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.

FACTORS ASSOCIATED WITH ADHERENCE TO ANTI TNF-Α THERAPY DURING THE COVID-19 PANDEMIC IN PATIENTS WITH RHEUMATOID ARTHRITIS

BackgroundRheumatoid Arthritis (RA) patients are effectively treated with anti-TNF-α therapy. However, pharmacological non-adherence limits the achievement of the therapeutic objective. This is a multifactorial behavior where factors such as the route of administration, frequency, tolerance, perception of improvement, polypharmacy and social factors are involved [1,2].ObjectivesTo explore the factors associated with non-adherence to anti TNF-α in RA patients during the COVID-19 pandemic.MethodsThis is a cohort of RA patients treated with anti TNF-α in Medicarte SAS, a Colombian center for Immune-Mediated Diseases, between January to December 2021. The program implements strategies such as pharmacotherapeutic support, informed dispensing, phone calls, text messages and home care services to increase adherence. Adherence was defined as dispensing at least 10/12 (>0.80) prescribed monthly doses for 1 year. Sociodemographic characteristics, time in the program, DAS28-CRP, HAQ and treatment were included as exposure variables. For continuous variables, median and interquartile range (IQR) were calculated. Adjusted Odds Ratio (AOR) with logistic regression were calculated, and a p-value <0.05 was considered as statistically significant.Results565 patients were included, 85.8% (n=485) were women, median age 56 years (IQR: 49-65), disease evolution time 13.7 years (IQR: 7.7-20.8), 51% (n=288) had been in the program for more than 3 years, the median time in treatment with anti TNF-α was 3 years (IQR: 1-3) and DAS-28-CRP 2.4 (IQR: 1.6-3.4). The most frequently anti TNF-α prescribed was etanercept 46.0% (n=260), followed by adalimumab 23% (n=130), subcutaneous golimumab 13.3% (n=75), certolizumab 11.0% (n=62) and intravenous golimumab 6.7% (n=38). At the admission, 18.2% (n=103) of the patients had high activity, 38.6% (n=218) mild activity, 9.2% (n=52) low activity and 34% (n=192) were in remission. At the end of follow-up, 6.4% (n=36) of patients had high activity, 18.2% (n=103) mild activity, 14.3% (n= 81) low activity and 61.1% (n= 345) were in remission. The 51.5% (n=291) did not have pharmacological adherence. The use of etanercept (AOR 0.36 CI95% 0.23- 0.58, p < 0.001) and adequate functionality measured through HAQ (AOR 0.64 CI95% 0.42- 0.97, p < 0.04) were associated with a lower risk of non-adherence. Higher DAS28-CRP at the end of follow up was associated with non-adherence (AOR 1.29 CI95% 1.12 - 1.48, p < 0.001).ConclusionDuring COVID-19 pandemic, the implementation of strategies in the home care patient program guaranteed adherence close to 50% in our cohort. Higher values of DAS28-CRP were associated with non-adherence, whilst etanercept use and a normal HAQ value were associated with a higher probability of adherence.References[1]Marengo MF, Suarez-Almazor ME. Improving treatment adherence in patients with rheumatoid arthritis: what are the options? Int J Clin Rheumtol. 2015 Oct 1;10(5):345-356.[2]Smolen JS, Gladman D, McNeil HP, Mease PJ, Sieper J, Hojnik M, et al. Predicting adherence to therapy in rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis: a large cross-sectional study. RMD Open. 2019 Jan 11;5(1):e000585.Acknowledgements:NIL.Disclosure of InterestsWilmer Gerardo Rojas Zuleta Speakers bureau: Pfizer, Jannsen Cilag, Bristol Myers Squibb, Amgen, Eli lilly, Mario Barbosa: None declared, Oscar Jair Felipe Díaz Speakers bureau: Pfizer, Jannsen Cilag, Bristol Myers Squibb, Amgen, Eli lilly, Adelis Enrique Pantoja Marquez: None declared, Jeixa Canizales: None declared, Carolina Becerra-Arias: None declared, Jorge Hernando Donado Gómez: None declared, Natalia Duque Zapata: None declared.

