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 pregnant patients with ankylosing spondylitis

Objective: To describe the course of COVID-19 in women with AS during pregnancy and the effect of COVID-19 on AS activity. Material and Methods: 75 pregnant women with confirmed AS (modified New York criteria, 1984) were included for prospective observation. 26 of them were followed during the Covid-19 pandemic (03.2020 -04.2022). The average age of the patients was 33.0 ± 3.9 years, the duration of the disease was 117.0 ± 72 months. The activity according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in the 1st, 2nd and 3rd trimesters of pregnancy was 2.0 ± 1.4;2.0 ± 1.4 and 1.9 ± 1.5, respectively. The Ankylosing Spondylitis Disease Activity Score CRP (ASDAS-CRP) was 1.5 [1.3;2.1];1.8 [1.3;2.5] and 1.7 [1.1;2.0], respectively. The delivery period was 38.7 ± 1.6 weeks. Results: COVID-19 was transferred to 4 pregnant women, 3 of them -at the end of the 1st -beginning of the 2nd trimester, one -at 38 weeks of pregnancy. No women have been vaccinated against COVID-19. In 3 cases, the activity of AS was low, in one -high due to axial manifestations and arthritis. In 3 women, the course of COVID-19 was mild, in one -moderate (febrile temperature for more than 3 days);only 1 woman had a dry cough. One pregnant woman canceled AS therapy (certolizumab pegol, CZP), against which the back pain of the inflammatory rhythm increased. In other cases, AS therapy was not canceled, there was no effect of COVID-19 on AS activity. (Table Presented) Conclusion: According to preliminary data, COVID-19 in pregnant women with AS can be characterized by a mild and moderate course. There was no increase in AS activity during ongoing AS therapy.

COVID-19 within a year after childbirth in women with ankylosing spondylitis (AS)

Objective: Describe the course of COVID-19 and its effect on AS activity in women infected within 1 year after childbirth. Material(s) and Method(s): 75 pregnant women with confirmed AS (modified New York criteria, 1984) were included for prospective observation. 22 of them were followed during the COVID-19 pandemic (03.2020 -04.2022) for a maximum of 12 months after childbirth. The average age of the patients was 31.5 +/- 4.3 years, the duration of the disease was 124.8 +/- 75.7 months. The activity according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 1, 6 and 12 months after delivery was 2.0 +/- 1.3;2.2 +/- 1.3 and 2.5 +/- 2.0, respectively. The Ankylosing Spondylitis Disease Activity Score CRP (ASDAS-CRP) was 2.2 [1.2;2.9];2.0 [1.5;2.8] and 1.7 [1.3;2.3], respectively. Result(s): 4 women suffered COVID-19 within a year after giving birth. None of them have been vaccinated against COVID-19. At the time of infection, the activity of AS in all patients was low, 3 women received certolizumab pegol (CZP). In all cases, COVID-19 proceeded with febrile fever for at least 1 day, while the general symptoms were stopped for a maximum of 7 days. Only 1 woman had a dry cough. The effect of COVID-19 on the activity of AS was not revealed, including 2 patients who canceled CZP. All the women continued lactation. 2 children had mild catarrhal phenomena for 3 days, one child underwent a PCR test, SARS-CoV- 2 RNA was detected. Conclusion(s): According to preliminary data, there is no effect of COVID-19 on initially low AS activity in women during lactation. One of the main symptoms of COVID-19 in all patients was febrile fever, regardless of the time of infection that has passed after childbirth.

Effects of COVID-19 on axial spondyloarthritis disease flare

Aims: Rheumatological disease flares may occur after many infections. However, our knowledge of the post-Coronavirus disease-2019 (COVID-19) axial spondyloarthritis (SpA) flares and related factors is limited. Methods: We retrospectively assessed the axial SpA patients who had COVID-19. Demographic and clinical data were collected from the medical records. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was applied via telephone for pre- and post-COVID-19 SpA symptoms. An increase of ≥2 points in the BASDAI score or any new extra-articular manifestations were defined as SpA flares and SpA patients were grouped as flares and noflare. Factors predicting SpA flare were also analyzed. Results: A total of 48 axial SpA patients were included in the study [age, mean±standard deviation (SD): 42.3±8.6 years;male: 65%]. Post-COVID-19 SpA flare was identified in 19 patients (40%), and new extra-articular manifestations were recorded in 6 patients (13%). Although the diagnosis of inflammatory bowel disease was more common in the flare group, the difference was not significant compared with that of the no-flare group. Other features of SpA and COVID-19 disease severity were similar between the flare and no-flare groups. In the flare group, the frequency of back pain (84% vs. 62%, p=0.091) and diarrhea (53% vs. 28%, p=0.080), and headache (84% vs. 52%, p=0.021) were higher than the no-flare group. No risk factor for a post-COVID-19 SpA flare could be identified. Conclusions: Post-COVID-19 flare was common in the axial SpA, and even new extra-articular manifestations could be reported. Although some clinical manifestations of COVID-19 were more common in patients with a flare, any predictive factor could not be identified among the study variables. [ FROM AUTHOR]

EFFECTS of the COVID-19 DISEASE on AXIAL SPONDYLARTHRITIS DISEASE FLARE

Background: Rheumatological disease fares may be seen after many infections. However, our knowledge for the post-COVID axial spondyloarthritis (SpA) fares and its related factors is limited. Objectives: We aimed to evaluate disease activity and factors that may be associated with disease activity in axial SpA patients in post-COVID period. Methods: We retrospectively assessed the axial SpA patients who have had COVID-19 disease confrmed by a positive SARS-CoV-2 polymerized chain reaction (PCR) test result. Demographics, comorbid diseases, active medical treatments for SpA and information regarding COVID-19 clinical courses were collected from medical records. PCR positive patients were reached via telephone and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scored for pre-and post-COVID SpA symptoms. An increase of ≥2 points in the BASDAI score was defned as fare, and SpA groups with and without fare were compared. Factors predicting SpA fare were also analyzed by the logistic regression analysis. Results: A total of 48 axial SpA patients were included in our study, 65% of them male and the mean±SD age was 42.3±8.6 years. Post-COVID SpA fare was seen in 38% patients. Demographic, clinical, medical features of the SpA patients and COVID-19 disease severity were similar between Flare and No fare groups. In comparison of the COVID-19 symptoms, although most of the COVID-19 related symptoms were similar between two groups, the frequency of the back pain and diarrhea were higher in the Flare group than No fare group. But in multivariate analysis, only history of the infammatory bowel disease had an increased risk for post-COVID SpA fare (Table 1). Conclusion: The presence of infammatory bowel disease statistically signifcant related post-COVID SpA fares. In addition, diarrhea and back pain symptoms in COVID-19 disease may be stimulating factors for SpA fares but we found no effect of rheumatological therapies.

