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

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

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.

[How many patients with inflammatory rheumatic diseases have the technical prerequisites for video consultations and are also willing to use this to carry out visits by medical specialist visits?] / Wie viele Patienten mit entzündlich rheumatischen Erkrankungen haben die technischen Voraussetzungen für Videosprechstunden und sind bereit, fachärztliche Visiten so durchzuführen?

BACKGROUND: The currently disseminating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and limited capacities in outpatient rheumatological care, pose questions about possible alternatives to clinical visits, also in view of the digital revolution. It is unclear whether and to what extent patients with inflammatory rheumatic diseases are willing and in a position to deal with the new media, such as video consultation. METHODS: In the middle of the pandemic in May 2020 outpatients were surveyed using a standardized questionnaire in order to document their possibilities and willingness to participate in a video consultation. The treating physicians were asked whether carrying out a video consultation was considered to be a possible and meaningful option. RESULTS: Overall, 232 patients with inflammatory rheumatic diseases were surveyed (64.7% female, average age 54.0 ± 15.2 years), seropositive (n = 58) and seronegative (n = 51) rheumatoid arthritis (RA), spondyloarthritis (SpA, n = 77) including axial SpA (axSpA) and psoriatic arthropathy (PsA) as well as collagenosis and vasculitis (CoV, n = 46). The mean duration of disease was 5.5 ± 8.2 years, whereby in 75 patients (32.3%) it was the first diagnosis. The mean disease activity (0-10, subjective patient self-estimation) was 4.7 ± 2.5. Overall, 176 patients were basically aware of the possibility to carry out video consultations (75.9%) and 166 considered that they were technically capable to participate (71.6%) but only 131 were principally willing to participate (56.5%). Logistic regression analyses showed that the willingness to participate in video consultations decreased with increasing age (ß = 0.28, p = 0.01). According to the medical estimation video consultations were thought to be principally possible for 161 patients for technical reasons (69.4%) and for 127 for medical reasons (54.7%); however, a video consultation within the framework of treatment was only considered to be meaningful by the physician for 76 patients (32.8%). CONCLUSION: Not all patients can or want to participate in video consultations and the willingness declines with increasing age. The estimation of the meaningfulness of video consultations by physicians was also limited to approximately one third of the patients surveyed. This must be taken into consideration for the future planning of video consultations.

Efficacité d'upadacitinib chez des patients atteints de spondyloarthrite axiale non radiographique en fonction des signes objectifs d'inflammation à l'inclusion

L'essai de phase 3 SELECT-AXIS 2 (NCT04169373) a évalué l'efficacité et la tolérance d'upadacitinib (UPA) chez des patients atteints de spondyloarthrite axiale non radiographique (nr-axSpA). Nous présentons ici une analyse en sous-groupes (ss-gpes) en fonction de la valeur de la hsCRP et de l'inflammation des sacro-iliaques (SI) à l'IRM à la sélection. Dans SELECT-AXIS 2 [1] , des patients de ≥ 18 ans ayant un diagnostic clinique de nr-axSpA remplissant les critères de classification de 2009 de l'ASAS, mais sans le critère radiologique des critères de New-York modifiés, et présentant des signes objectifs d'inflammation active à l'IRM selon la définition de l'ASAS (évaluation par 2 lecteurs et un arbitre) et/ou un taux de hsCRP supérieur à la limite supérieure de la normale (LSN, 2,87 mg/L) à la sélection, ont été randomisés selon un ratio 1/1 pour recevoir UPA 15 mg 1x/j ou un placebo (PBO). Le critère principal était la réponse ASAS40 à la semaine (S) 14. Les autres critères incluaient la faible activité de la maladie (LDA) selon l'ASDAS (≤ 2,1), la variation par rapport à l'inclusion du SPARCC-IRM articulations SI, du BASFI et de la douleur rachidienne évaluée par le patient, à S14. Les analyses en ss-gpes préspécifiées (ASAS40) et post-hoc (autres critères) ont été réalisées en fonction du statut inflammatoire à la sélection : taux de hsCRP (> LSN vs ≤ LSN) et inflammation des articulations SI à l'IRM (positive vs négative). L'imputation des non-répondeurs (NRI) avec imputation multiple (MI) pour prendre en compte des données manquantes liées au COVID-19, a été utilisée pour les variables binaires. Un modèle mixte pour mesures répétées sur les données observées (AO) a été utilisé pour les variables continues sauf pour le score SPARCC-IRM pour lequel une analyse de covariance sur les AO a été utilisée. Sur les 312 patients inclus dans l'analyse, 176 (56 %) avaient une hsCRP > LSN et une IRM négative (IRM−), 73 (23 %) une hsCRP > LSN et une IRM positive (IRM+) et 63 (20 %) une hsCRP ≤ LSN et une IRM+. Les caractéristiques démographiques et cliniques à l'inclusion étaient similaires dans les ss-gpes ;cependant, le ss-gpe hsCRP > LSN et IRM+ était plus fréquent chez les patients HLA-B27 positifs et avait un plus faible taux de traitement antérieur par DMARDs biologiques (Tableau 1). À S14, des taux plus élevés de réponse ASAS40 et ASDAS-LDA et une réduction plus importante par rapport à l'inclusion des scores SPARCC-IRM, BASFI et de douleur rachidienne ont été associés à UPA vs PBO pour tous les ss-gpes (Fig. 1). La différence UPA vs PBO était plus importante pour le groupe hsCRP > LSN et IRM+, pour tous les critères. Dans SELECT-AXIS 2, les résultats chez les patients atteints de nr-axSpA ont été améliorés pour UPA versus le PBO pour tous les sous-groupes d'inflammation à l'inclusion ;le bénéfice le plus important a été observé chez les patients ayant à la fois un taux élevé de CRP et des signes d'inflammation à l'IRM à la sélection. (French) [ FROM AUTHOR]

