgene, and Amgen, Grant/research support from: Novartis, Pfizer, AbbVie, Eli Lilly, UCB Pharma, Galapagos, Janssen, Celgene, and Amgen, Marina Magrey Consultant of: UCB, Novartis, Eli Lilly, Pfizer, and Janssen, Grant/research support from: Amgen, AbbVie, BMS, and UCB Pharma, Louis Bessette Speakers bureau: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Organon, and Sanofi, Grant/research support from: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Sanofi, and Gilead, Kurt de Vlam Speakers bureau: Amgen, Celgene, Eli Lilly, Galapagos, Novartis, and UCB, Consultant of: Amgen, AbbVie, Celgene, Eli Lilly, Galapagos, Novartis, and UCB, Grant/research support from: Amgen, UCB, and MSD, Tianming Gao Shareholder of: AbbVie, Employee of: AbbVie, Anna Shmagel Shareholder of: AbbVie, Employee of: AbbVie, Ralph Lippe Shareholder of: AbbVie, Employee of: AbbVie, Ana Biljan Shareholder of: AbbVie, Employee of: AbbVie, Victoria Jasion Shareholder of: AbbVie, Employee of: AbbVie, Peter C. Taylor Speakers bureau: AbbVie, Consultant of: Lilly, AbbVie, Pfizer, Galapagos, Gilead, Janssen, GlaxoSmithKline, Sanofi, Fresenius, Nordic Pharma, UCB, and Biogen, Grant/research support from: Galapagos.

BIMEKIZUMAB MAINTAINED IMPROVEMENTS IN EFFICACY ENDPOINTS AND HAD A CONSISTENT SAFETY PROFILE THROUGH 52 WEEKS IN PATIENTS WITH NON-RADIOGRAPHIC AND RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS: RESULTS FROM TWO PARALLEL PHASE 3 STUDIES

BackgroundBimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, met all primary/secondary endpoints at Week (Wk) 16 in patients (pts) with active non-radiographic axial spondyloarthritis (nr-axSpA) and radiographic axSpA (r-axSpA;i.e., ankylosing spondylitis), in the parallel phase 3 BE MOBILE 1 and 2 studies, respectively.[1,2]ObjectivesTo assess efficacy and safety of BKZ in these pts up to Wk 52.MethodsBE MOBILE 1 (NCT03928704) and 2 (NCT03928743) both involved a 16-wk placebo (PBO)-controlled and 36-wk maintenance period.[1,2] Pts were randomised to subcutaneous BKZ 160 mg Q4W (BKZ) or to PBO then BKZ from Wk 16 (PBO/BKZ).Results220/254 (86.6%) randomised pts with nr-axSpA and 298/332 (89.8%) with r-axSpA completed Wk 52. Efficacy was sustained to Wk 52 in both studies (Table 1). ASAS40 responses in BKZ-randomised pts increased from Wk 16 (nr-axSpA: 47.7%;r-axSpA: 44.8%;non-responder imputation [NRI]) to Wk 52 (60.9%;58.4%;NRI) with high levels of efficacy across TNFi-naïve and TNFi-IR populations (Table 1). At Wk 52, ASDAS <2.1 was achieved by 61.6% and 57.1%, and ASDAS <1.3 by 25.2% and 23.4%, of BKZ-randomised pts with nr-axSpA and r-axSpA, respectively (Figure 1). Wk 16 reductions from baseline in objective signs of inflammation (MRI, hs-CRP), and improvements in function (BASFI) and ASQoL, were maintained through 52 wks. Efficacy at Wk 52 was similar in PBO/BKZ-treated and BKZ-randomised pts (Table 1).At Wk 52, 75.0% (183/244) of pts with nr-axSpA and 75.5% (249/330) of pts with r-axSpA had ≥1 treatment-emergent adverse event (TEAE) on BKZ;the most frequent (% pts) TEAEs by preferred term (MedDRA v19.0) were nasopharyngitis (nr-axSpa: 12.3%;r-axSpA 9.1%) and upper respiratory tract infection (9.4%;6.4%);few COVID-19 infections were reported (7.0%;2.1%). Incidence (pts/100 pt years) of serious TEAEs were low (4.4;7.1);no major adverse cardiovascular events, active tuberculosis cases, serious COVID-19 infections, or deaths were reported. Most incidences of fungal infection (19.6;14.9;none serious or systemic) were Candida (12.8;8.3) and mild to moderate;two pts in both studies discontinued the study due to Candida infections. Incidence of IBD (1.0;1.0) and uveitis (1.5;2.4) were low.ConclusionAcross the axSpA spectrum, BKZ resulted in sustained efficacy to Wk 52. No new safety signals were observed, consistent with the Wk 24 safety profile.[1,2]References[1]Deodhar A. Ann Rheum Dis 2022;81:772–3;2.[2]van der Heijde D. Ann Rheum Dis 2022;81:12–3.Table 1.Efficacy at Wk 52Mean (SE), unless statedBE MOBILE 1BE MOBILE 2PBO→BKZ N=126BKZ N=128PBO→BKZ N=111BKZ N=221ASAS40 [NRI] n (%)64 (50.8)78 (60.9)76 (68.5)129 (58.4)ASAS40 in TNFi-naïve [NRI] n (%)58 (53.2)a73 (61.9)b67 (71.3)c108 (58.7)dASAS40 in TNFi-IRe [NRI] n (%)6 (35.3)f5 (50.0)g9 (52.9)f21 (56.8)hASAS20 [NRI] n (%)88 (69.8)94 (73.4)89 (80.2)158 (71.5)ASAS PR [NRI] n (%)38 (30.2)38 (29.7)41 (36.9)66 (29.9)ASAS 5/6 [NRI] n (%)65 (51.6)71 (55.5)74 (66.7)124 (56.1)BASDAI CfB [MI]–3.5 (0.2)–3.9 (0.2)–4.0 (0.2)–3.6 (0.1)BASFI CfB [MI]–2.6 (0.2)–3.0 (0.2)–2.8 (0.2)–2.8 (0.1)ASDAS-MI [NRI] n (%)37 (29.4)47 (36.7)49 (44.1)71 (32.1)Nocturnal spinal pain CfB [MI]–4.1 (0.2)–4.3 (0.3)–4.6 (0.3)–4.1 (0.2)ASQoL CfB [MI]–5.3 (0.4)–5.9 (0.4)–5.6 (0.4)–5.7 (0.3)SF-36 PCS CfB [MI]11.4 (0.9)12.2 (0.9)12.3 (0.9)12.0 (0.6)BASMI CfB [MI]–0.4 (0.1)–0.6 (0.1)–0.7 (0.1)–0.7 (0.1)Total resolution of enthesitisi [NRI] n (%)41 (44.6)j51 (54.3)c31 (46.3)k67 (50.8)lASDAS-CRP CfB [MI]–1.6 (0.1)–1.8 (0.1)–1.9 (0.1)–1.7 (0.1)SPARCC MRI SIJ score CfB [OC]mMean (SD)–6.4 (10.7)n–7.6 (10.5)o–2.8 (6.1)p–4.7 (8.2)qBerlin MRI spine score CfB [OC]mMean (SD)–0.4 (2.0)k–0.7 (2.5)r–2.1 (3.4)p–2.4 (3.9)shs-CRP, mg/L [MI] Median2.21.72.02.3RS. n: a109, b118, c94, d184;eMax 1 TNFi;n: f17, g10, h37;iMASES=0 in pts with MASES >0 at BL;n: j92, k67;l132;mMRI sub-study;n: n70, o82, p48, q90, r79, s89.AcknowledgementsThis study was funded by UCB Ph rma. Medical writing support was provided by Costello Medical, funded by UCB Pharma.Disclosure of InterestsXenofon Baraliakos Speakers bureau: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer and UCB Pharma, Paid instructor for: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer and UCB Pharma, Atul Deodhar Speakers bureau: Janssen, Novartis and Pfizer, Consultant of: AbbVie, Amgen, Aurinia, BMS, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, BMS, Celgene, Eli Lilly, MoonLake, Novartis, Pfizer and UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, GSK, Janssen, Eli Lilly, Novartis, Pfizer and UCB Pharma, Employee of: Director of Imaging Rheumatology BV, Marina Magrey Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie and UCB Pharma, Walter P Maksymowych Consultant of: AbbVie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie and Pfizer;educational grants from AbbVie, Janssen, Novartis and Pfizer, Employee of: Chief Medical Officer for CARE ARTHRITIS, Tetsuya Tomita Speakers bureau: AbbVie, Astellas, BMS, Eisai, Eli Lilly, Janssen, Kyowa Kirin, Mitsubishi-Tanabe, Novartis and Pfizer, Consultant of: AbbVie, Eli Lilly, Gilead, Novartis and Pfizer, Huji Xu Speakers bureau: AbbVie, Janssen, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Beigene, BioMap, IASO, Pfizer and UCB Pharma, Employee of: Clinical investigator for Peking-Tsinghua Center for Life Sciences, Marga Oortgiesen Shareholder of: UCB Pharma, Employee of: UCB Pharma, Ute Massow Employee of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Alicia Ellis Employee of: UCB Pharma, Thomas Vaux Employee of: UCB Pharma, julie smith Employee of: UCB Pharma, Alexander Marten Employee of: UCB Pharma, Lianne S. Gensler Consultant of: AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer and UCB Pharma, Grant/research support from: Novartis and UCB Pharma paid to institution.