CLINICAL CHARACTERISTICS of PATIENTS with SPONDYLOARTHRITIS with COVID-19 in ANAMNESIS in the REPUBLIC of TATARSTAN

Background: The management of patients with spondyloarthritis (SpA) during the period of the novel coronavirus infection (NCI) pandemic is a signifcant problem due to insufficient evidence base. Objectives: To study the features of the course NCI and its influence on the course of SpA. Methods: From March 2020 to January 2022, 55 patients with SpA who underwent NCI (with a confrmed result of SarsCoV2 PCR and/or using X-ray computed tomography (CT) of the lungs): ankylosing spondylitis (AS) 37 people, with psoriatic arthritis (PsA) 18 people. Of these 32 (58.2%) were men, 23 (41.8%)-women, the average age of patients was 49 [37.5;57.5] years. The duration of SpA at the time of NCI was 11 [7;16] years. SpA activity before NCI was low in 15 (34.8%) patients, moderate in 25 (58.1%), and high in 3 (6.9%) patients. The results of clinical and laboratory examinations were evaluated during the NCI and after 1, 3, 6 months. Results: Symptoms of NCI in patients with SpA were comparable in frequency and severity to the course of infection in the population. 47.3% had a mild course of NCI, and 52.7% of those observed had a moderate course, which is comparable with the general population data. Lung involvement was detected in 29 (52.7%) patients. The outcome of COVID-19 in all patients is recovery. Analysis of the course of SpA showed an increase in activity 1 and 3 months after NCI: BASDAI from baseline to COVID-19 4.3±1.57 to 4.9±1.7 points after 3 months, similar to ASDAS-CRP from 2.6±1, 2 to 3.7±0.2, BASFI from 3.0±1.9 to 3.8±1.8. A positive correlation was found between the severity of NCI and the BASFI index after 3 months (0.870). Analysis of the course of PsA showed an increase in activity 1 and 3 months after NCI: DAS28 from the baseline 2.78±0.98 to 4.15±1.16 points after 3 months. Of the total number of recoveries, 72.2% of patients showed an increase in activity due to clinical and laboratory parameters. 78.1% of patients noted the presence of post-COVID symptoms after NCI, 56.3% had a combination of more than 3 different symptoms. Most often there was an increase/appearance of pain in the joints-in 78.1%: signifcant-in 61.8%, insignifcant-in 16.3% of respondents. Strengthening/appearance of muscle pain and/or headache and/or dysautonomia occurred in 72.7%. This can be assessed as an exacerbation of the underlying disease, or, conversely, the appearance of arthralgia and myalgia could have an impact on the increase in AS and PsA activity indices. The second most frequent were a decrease in the quality of life (QOL) and working capacity in 69.0% of patients: signifcant in 36.3% of patients, insignifcant in 32.7%. The appearance/intensifcation of shortness of breath and a decrease in exercise tolerance were noted by 60% of the respondents. Among them, 34.5% of patients with moderate severity, 25.4%-with mild NCI. Appearance/intensifcation of chest pain and/or palpitations was noted by 16.3% of patients Conclusion: The prevalence and course of the NCI in patients with SpA did not differ from that in the population. However, coronavirus infection has led to increased pain and an increase in AS activity, long-term persistence of post-COVID manifestations in the form of musculoskeletal pain and asthenic symptoms in the form of a decrease in the quality of life. At the same time, specifc respiratory symptoms occurred in a third of patients and were not associated with the severity of the NCI.

ANALYSIS of the ACCEPTANCE and USEFULNESS of A NON-PRESENTIAL CONSULTATION, in PATIENTS with CHRONIC INFLAMMATORY JOINT DISEASES USING A DIGITAL PLATFORM

Background: The Covid-19 pandemic has meant a modifcation of the patterns of the doctor-patient relationship, favoring online visits and reducing face-to-face visits. Likewise, the implementation of Patient-Reported Outcomes (PROs) that do not require the intervention of the doctor in our clinical practice and that given their close relationship with the clinical activity of chronic infammatory joint diseases (CIJD) has favored an empowerment of patients and can allow the development of the online visit. Objectives: Know the use and acceptance of patients with CIJD: rheumatoid arthritis (RA), psoriatic arthritis (PsA) and spondyloarthropathies (SpA) of a non-face-to-face online visit, through a digital environment. Methods: Patients were included in a platform called Rheumanet for access by username and passwords (https://www.laconsultacercadetI.com/). At the time of inclusion, demographic variables were collected: date of birth, sex, level of education (primary education, secondary education, vocational training, further education and higher education), distance from the hospital to the patient's home, and clinical variables such as diagnosis: RA, PsA or SpA, as well as the duration of the disease. Prior to the appointment, patients were encouraged to complete a PRO survey to assess their clinical situation: Routine Assessment of Patient Index Data 3 (RAPID3) for RA, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for SpA and RAPID3 and/or BASDAI for the PsA. Both the RAPID3 and BASDAI were scored for the patient's knowledge and assigned to a color scale based on disease activity in green (remission or low activity), orange (moderate activity) or red (severe activity). Likewise, they were ordered to express through a free text what they would tell us as if they were in a face-to-face consultation. Complementary tests (analytical, radiological studies and others) are obtained simultaneously from the medical records and a joint assessment of the visit is carried out. Results: Between September 1, 2020 and January 31, 2022, a total of 248 patients (113 RA, 53 SpA and 82 PsA) were included in the platform. 172 (69.3%) patients used the digital platform and made at least one non-face-to-face visit during follow-up. The number of online visits made by each patient ranged from 1 to a maximum of 13 visits. 80 patients (70.7%) suffered from RA, 40 (75.4%) from SpA and 52 (63.4%) from PsA. The number of patients who made non-face-to-face visits was 38 (72.3%) for a disease duration of <5 years and 137 (64.5%) for >5 years. When the ages of the patients were analyzed, the number of patients who made visits was 75 (73.5%) between 18 and 30 years old, 50 (67.7%) between 30 and 50 and 47 (66.4 %) from 50 years. According to the degree of activity of the disease, 75 patients were in remission or low activity at some point during the visits, 63 patients with moderate activity and 34 with severe activity. The distribution according to level of education was: 11 (6.3%) primary education, 21 (12.2%) secondary education, 37 (21.5%) vocational training, 63 (36.6%) further education and 40 (23.2%)higher education. The number of online visits was higher in patients who lived at a distance of 50 km or more from the hospital, reaching 100% of the visits in this subgroup of patients. Conclusion: The online visit through a digital platform through PROs is well accepted by our population with CIJD, especially in the young population, with a higher cultural level and whose home is far from the hospital. The online visit was made by patients regardless of the severity of their disease activity. Speed and ease of use using PROs already known to the patient and clinician is an important consideration for rheumatolo-gists working in healthcare systems where patient contact time is limited. It would be interesting to obtain this information in non-pandemic situations such as COVID-19, which would make it possible to assess actual acceptance and its use in this type of patient in circumstances in which fear of contagion is not a variabl to consider.

