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Background MRI is frequently used for early diagnosis of axial spondyloarthritis (axSpA). However, evaluation is time-consuming and requires profound expertise because noninflammatory degenerative changes can mimic axSpA, and early signs may therefore be missed. Deep neural networks could function as assistance for axSpA detection. Purpose To create a deep neural network to detect MRI changes in sacroiliac joints indicative of axSpA. Materials and Methods This retrospective multicenter study included MRI examinations of five cohorts of patients with clinical suspicion of axSpA collected at university and community hospitals between January 2006 and September 2020. Data from four cohorts were used as the training set, and data from one cohort as the external test set. Each MRI examination in the training and test sets was scored by six and seven raters, respectively, for inflammatory changes (bone marrow edema, enthesitis) and structural changes (erosions, sclerosis). A deep learning tool to detect changes indicative of axSpA was developed. First, a neural network to homogenize the images, then a classification network were trained. Performance was evaluated with use of area under the receiver operating characteristic curve (AUC), sensitivity, and specificity.

Objectives In radiographic axial spondyloarthritis (r-axSpA), spinal damage manifests as syndesmophytes and facet joint ankylosis (FJA). We evaluated whether the presence of one lesion increased the risk of the other lesion. Methods Patients with r-axSpA underwent low-dose CT (ldCT) and MRI of the whole spine at baseline and 2 years. On ldCT, vertebrae were scored for presence and size of syndesmophytes; facet joints were assessed for ankylosis. MR images were assessed for inflammation. Two hypotheses were tested: (i) presence of FJA is associated with new syndesmophyte(s) on the same vertebral unit (VU) 2 years later, and (ii) presence of bridging syndesmophyte(s) is associated with new FJA on the same VU 2 years later. Two generalized estimating equations models were tested per hypothesis using increase of FJA/syndesmophytes (model A) or presence of FJA/syndesmophytes (model B) as outcome, adjusted for inflammation at baseline. Secondary analyses tested the hypotheses with outcomes on adjacent VUs and dose–response effects. Results Fifty-one patients were included (mean age 49, 84% male, 82% HLA-B27+). Baseline bridging syndesmophytes occurred more often (range: 10–60% per VU) than FJA (range: 8–36%). Odds ratios (ORs) (95% CI) for presence of bridging syndesmophytes on development of FJA were 3.55 (2.03, 6.21) for model A and 3.30 (2.14, 5.09) for model B. ORs for presence of baseline FJA on new syndesmophytes were 1.87 (1.20, 2.92) for model A and 1.69 (0.88, 3.22) for model B. Secondary analyses yielded positive ORs for both hypotheses. Conclusions Bone formation in vertebrae and in facet joints influence each other’s occurrence, with the effect of syndesmophytes being larger than that of FJA.

Objective To assess the effect of filgotinib, which preferentially inhibits Janus kinase 1 (JAK1), on MRI measures of structural change in the SI joint in patients with active AS in the TORTUGA trial. Methods Adults with active AS and inadequate response/intolerance to two or more NSAIDs were randomized 1:1 to filgotinib 200 mg (n = 58) or placebo (n = 58) once daily for 12 weeks. In this post hoc analysis, T1-weighted MRI scans of the SI joint were evaluated by two independent readers using Spondyloarthritis Research Consortium of Canada (SPARCC) Sacroiliac Joint Structural Score (SSS) definitions for erosion, backfill, fat metaplasia and ankylosis. Correlations between SPARCC SSS and improvement in clinical outcomes were also assessed. Results MRI scans from 87 patients (48 filgotinib, 39 placebo) were evaluated. At baseline there were no notable differences between filgotinib and placebo for any MRI structural lesion types. From baseline to week 12, filgotinib was associated with a significant reduction in SI joint erosion score (P = 0.02) and an increase in backfill score (P = 0.005) vs placebo, with no significant between-group differences for ankylosis (P = 0.46) or fat metaplasia (P = 0.17). At week 12, the change in SPARCC MRI SI joint inflammation scores correlated positively with erosion scores but negatively with backfill scores. Conclusion The significant changes in MRI structural lesions induced by filgotinib in the SI joint by week 12 demonstrate that tissue repair can be observed very soon after starting treatment with a JAK1 preferential inhibitor. This could have prognostic implications for development of ankylosis. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov, NCT03117270