REFERRAL BEHAVIOUR OF PRIMARY CARE DOCTORS TO RHEUMATOLOGY CLINIC IN MALAYSIA

BackgroundThe workload at rheumatology clinics have been growing relentlessly and an audit on new.referrals helps to identify referral behaviour of primary care doctors and improvement can be done by providing further training.ObjectivesTo audit on new referral cases to rheumatology clinic from 2020-2022 and to identify new cases with misdiagnosis for future training purpose.MethodsThis was a retrospective study. The medical records of all new referral to rheumatology clinic Hospital Sultan Ismail and Hospital Pakar Sultanah Fatimah from 1st January 2020 to 31th November 2022 were reviewed. The referral diagnosis and final diagnosis were identified and analysed.ResultsThere were total of 927 new cases referral throughout the 35 months during Covid-19pandemic. Majority of them were diagnosed to have rheumatoid arthritis (217/927)followed by systemic lupus erythematosus (190/927), psoriatic arthritis (147/927),gout (62/927), osteoarthritis (58/927), systemic sclerosis (25/927), ankylosing spondylitis (25/927), soft tissue rheumatism (24/927), Sjogren syndrome (24/927),mixed connective tissue disease (14/927), vasculitis (11/927), fibromyalgia (10/927),polymyositis (7/927) and miscellaneous (39/927).45 out of the new cases were diagnosed as unlikely rheumatic diseases. There were 29pending cases awaiting final diagnosis.212 of the referrals were identified as misdiagnosis with the highest as nodal osteoarthritis.(55/212) followed by unlikely rheumatic disease (43/212), soft tissue rheumatism (24/212),psoriatic arthritis (20/212), Sjogren syndrome (14/212), gout (8/212), rheumatoid arthritis (7/212), fibromyalgia (6/212), systemic lupus erythematosus (5/212), ankylosing spondylitis (4/212), mixed connective tissue disease (3/212), systemic sclerosis (2/212), polymyositis (2/212) and others (19/212): diffuse idiopathic skeletal hyperostosis, hypermobility syndrome, RS3PE syndrome, idiopathic uveitis, graft versus host disease, juvenile idiopathic arthritis, antiphospholipid syndrome, hypothyroidism, post streptococcal arthritis, prolapsed intervertebral disc, cerebrovascular disease, traumatic sternoclavicular joint subluxation, ledderhose disease, paraspinal muscle spasm and viral myalgia).ConclusionNodal osteoarthritis and soft tissue rheumatism can be great mimicker for inflammatory.arthritis and if wrongly diagnosed will lead to unnecessary anxiety or wrong treatment. More training is needed to improve clinical skills amongst primary care doctors.ReferencesNA.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

CLINICAL COURSE IN COVID 19 DISEASE IN IMMUNOSUPRESSED PATIENTS DIAGNOSED WITH RHEUMATIC DISEASES

BackgroundPatients with pre-existing rheumatic diseases may be exacerbated during SARS-CoV-2 infection, or may develop new autoimmune features. Furthermore, immunosuppressive agents used to treat autoimmunity-inflammation as well as comorbidities can also affect the disease outcome.ObjectivesTo evaluate the outcome of rheumatic diseases after Covid 19 infection in patients diagnosed with rheumatic diseases, under various immunosuppressive treatment, as well as the effects of vaccines against Covid or antiviral treatment in this sensitive population group.MethodsDuring the pandemic, 1493 patients with autoimmune or autoinflammatory disease who were continuously followed up in two tertiaries hospitals in northern and northwestern Greece were included in the current study. The patients were compared with 769 controls after adjustment for age, sex, weight, vaccination status and comorbidities. Of the 1493 patients, 648 had rheumatoid arthritis, 282 psoriatic arthritis, 173 ankylosing spondylitis, 122 systemic lupus erythematosus, 98 Sjogren's syndrome, 43 polymyalgia rheumatica, 34 mixed connective tissue disease or overlapping syndromes, 31 vasculitis, 27 systemic sclerosis, 18 myositis, 10 Behcet syndrome, 5 primary antiphospholipid syndrome and 2 had Familial Mediterranean Fever. The vast majority of patients and controls were fully vaccinated (82%) and 397 patients received antiviral treatment, 94% of them were fully vaccinated.ResultsCovid 19 disease in vaccinated patients with rheumatic diseases was shown to perform the same or about the same as those in the control group after adjustment for risk factors for severe disease. 19 of our patients required admission in the intensive care unit (62% full vaccinated) while a total of 12 died (66% non vaccinated). Major risk factors for severe disease were previous respiratory failure, chronic renal impairment, obesity, and failure to receive antiviral therapy. It was also shown that infection with Covid led to an exacerbation or induction of autoimmune disorders in 25 of the participants.ConclusionIn this large cohort, Covid 19 disease was shown to affect patients with autoimmune rheumatic diseases the same or approximately the same way as the general population if they are fully vaccinated and if they start timely antiviral treatment where indicated. Further research and monitoring of the results after the multiple mutations of the virus is advisable.ReferencesNone.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

LONG-TERM EFFICACY AND SAFETY OF UPADACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS: 3-YEAR RESULTS FROM THE PHASE 3 SELECT-PsA 1 STUDY