SOURCES of INFORMATION about SARS-COV-2 USED by PATIENTS with CHRONIC INFLAMMATORY RHEUMATIC DISEASES (CIRD)

Background: Patients with chronic infammatory rheumatic diseases (CIRD) may be at increased risk of Corona Virus Disease 2019 (COVID-19).1 The quality of information obtained plays a crucial role for patients' decision to be vaccinated. Knowing patients' needs for information and which sources are used is important for the management of CIRD patients by rheumatologists and other physicians. Objectives: To identify main sources of information on SARS-CoV-2 used by patients with CIRD and to analyze their influence on opinions and willingness to be vaccinated. Methods: CIRD patients presenting to our tertiary rheumatology hospital were, after informed consent, consecutively included in the study once the vaccination campaign in Germany had started, to fll out a questionnaire. Next to sociode-mographic and disease-specifc data, vaccination willingness and knowledge regarding SARS-CoV-2 were assessed. Furthermore, patients' sources of information and their concerns about accuracy of information were evaluated. A numerical rating scale (NRS) ranging from 0 (completely disagree) to 10 (completely agree) was used. Values between ≥7 were taken as positive answer. Nonparametric tests and multivariate linear regression analyses were performed. Results: In early 2021, a total of 514 patients were interviewed (Table 1). The majority (63.9 %) reported to be well-informed (NRS ≥7), whereas 18% had doubts regarding information on SARS-CoV-2. The most often used source of information was television, and only 8.6% reported to have been informed by a rheumatologist (Figure 1). About 20% of patients were no longer interested in receiving any information on SARS-CoV-2 through media. Information from rheumatologists, general practitioners, public health authorities or health related web sites did not reach 30.5% of patients. Of interest, 16% of subjectively well-informed patients were hesitant towards vaccination. As many as 43.6% of patients with doubts regarding information about SARS-CoV-2 indicated that they were not willing to be vaccinated. No source of information showed a strong correlation with SARS-CoV-2 vaccination willingness or with knowledge on SARS-CoV-2. Weak positive correlations were found between age and education level on the one hand and information sources about SARS-CoV-2 on the other hand. A weak negative correlation was found between doubts about information and health authorities, whereas positive correlations were found with social networks, friends and family. Conclusion: Most CIRD patients think that they are well-informed about SARS-CoV-2. However, their information rarely comes from expert-based sources and rarely from rheumatologists. Thus, there is an unmet need for CIRD patients to receive appropriate and comprehensive information about SARS-CoV-2, its infu-ence on rheumatic diseases, and about vaccination of patients with CIRD.

