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Abstract Objectives To analyse clinical outcomes of a non-medical switch from originator adalimumab (ADA) to its ABP501 biosimilar (ABP) over 6 months in patients with inflammatory rheumatic musculoskeletal diseases (RMD) in relation to comorbidity as a risk factor for therapy discontinuation. Methods RMD patients switching from originator ADA to ABP were identified from a large routine database from October 2018 onwards. Documented clinical data at the time of non-medical switching (baseline), and at 3 and 6 months were collected. Comorbidities were represented by the Charlson Comorbidity Index (CCI) at baseline and patients were categorized based on CCI > 0. Differences in the ABP retention rate over 6 months between patients with CCI = 0 and patients with CCI > 0 were analysed using Bayesian exponential regression. Results A total of 111 patients with axial spondyloarthritis (n = 68), rheumatoid arthritis (n = 23) and psoriatic arthritis (n = 15), were identified, 74.8% of whom had continued treatment with ABP after 6 months, while a smaller proportion had either switched to another ADA biosimilar (10.8%), switched back to originator ADA (7.2%), switched to a different biologic (3.6%), or dropped out (3.6%). At baseline, a CCI > 0 was found in 38% of patients. Cardiovascular comorbidities (40%) were most prevalent followed by diseases of the skin (33%), the gastrointestinal tract (20%) and the eye (20%). ABP treatment was continued after 6 months in 74% of patients with CCI = 0 and in 76% with CCI > 0. Bayesian analysis showed only a small difference (months) in the APB continuation rate between groups (estimate 0.0012, 95% credible interval (CrI) -0.0337 to 0.0361). Adjusting for age, sex, and disease subtype revealed somewhat shorter retention rates for patients with CCI > 0, but the distribution of the difference included 0 (estimate -0.0689, 95% CrI -0.2246 to 0.0234). Conclusion In a non-medical switch scenario of RMD patients, there was no evidence for a considerable difference in ABP retention rates over 6 months between comorbidity groups.

Abstract Objective Define the prevalence and location of inflammatory and structural lesions on magnetic resonance imaging (MRI) in patients with rheumatoid arthritis (RA) and radiographic axial spondyloarthritis (r-axSpA) with neck pain as leading clinical symptom. Methods Patients with diagnosis of RA and r-axSpA were consecutively included if they had chronic (> 3 months) neck pain. Clinical assessment, neck pain questionnaires and MRIs of the cervical spine (CS) were performed. Results 107 patients (59 RA and 48 r-axSpA) were included. While there was no difference in the Northwick-Park-Neck-Pain-questionnaire, patients with RA reported higher neck pain compared to r-axSpA on a numeric rating scale (5.0 ± 3.6 vs. 3.0 ± 3.1; p = 0.003). Inflammatory lesions occurred predominantly in the craniocervical area in RA and in the lower CS segments in r-axSpA. Bone marrow edema (BME) was more frequent in axSpA (BME-score axSpA/RA: 0.35vs0.17; p

Background: Patients with axial spondyloarthritis (axSpA) are often compromised by impaired function and mobility. The standardized 2-week inpatient program ‘multimodal rheumatologic complex treatment’ (MRCT) was designed for patients with axSpA. The Epionics SPINE (ES) is an objective tool validated to assess mobility. Objective: To investigate the impact of MRCT on physical function and mobility including range of motion (RoM) and kinematics (RoK). Design: Single-center interventional, observational trial. Methods: Patients with axSpA presenting with high disease activity and impaired physical function were consecutively recruited to undergo MRCT. Assessments performed before (V1) and after (V2) the intervention included Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis functional index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), the ankylosing spondylitis physical performance index (ASPI), the Short Physical Performance Battery (SPPB), and ES measurements. Results: At baseline, the 80 patients included had: BASDAI 5.5 ± 1.5, BASFI 5.6 ± 2.0, BASMI 4.2 ± 1.8, SPPB 13.8 ± 1.8, and ASPI 37.3 ± 18.1 s. Clinically relevant improvements between V1 versus V2 were noted for BASFI, BASMI, and all other assessments ( p 0.05). Conclusion: The 2-weeks MRCT was associated with definite improvements of function and mobility. Importantly, the effect of this extensive physical activity was confirmed by using the ES as an objective tool to assess spinal mobility. The ES demonstrated for the first time that the RoK of spinal mobility can significantly improve related to an exercise intervention. Trial registration: Ethical Committee: Ruhr-Universität (reference-number: 19-6735-BR).