THE COURSE of COVID-19 in A COHORT of SPONDYLOARTHRITIS PATIENTS: A CASE-CONTROL PROSPECTIVE STUDY

Background: With the outbreak of the SARS-CoV-2 pandemic, the rheumatol-ogists' attention was directed at understanding whether infected patients could have a less favorable outcome. Available data seem to indicate that the course in rheumatic patients is not dissimilar from that in the general population. However, data on the outcome of COVID-19 in patients with spondyloarthritis (SpA) are scant. Objectives: To describe the outcome of COVID-19 in patients with SpA in terms of hospitalization, need of oxygen therapy, and symptoms compared to a control group. The variation in disease activity before and after COVID-19 was also assessed. Methods: We enrolled adult patients with psoriatic arthritis (PsA) and ankylosing spondylitis (AS) classifed according to standard criteria, that received a diagnosis of COVID-19 through molecular or rapid antigen swab tests between September 2020 and January 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, symptoms and additional therapy during the infection and vaccination status were collected through a questionnaire and recorded on an electronic database. Disease activity, assessed by DAPSA in PsA patients and by BASDAI and ASDAS in AS patients, was evaluated before and at the frst visit after the infection. As controls, individuals with COVID-19 but with no known diagnosis of rheumatic/autoimmune disease were recruited using the 'best friend' system. Results: Sixty-two patients were enrolled [43 with PsA and 19 with AS;F:M=40:22;median age 51 years, 25th-75th percentile 39.5-61;median BMI 25.5, 25th-75th percentile 21.75-28;median disease duration 90 months, 25th-75th per-centile 36-192;6 (9.7%) smokers, 37 (59.7%) non-smokers, 19 (30.6%) past smokers;15 (24.2%) only treated with one conventional DMARD, 27 (43.5%) with bDMARDs and 20 (32.3%) with both;44 (71%) had received no vaccine, 18 (29%) one or more doses of vaccine]. Forty-eight controls were also recruited [F:M=29:19;median age 48 years, 25th-75th percentile 41.5-57;median BMI 23.86, 25th-75th percentile 20.69-28.03;10 (20.83%) smokers, 28 (58.33%) non-smokers, 10 (20.83%) past smokers;43 (89.6%) had received no vaccine, 5 (10.4%) one or more doses of vaccine]. Among patients, 10 (16.1%) were hospitalized, of whom 8 (80%) required noninvasive oxygen therapy. Among controls, 7 (14.5%) were hospitalized, of whom 5 (71.4%) required noninvasive oxygen therapy. No differences were observed compared to the control group in terms of hospitalization and need for oxygen support. Likewise, the two groups did not bear any statistically signifcant difference in terms of symptoms (fever, dys-geusia, dyspnoea) and cardiovascular and respiratory comorbidities. BMI and smoking habit did not influence the outcome of COVID-19 in SpA patients, while a BMI of 25 or above was associated with hospitalization in the control group (p=0.0004, RR 3.417). Baseline treatment with immunosuppressants did not influence the disease outcome. DAPSA, ASDAS, and BASDAI did not signif-cantly change after the infection (Table 1). We did not record any COVID-19-re-lated death in either group. Conclusion: Our data show that patients with SpA do not face a worse prognosis of COVID-19 than subjects without rheumatic/autoimmune diseases and that demographic and clinical features did not influence the course of the disease.

ASYNCHRONOUS TELECONSULTATION by WHATSAPP CHATBOT in CONTROLLED AXIAL SPONDYLOARTHRITIS (SPA) PATIENTS under BIOLOGICAL THERAPY: 10 MONTHS EXPERIENCE at A SINGLE CENTRE