SARS-COV-2 VACCINATION WILLINGNESS and PREDICTORS in PATIENTS with CHRONIC INFLAMMATORY RHEUMATIC DISEASES (CIRD) and WITHOUT CIRD

Background: Recent surveys in chronic infammatory rheumatic diseases (CIRD) showed a high degree of vaccine hesitancy. Current knowledge about patients' attitudes towards vaccination against SARS-CoV-2 is limited. Objectives: To assess the willingness of CIRD patients to be vaccinated against SARS-CoV-2 and to identify influencing factors compared to non-CIRD patients. Methods: In this cross-sectional study, two cohorts of consecutively in parallel recruited patients with and without CIRD presenting to our tertiary hospital answered questions of a structured interview to assess vaccination willingness to SARS-CoV-2, experience with SARS-CoV2 in their environment and their personal history of infections and vaccinations. Vaccination willingness was assessed by a numerical rating scale (0: fully disagree;10: fully agree). Arbitrarily defned cut-offs were used to defne defnite (score ≥7) and probable willingness (scores of 5 or 6) to be vaccinated. Statistical analyses were performed with appropriate tests such as Kendall-tau b. Results: A total of 514 CIRD and 100 non-CIRD patients, mean age 54.7±12.8 and 55.6±9.8 years, were included. Defnite and probable willingness to be vaccinated against SARS-CoV-2 was declared by 79.6% and 90.7% vs. 76.0% and 85.0% of CIRD and non-CIRD patients, respectively. Only 60% of CIRD patients believed that the vaccines against SARS-CoV-2 were safe, and 42% indicated to be afraid of side effects. Vaccination willingness correlated signifcantly with the degree of education, age, identifcation with a risk group for COVID-19 disease, hypertension, and the degree of information about preventable diseases. There was no correlation with the history of infections or with immunosuppressive therapy. Conclusion: Although our results show a high willingness for vaccination against SARS-CoV-2 in both groups, there was quite some uncertainty regarding the safety and efficacy of the vaccines. Since major influencing factors were education and information about SARS-CoV-2 and COVID-19, patient education should be immediately improved.

DIFFERENT HUMORAL but SIMILAR CELLULAR RESPONSES of PATIENTS with AUTOIMMUNE INFLAMMATORY RHEUMATIC DISEASES under DISEASE-MODIFYING ANTI-RHEUMATIC DRUGS after COVID-19 VACCINATION

Background: The interplay between humoral and cellular response after vaccination against SARS-CoV-2 in patients (pts.) with autoimmune infammatory rheumatic diseases (AIRD) remains unknown. Objectives: To investigate the impact of different immunosuppressive therapies on the development of humoral and cellular immune responses to full 2-dose SARS-CoV-2 vaccination in AIRD pts. with stable low disease activity. Methods: The immune reactivity to COVID-19 vaccination was investigated in a prospectively recruited AIRD cohort with rheumatoid arthritis, axial spondy-loarthritis or psoriatic arthritis which received a therapy with IL-17i, TNFi, JAKi or MTX (alone or in combination). Almost all patients received mRNA-based vaccine, only 4 patients had a heterologous scheme. Anti-spike(S) antibodies(ab.) and sera neutralizing capacity (neutralization dilution 50;ND50) were measured 4 weeks after the frst (prime+4w) and 4 weeks after the second vaccination (boost+4w). Vaccine-specifc cellular immunity was evaluated by quantifying expression of activation markers on T cells as well as their production of key cytokines, at prime+4w and boost+4w. Results: Overall, a total of 92 pts. were included in the fnal cohort. 31 (33.7%) pts. were on TNFi, 24 (26.1%) on IL-17i, 24 (26.1%) on JAKi, each group encompassing pts. receiving drug inhibitors alone or in combination with MTX.13 (14.1%) were treated with MTX alone. The median time between the vaccination and blood sampling was 31 [IQR: 28-34] days after prime+4w and 28 [IRQ: 28-28] days after boost+4w. Although at prime+4w only 34/90 (37.8%) of pts. presented neutralizing ab., the majority (86/91, 94.5%), developed them at boost+4w. The highest neutralization titer developed the pts. on IL-17i both at prime+4w (74 [IQR: 13-91]) and boost+4w (798 [IQR: 511-1344]), while no statistically signifcant differences were found in the neutralization titer at boost+4w for the TNFi, JAKi, and MTX groups: 207 ND50 [IQR: 120-576], 319 [IQR: 133-461] and 749 [IQR: 264-1920], respectively. 81/90 (90.0%) pts. developed IgG ab. against SARS-CoV-2 S-protein at prime+4w and 91/92 (98.9%) at boost+4w. Pts. receiving IL-17i developed higher ab. titers (8295 U/mL [IQR: 4586-11,237]) compared to the other three groups: JAKi (4405 U/mL [IQR: 1436-7265], TNFi (2313 [IQR: 1156-3630] U/mL) and MTX (2010 U/mL [IQR: 693-9254]). Neutralization capacity correlated well with the titer of anti-S ab. at both timepoints. Co-administration of biologic/tsDMARDs and MTX led to lower titers compared to biologic/tsDMARDs mon-otherapy. All therapies left frequencies of CD154+CD137+ CD4+ T cells and CD137+ CD8+ T cells at prime+4w and boost+4w unchanged. Polyfunction-ality and T cell cytokine profiles across therapies did not signifcantly vary at boost+4w. Conclusion: Even after insufficient seroconversion for neutralizing capacity and ab. response against SARS-CoV-2 S-proteins between pts. of different mod of action agents, particularly for MTX and JAKi after frst vaccination, a second vaccination covered almost all pts. regardless of DMARDs therapy, with better outcomes in those on IL-17I. T cell immunity revealed similar frequencies of activated T cells in all modes of action after the second vaccination.