BackgroundUpadacitinib (UPA) improved symptoms in patients (pts) with psoriatic arthritis (PsA) with prior inadequate response or intolerance to ≥1 non-biologic disease-modifying antirheumatic drug (nbDMARD-IR) through week (wk) 104 or 2 years of treatment in SELECT-PsA 1 [1].ObjectivesTo evaluate efficacy and safety of UPA vs adalimumab (ADA) through wk 152 or 3 years from the ongoing long-term open-label extension of SELECT-PsA 1.MethodsPts were randomized to receive UPA 15 mg (UPA15) or UPA 30 mg (UPA30) once daily, ADA 40 mg (ADA) every other wk, or placebo (PBO). At wk 24, PBO pts switched to UPA15 or UPA30. Following approval of UPA15, the protocol was amended so pts on UPA30 switched to UPA15 (earliest at wk 104). Efficacy was assessed through wk 152, and safety through June 13, 2022.ResultsOf 1704 pts randomized, 911 completed 152 wks of treatment. The proportions of pts achieving.≥20%/50%/70% improvement in American College of Rheumatology criteria (ACR20/50/70), minimal disease activity (MDA), and ≥75%/90%/100% improvement in Psoriasis Area and Severity Index at wk 152 were generally consistent with those at wk 1041. UPA had greater ACR20/50/70 and MDA responses vs ADA, and a greater mean change from baseline (BL) in Health Assessment Questionnaire-Disability Index, pt's assessment of pain, and Bath Ankylosing Spondylitis Disease Activity Index vs ADA. Change from BL in modified total Sharp/van der Heijde score were similar between UPA30 and ADA, and numerically higher with UPA15 (Table 1). The overall UPA safety profile remained unchanged (Figure 1) [1,2]. UPA had numerically higher rates of serious infection (SI), herpes zoster (HZ), anemia, lymphopenia, creatine phosphokinase (CPK) elevation, and non-melanoma skin cancer (NMSC) vs ADA. Increases for SI, HZ, anemia, and CPK elevation with UPA were dose dependent. Rates of major adverse cardiovascular events, venous thromboembolism, and malignancy excluding NMSC were low and generally similar across groups. The most common cause of death was COVID-19.ConclusionEfficacy of UPA in nbDMARD-IR pts with PsA was maintained through 3 years of treatment. No new safety signals were identified.References[1]McInnes IB, et al. Rheumatol Ther 2022;1–18 [Epub ahead of print].[2]McInnes IB, et al. RMD Open 2021;7(3):e001838.Table 1.Efficacy endpoints at wk 152UPA15 (n=429)UPA30a (n=423)ADA (n=429)Proportion of pts (%)NRIAONRIAONRIAOACR20/50/7064.6/52.0/35.9*89.8/71.6/ 48.263.1/54.1*/ 35.787.9/74.4/ 47.861.1/46.6/ 28.786.2/65.2/ 39.8Minimal disease activity37.555.143.5*60.335.950.2PASI75/90/100b50.5/42.5/32.269.2/58.5/ 43.458.1/46.7/3 7.678.6/63.5/ 50.954.0/40.8/ 30.379.6/59.9/ 44.6Resolution of enthesitis by Leeds Enthesitis Indexc50.475.248.973.846.077.0Resolution of dactylitis by Leeds Dactylitis Indexd65.495.266.197.965.497.1Change from BLeMMRMAOMMRMAOMMRMAOHealth Assessment Questionnaire- Disability Index-0.51-0.55-0.53*-0.58-0.45-0.49Pt's assessment of pain (numeric rating scale)-3.3*-3.5-3.3*-3.6-2.8-3.0Bath Ankylosing Spondylitis Disease Activity Indexf-3.09-3.27-3.16-3.54-2.81-2.71Modified total Sharp/van der Heijde score0.210.190.050.040.090.09aFollowing a protocol amendment, all pts on UPA30 switched to UPA15 (earliest switch at wk 104);data are presented by originally randomized group. bPts with psoriasis affecting ≥3% of body surface area at BL. cPts with LEI >0 at BL;resolution LEI=0. dPts with LDI >0 at BL;resolution LDI=0. eData shown as MMRM (least squares mean) and AO (mean). fPts with psoriatic spondylitis at BL. n value ranges: UPA15 (99–429), UPA30 (95–423), ADA (89–429). Nominal *p<0.05 UPA vs ADA.ACR20/50/70, ≥20%/50%/70% improvement in American College of Rheumatology criteria;ADA, adalimumab;AO, as observed;BL, baseline;MMRM, mixed effect model repeated measurement;NRI, non-responder imputation;PASI75/90/100, ≥75%/90%/100% improvement in Psoriasis Area and Severity Index;pt, patient;UPA15/30, upadacitinib 15/30 mg once daily;wk, weekAcknowledgementsAbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, and the review and approval of the publication. 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 Carl Davies, MSc, of 2 the Nth (Cheshire, UK), and was funded by AbbVie.Disclosure of InterestsIain McInnes Grant/research support from: AbbVie, AstraZeneca, Bristol Myers Squibb, Celgene, Eli Lilly, Evelo, Causeway Therapeutics, Gilead, Janssen, Novartis, Pfizer, Sanofi Regeneron, and UCB Pharma, Koji Kato Employee of: AbbVie and may hold stock or options, Marina Magrey Consultant of: BMS, Eli Lilly, Janssen, Novartis, Pfizer, and UCB Pharma, Grant/research support from: AbbVie, Amgen, BMS, and UCB Pharma, Joseph F. Merola Consultant of: AbbVie, Arena, Avotres, Biogen, Bristol Myers Squibb, Celgene, Dermavant, Eli Lilly, EMD Sorono, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB Pharma, Mitsumasa Kishimoto Consultant of: AbbVie, Amgen, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Celgene, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, and UCB Pharma, Derek Haaland Speakers bureau: AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Novartis, Pfizer, Roche, Sanofi Genzyme, Takeda, Grant/research support from: AbbVie, Adiga Life Sciences, Amgen, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, UCB;and has received honoraria or other fees from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi Genzyme, Takeda, and UCB Pharma, Yihan Li Employee of: AbbVie and may hold stock or options, Yanxi Liu Employee of: AbbVie and may hold stock or options, Jianzhong Liu Employee of: AbbVie and may hold stock or options, Ralph Lippe Employee of: AbbVie and may hold stock or options, Peter Wung Employee of: AbbVie and may hold stock or options.