Magnetic resonance imaging/ultrasound fusion-guided sacroiliac joint corticosteroid injection in patients with axial spondyloarthritis.

Local glucocorticoid injections are used in the treatment of isolated sacroiliitis in patients with spondyloarthritis. Sacroiliac joint injections can be performed intraarticularly or periarticularly. Since the accuracy of blind injections is low, fluoroscopy, magnetic resonance imaging, computed tomography, or ultrasonography guidance are used to increase the accuracy of sacroiliac joint injections. Currently, imaging fusion software is successfully used in sacroiliac joint interventions with three-dimensional anatomic information added to ultrasonography. Herein, we present two cases of sacroiliac joint corticosteroid injections under ultrasonography-magnetic resonance imaging fusion guidance.

Trends for Opioid Prescriptions and the Impact of the Covid-19 Pandemic among Patients with Rheumatic and Musculoskeletal Diseases between 2006 and 2021

Background/Aims Rheumatic and musculoskeletal diseases (RMDs) are some of the most common indications for prescribed opioids. It is unclear how opioid prescribing has changed in the UK for RMDs, especially during the COVID-19 pandemic with limited healthcare access and cancelled elective-surgical interventions, which could impact prescribing in either direction. We aimed to investigate trends in opioid prescribing in RMDs and assess the impact of the pandemic in the UK. Methods Adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), systemic lupus erythematosus (SLE), osteoarthritis (OA) and fibromyalgia with opioid prescriptions between 01/Jan/2006-31/Aug/2021 without prior cancer in the UK Clinical Practice Research Datalink (CPRD) were included. We calculated ageand gender-standardised yearly rates of people with opioid prescriptions between 2006-2021, and identified change points in trends by checking whether the rate of change of standardised rates crossed zero. For people with opioid prescriptions, monthly measures of mean morphine milligram equivalents (MME)/day were calculated between 2006-2021. To assess the impact of the pandemic, we fitted regression models to the monthly number of people with opioid prescriptions between Jan/2015-Aug/2021. The time coefficient reflects the trend pre-pandemic and the interaction term coefficient represents the change in the trend during the pandemic. Results We included 1,313,519 patients: 36,932 with RA, 12,649 with PsA, 6,811 with AxSpA, 6,423 with SLE, 1,255,999 with OA, and 66,944 with fibromyalgia. People with opioid prescriptions increased from 2006 to 2018 for OA, to 2019 for RA, AxSpA and SLE, to 2020 for PsA, and to 2021 for fibromyalgia, and all plateaued/decreased afterwards. OA patients on opioids increased from 466.8/10,000 persons in 2006 to a peak of 703.0 in 2018, followed by a decline to 575.3 in 2021. From 2006 to 2021, there was a 4.5-fold increase in fibromyalgia opioid users (17.7 vs.78.5/10,000 persons). In this period, MME/day increased for all RMDs, with the highest for fibromyalgia (>=35). During COVID-19 lockdowns, RA, PsA and fibromyalgia showed significant changes in the trend of people with opioid prescriptions. With a decreasing trend for RA (-0.001,95%CI=-0.002,-0.001) and a decreasing-to-flat curve for PsA (0.0010,95%CI=0.0006,0.0015) prepandemic until Feb/2020, the trends changed by -0.005 (95%CI=-0.008,-0.002) for RA and -0.003 (95%CI=-0.006,-0.0003) for PsA, leading to steeper decreasing trends during the pandemic (Mar/2020-Aug/2021). Fibromyalgia, conversely, had an increasing trend (0.009,95%CI=0.008,0.009) pre-pandemic, and this trend started decreasing by -0.009 (95%CI=-0.011,-0.006) during the pandemic. Conclusion The plateauing/decreasing trend of people with opioid prescriptions in RMDs after 2018 may reflect the efforts to tackle the rising opioid prescribing in UK primary care. Of all RMDs, fibromyalgia patients had the highest MME/day throughout the study period. COVID-19 lockdowns contribute to fewer people on opioids for most RMDs, reassuring there was no sudden increase in opioid prescribing during the pandemic.