PERFORMANCE of AN EARLY TRIAGE SYSTEM for IDENTIFICATION of PATIENTS with INFLAMMATORY RHEUMATIC DISEASES

Background: The preselection of patients with suspicion of an infammatory rheumatic disease is not easy for general practitioners and orthopedists. In countries with a limited number of practicing rheumatologists waiting lists are often long, since a full rheumatologic examination often needs a long consultation time. Objectives: To test the performance of an early triage strategy for early identif-cation of patients with infammatory rheumatic diseases. Methods: Prior to the SARS-CoV 2 pandemic, physicians caring for patients contacting a tertiary rheumatologic cente were frst contacted by a health-care professional (HPR) who offered an appointment the timing of which was based on the symptoms reported (Step 1). Patients were then seen by a rheumatolo-gist who, within a 10-minute consultation (Step 2), shortly examined the patient to determine the urgency of a planned full work up. The main outcome of the study was the comparison between the initial assessment and the fnal expert diagnosis (Step 3). Results: Within 9 months, physicians caring for 1.180 patients contacted the hospital, 972 of whom kept their appointment (82.4%). Most patients were transferred by GPs (73.1%) and orthopedists (22.1%). The mean time between Step 1 and Step 2 was 10.4 days, while 6.2% of patients were seen within 4 days, 24.4% within 7 days and 69.3% within 12 weeks. Only 36 patients (3.7%) of patients had an already established rheumatic disease. Complaints lasting between 0-4 weeks were reported by 69 (7.1%), of > 4-12 weeks by 100 (10.3%), and of > 12 weeks by 973 (82.6%) patients. Almost 90% of patients reported a pain intensity >4/10 (NRS) for < 2 weeks. An elevated CRP was found in 207 patients (24.5%). Prior treatment with glucocorticoids was reported in 163 (16.8%) and with NSAIDs in 730 (75.1% of) patients. The confirmed diagnosis at Step 3 was rheumatoid arthritis in 127 (13.1%), spondyloarthritis including pso-riatic arthritis in 72 (7.4%), systemic diseases including connective tissue diseases in 112 (11.5%), vasculitides in 41 (4.2%), and crystal arthropathy in 38 (3.9%) patients, while 38 (3.9%) had an infection, a malignancy or a differential diagnosis such as Raynaud's phenomenon or sicca syndrome. Degenerative joint diseases (n=254;26.1%) and non-inflammatory soft tissue syndromes such as fibromyalgia (n=369;38%) accounted for more than half of the patients. Conclusion: This study describes the performance of a standardized triage system hereby confrming the need for an early identifcation and preselection of patients with rheumatic musculoskeletal symptoms, including involvement of HPRs in the initial phase of contact. Based on the results, three patients with musculoskeletal complaints had to be examined in order to identify one patient with an infammatory rheumatic disease.