COVID-19 WAS NOT TRIGGER FOR RHEUMATIC DISEASE ACTIVITY AFTER 6 MONTHS FOLLOW-UP: RESULTS FROM REUMACOV BRASIL REGISTER

BackgroundThe COVID-19 pandemic has brought uncertainties to rheumatology practice, mainly related to the possibility of triggering disease activity after infection in immune mediated rheumatic diseases (IMRD). To date, there are few data in the literature specifically evaluating this issue.ObjectivesEvaluate the disease activity in IMRD patients after 6 months of the infection, compared to pre infection status.MethodsReumaCoV Brasil is a longitudinal study performed at 35 study centers designed to follow-up IMRD patients for 6 months after clinical or laboratorial COVID-19 diagnosis (cases), comparing with patients with IMRD who had not had the infection at the time of inclusion (controls). Demographic data such as age, sex, comorbidities, clinical characteristics, treatment, evolution of COVID-19 and disease activity status were collected using a Research Eletronic Data Capture (REDCap) database on three consecutive visits (inclusion and 6 months). The analysis was carried out on the four diseases with the highest inclusion number in the study: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA). In addition to specific disease activity assessment metrics, we used patient's global assessment of disease activity (PGA), ranging from 0 to 10, at all visits, with 0 being no activity and 10 being intense activity. All conclusions were drawn considering the significance level of 5%. This study was registered at the Brazilian Registry of Clinical Trials—REBEC, RBR-33YTQC. All patients read and signed the informed consent form before inclusion.ResultsBetween May 2020 and January 2021, 2032 patients were included in the registry, and of these, 1322 patients (721 cases and 601 controls), completed 6 months of follow-up, being 550 SLE (42.0%), 497 RA (37.6%) and 176 SpA (13.3%) and 99 (7.4%) PsA. Most patients were female (82.0%);the median age was 46.7 (13.8). Disease activity at the time of enrollment, according to the PGA, was similar between cases and controls, except for patients with RA and AS, where it was higher in controls. After the follow up time, no worsening of activity was observed in any of the diseases evaluated in the case group (Table 1). Despite this, worsening of disease symptoms after COVID-19 was reported by 23.3%, 24.6%, 25.0% and 25.8% of patients with SLE, RA, AS and PsA respectively, not related with disease activity.ConclusionIn patients with IMRD, no worsening of disease activity was observed after COVID-19 in this cohort of Brazilian patients. Despite this, many patients noticed worsening of symptoms, possibly associated not with the triggering of the activity, but with the so-called long COVID syndrome.Table 1.Comparison of disease activity, according to PGA, comparing disease activity status at inclusion and after 6 months of follow up, in cases and controlsINCLUSIONAFTER 6 MONTHSCasesControlsp-valueCasesControlsp-valueSLE2 (0-4,5)2 (0-4)0,8102 (0-5)2 (0-4)0,172RA3 (1-5)4 (2-6)0.0013 (1-5)3 (1-5,5)0,731AS2 (0-5)4 (1-6)0,0022 (0-5)3,5 (1-6)0,044PsA2 (0-4)2 (0-5)0,8162 (0-5)2 (0-5)0,939*Median and interquatile range;Student t test;CI 95%AcknowledgementsReumaCoV Brasil researchers, Brazilian Society of Rheumatology and National Council for Ccientific and Technological Development.Disclosure of InterestsNone Declared.