Patients with Axial Spondyloarthritis Have Better Sars-Cov-2 Outcomes Compared with Patients with Rheumatoid Arthritis: Data from the National Sar-Covid Registry

Objectives: To assess the severity of SARS-CoV-2 infection in patients with axSpA from the SAR-COVID registry, comparing them with patients with rheumatoid arthritis (RA), and to determine the factors associated with poor outcomes and death. Method(s): Patients >=18 years of age from the SAR-COVID national registry with diagnosis of axSpA (2009 ASAS criteria) and RA (2010 ACR/EULAR criteria) who had confirmed SARS-CoV-2 infection (RT-PCR or positive serology), recruited from August 2020 to June 2022 were included. Sociodemographic and clinical data, comorbidities, treatment and outcomes of the infection were collected. Infection severity was assessed using the WHO-ordinal scale (WHO-OS): ambulatory (1), mild hospitalizations (2.3 y 4), severe hospitalizations (5.6 y 7) and death (8). Result(s): A total of 1226 patients were included, 59 (4.8%) with axSpA and 1167 (95.2%) with RA. RA patients were significantly older, more frequently female, and had a longer disease duration. 43.9 % presented comorbidities. t the time of SARS-Cov-2 diagnosis, patients with RA used glucocorticoids and conventional DMARDs more frequently than those with axSpA, while 74.6% of the latter were under treatment with biological DMARDs being anti-TNF the most used (61%). 94.9 % of the patients in both groups reported symptoms related to SARS-CoV-2 infection. During the SARS-CoV-2 infection, 6.8% and 23.5% of the patients with axSpA and RA were hospitalized, respectively. All the patients with axSpA were admitted to the general ward, while 26.6%of those with RA were admitted to the intensive care units. No patient with axSpA had complications or severe COVID-19 (WHO-OS> = 5) or died as a result of the infection while mortality in the RA group was 3.3% (Figure 1). In the multivariate analysis adjusted for poor prognosis factors, no association was found between the diagnosis of axSpA and severity of SARS-CoV-2 infection assessed with the WHO-OS (OR-0.18, IC 95%(-0.38, 0.01, p = 0.074). Conclusion(s): Patients with axSpA did not present complications from SARSCoV-2 infections and none of them died due COVID-19.

Vaccination in Patients with Inflammatory Rheumatic Diseases: Preliminary Results of an International, Real-World Life Panlar's Register

Objectives: To evaluate vaccination among patients with inflammatory rheumatic diseases initiating disease-modifying antirheumatic drugs (DMARD) Methods: Data from the real-world life PANLAR's register of consecutive patients diagnosed with RA, PsA, and axSpa (2010 ACR-EULAR /2006 CASPAR-2009 ASAS) from Dec 2021 to Dec 2022 were analyzed. Prevalence of recommended vaccinations were compared between different inflammatory rheumatic diseases. Categorical variables were expressed as %. Tables were analyzed with chi2 or Fisher tests, continuous variables (median, IQR)with the Kruskal-Wallis test, according with the variables type. A p value <=0.05 was considered significant. Result(s): 608 patients were included. Among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial Spondyloarthritis (axSpA) are presented in the table. RA and axSpA seemed to have lower vaccination rate of pneumococcal vaccines than PsA. (p = 0.045 for conjugate anti pneumococcal vaccine in RA vs PsA). A large percentage of the population was vaccinated against COVID-19. There was a high rate of influenza vaccination in all three diseases. Conclusion(s): In Latin America, anti-pneumococcal vaccination is low, especially in patients with RA and axSpA. For other vaccines there was an acceptable level of vaccination without differences between diseases.

Incidence and Management of Inflammatory Arthritis in England before and during the Covid- 19 Pandemic: A Population-Level Cohort Study Using Opensafely