FACILITATORS and BARRIERS of VACCINE UPTAKE in PATIENTS with CHRONIC INFLAMMATORY RHEUMATIC DISEASE: A SCOPING REVIEW

Background: Patients with chronic infammatory rheumatic diseases (CIRD) remain underrepresented in receiving vaccinations despite being disproportionately affected by infectious complications. Objectives: To systematically review the literature regarding vaccination willingness and vaccination hesitancy in CIRD patients with focus on the perspective of patients and physicians. Methods: A scoping review was conducted in PUBMED, EMBASE and the Cochrane Library through 2021. Study selection was performed by two independent reviewers, data were extracted using a standardized form and risk of bias was assessed using instruments from the McMaster University. Identifed barriers and hurdles were synthesized by categorizing them into the WHO's Measuring Behavioural and Social Drivers of Vaccination (BeSD) conceptual model. Results: The search yielded 1,644 hits, of which 30 were included (cross-sectional studies (n=27) based on interviews and 3 intervention studies). The majority of studies reported barriers to infuenza and pneumococcal vaccination (n=11), or infuenza vaccination only (n=9) from the patients perspective. Two studies assessed the attitudes towards COVID-19 vaccinations. Only one study assessed the view of rheumatologists. Patients mainly mentioned behavioral and social factors that negatively influence their willingness to be vaccinated while physicians see defcits in the organization and lack of time as a major barrier. Coverage of domains matched to the BeSD model suggests a lack of awareness of infection risk by both patients and physicians (Figure 1). Conclusion: The view of vaccination in CIRD patients diverges between patients and rheumatologists. Our results show that in-depth counseling on vaccines is important for patients, whereas physicians need support in implementing specifc immunization recommendations. The themes identifed provide a starting point for future interventions to improve vaccine rates in CIRD patients.

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.

VACCINATION of PATIENTS with CHRONIC INFLAMMATORY RHEUMATIC DISEASES: AN ANALYSIS of BARRIERS and FACILITATORS in A PROSPECTIVE COHORT

Background: Patients (pts.) with chronic infammatory rheumatic diseases (CIRD) are often not adequately protected against infectious diseases. As shown in an earlier study, less than 50% of CIRD pts. were vaccinated against pneumo-cocci and infuenza before the SARS-CoV2 pandemic started 1. High vaccination rates are critical to achieve herd immunity. Knowledge on barriers and facilitators of vaccine uptake in CIRD pts. is limited. Objectives: The aim of this study was to characterize barriers and facilitators towards vaccines in general and specifcally against pneumococci, infuenza and SARS-CoV-2 in adult CIRD pts. Methods: In early 2021, consecutive CIRD pts. completed a structured questionnaire including knowledge on vaccination, attitudes, and perceived barriers and facilitators towards vaccination. A total of 12 facilitators and 11 barriers towards vaccination was assessed in general, and specifcally for vaccination against pneumococci, infuenza and SARS-CoV2. The Likert scales had 4 response options, ranging from 1 (completely disagree) to 4 (completely agree). Patient and disease characteristics, their vaccination history and attitudes towards vaccination against SARS-CoV-2 were assessed. Results: Of 514 prospectively recruited pts., 441 responded (85.8%) to the questionnaire (table 1). Self-reported vaccine uptake was 48.8% against pneumococci and 66.2% against seasonal influenza. The majority (82.2%) was willing to be vaccinated against SARS-CoV-2. The majority (≥70%) had decent knowledge about vaccination, and only <10% doubted its effectiveness. The level of knowledge did not differ between the studied 3 vaccinations. Pts. were more likely to rate statements about facilitators favorably compared to statements about barriers. Facilitators for SARS-CoV-2 vaccination did not different from vaccination in general (Figure 1). Societal and organizational facilitators such as public vaccine campaigns or protection for high-risk pts. were more commonly named compared to inter-or intrapersonal facilitators. Protection of high-risk pts. was by far the most frequently cited facilitator. Most pts. indicated that they were likely to receive a vaccine if their health care professional would recommend it-without preference for GP or rheumatologist. The frequency of barriers was much lower compared to facilitators and more barriers towards SARS-CoV-2 vaccination were reported in comparison to vaccination in general or pneumococci and influenza, respectively. However, pts. frequently cited intrapersonal issues as barriers against vaccination. Importantly, the major barrier was an inadequate risk perception between the severity of COVID-19 and the potential adverse events of the vaccine. Conclusion: A relatively high number of pts. was vaccinated against pneumo-cocci and infuenza,-a probable campaign success during the last years. In addition, more than 80% of pts. were willing to be vaccinated against SARS-CoV2. Facilitators were of greater signifcance than barriers in this scenario. The high number of societal and organizational facilitators enables the implementation of effective strategies to increase future vaccination rates.