IS THERE HIGHER RISK OF FATIGUE, DEPRESSION, ANXIETY AND STRESS AFTER COVID-19 IN PATIENTS WITH IMMUNE-MEDIATED RHEUMATIC DISEASES? DATA FROM THE REUMACOV BRASIL COHORT

BackgroundSome individuals may have persistent symptoms after COVID-19, a new condition known as long COVID-19. However, these complaints can be misunderstood with disease activity in patients with immune-mediated rheumatic diseases (IMRD), especially fatigue and mental distress.ObjectivesTo evaluate fatigue, depression, anxiety, and stress in IMRD patients after 6 months of COVID-19, compared with IMRD patients without COVID-19.MethodsThe ReumaCoV Brasil is a longitudinal study designed to follow-up IMRD patients for 6 months after COVID-19 diagnosis (cases) compared with IMRD patients no COVID-19 (controls). Clinical data, such as age, sex, comorbidities, as well as disease activity measurements and current treatment regarding IMRD, and COVID-19 outcomes were evaluated in all patients. The FACIT questionnaire (Functional Assessment of Chronic Illness Therapy) and the DASS 21 (Depression, Anxiety and Stress Scale - 21 Items) were applied at 6 months after COVID in both groups.ResultsA total of 606 IMRD patients were included, of whom 322 (53.1%) cases and 284 (46.9%) controls. Most patients were female (85.3%) with mean age 46.1 (13.0) years old. Specific disease activity were similar between cases and controls. There was a significant difference between FACIT scores and 3 domains of DASS-21 comparing cases and controls (Figure 1). The factors associated with FACIT were female gender, diabetes, obesity, no comorbidities, COVID manifestations (skin, joint pain, asthenia, diarrhea, and dyspnea), and chronic oral corticosteroid use. DASS-21 Depression was associated with these same factors. Female gender, COVID manifestations as skin, joint pain, asthenia, cough, dyspnea, and chronic oral corticosteroid use were associated with DASS-21-Anxiety. DASS-21 Stress was associated with female gender, asthenia, diarrhea, dyspnea, cough, chronic oral corticosteroid use, and hospitalization. Table 1 shows the variables that remained in the models after the univariate logistic analysis. A weak correlation between disease activity and FACIT was observed in rheumatoid arthritis (p=0.010;r2 = 0.035) and ankylosing spondylitis patients (p=0.010;r2 = 0.129). No other correlations were observed between the scores results and disease activity (patient's global assessment - PGA), medications or specific IMRD.ConclusionFatigue and mental changes such as depression, anxiety, and stress, occurred more frequently in IMRD patients who had COVID-19 than in those who did not have COVID-19, especially in women, regardless of disease activity score. Fatigue was more related to female gender, diabetes, obesity, and current joint pain. Mental impairment was more associated with severity of COVID-19, including respiratory and non-respiratory symptoms.Figure 1.Comparison between cases and controls of FACIT and DASS-21 depression, anxiety, and stress scoresFACIT (Functional Assessment of Chronic Illness Therapy);DASS-21 (Depression, Anxiety and Stress Scale - 21 Items):Table 1.Final model using binary Logistic Regression analysis to evaluate the preditive factors associated with FACIT and DASS-21 scoresFACIT Score ≤ 37 x score > 37§DASS-21-DEPRESSION Score ≤ 6 (normal/mild) x score > 6 (moderate/severeDASS-21-ANXIETY Score ≤ 5 (normal/mild) x score > 5 (moderate/severe)DASS-21-STRESS Score ≤ 9 (normal/mild) x score > 9 (moderate/severeVariableP-valueOR (CI 95%)VariableP-valueOR (CI 95%)VariableP-valueOR (CI 95%)VariableP-valueOR (CI 95%)Female0.151.83 (1.12-2.98)No comorbidities0.0290.66 (0.46-0.95)Joint pain0.0022.44 (1.39-4.26)Female0.0122.31 (1.20-4.46)Diabetes0.0062.35 (1.28-4.32)Joint pain**0.0012.58 (1.57-4.22)Dyspnea0.0013.61 (2.11-6.19)Dyspnea0.0013.69 (2.09-6.51)Dyspneia0.0012.00 (1.23-3.26)Dyspnea0.0012.82 (1.79-4.44)Oral CE0.0141.55 (1.09-2.21)Joint pain0.0052.20 (1.41-3.43)Oral CE0.0481.41 (1.00-1.99)§Lower scores mean worse fatigue;CE: corticosteroid;OR: odds ratio;CI: confiance intervalAcknowledgementsReumaCoV Brasil researchers, Brazilian Rheumatology Society and National Council for Scientific and Technological Deve opment.Disclosure of InterestsNone Declared.