Objective Interim analysis of the RELIANCE registry, an on-going, non-interventional, open-label, multicentre, prospective study evaluating the long-term safety, dosing regimens and effectiveness of canakinumab in patients with cryopyrin-associated periodic syndromes (CAPS), familial Mediterranean fever (FMF), tumour-necrosis factor receptor-associated periodic syndrome (TRAPS) or mevalonate-kinase deficiency (MKD)/hyperimmunoglobulin-D syndrome (HIDS).Methods From September 2017 for patients with CAPS, and June 2018 for patients with FMF, TRAPS or MKD/HIDS, the registry enrolled paediatric (aged ≥2 years) and adult patients (aged ≥18 years) receiving canakinumab as part of their routine medical care. Safety, canakinumab dose, disease activity and quality of life outcome measures were evaluated at baseline and every 6 months until end of study visit.Results At the analysis cut-off date (December 2020), 168 patients (91 CAPS, 54 FMF, 16 TRAPS and 7 MKD/HIDS) were enrolled. 85 (50.9%) patients were female and 72 (43.1%) were children (SD of canakinumab was observed in the pooled population. The majority of patients were reported as having either absent or mild/moderate disease activity (physician’s global assessment) from baseline to Month 30, with a stable proportion of patients (~70%) in remission under canakinumab treatment. Patient-reported disease activity (Visual Analogue Scale (VAS), Autoinflammatory Disease Activity Index), fatigue (VAS); markers of inflammation (C-reactive protein, serum amyloid A and erythrocyte sedimentation rate) remained well-controlled throughout.Conclusion Data from this analysis confirm the long-term safety and effectiveness of canakinumab for the treatment of CAPS, FMF, TRAPS and MKD/HIDS.

Objective Patients with axial spondyloarthritis (axSpA) suffer from clinical symptoms like morning stiffness and back pain. Mobility of patients with axSpA is often impaired. The aim of this study is to compare the performance of patients with axSpA regarding mobility measures including performance-based tests and objective electronic assessments with the Epionics SPINE device (ES) at different times of the day compared with healthy controls (HC).Methods Observational trial, consecutive inpatients with axSpA (n=100) and 20 HCs were examined in the morning (V1: before 10:00 am) and in the afternoon (V2: after 02:00 pm) by the Bath Ankylosing Spondylitis Metrology Index (BASMI), the AS physical performance index (ASPI), the Short Physical Performance Battery (SPPB) and ES measurements, including range of motion (RoM) and range of kinematics (RoK).Results The assessments of patients with axSpA performed in the morning clearly differed from those in the afternoon, especially regarding performance-based tests. Significant improvements were seen for BASMI (4.0±3.8 to 3.8±1.9; p

Background: Previous experiences with non-medical switching of adalimumab (ADA) in patients with chronic inflammatory rheumatic diseases (CIRD) come mainly from phase III extension of randomised clinical trials and little from routine care. Objectives: To analyse treatment trajectories over 2 years in patients with CIRD conducting a non-medical switch from originator to biosimilar ADA. Design: A retrospective observational cohort study was conducted with data from a third-level rheumatology centre in Germany. CIRD patients on originator ADA who switched to ADA biosimilar from October 2018 onwards were identified and followed until September 2020. Methods: Patients’ characteristics were compared between the four a priori defined treatment trajectories ‘continued biosimilar ADA therapy’, ‘back-switch to originator ADA therapy’, ‘switch to another biological disease-modifying anti-rheumatic drug (bDMARD) therapy’ and ‘stopped bDMARD therapy/death/drop out’. Factors associated with continuing biosimilar ADA therapy were analysed using Cox proportional hazards regression analyses. Results: A total of 121 CIRD patients were included. Most patients (66.9%) continued therapy with biosimilar ADA over 2 years, with a treatment retention rate of 73.1%. Whereas 21 patients (17.4%) switched back to originator ADA, mainly due to adverse events, and 8 patients (6.6%) switched to a different bDMARD, mainly due to lack of effect. The estimated risk of withdrawal was lower for longer prior duration on originator ADA [hazard ratio (HR): 0.82; 95% CI: 0.69–0.97] and higher for higher C-reactive protein levels at baseline (HR: 1.18; 95% CI: 1.00–1.39). Male patients, older patients and those for whom originator ADA was their first bDMARD tended to have a lower risk of withdrawal. Conclusion: Our results indicated that three of four patients continue biosimilar ADA over 2 years with lower risks of withdrawal for male sex, older age, longer prior duration on originator ADA and originator ADA as first bDMARD.