ObjectiveTo investigate the performance of a health app with respect to usability, adherence, and equivalence of data in daily care of patients with axial spondyloarthritis (axSpA).MethodsConsecutive patients with axSpA were asked to export patient-reported outcomes (PRO) electronically with the AxSpA Live App regularly every 2 weeks over a period of 6 months. The first clinical visit was followed by 2 further personal visits after 3 and 6 months. Patients completed paper-based PRO at every visit; they also completed the Mobile App Rating Scale and the System Usability Scale after 3 and 6 months.ResultsOf 103 patients with axSpA, 69 agreed to participate (67.0%): age 41.5 (11.3) years, 58.0% male, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 4.3 (2.0), and 76.8% treated with biologic disease-modifying antirheumatic drugs. Patients’ adherence to regular app exports was 29.0% and 28.4% after 3 and 6 months, respectively. Significant predictors for good adherence were high disease activity (P = 0.02) and older age (P = 0.04). No systematic differences between digital and paper-based BASDAI scores were found (intraclass correlation coefficients 0.99 [95% CI 0.98-0.99]). Performance of the app was rated as good.ConclusionCollection of digital PROs by AxSpA Live App may be successfully used in patients with axSpA with high disease activity. Our study showed equivalence of digital data, but adherence to the app after 6 months was poor. Higher disease activity and older age resulted in increased adherence to the app. This suggests that the use of health apps like this should concentrate on more severely affected patients.

Objective To evaluate response rates at week 16 with ixekizumab in patients with radiographic axial SpA (r-axSpA) and elevated or normal/low baseline inflammation measured by serum CRP or spinal MRI using data from two randomized, double-blind, placebo (PBO)-controlled phase III trials. Methods Biologic-naïve (COAST-V) or TNF inhibitor-experienced (COAST-W) adults with active r-axSpA received 80 mg ixekizumab every 2 weeks (IXEQ2W) or 4 weeks (IXEQ4W) or PBO or active reference [40 mg adalimumab every 2 weeks (ADAQ2W) in COAST-V. At week 16, patients receiving ixekizumab continued as assigned and patients receiving PBO or ADA were rerandomized 1:1 to IXEQ2W or IXEQ4W through week 52. Assessment of SpondyloArthritis international Society 40% (ASAS40) response rates were examined by baseline CRP (≤5 or >5 mg/l) and Spondyloarthritis Research Consortium of Canada (SPARCC) MRI spine inflammation score ( Results In the COAST-V/W integrated dataset (N = 567), significantly more patients treated with ixekizumab achieved ASAS40 response at week 16 by CRP ≤5 mg/l (27% IXEQ4W, P 5 mg/l (39% IXEQ4W, P Conclusion Ixekizumab demonstrated efficacy in the treatment of AS/r-axSpA in patients with and without elevated CRP or evidence of spinal inflammation on MRI. Trial registration ClinicalTrials.gov (https://clinicaltrials.gov): NCT02696785, NCT02696798

BACKGROUND: The current core outcome set for ankylosing spondylitis (AS) has had only minor adaptations since its development 20 years ago. Considering the significant advances in this field during the preceding decades, an update of this core set is necessary.OBJECTIVE: To update the ASAS-OMERACT core outcome set for AS into the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA).METHODS: Following OMERACT and COMET guidelines, an international working group representing key stakeholders (patients, rheumatologists, health professionals, pharmaceutical industry and drug regulatory agency representatives) defined the core domain set for axSpA. The development process consisted of: i) Identifying candidate domains using a systematic literature review and qualitative studies; ii) Selection of the most relevant domains for different stakeholders through a 3-round Delphi survey involving axSpA patients and axSpA experts; iii) Consensus and voting by ASAS; iv) Endorsement by OMERACT. Two scenarios are considered based on the type of therapy investigated in the trial: symptom modifying therapies and disease modifying therapies.RESULTS: The updated core outcome set for axSpA includes 7 mandatory domains for all trials (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health, and adverse events including death). There are 3 additional domains (extra-musculoskeletal manifestations, peripheral manifestations and structural damage) that are mandatory for disease modifying therapies and important but optional for symptom modifying therapies. Finally, 3 other domains (spinal mobility, sleep, and work and employment) are defined as important but optional domains for all trials.CONCLUSION: The ASAS-OMERACT core domain set for AS has been updated into the ASAS-OMERACT core domain set for axSpA. The next step is the selection of instruments for each domain.