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.

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.

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.

Long-Term Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis Refractory to Biologic Therapies: 2-Year Results from the Phase 3 Select-Psa 2 Study

Background/Aims Upadacitinib (UPA), an oral Janus kinase (JAK) inhibitor, demonstrated efficacy and safety in patients (pts) with psoriatic arthritis (PsA) and prior inadequate response or intolerance to >=1 biologic disease modifying antirheumatic drug (bDMARD) at week (wk) 56 in the phase 3 SELECT-PsA 2 study. We aimed to evaluate the efficacy and safety of UPA at wk 104 from the ongoing long-term extension of SELECTPsA 2. Methods Pts were randomized to UPA 15mg (UPA15), UPA 30mg (UPA30), or placebo (PBO) for 24 wks;PBO pts were then switched to UPA15 or UPA30. For continuous UPA treatment groups, efficacy endpoints at wk 104 were analyzed using non-responder imputation (NRI) and as observed (AO) (binary endpoints) or mixed-effect model repeated measures (MMRM) and AO (continuous endpoints). Treatmentemergent adverse events (TEAEs) were summarized for pts who received >=1 dose of study drug using visit-based cut-off at wk 104. Results A total of 641 pts received >=1 dose of study drug. At wk 104, 38.4% of all patients had discontinued study drug, with the highest discontinuation observed in patients randomized to PBO at baseline (all PBO: 46.7%). The most common reasons for discontinuation were lack of efficacy (UPA15: 12.3%, UPA30: 8.7%, all PBO: 21.7%) and adverse event (UPA15: 10.9%, UPA30: 13.3%, all PBO: 12.7%). The proportion of UPA pts that achieved ACR20/50/70, MDA, PASI75/90/100, and resolution of dactylitis and enthesitis were generally similar, or further improved, with 104 wks of treatment vs 56 wks. Similarly, mean change from baseline in HAQ-DI, patient's assessment of pain, BASDAI, and ASDAS was improved with UPA treatment. At 104 wks of therapy, clinical responses were largely similar with UPA15 and UPA30. Generally, safety data at wk 104 were consistent with that reported at wk 56. Rates of serious infection, herpes zoster, hepatic disorder, anemia, neutropenia, lymphopenia, and CPK elevation remained numerically higher with UPA30 vs UPA15, while rates of malignancies, MACE, and VTE were similar for both UPA groups. One death was reported with UPA15 (unexplained due to lack of information;however, the patient had recently been diagnosed with ovarian cancer) and two with UPA30 (pancytopenia and COVID-19 pneumonia). Conclusion In PsA pts with prior inadequate response or intolerance to>=1 bDMARD, clinical responses were maintained with UPA15 and UPA30 up to two years of treatment. No new safety signals were identified in this long-term extension.

Comparing Ankylosing Spondylitis Disease Activity during the Covid-19 Pandemic Using Patient-Reported Outcome Measures with Face-Toface Clinical Evaluation of Disease Scores Prepandemic

Background/Aims During the COVID-19 pandemic, asynchronous consultations were introduced for patients with ankylosing spondylitis (AS). To assess disease activity in the absence of face-to-face clinical review and blood testing, patients submitted patient-reported outcome measures (PROMs) via electronic survey forms which were subsequently triaged by clinicians. We compared pre-pandemic clinician-reported scores with intra-pandemic self-reported scores and assessed clinical outcomes including allocation of follow-up and further management/ treatment escalation. Methods Clinician-reported scores were obtained in-person pre-pandemic (defined as 01/01/2019-01/03/2020). Self-reported BASDAI scores were submitted by patients via electronic forms sent out duringpandemic (defined as 01/12/2020-31/03/22). The responses were stored and analysed in a secure database. These scores are analogous to disease activity scores completed by clinicians during outpatient appointments. Score comparison was performed using Wilcoxon Sign Rank testing. We used the need for a follow-up within 3 months as target for those with severe disease. Data analysis was performed in Microsoft Excel and R (version 4.2.1). Results We noted a significantly higher overall level of patient-reported disease activity during the pandemic. In the total cohort of AS patients, the median BASDAI Score collected during-pandemic increased from 5.30 (n=124, range 0-10) compared to 2.80 pre-pandemic (n=590, range 0-12) (p<0.001). The proportion of patients with severe/active disease (defined as BASDAI >4) increased from 36% pre- to 65% during pandemic. In a smaller cohort of 34 patients for whom we had both pre- and during-pandemic scores, all patient parameters worsened during the pandemic. Notably, median BASDAI increased from 2.65 to 5.62 (p<0.0001). Patients with severe AS increased from 10 (29.4%) to 21 (61.8%) intra-pandemic. Follow-up data was available for 12/21 patients with severe AS during-pandemic. 7/12 patients (58%) received a follow-up appointment within one month;11/12 (91%) were seen within three months. On subsequent clinician assessment, only 7 (58%) of patients with self-reported severe AS were felt to have active disease;treatment was escalated for 3 patients. Conclusion There was a significantly higher reported level of AS disease activity during the COVID-19 pandemic, with 62 % of patients qualifying for biologic therapy (BASDAI >4). In a focussed sample, 91% of patients with new severe disease during-pandemic were followed up within the target of 3 months. The BASDAI score is independent from clinical examination and inflammatory markers, and therefore self-reported score should reliably reflect a patient's perception of disease activity. Further work is required to determine the reason for the increased disease activity observed during pandemic, and for the disparity between clinician impression and score results.