Background: The use of telehealth in the control of rheumatic diseases had been scarce, but COVID pandemic forced rheumatologists to try alternatives to classic face-to-face consultation. In times of lockdown phone calls and video calls were easy to perform, but later on an asynchronous model of teleconsultation would probably ft better. The purpose of this study is to prove that asynchronous whatsapp teleconsul-tation is an effective alternative to classic healthcare consultation models out of pandemic. So, we selected axial spondyloarthritis (SPA) patients with stable controlled disease under biological therapy and we offered teleconsultation with a whatsapp platform chatbot, that's been created for this purpose as a way to send PROMS (BASDAI, VAS for patient global disease assesment, ASDAS, and 3 questions for extraarticular disease), and receive feedback and schedule for the following visits Objectives: To prove that teleconsultation through whatsapp platform was not inferior to face-to-face consultation in terms of mantaining axial SPA patients disease under control. And to prove that teleconsultation model was less time and resources consuming for the patient and the system, and probably preferred by a group of patients. Methods: Prospective study with retrospective control of patients diagnosed of Axial SPA, fullflling ASAS criteria and with stable disease under biological therapy for the previous year, recruited from 01 jan to 30 nov 2021. We offered them two teleconsultation visits using their personal mobile device, once every four months and a face-to-face visit at the end of the study (one year since inclusion). If there is a deviation in the lab test or PROMs or if the patient asks for contact (via whatsapp) he is called up by the person in charge (nurse/doctor) that solves the question and arranges an aditional presential visit when 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, use of mobile devices, duration and characteristics of the disease, previous and actual treatment), activity (BASDAI, PCR, ASDAS), physical function (BASFI), Quality of life (AsQol) ansd productivity (WAPAI), and we also check number of face-to-face and phone consultations and patient's preferences. Results: 62 patients (52 men and 10 women) were recruited, mean aged 47,7 years (range 26-72), 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 (90%) and with longstading disease (mean 24 years), and only 6 patients less than five years. 16% had peripheral involvement (arthri-tis/dactylitis), and 40% presented extraarticular manifestations, mainly uveitis (20%). 70% were under their frst biological (TNF inhbitor, mostly adalimumab), 24% were refractory to the frst, 3 patients to 2 previous biologicals and just 1 patient was refractoy to 5. 50% of patients were treated with tapered dose of TNF inhibitors. We have now a mean followup of 10 months, in which we have had 109 scheduled teleconsultations with aditional need of 36 phone calls and 10 aditional presential visits for the whole group. To date, 3 patients with reduced dose increased to standard dose of biological drug and none change of biological was required. Conclusion: Asynchronous teleconsultation seems promising, specially for followup in patients with stable rheumatic disease, less interfering with daily activities, less time consuming for the patient and less resource consuming for healthcare systems, with no impairment of disease control and quailty of healthcare. This study will also show patient's preference, and wéll try to describe a profile of patient more prone to teleconsultation.

THE VALUE of REMOTE CONSULTATIONS with A PHYSIOTHERAPIST, SPECIALISED in AXIAL SPONDYLOARTHRITIS during the COVID 19 PANDEMIC: EVALUATION of A MEMBER-SUPPORT PROJECT with the NATIONAL AXIAL SPONDYLOARTHRITIS SOCIETY

Background: COVID-19 caused signifcant disruption to Axial Spondyloarthritis (AxSpA) services during the intial 2020 lockdown1. In response, The National Axial Spondyloarthritis Society (NASS) piloted provision of remote consultations with a physiotherapist specialised in the management of AxSpA to their members in urgent need. This project was funded by the UK National Lottery Fund Objectives: To provide a total of 130 hrs of remote consultation to members of NASS, unable to access specialist care and in need of self-management advice for their condition Methods: Remote consultations were offered to NASS members from Sept 2020 to Feb 2021. The preferred format being 1hr assessment and 2 x 30 min at 1 and 3 weeks from assessment. Participants consented to video consultations via Zoom and the inclusion of anonymised outcomes and comments in the project evaluation. Patient Reported Outcomes (BASDAI and BASFI) were collected immediately prior to assessment, at fnal consultation and in April 2021, between 8-16 weeks from fnal consultContent was individually tailored, centring on self-management (pacing, sleep management), education (AxSpA pathology, medication) and individualised exercise plans. Exercise plans were formulated through 'Rehab My Patient' software, including links to YouTube video references and daily exercise log sheets. Results: 67 members received online consultations, 63 receiving the full 3 sessions. Missed appointment rate = 2.5% Participants represented a wide geographical area across England and a spread in time since diagnosis. Patient Reported Outcomes Measures (PROMs) on assessment: Mean BASDAI score (n=55) on assessment = 5.8 Mean BASFI score on assessment (n=56) = 5.5 24 participants returned PROMS at fnal consultation, 10 at longer follow-up (8-16 weeks). Results for complete data set (n=10): Satisfaction: 60 members completed an online feedback survey provided by NASS: 9 Feedback to questions were asked, with a satisfaction scale of 1-5 (ascending positivity) 99.6% of all scores were 3 or above. Example responses: How would you rate the overall experience: 92% = 5, 100% = 3-5 To what extent do you feel more confdent to manage your condition: 40% = 5, 100% = 3-5 How useful was it to be in direct contact with a Physiotherapist: 93% = 5, 100% = 3-5 46 members chose to leave additional, overwhelmingly positive comments, with 2 obvious themes arising: 1)The value of the experience and knowledge of the therapist. 'was great to have the guidance and support of a professional who knows what they are talking about when it comes to AxSpA' 2)The value of education in condition management 'set me back on track', 'very helpful for my mental strength in dealing with this enduring disease', 'I learned so much about my AS and ways to keep mobile' Conclusion: A set of 1-3 sessions per person achieved desirable patient reported outcomes with modest and enduring improvements seen in disease activity and function. This pilot project enabled those living with Axial SpA across England access to a Physiotherapist highly experienced in treatment of their condition. The majority of participants reported having no previous experience of seeing a therapist with specialised knowledge of their condition. The knowledge and experience of the clinician was a key theme in the positive nature of feedback linking to another key theme of improved confdence to manage their condition. These results highlight the value to patients of specialised knowledge amongst health professionals. Remote consultations may provide access to specialist knowledge 'out of area' and may be an efficient method of delivering self-management advice.

SLEEP DISORDERS ARE FREQUENT in SPONDYLOARTHRITIS, ASSOCIATED with REDUCED QUALITY of LIFE and DEPRESSION and MORE PREVALENT in FEMALE PATIENTS