Changes of immunosuppressive medication because of COVID-19 by patients with chronic inflammatory rheumatic diseases: anxiety was not a major driver

OBJECTIVES: To study treatment decisions of patients with chronic inflammatory rheumatic diseases (CIRD) at the beginning of the SARS- CoV-2 pandemic in relation to disease characteristics with focus on anxiety. METHODS: A total of 970 CIRD patients diagnosed with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriasis arthritis (PsA) and connective tissue diseases (CTD), selected from our records who had presented to our hospital at least twice during last year, were contacted by telephone to be asked about medication changes, health status and therapy satisfaction. Standardised tools were used to assess disease activity, anxiety and depression, the latter by Hospital Anxiety and Depression Score (HADS) with a score >=8 denoting definite anxiety and/or depression. The cut-off for RADAI was set at >=3.2 and for BASDAI >=4. Compliance with prevention rules and vaccination status were assessed. RESULTS: Complete interviews of 557 patients (57.4%) made between April and July 2020 were available for analysis. The median age was 55 (47-63), disease duration 9.0 (4.5-17.0) years, 61.9% females. A recent change in medication was reported by 197 patients (35.4%), 51.2% of which admitted that this decision was mainly made due to the pandemic with more changes occurring with bDMARDs (21.8%) than cDMARDs (6.6%) and corticosteroids (5.4%). There was no major difference between patients who changed because of the pandemic or self-reported inactive disease versus patients who did not change therapy regarding disease activity, depression and anxiety (41%, 17.2%, 31.3% vs. 47.5%, 22.5%, 35.0% vs. 48.9%, 27.7%, 34.1%). More than 90% of patients reported that they rigorously followed Corona prevention rules. The majority of patients were vaccinated against influenza (55.3%) and pneumococci (61.3%), respectively. CONCLUSIONS: Anxiety, depression and disease activity did not play an important role in decisions favouring change of therapy, even though many patients changed medication due to the pandemic. Patients probably protected themselves by strictly adhering to hygiene recommendations. Vaccination rates against influenza and pneumococci were better than previously reported, but still too low.

[Are SARS-CoV-2 reactive T cells detectable and potentially protective in patients under anti-CD20 treatment with an impaired humoral response?] / Sind SARS-CoV-2-reaktive T­Zellen bei Patienten unter Anti-CD20-Therapie mit einer beeinträchtigten humoralen Antwort nachweisbar und potenziell protektiv?

The pandemic attributable to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has greatly changed life in most countries of the world for more than 1.5 years now. The spread could be more or less well-controlled and fatalities could partly be avoided by obligatory wearing of masks, contact restrictions and since the beginning of the year by vaccinations. Patients with chronic inflammatory diseases and organ transplant patients under immunosuppression, are somewhat more at risk to become ill with coronavirus disease 2019 (COVID-19). The probability and severity of an infection depends on the ability of the humoral and cellular immune systems to effectively combat the virus. This can be substantially improved by vaccination. The B cell depleting monoclonal antibody rituximab (RTX) is frequently employed in rheumatic diseases, whereby antibody formation against the new pathogen within the framework of vaccination is restricted. Recent study results in patients treated with RTX indicate that an effective cellular immune response can be developed despite the impaired humoral response.

SARS-CoV-2 outbreak in autoimmune diseases: The euro-covimid study

Background: Coronavirus disease 2019 (COVID-19), has raised several questions in patients with immune-mediated inflammatory diseases (IMID). Whether the seroprevalence and factors associated with symptomatic COVID-19 are similar in IMID patients and in the general population is still unknown. Objectives: To assess the serological and clinical prevalence of COVID-19 in European IMID patients, along with the factors associated with its risk and the impacts the pandemic had on the IMID management. Methods: Prospective multicentre cross-sectional study among patients with five IMID (i.e. systemic lupus erythematous, Sjögren's syndrome, rheumatoid arthritis, axial spondylarthritis or giant cell arteritis) from six tertiary-referral centers from France, Germany, Italy, Portugal, Spain and United Kingdom. Demographics, comorbidities, IMID, treatments, flares and COVID-19 details were collected. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests were systematically performed. Results: Between June 7 and December 8, 2020, 3028 patients were included (median age 58 years, 73.9% females). SARS-CoV-2 antibodies were detected in 166 (5.5%) patients. Symptomatic COVID-19 was seen in 122 patients (prevalence: 4.0%, 95% CI 3.4-4.8%);23 (24.2%) of them were hospitalized and four (3.2%) died. In multivariate logistic regression analysis, symptomatic COVID-19 was more likely to be observed in patients with higher levels of C-reactive protein (OR: 1.18;95% CI 1.05-1.33;p = 0.006), and increased with the number of IMID flares (OR: 1.27;95% CI 1.02-1.58;p = 0.03). Conversely, it was less likely to occur in patients treated with biological therapy (OR: 0.51;95% CI 0.32-0.82;p = 0.006). During the pandemic, at least one self-reported disease flare was seen in 654 (21.6%) patients. Also, 519 (20.6%) patients experienced changes in their treatment, with 125 of these (24.1%) being due to COVID-19. Conclusion: The SARS-CoV-2 prevalence in IMID patients over the study period seems to be similar to that of the general population1. The IMID inflammatory status seems to be independently associated with the development of COVID-19.