Covid 19 in Patients with Rheumatic Diseases

Objectives: BIOBADAGUAY is the Paraguayan/Uruguayan registry of adverse events in patients with inflammatory rheumatic conditions under biologic therapy (BT). Three years have elapsed from the first case of coronavirus and data about South American patients with COVID are still scarce. In this study we analyzed the frequency and clinical outcomes of COVID-19 in a cohort of patients with rheumatic diseases from Paraguay. Method(s): A cross sectional study of Paraguayan patients with rheumatic diseases from BIOBADAGUAY and controls without BT. Clinical, epidemiological, and COVID-19 data were analyzed. Only cases confirmed by SARSCoV-2 positive PCR test were included. Descriptive analysis were performed for this study. Result(s): 832 patients were included (696 under BT and 136 controls). 116 (13.9%) had COVID-19. 22 had a second infection and 9 a third reinfection. Table 1 shows characteristic of COVID-19 patients. The most frequent diagnosis was rheumatoid arthritis (n = 93, 80.2%) followed by ankylosing spondylitis (n = 6, 5.2%), undifferentiated spondylarthritis (n = 5, 4.3%), psoriatic arthritis (n = 4, 3.4%), juvenile onset arthritis (n = 2, 1.7%), vasculitis (n = 2, 1.7%). Only 1 case (0.8%) were registered for Still's disease, enteropathic spondylarthritis, systemic sclerosis and seronegative polyarthritis, respectively. When comorbidities were analyzed, 46 (39.6%) patients had at least one (Table 1). Of the total treatments received: 65 (56.0%) had methotrexate, 53 (45.7%) leflunomide, 3 (2.5%) sulfasalazine, 15 (12.9%) hydroxychloroquine, 25 (21.5%) glucocorticoid, 52 (44.8%) anti-TNF and 20 (17.2%) non-anti-TNF. COVID-19 severity outcomes were: 101(87%) non severe, 31 (26.7%) severe and 1 fatal(0.8%). 189 (90.9%) patients received vaccination and the mean number of doses were 2.5 doses. 55 (26.4%) had COVID prior to vaccination Conclusion(s): In this study we examined the frequency of COVID-19 in Paraguayan patients with rheumatic diseases. In this cohort of rheumatologic patients, COVID 19 severity was similar to the one in the general population.

Covid Vaccine Made My Joints Hurt: Effect of Covid Vaccine on Systemic Rheumatic Disease