Axial SpA (axSpA) is a common rheumatic disease characterized by inflammation leading to bone formation and functional impairment. TNF-α and IL-17 represent established targets in axSpA. TNF-α and IL-17 inhibitors have demonstrated efficacy in clinical trials and are currently approved biologic DMARDs for all subsets of the disease. Several lines of evidence implicate a role of an IL-23–IL-17 axis in the disease pathogenesis. In this light, and given the success of IL-17 blockade in axSpA, a similar good response to IL-23 was anticipated. Nevertheless, two clinical trials of anti-IL-23 monoclonal antibodies in axSpA have clearly exhibited negative results. This failure has raised theories for a degree of IL-23 independent pathway. The Janus kinase (JAK) pathway is also a potential therapeutic target, since several cytokines, including those involved in the IL-23–IL-17 axis, signal through the JAK family of tyrosine kinases. Further studies and more extended evaluation of response to cytokine inhibition across different tissues will be required to improve our understanding of SpA pathogenesis and determine its optimal management.

To evaluate the effectiveness and safety of non-medical switching from reference to biosimilar etanercept in adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) using different information strategies before switching.Data of adult patients with RA, PsA or axSpA who had received reference etanercept were retrospectively analysed. Whether or not patients were informed about the switch from reference to biosimilar etanercept was left to the discretion of the treating rheumatologist. Disease activity and function were regularly assessed in two consecutive visits (week 12 and 24). The scores documented at week 12 week after the switch were defined as primary outcome. Adverse drug events (ADE) were documented.Data of 84 patients were available (44 RA, 25 axSpA and 15 PsA patients), of whom 24 had been informed about the planned switch (28.5%). The scores at week 12 of disease activity and function remained rather unchanged. Neither outcomes nor frequency of ADE were influenced by information strategy. The retention rate was high (96.4% at week 12, 87.6% at week 24). Seven patients were lost to follow-up, and six patients discontinued due to inefficacy or ADE. 18 ADEs were reported in 10 patients (12%). In 3 patients (3.6%) who had 5 ADEs in the first 12 weeks the reference etanercept was successfully readministered.Systematic switch from reference to biosimilar etanercept was not associated with changes in disease activity or function in. This was independent of information on the switch transmitted to the patients.

Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disease that manifests primarily in the axial skeleton, initially mostly in the sacroiliac joints (SIJ), usually later spreading to the spine. The disease is characterised by inflammation and new bone formation which are mainly assessed by conventional radiography (CR) and magnetic resonance imaging (MRI). Tumour necrosis factor inhibitors (TNFi) and interleukin-17 antagonists have been shown to be efficacious and efficient in patients with axSpA. This treatment seems to also inhibit structural damage, for example, retard radiographic progression. Indeed, a reduction of new bone formation in the spine, as assessed by CR, has been reported to occur after at least 2 years of therapy with TNFi. Recently, a reduction of erosions and ankylosis in the SIJ has also been observed in axSpA patients treated with etanercept and filgotinib. In this narrative review, we discuss the limited significance of such findings.

Objectives To assess the effects of filgotinib on inflammatory and structural changes at various spinal locations, based on MRI measures in patients with active AS in the TORTUGA trial. Methods In the TORTUGA trial, patients with AS received filgotinib 200 mg (n = 58) or placebo (n = 58) once daily for 12 weeks. In this post hoc analysis, spine MRIs were evaluated using the Canada–Denmark (CANDEN) MRI scoring system to assess changes from baseline to week 12 in total spine and subscores for inflammation, fat, erosion and new bone formation (NBF) at various anatomical locations. Correlations were assessed between CANDEN inflammation and clinical outcomes and Spondyloarthritis Research Consortium of Canada (SPARCC) MRI scores and between baseline CANDEN NBF and baseline BASFI and BASMI scores. Results MRIs from 47 filgotinib- and 41 placebo-treated patients were evaluated. There were significantly larger reductions with filgotinib vs placebo in total spine inflammation score and most inflammation subscores, including posterolateral elements (costovertebral joints, transverse/spinous processes, soft tissues), facet joints and vertebral bodies. No significant differences were observed for corner or non-corner vertebral body inflammation subscores, spine fat lesion, bone erosion or NBF scores. In the filgotinib group, the change from baseline in the total inflammation score correlated positively with the SPARCC spine score. Baseline NBF scores correlated with baseline BASMI but not BASFI scores. Conclusions Compared with placebo, filgotinib treatment was associated with significant reductions in MRI measures of spinal inflammation, including in vertebral bodies, facet joints and posterolateral elements. Trial registration ClinicalTrials.gov (https://clinicaltrials.gov), NCT03117270.