Background: Axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) may have a profound impact on health-related quality of life (HRQoL) and sleep despite effective treatment. Objectives: To assess sleep and HRQoL in SpA and determine associated factors. Methods: Monocentric questionnaire-based assessment of HRQoL, function, sleep and depression in 314 SpA patients (n=168 PsA, n=146 axSpA). Results: Under effective treatment 138 SpA patients (46.5%) demonstrated abnormal sleep behaviour. 49.3% reported not being able to sleep through the night, with 6.1 % needing sleeping pills. 11.9% indicated feeling unrefreshed most mornings. Abnormal sleep behaviour was associated with female sex (p=0.005), HLAB27 (p=0.034), functional impairment (p=0.001) and depression (p<0.001). Patients reporting unrestful sleep had signifcantly more depressive symptoms (p<0.001) and highly reduced physical and mental HRQoL (p<0.001). Satisfaction with health was rated signifcantly lower (p<0.001). Patients with axial involvement (axSpA/axPsA) reported worse sleep quality (p=0.002) and waking too early (p=0.038) despite 73.7% receiving biologics. Sleep quality and early awakening correlated with BASDAI (p<0.001). Smokers had a reduced HRQoL (p=0.018) despite younger age (p=0.008). Female patients had worse sleep quality (p<0.001), needing more time to fall asleep (p=0.022), not being able to sleep through the night (p=0.026) and feeling unrefreshed in the morning (p<0.001). They had a reduced physical (p=0.019) and mental HRQoL (p=0.003), more depressive symptoms (p=0.040) and lower functional capacity (p=0.002). Functional capacity was associated with younger age (p<0.001), sex (p=0.042), smoking (p=0.008), sleep quality (p<0.001) and depression (p<0.001). 66.2% of patients have been assessed longitudinally, before and 3y later during COVID19 pandemic. Physical and mental HRQoL were stable over time. Functional capacity had decreased slightly. Subjective QoL during the COVID19 pandemic was not reduced compared to before. Regarding depressive symptoms, there was a mild but signifcant improvement over time (p=0.019). Furthermore, we observed an improvement of environmental QoL (p=0.034) during COVID pandemic. Overall subjective QoL as well as satisfaction with health did not change signif-cantly. Patients who had changed therapy (37% of the cohort) still had a reduced physical HRQoL (p=0.022) as well as signifcantly more depressive symptoms (p=0.010) and perceived their overall QoL as being worse (p=0.016). Conclusion: Despite treatment many SpA patients have a reduced HRQoL and impaired sleep quality with signifcant differences between male and female patients. Impact of COVID19 pandemic was low.

EFFECT of PRO-INFLAMMATORY CYTOKINE-INTERLEUKIN 6 on the COURSE of ANKYLOSING SPONDYLITIS in PATIENTS after COVID-19

Background: Everyone knows that COVID-19 not only has a severe effect on the pulmonary system, but also triggers a whole cascade of autoimmune reactions. The study of the effect of the pro-infammatory cytokine-interleukin 6 (IL6) on the clinical course of patients with ankylosing spondylitis (AS) undergoing COVID-19 is an important problem in rheumatology. Objectives: To study the signifcance of the pro-infammatory cytokine-IL-6 on the clinical features of the course of AS in patients who have undergone COVID-19. Methods: In the period from 2020-2021, 44 patients with a diagnosis (AS) were hospitalized in the City Clinical Hospital # 3 of Tashkent city. The patients were divided into two groups: Group I-20 patients with AS who underwent COVID-19 and Group II of 24 patients with no history of AS who had COVID-19 infection. The average age of patients in group I was 32 ± 4.1 years and in group II-36.5 ± 5.2 years. All patients underwent clinical and laboratory studies, including studies of serum IL-6 levels. Disease activity was assessed using the BASDAI and ASDAS scales, pain was assessed using a numerical rating scale (NRS), and peripheral joint damage was assessed by the presence of pain and swelling in 44 joints. All patients underwent PCR, as well as ELISA-IHLA tests for the presence of antibodies to COVID-19. Results: Clinical examination of the patients revealed the presence of pain in the spine, which was assessed using the numerical rating scale-(NRS) in group I it was 8.5 ± 1.2 points and 5.9 ± 2.3 points in patients of group II. Examination of peripheral joints showed an average number of painful joints (PJ) of 16.9 ± 3.2 in group I and 8.6 ± 2.7 in group II, the number of swollen joints (NSJ) 8.8 ± 2.1 in group I and 4.2 ± 1.7 in group II. group. The study of AS activity using the BASDAI scale showed an average level of 5.1 ± 1.7 points in group I and 4.4 ± 2.1 points in group II. And the study of activity on the ASDAS scale showed an average level of 4.0 ± 1.7 points in group I and 2.5 ± 0.8 points in group II, which indicates a very high activity of the pathological process in group I and medium-high activity in group II. The IL-6 level in group I was 10.2 ± pg/mL, 4.2 pg/mL in group II and 1.39 pg/mL in the control group. Conclusion: 1. The clinical course of AS in patients who have undergone COVID-19 is characterized by a more pronounced disease activity according to the BASDAI and ASDAS scales, a high intensity of pain syndrome according to a NRS, as well as a high level of IL-6. 2. A high level of IL-6 in group I indicates the impact of COVID-19 on the course, activity and severity of the autoimmune process in patients with AS, which is many times higher than in patients of group II, which allows us to consider it as a biomarker of damage to the articular and connective tissue in this infection.

EFFICACY and SAFETY of UPADACITINIB in PATIENTS with ACTIVE ANKYLOSING SPONDYLITIS REFRACTORY to BIOLOGIC THERAPY: A DOUBLEBLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE 3 TRIAL