Background/Aims The impact of the pandemic on the incidence and management of inflammatory arthritis (IA) is not understood. Routinely-captured data in secure platforms, such as OpenSAFELY, offer unique opportunities to understand how IA was impacted upon by the pandemic. Our objective was to use OpenSAFELY to assess the effects of the pandemic on diagnostic incidence and care delivery for IA in England, and replicate key metrics from the National Early Inflammatory Arthritis Audit. Methods With the approval of NHS England, we used primary care and hospital data for 17 million adults registered with general practices using TPP health record software, to explore the following outcomes between 1 April 2019 and 31 March 2022: 1) incidence of IA diagnoses (rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, undifferentiated IA) recorded in primary care;2) time to first rheumatology assessment;3) time to first prescription of a conventional synthetic DMARD (csDMARD) in primary care, and choice of first csDMARD. Results From 17,683,500 adults (representing 40% of the English population), there were 31,280 incident IA diagnoses recorded between April 2019 and March 2022. New IA diagnoses decreased by 39.7% in the early months of the pandemic. Overall, a 20.3% decrease in IA diagnoses was seen in the year commencing April 2020, relative to the preceding year (5.1 vs. 6.4 diagnoses per 10,000 adults, respectively). Further decreases coincided with rising COVID-19 numbers, before returning to pre-pandemic levels by the end of the study period. No rebound increase in IA incidence was observed as of April 2022. The median time from referral to first rheumatology assessment was shorter during the pandemic (18 days;IQR 8-35 days) than before (21 days;9-41 days). The proportion of patients prescribed csDMARDs in primary care was comparable to before the pandemic;however, fewer people were prescribed methotrexate or leflunomide, and more were prescribed sulfasalazine or hydroxychloroquine. Conclusion IA diagnoses decreased markedly during the early phase of the pandemic;however, the impact on rheumatology assessment times and DMARD prescribing was less marked than might have been anticipated. This study demonstrates the feasibility of using routinelycaptured, near real-time data in the secure OpenSAFELY platform to benchmark care quality on a national scale, without the need for manual data collection.

A Systematic Review of New Rheumatic Immune-Mediated Inflammatory Diseases (R-Imid) Following Sars-Cov-2 Vaccinations

Background/Aims There are sporadic reports about the development of new rheumatic immune-mediated inflammatory diseases (R-IMIDs) in adults after receiving SARS-CoV-2 vaccines. This systematic review (SR) aimed to critically review and summarize the clinical profile, patient demographics, treatment, and prognosis of new-onset R-IMIDs following SARS-CoV-2 vaccination. Methods We retrieved English-language articles (Case reports and series and observational studies) on new-onset R-IMIDs following SARS-CoV-2 vaccination, published until June 2022, from standard databases (MEDLINE, Embase, Cochrane). The search strings used during the literature search incorporated 'SARS-CoV-2 vaccination' (along with related MeSH terms) and various key terms for R-IMIDs [which included (but was not limited to) inflammatory arthritis, connective tissue disease (CTD), vasculitis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis, systemic sclerosis, idiopathic inflammatory myositis, anti-synthetase syndrome, Adult-onset Stills disease (AOSD), giant cell arteritis (GCA), and polymyalgia rheumatica (PMR)]. The protocol was registered in PROSPERO (CRD42022318561). Results Of the total 2179 articles retrieved, 1986 articles were excluded following the title- screening, and 107 articles that did not meet inclusion criteria. We included the remaining 86 articles (130 cases) upon full-text screening. Furthermore, we added four articles (six cases) based on a manual search, comprising 90 articles (136 cases) for final analysis. These 136 new R-IMID cases were reported from 27 different countries. Of these, more than one-third of the cases were reported from three countries (viz., Italy, Japan, and the USA). The patients had a mean age of 57 (range:17-90) years, and the majority were females (63.0%). Most patients developed R-IMIDs after receiving Pfizer-BioNTech vaccine (76;55%), followed by Oxford AstraZeneca vaccine (35;25%). The mean duration between SARSCoV- 2 vaccination and R-IMIDs development was 9.2 (range:1-90) days. The second dose of the vaccine resulted in more R-IMIDs (74;54%) than the first (53;39%). CTDs (34;25%) and small vessel vasculitis (33;24%) were the commonest R-IMID manifestations, followed by inflammatory arthritis and AOSD, each in 13 (9.5%) cases. Nearly half of the patients with CTDs had Idiopathic Inflammatory Myositis. PMR and GCA accounted for 16 (11.7%) and 5 (3.6%) cases, respectively. However, no cases of axial spondylarthritis were reported. Most (118;86%) R-IMID patients were treated with corticosteroids, with a small number receiving steroid-sparing drugs, such as methotrexate, rituximab and cyclophosphamide. Most (125;91%) went into either disease remission or improvement following the treatment. Only three patients were admitted to the intensive care unit (ICU) to manage their disease;One of them died due to fatal myositis and rhabdomyolysis;two surviving ICU patients had ANCA-associated vasculitis with lung involvement. Conclusion Although rare, this SR highlights the emergence of de novo R-IMIDs following SARS-CoV-2 vaccination. We cannot confirm the causality between the vaccination and the onset of R-IMID. However, further research is warranted in this area.