Introduction To identify facilitators and barriers towards vaccination in general and specifically against pneumococci, influenza and SARS-CoV-2 in patients with rheumatic musculoskeletal diseases (RMD).Methods Between February and April 2021, consecutive patients with RMD were asked to complete a structured questionnaire on general knowledge about vaccination, personal attitudes and perceived facilitators and barriers towards vaccination. General facilitators (n=12) and barriers (n=15) and more specific ones for vaccination against pneumococci, influenza and SARS-CoV-2 were assessed. Likert scales had four response options: from 1 (completely disagree) to 4 (completely agree). Patient and disease characteristics, their vaccination records and attitudes towards vaccination against SARS-CoV-2 were assessed.Results 441 patients responded to the questionnaire. Knowledge about vaccination was decent in ≥70% of patients, but

Objective To analyse the clinical profile of SARS-CoV-2 breakthrough infections in at least double-vaccinated patients with inflammatory rheumatic diseases (IRDs).Methods Data from the physician-reported German COVID-19-IRD registry collected between February 2021 and July 2022 were analysed. SARS-CoV-2 cases were stratified according to patients’ vaccination status as being not vaccinated, double-vaccinated or triple-vaccinated prior to SARS-CoV-2 infection and descriptively compared. Independent associations between demographic and disease features and outcome of breakthrough infections were estimated by multivariable logistic regression.Results In total, 2314 cases were included in the analysis (unvaccinated n=923, double-vaccinated n=551, triple-vaccinated n=803, quadruple-vaccinated n=37). SARS-CoV-2 infections occurred after a median of 151 (range 14–347) days in patients being double-vaccinated, and after 88 (range 14–270) days in those with a third vaccination. Hospitalisation was required in 15% of unvaccinated, 8% of double-vaccinated and 3% of triple-vaccinated/quadruple-vaccinated patients (p

Background: Biosimilar disease-modifying anti-rheumatic drugs (bsDMARDs) has created a financial incentive to encourage switching to cheaper products. Objectives: We aim to study the effectiveness and safety of a non-medical bsDMARD-to-bsDMARD switch from originator etanercept (ETN) to bsDMARD ETN (SB4) and successive to another bsDMARD ETN (GP2015) in patients with chronic inflammatory rheumatic diseases in a real-life setting. Methods: Retrospective chart review of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) who had been treated with originator ETN and were switched twice to ETN bsDMARD for non-medical reasons thereafter. All patients received ETN 50 mg/week. Disease activity and physical function was assessed every 12 weeks with standardized questionnaires. Results: A total of 100 patients who switched twice [54 RA, 27 axSpA, 19 PsA, mean age 54.3 (15.1), 46% male] were included. Patients with axSpA were younger than RA and PsA patients. Patients with SpA were less likely to receive conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) than RA patients. Duration of treatment with originator ETN before the first switch was 3.3 (2.3) years. Retention rate 6 months after the second ETN bsDMARD switch was 89%. Disease activity and physical function scores remained rather unchanged in patients with RA and axSpA longitudinally, while there was some more fluctuation in PsA patients. Six patients lost efficacy and were switched back to originator ETN in month 6 ( n = 4) or to another mode of action ( n = 2). There were 14 adverse events (AE) reported in eight patients. One patient re-administered bsDMARD GP2015 successfully 3 months after healing of mucosal erosions. Conclusion: No relevant change in disease activity and physical function were observed in a non-medical bsDMARD-to-bsDMARD switch scenario. The retention rate after switches from originator ETN to two ETN bsDMARD was close to 90%. Multiple switches resulted in a high adherence rate without clinically important efficacy or safety signals.