Background: Upadacitinib (UPA) was shown to be safe and effective through 2 years in patients (pts) with active ankylosing spondylitis (AS) naïve to biologic disease-modifying antirheumatic drugs (bDMARDs) in the pivotal phase 2/3 SELECT-AXIS 1 trial.1,2 Objectives: To assess the efficacy and safety of UPA in pts with active AS with an inadequate response (IR) to bDMARDs. Methods: SELECT-AXIS 2 (NCT04169373) was conducted under a master protocol and includes two separate studies (one for AS bDMARD-IR and one for non-radiographic axial spondyloarthritis [nr-axSpA]). The AS bDMARD-IR study is a randomized, double-blind, placebo (PBO)-controlled, phase 3 trial that enrolled adults ≥18 years with AS who met modifed New York criteria, had BAS-DAI and pt's assessment of total back pain scores ≥4 (numeric rating scale 0-10) at study entry, and had an IR to one or two bDMARDs (TNF inhibitor or IL-17 inhibitor). Pts were randomized 1:1 to receive oral UPA 15 mg once daily (QD) or PBO during the 14-week (wk) double-blind treatment period. The primary endpoint was ASAS40 response at wk 14. Multiplicity-controlled secondary endpoints evaluated at wk 14 were improvements from baseline in disease activity (ASDAS [CRP], ASDAS ID [<1.3], ASDAS LDA [<2.1], BASDAI50, ASAS20, and ASAS PR), pain (total and nocturnal back pain), function (BASFI), objective measure of infammation (SPARCC MRI score of the spine), spinal mobility (BASMI), enthesitis (MASES), and quality of life (ASQoL and ASAS HI). Non-responder imputation incorporating multiple imputation (NRI-MI) was used to handle intercurrent events and missing data for binary endpoints. Cochran-Mantel-Haenszel (CMH) test and mixed-effect model for repeated measures (MMRM) were used for analyzing binary and continuous endpoints, respectively. Treatment-emergent adverse events (TEAEs) assessed through wk 14 are reported for pts who had ≥1 dose of study drug. Results: All 420 randomized pts with active AS received assigned treatment (UPA 15 mg, n=211;PBO, n=209);409 (97%) received study drug through wk 14. Baseline demographic and disease characteristics were generally similar between treatment groups and refective of an active AS bDMARD-IR population (74% male;mean age 42.4 years;mean disease duration 7. 7 years;83% HLA-B27 positive;mean BASDAI 6.8). Signifcantly more pts achieved the primary endpoint of ASAS40 response at wk 14 with UPA vs PBO (45% vs 18%;P<0.0001;Figure 1);UPA showed onset of effect in ASAS40 as early as wk 4 (nominal P≤0.05). All multiplicity-controlled secondary endpoints met statistical signifcance for UPA vs PBO at wk 14 across multiple clinical domains of AS (P<0.0001;Figure 1). The rate of TEAEs was similar between treatment groups through wk 14 (UPA, 41%;PBO, 37%). TEAEs led to discontinuation in 3 (1.4%) pts treated with PBO and none with UPA. Serious infections occurred with UPA (2.4%) but not with PBO and included 4 events of COVID-19 and 1 event of uveitis. Additional events of uveitis were reported in 3 (1.4%) pts treated with PBO. Infammatory bowel disease (IBD) occurred in 1 (0.5%) pt on UPA and none on PBO. No malignancy, major adverse cardiovascular events, venous thromboembolic events, or death were reported with UPA;1 event of malignancy was observed with PBO. Conclusion: UPA 15 mg QD was signifcantly more effective than PBO over 14 wks of treatment in pts with active AS and IR to bDMARDs. No new safety risks were identifed with UPA compared with its known safety profile.3,4 These fndings are consistent with and complementary to those of SELECT-AXIS 1 (bDMARD-naïve AS population),1,2 and support the use of UPA in pts with active AS, including those who had a previous IR to bDMARD therapy.

IMPACT of SARS-COV-2 INFECTION on the DISEASE ACTIVITY of PATIENTS with PSORIATIC ARTHRITIS under BDMARDS: REAL LIFE DATA

Background: SARS-CoV-2 infection can lead to severe infammation and has been suggested to induce Psoriatic Arthritis (PsA) fares.1 However, the impact on disease activity and response to biological disease modifying anti-rheumatic drugs DMARDs (bDMARDs) remains unknown. Objectives: To evaluate the effect of SARS-CoV-2 infection on disease activity and bDMARDs responses in patients with PsA. Methods: We performed a retrospective analysis including all the patients with PsA, meeting the CASPAR criteria and under biologic therapy, followed in the Rheumatology department of a tertiary university hospital. Demographic and clinical data, including occurrence of SARS-CoV-2 infection, were collected from our national database (reuma.pt). Disease activity (CDAI, SDAI, DAS28 4v, BASDAI, ASDAS) and bDMARDs responses (EULAR, ASDAS, ASAS, ACR and PsARC responses) were evaluated before and after SARS-Cov-2 infection. Statistical analysis was performed with SPSS. Continuous variables were compared through paired samples t-test. Results: A total of 102 patients with PsA were included. Fifty-two were females (51%).The mean age was 53 ± 11.09 years and the median disease duration was 15 years [min 2, max 47]. Overall, 54 (53%) patients had predominant axial involvement, 26 (26%) peripheric and 36 (37%) enthesopathic. The most used bDMARD was etanercept (n=28, 27.5%) followed by adalimumab (n=22, 21.6%) and secukinumab (n=18, 17.6%). The prevalence of SARS-CoV-2 infection was 15.7% (n=16). Sixty-three per cent received the BNT162b2 (Pfzer/BioNtech) vaccine, 31% received mRNA-1273 (Moderna), 13% received AZD1222 (AstraZeneca) and 13% received AD26. COV2.S (Janssen/Johnson & Johnson). Sixty-three percent were infected before any vaccination, 13% after the frst dose and 25% after the second. The most common symptoms were anosmia (65%), dysgeusia (56%) and cough (56%). All patients fully recovered from the infection, with no need for hospitalization. Regardless of the score used, the difference between the mean disease activity after SARS-CoV-2 infection and that at baseline did not reach statistical significance. At baseline and after infection, mean (SD) disease activity parameters were, respectively: CDAI 8.6±5.7 vs 8.6±5.7, p=0.997;SDAI 9.3±6.6 vs 9.2±6.1, p=0,928;DAS 28 4v 2.9±1.2 vs 2.9 ±1.2, p= 0.818;BASDAI 3.6 ±2.6 vs 3.2±2.7, p=0.506;ASDAS 2.2±1.2 vs 2.2±1, p=0.721. The number of patients unresponsive to bDMARDs (according EULAR, ASDAS, ASAS, ACR and PsARC) before the infection wasn't different from post-infection. Conclusion: Our study suggests that SARS-CoV2 infection has no negative impact on PsA disease activity and bDMARD responses. However, more studies are still needed to better understand the long-term effects of SARS-CoV2 infection.