Background/Aims Vaccination against SARS-CoV-2 is crucial for patients with systemic rheumatic diseases (SRDs) who may be at increased risk of severe outcomes post-COVID-19. Sparse data suggests vaccines used for COVID -19 may be associated with SRD flares, possibly from molecular mimicry triggering immune activation or non-specific adjuvant effects. As SRD flares are associated with disease deterioration, increased flares could have serious clinical implications. We report the interim results of a survey evaluating SRD flare incidence post-SARS-CoV-2 vaccine. Methods We surveyed 200 patients of different age group with different SRDs via telephone or paper copy during their appointment in Rheumatology department at North Cumbria Integrated Care NHS Foundation Trust, from September 2022 to March 2022 who received at least one dose of Pfizer or Astra Zeneca vaccine. The results of the survey were recorded. Results The mean age of the patients was 62.5 years. 63% of the patients (N- 126) were females. 53 (26.5 %) of these patients had Rheumatoid Arthritis (RA), 43 (21.5 %) had Psoriatic Arthritis, 37 (18.5%) had Serove Spondyloarthropathy, 22 (11%) had Ankylosing Spondylitis, 16 (8 %) had CTD, 12 (6%) had PMR, 10 (5%) Vasculitis and 7 (3.5%) had Palindromic arthritis. 96 (48%) of these patients were on synthetic DMARDs, 56 (28%) on Biologic DMARDs and 41 (20.5%) were on combination. 7(3.5%) patients were on NSAIDS. The most common adverse effects from the vaccine were pain at the site of injection and generalized body aches in 90%of patients followed by fatigue in 80%. 22% had fever. 21 (10.5 %) patients had flare up of their existing rheumatic disease after the first dose and 22 (11%) had a flare after 2nd dose and another 24 (12%) after the 3rd dose. 30 (15%) patients had some flare up after two doses. Out of these 26 had mild flare up and improved with Paracetamol/codeine. 30 had mild to moderate flare required different NSAIDs and 21 had severe requiring a course of prednisolone. 3 of these patients required step up of DMARDS. These flares were described as typical, suggesting these symptoms were not vaccine's adverse effects being misreported as disease flares. Conclusion Interim data from our cohort demonstrates about 12% of patients had severe flare up, with some lasting for weeks requiring switching of DMARDs. Although SARS-CoV-2 vaccine might be associated with some flare up in SRD, but the morbidity and mortality of non-vaccinated patients with SRD can be very devastating signifying the importance of the vaccine. Further data is required for a wider cohort.

Characteristics associated with poor COVID-19 outcomes in people with psoriasis, psoriatic arthritis and axial spondyloarthritis: data from the COVID-19 PsoProtect and Global Rheumatology Alliance physician-reported registries.

OBJECTIVES: To investigate factors associated with severe COVID-19 in people with psoriasis (PsO), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). METHODS: Demographic data, clinical characteristics and COVID-19 outcome severity of adults with PsO, PsA and axSpA were obtained from two international physician-reported registries. A three-point ordinal COVID-19 severity scale was defined: no hospitalisation, hospitalisation (and no death) and death. ORs were estimated using multivariable ordinal logistic regression. RESULTS: Of 5045 cases, 18.3% had PsO, 45.5% PsA and 36.3% axSpA. Most (83.6%) were not hospitalised, 14.6% were hospitalised and 1.8% died. Older age was non-linearly associated with COVID-19 severity. Male sex (OR 1.54, 95% CI 1.30 to 1.83), cardiovascular, respiratory, renal, metabolic and cancer comorbidities (ORs 1.25-2.89), moderate/high disease activity and/or glucocorticoid use (ORs 1.39-2.23, vs remission/low disease activity and no glucocorticoids) were associated with increased odds of severe COVID-19. Later pandemic time periods (ORs 0.42-0.52, vs until 15 June 2020), PsO (OR 0.49, 95% CI 0.37 to 0.65, vs PsA) and baseline exposure to TNFi, IL17i and IL-23i/IL-12+23i (OR 0.57, 95% CI 0.44 to 0.73; OR 0.62, 95% CI 0.45 to 0.87; OR 0.67, 95% CI 0.45 to 0.98; respectively; vs no disease-modifying antirheumatic drug) were associated with reduced odds of severe COVID-19. CONCLUSION: Older age, male sex, comorbidity burden, higher disease activity and glucocorticoid intake were associated with more severe COVID-19. Later pandemic time periods, PsO and exposure to TNFi, IL17i and IL-23i/IL-12+23i were associated with less severe COVID-19. These findings will enable risk stratification and inform management decisions for patients with PsO, PsA and axSpA during COVID-19 waves or similar future respiratory pandemics.

Impact on Pharmaceutical Industry due to Sudden Pandemic Attack (COVID-19)

The coronavirus disease (COVID-19) was first detected in Wuhan, China, in the month of December 2019. Further, in March 2020, the COVID-19 epidemic was described by the World Health Organisation (WHO) as a global pandemic. COVID-19 quickly spread around the world in the following months, affecting about 2.5 million individuals by April 2020. World markets, including the pharmaceutical industry, were devastated by this pandemic. Although no specific solution for this emerging infectious disease is currently available, the pharmaceutical industry is helping policymakers meet unmet COVID-19 desires, ranging from research and advancement initiatives on possible prevention methods to the management of the supply chain of drugs in times of crisis. Changes in demand, commodity shortages, contact adjustments, etc., are hindering developments in the mechanism of technology, research and development and are putting an impact on the health market of COVID-19. Other implications of COVID-19 on the physical condition and pharmaceutical market may include acceptance delays, heading to self-sufficiency in the delivery chain, etc. In addition, the pharmaceutical markets are battling to sustain natural consumer flows, as the latest pandemic has had an effect on access to essential drugs at reasonable rates, which is the key priori-ty of all pharmaceutical systems.Copyright © 2022 Bentham Science Publishers.