Background: Recent surveys in chronic inflammatory rheumatic diseases (CIRD) showed a high degree of vaccine hesitancy. Current knowledge about patients’ attitudes toward 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 the influencing factors compared with non-CIRD patients. Methods: In this cross-sectional study, two cohorts of consecutive patients with and without CIRD were recruited in parallel when presenting to our tertiary hospital and asked to answer questions of a structured interview to assess vaccination willingness to SARS-CoV-2 their experience with SARS-CoV-2 and their personal history of infections and vaccinations. Vaccination willingness was assessed using a numerical rating scale (0: fully disagree; 10: fully agree). Arbitrarily defined cut-offs were used to define definite (score ⩾7) and probable willingness (score of 5 or 6) to be vaccinated. Factors associated with willingness were assessed using Kendall’s tau- b correlation measure and linear regression analysis. Results: A total of 514 CIRD and 100 non-CIRD patients, mean age of 54.7 ± 12.8 and 55.6 ± 9.8 years, respectively, were included. Definite and probable willingness to be vaccinated against SARS-CoV-2 was declared by 79.6% and 90.7% versus 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 was significantly correlated with being in a risk group for COVID-19 (tau- b = −0.149), hypertension (tau- b = 0.14), and information about disease prevention (tau- b = 0.19), while a history of infections or immunosuppressive therapy was not. Vaccination willingness was significantly associated with higher education ( b = 0.65) and age ( b = 0.06). Conclusion: This survey highlights several predictors of relevance for the vaccination willingness of patients with CIRD and controls including appropriate information about its relevance. The good news, however, is that the vast majority of CIRD patients indicated their willingness to be vaccinated. However, there was some uncertainty regarding the safety and efficacy of the vaccines. Since the major influencing factors were education and information about SARS-CoV-2 Vaccine and COVID-19 Disease, patient education should be improved soon.

Objective To evaluate the prevalence of infections, prevalence of hospitalisation due to infections, the vaccination status and perceived screening of infections prior to the start of biologic disease modifying antirheumatic drugs (bDMARDs) of a patient cohort with chronic inflammatory rheumatic diseases (CIRD).Methods Consecutive CIRD patients reporting to our specialised centre were prospectively included (n=975) in this cross-sectional study. Data on comorbidities including infections, treatment, vaccination status, screening for latent tuberculosis infection (LTBI) and hepatitis B (HepB) were collected. Antibodies against measles and HepB were measured by ELISA. The vaccination status was assessed by a predefined vaccination score (0–26) categorising patients into four immunisation states: low (0–6), moderate (7–13), good (14–20), high (21–26).Results All patients on bDMARDs (n=499) were screened for LTBI, and 469 for HepB (94%). All LTBI patients (n=16) received isoniazid (3.2%) and 16 chronic HepB patients received lamivudine (3.4%). Protective measles specific IgG-antibodies were found in 901 patients (92.4%). Although 629 patients were educated about vaccination strategies (64.5%), only 540 showed a vaccination card (55.4%). Only 49% of patients had undergone pneumococcal vaccination and less than 30% were protected against HepB and influenza, while 7.6% have not protective antibody titres against measles. No patient met the German national vaccination recommendations requiring a complete documentation of vaccines. The mean vaccination score was 13.3±4.2 with 5.7% of patients having a low, 43.9% a moderate, 47.0% a good and 3.3% a high score.Conclusions The majority of CIRD patients are n0t sufficiently vaccinated against pneumococci, HepB, influenza and measles. Although CIRD patients and general practitioners regularly receive professional information about the need of vaccination, vaccination rates were low to moderate. Interdisciplinary quality projects should be planned to change that inacceptable result.