ANKYLOSING SPONDYLITIS and TELE-YOGA during COVID-19 PANDEMIC: PRELIMINARY RESULTS of A RANDOMIZED CONTROLLED TRIAL

Background: Yoga is an ancient discipline that emerged thousandans of years ago in India to unite the mind, body and spirit. Yoga is widely used by patients with various rheumatic diseases. Although it is recommended for ankylosing spondylitis (AS) patients, there is no randomized controlled study on this subject in the literature. Due to Covid-19, which has changed the world and the people's lifestyle, tele-yoga practice can be considered as an alternative to traditional face-to-face yoga classes. The use of online platforms provides a safe environment for yoga training at home. Objectives: The aim of this study was to investigate the effects of tele-yoga on disease activity, functional status, spinal mobility, sleep quality, depression, anxiety, stress and quality of life in ankylosing spondylitis patients. Methods: Thirty-six volunteer AS patients (21 male, 15 female) who applied to Dokuz Eylül University, Department of Internal Medicine, Division of Rheumatology and Immunology were included in the study. Participants were randomly assigned to a tele-yoga (n=18, mean age 43.22 ±8.54 years) or waiting-list control group (n=18, mean age 44.9 ±8.01 years) by block randomization method. Patients in the tele-yoga group participated in 1-hour tele-yoga sessions with a maximum of 5 people in each group using Zoom (online video-conference method) 3 days a week for 8 weeks. Assessments were performed before and after 8 weeks of yoga training. The waiting list control group did not receive any intervention, participants were advised to maintain their usual activities and continue their routine medical treatments. Assessments were performed at baseline and after an 8-week waiting period. After assessments, patients who wished participated the tele-yoga program. The following inventory was used for assessment: Bath AS Disease Activity Index (BASDAI) for disease activity, Bath AS Functional Index (BASFI) for functionality, Bath AS Mobility Index (BASMI) for spinal mobility, ASAS Health Index, Pittsburgh Sleep Quality Index (PSQI), Short Form-36 (SF-36), Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS). Results: The groups were similar at baseline in terms of age, height, weight, body mass index, gender and physical activity level (p>0.05). While all parameters improved signifcantly in the tele-yoga group (p<0.05), no change was observed in the control group after 8 weeks (p>0.05). When the changes in the tele-yoga group and the control group were compared, the improvements in the BASDAI, BASFI, BASMI, ASAS Health Index, SF-36 Physical Function, SF-36 Role Physical, SF-36-Bodily Pain, PSQI and PSS were found to be statistically signifcant in the tele-yoga group (p<0.05). Conclusion: According to our preliminary results, tele-yoga is benefcial in reducing disease activity and stress, improving functional level, spinal mobility, sleep quality and quality of life. Due to its therapeutic effects, tele-yoga can be considered as an alternative approach for AS patients.

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: 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 antirheu-matic drug (bDMARD) at week (wk) 56 in the phase 3 SELECT-PsA 2 study.1 Objectives: To evaluate the efficacy and safety of UPA at wk 104 from the ongoing long-term extension of SELECT-PsA 2. Methods: Pts were randomized to UPA 15 mg (UPA15), UPA 30 mg (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). Treatment-emergent 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 wks1 (Table 1). 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 (Figure 1) were consistent with that reported at wk 56.1 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 2 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 2 years of treatment. No new safety signals were identifed in this long-term extension.

COVID19 in SPONDYLOARTHRITIS PATIENTS under BDMARD-A COMPREHENSIVE ASSESSMENT

Background: SARS-Cov-2 infection had a major impact on patients with infam-matory rheumatic diseases. Spondyloarthritis (SpA) patients were one of the most affected groups of these patients. Objectives: To assess the impact of Covid19 in spondyloarthritis patients under biological disease modifying anti-rheumatic drugs (bDMARDs). Methods: A retrospective observational study was conducted using registry data of patients with SpA under bDMARD therapy, followed at a tertiary level hospital, that have been diagnosed with COVID19 from March 2019 to December 2021. At least one evaluation previous (t0) and two evaluations after SARS-CoV-2 infection (t1, t2) were included in our analysis. Sociodemographic, clinical, disease activity, therapeutic response, function and general health status data were collected. Statistical analysis (signifcance at p < 0.05) was performed using paired T-test, Wilcoxon test and McNemar tests for paired samples. Linear and logistic regression models were performed to assess direction and strength of association Results: Thirty-two patients with SpA under bDMARD had COVID19, mostly women (20, 62.5%), with a disease course time averaged 18.65 (± 9.69) years, mainly with axial involvement (19, 59.4%) and positive for HLA-B27 antigen (11, 64.7%). The majority were under TNF inhibitors (30, 93.75%), with golimumab being the most common (9, 28.1%), and with a median bDMARD persistence of 2.63 (5.09) years. Seven (21.9%) were under a cDMARD, 3 (9.4%) under NSAID and 18 (56.3%) under corticosteroids. Three (9.4%) were already vaccinated against SARS-CoV-2, 2 (66.6%) with the mRNA-1273 vaccine, presenting a medium time since inoculation of 240 (± 234.01) days. Arterial hypertension was the most common comorbidity (5, 15.6%) and one patient (3.1%) had a previous diagnosis of type 2 diabetes. Most were never-smokers (17, 53.1%) and never-drinkers (29, 90.6%). The average age at infection was 40.97 (± 6.15) years and the most common symptom was cough (22, 68.8%), followed by headache (20, 62.5%) and myalgia (19, 59.4%). Event tree analysis didn't show association with SpA subtype, education level, work status, tobacco or alcohol consumption. Only one patient needed hospital admission but without needing of oxygen, therapy, ventilator or ECMO. Only one patient had an overlaid bacterial infection and no thromboembolic complications were observed. Two patients needed specific SARS CoV-2 infection treatment, one with hydroxychloroquine and another with azithromycin. Twelve (37.5%) patients suspended bDMARD at the time of infection, with only 2 (6.3%) maintaining suspension at the time of the first post-infection visit. When comparing clinical variables, higher disease activity was seen at t1 only for BASDAI mean values, without statistical signifcance. Higher all domains VAS scores were also observed at t1, but not at t2, also without statistical signifcance;moreover, physical function didn't change signifcantly. No differences were observed according to gender or SpA subtype, nor with the use of cDMARDs, NSAIDs or corticosteroids. The only statistically signifcant difference concerned MASES score between t0 and t1 (1 ± 4 vs. 2 ± 6, p=0.04), but not between t0 and t2. Higher baseline tender joint score (p < 0.01) and higher baseline LEI (p=0.03) negatively correlated with MASES score variation. Several baseline variables correlated positively with MASES at t1, including female gender (p < 0.01), corticosteroid use (p = 0.04), BASDAI (p < 0.01), ASDAS-ESR (p < 0.01), ASDAS-CRP (p < 0.01), DAS28 (p < 0.01), SPARCC (p = 0.04), physician VAS (p = 0.03) and total spine VAS (p = 0.01). Working status varied signifcantly after SARS-Cov-2 infection (at least part-time-29, 90.6% vs. 22, 68.8%, p= 0.016). Conclusion: SpA patients on bDMARD had a mild course of SARS-CoV-2 infection, with slight changes in enthesitis score in the short term, the latter particularly in those with higher disease activity in the pre-infection period. Long-term effects on work status could represent confounding factors related to the e onomic constraints of the pandemic.