Less than 20% of patients with a chronic inflammatory rheumatic disease changed their immunosuppressive medication because of the COVID 19 pandemic

Background: The best treatment options of patients with chronic inflammatory rheumatic diseases (CIRD) in the pandemic have not been completely clear, especially in the beginning of the lockdown. Whether and to which degree pandemic-related therapy changes have occurred, has not been studied in detail. Objectives: To study the behaviour of patients with CIRD initially facing the COVID 19 pandemic related to their disease status and medication. Methods: Patients with CIRD were contacted by telephone to assess their health status and ask for changes in medication. Standardized assessment tools were used to assess disease activity, depression and anxiety. High disease activity was assumed if RADAI-5 ≥ 3.2 and BASDAI ≥ 4. Anxiety (HADS-A) and depression (HADS-D) of patients were assessed using HADS. A score < 8 was taken as indication of no major problem in this regard. Results: A total of 886 patients was interviewed between April 15 and June 15 of 2020. Here we report on 550 patients with complete information on standard assessments (62%). About 60% were female, mean age 54.4±13.7, mean disease duration 12.2±10.5 years. Most had spondyloarthritis (SpA, n=287) including axial SpA (axSpA, n=172) and psoriatic arthritis (PsA, n=116), in total 52.2%, while 40.2% had rheumatoid arthritis (RA, n=221), and 7.6% connective tissue diseases (CTD, n=42). Most RA patients were on methotrexate (48.8%), while 43.8% took glucocorticoids. In addition, 61.0% of patients were on bDMARDs, mostly on TNF inhibitors (59.6%). More SpA than RA patients were on bDMARDs: 71.0% vs 49.7% respectively. A recent change in medication was reported by 182 patients (33.1%): 89 with RA (40.2%), 88 with SpA (30.6%) and 5 with CTD (11.9%). Half of those who changed (n=92;50.5%) admitted that the change was mainly made due to fear of the pandemic (16.7% of all patients). Altogether, significantly more patients changed bDMARDs (68.5%) than csDMARDs (57.3%). The data of patients who changed vs patients who didn't change is shown in the Table 1, including subgroup analyses. The median HADS scores were < 8. Conclusion: Two thirds of patients did not change medication but one third changed. A relatively high number of patients did so due to fear of the pandemic, mostly those on biologics. There were no major differences between RA and SpA. Anxiety and depression do not seem to play an important role for the decision to change medication (Table 1 below).

[Threat of a SARS-CoV-2 endemic in a large hospital specialized in rheumatic diseases-relative all clear through consistent testing]. / Drohende Corona-Endemie in einer rheumatologischen Spezialklinik ­ relative Entwarnung durch konsequente Testung.

The severe acute respiratory coronavirus type 2 (SARS-CoV-2) pandemic is keeping most countries of the world in suspense. In Germany the prevalence of SARS-CoV­2 infections is under 2% but for weeks the numbers in Germany have also been increasing. The care in rheumatology was temporarily impaired by the first wave of the pandemic. This article reports the infection situation in the largest specialized rheumatology clinic in Germany, the Rheumatism Center Ruhrgebiet, because recently during the second wave for the first time several SARS-CoV­2 infections occurred here over one weekend, which led to considerable anxiety in many of those involved. The situation could be clarified by consistent testing of patients and personnel with the rapid antigen test and the situation could be mollified. Ultimately, only a few persons were tested positive and the courses by the patients have so far remained bland. This shows the effectiveness of the protective hygiene measures consistently implemented since April.