THE IMPACT of the COVID-19 PANDEMIC on WORK PRODUCTIVITY in PATIENTS with SPONDYLOARTHRITIS: RESULTS from the DUTCH SPA-NET REGISTRY

Background: Since early 2020, governments have initiated local and nationwide measures to contain the spread of the coronavirus disease 2019 (COVID-19). In the Netherlands, people were strongly recommended to work from home, and several work sectors were shut down. In addition, hospitals had to reduce regular care. These changes, together with the risk of contracting COVID-19 and becoming ill, could have affected people's employment perspectives and work productivity. It is unknown to what degree this affected persons with chronic disorders, such as spondyloarthritis (SpA). Objectives: To investigate whether work productivity in patients with SpA changed following the onset of the pandemic and the associated government-initiated containment measures in the Netherlands. Methods: Data from the Dutch eHealth monitoring system SpA-Net were used. Since 2016, patients in SpA-Net completed outcome measurements when they attended outpatient rheumatology visits. Employment and work productivity were assessed with the Work Productivity and Activity Impairment questionnaire (WPAI, work productivity loss range 0-100%), capturing both sick leave and reduced at-work productivity. Covariables of interest were age, gender, education (high vs. low) and disease activity (ASDAS, BASDAI, patient global). The proportions of patients employed and their work productivity losses were compared during a 1-year period before and after the onset of the pandemic (March 2020). Generalized Estimating Equations (GEE) analysis of all assessments over time explored if work productivity in employed patients had changed with the onset of the pandemic, adjusting for potential confounders. Similar analyses with disease activity as outcome were used to facilitate interpretation of work productivity results. Results: Of 238 patients, data were available during the 1-year period both before and after onset of the pandemic. Pre-pandemic, 128 (54%) patients were employed. These employed patients had a mean age of 49.0 (SD 10.2) years, 66 (54%) were male and the mean ASDAS was 2.1 (0.9). After the onset of the pandemic, 7 (5.5%) were no longer employed. In addition, 8 out of 110 (7.3%) originally unemployed patients had become employed by this time. Work productivity loss (0-100%) was worse after the onset of the pandemic (37.0) compared to the pre-pandemic year (27.0) (p<0.01). In multivariable GEEs with work productivity loss as outcome (and stratifed by education due to interaction), patients with low education had work productivity losses that were almost 10% (absolute) higher after onset of the pandemic compared to pre-pandemic (B = 9.57, 95%CI 5.63-13.51) (Table 1). This was independent of ASDAS and other confounders. In patients with high education, however, no such association between pandemic onset and work productivity was seen. Analyses adjusting for other measures of disease activity (BASDAI, patient global) showed similar results. In GEEs with disease activity as outcome, disease activity before and after pandemic onset did not differ (B =-0.05, 95%CI-0.15 to 0.06 for ASDAS, model not shown). Conclusion: Work productivity has worsened in patients with SpA since the onset of the pandemic, especially in patients with lower educational attainment, while disease activity remained stable. Care should be taken to support patients in their work role during the pandemic, and thereafter.

IMPACT OF INTERMEDIATE TREATMENT INTERRUPTION ON SECUKINUMAB EFFICACY IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS AND ANKYLOSING SPONDYLITIS: INTERIM ANALYSIS RESULTS FROM THE SERENA STUDY

Background/Aims Secukinumab has demonstrated long-lasting efficacy and a favorable safety profile in patients with psoriatic arthritis (PsA) and ankylosing spondylitis (AS). SERENA is an ongoing, longitudinal, observational study in>2900 patients with moderate to severe psoriasis, active PsA, and AS. We report interim data on impact of intermediate treatment interruption on secukinumab effectiveness in patients with active PsA or AS. Methods This analysis included data for 534 PsA and 470 AS patients enrolled in SERENA between Oct 2016 and Oct 2018 and followed-up for at least 2 years. Patients (≥18 years) with active PsA or AS were required to have received ≥16 weeks of secukinumab treatment before enrolment. Treatment interruption was defined as interruption of secukinumab therapy for at least 3 months between the last injection and re-initiation. Effectiveness assessments included swollen and tender joint count in PsA patients, and Patient Global Assessment (PtGA) and BASDAI score in AS patients before and during treatment interruption and post secukinumab re-initiation. Patients with assessments in≥2 of the time periods were included. Last assessment prior to intermediate treatment interruption was used as baseline. The assessment closest to 6 months after re-initiation was considered the post-secukinumab re-initiation assessment. Results A total of 31 (5.8%) PsA patients and 42 (8.9%) AS patients had an intermediate treatment interruption since initiation of secukinumab treatment. The mean (SD) duration of treatment interruption was 24.8 (16.4) and 26.4 (22.9) weeks for PsA and AS patients, respectively. The mean (SD) duration of secukinumab treatment before the treatment interruption was 86.8 (50.3) and 90.2 (46.9) weeks, and after the treatment interruption was 73.6 (44.4) and 63.2 (46.8) weeks. The most commonly reported reasons included adverse events (AEs;18 [58.1%] PsA, 19 [45.2%] AS), patient decision (3 [9.7%] PsA, 3 [7.1%] AS), and COVID-19 outbreak-related reasons (1 [3.2%] PsA, 6 [14.3%] AS patients). More than 80% of PsA patients and 76% of AS patients reinitiated secukinumab without a loading phase after the treatment interruption. The swollen and tender joint count increased in PsA patients from the last assessment prior to the treatment interruption (1.3 [1.0] and 7.2 [11.4];n=6) to the first assessment during the treatment interruption (4.0 [1.4] and 16.5 [19.1];n=2), and gradually decreased post secukinumab re-initiation (0.4 [0.5] and 2.0 [0.7];n=5). PtGA and BASDAI remained stable in AS patients from the last assessment prior to the treatment interruption to the first assessment during the treatment interruption and after secukinumab re-initiation. Conclusion Secukinumab intermediate treatment interruption occurred due to a variety of reasons in the real-world setting, mainly AEs and patient decision. Most patients re-initiated secukinumab treatment without a loading phase. No notable impact of the intermediate treatment interruption was observed on the effectiveness of secukinumab.