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.Die durch das SARS-CoV-2-Virus bedingte Pandemie hat das Leben in den meisten Ländern der Welt seit über 1,5 Jahren ziemlich stark verändert. Durch Maskenpflicht und Kontakteinschränkungen sowie seit Anfang dieses Jahres auch durch Impfungen konnte die Ausbreitung mehr oder weniger gut kontrolliert werden, und Todesfälle konnten zum Teil verhindert werden. Patienten mit chronisch entzündlichen Erkrankungen und Transplantierte unter Immunsuppression sind wohl etwas mehr gefährdet, an COVID-19 zu erkranken. Die Wahrscheinlichkeit einer Infektion bzw. ihres Schwergrades hängt von der Fähigkeit des humoralen und des zellulären Immunsystems ab, das Virus effektiv zu bekämpfen. Diese kann durch Vakzinierung erheblich verbessert werden. Der B‑Zell-depletierende monoklonale Antikörper Rituximab (RTX) wird bei rheumatischen Erkrankungen häufig eingesetzt, wodurch die Antikörperbildung gegen neue Pathogene im Rahmen von Vakzinierungen eingeschränkt wird. Neuere Studienergebnisse bei mit RTX behandelten Patienten deuten darauf hin, dass trotz der beeinträchtigten humoralen Antwort nach erfolgter Impfung, eine effektive zelluläre Immunantwort ausgebildet werden kann.

ObjectiveEpionics SPINE (ES), a novel device that measures spinal movements using electronic sensors including range of motion (RoM) and speed (range of kinematics [RoK]), has already been validated in patients with mechanical back pain and healthy individuals. This study aimed to evaluate ES for quantification of spinal mobility in patients with axial spondyloarthritis (axSpA).MethodsA total of 153 individuals, 39 female and 114 male, were examined including 134 patients with axSpA, of whom 40 had nonradiographic (nr)-axSpA, 94 had radiographic (r)-axSpA; 19 were healthy controls (HCs). The results were compared using mean ES scores and modeling was performed using multivariable logistic regression models resulting in good validity and high discriminative power.ResultsES measurements showed meaningful differences between patients with axSpA and HCs (all P < 0.001), as well as between r- and nr-axSpA (P < 0.01). In patients with axSpA, a negative correlation between ES and Bath Ankylosing Spondylitis Metrology Index values was found: –0.76 ≤ r ≤ –0.52 (P < 0.05). Bath Ankylosing Spondylitis Functional Index scores showed a similar trend (r > –0.39). Patients with r-axSpA had a more limited and slower spinal mobility than those with nr-axSpA. Other patient-reported outcomes almost did not correlate.ConclusionThis study shows that the ES is an objective performance measure and a valid tool to assess spinal mobility in axSpA, also based on the Outcomes Measures in Rheumatology (OMERACT) criteria. RoK and RoM scores provide additional information on physical function of patients with axSpA.

Sodium magnetic resonance imaging (MRI) can be used to evaluate the change in the proteoglycan content in Achilles tendons (ATs) of patients with different AT pathologies by measuring the 23Na signal-to-noise ratio (SNR). As 23Na SNR alone is difficult to compare between different studies, because of the high influence of hardware configurations and sequence settings on the SNR, we further set out to measure the apparent tissue sodium content (aTSC) in the AT as a better comparable parameter. Ten healthy controls and one patient with tendinopathy in the AT were examined using a clinical 3 Tesla (T) MRI scanner in conjunction with a dual tuned 1H/23Na surface coil to measure 23Na SNR and aTSC in their ATs. 23Na T1 and T2* of the AT were also measured for three controls to correct for different relaxation behavior. The results were as follows: 23Na SNR = 11.7 ± 2.2, aTSC = 82.2 ± 13.9 mM, 23Na T1 = 20.4 ± 2.4 ms, 23Na T2s* = 1.4 ± 0.4 ms, and 23Na T2l* = 13.9 ± 0.8 ms for the whole AT of healthy controls with significant regional differences. These are the first reported aTSCs and 23Na relaxation times for the AT using sodium MRI and may serve for future comparability in different studies regarding examinations of diseased ATs with sodium MRI.

Background Axial involvement constitutes a specific domain of psoriatic arthritis (PsA). Interleukin (IL)-23 inhibitors have demonstrated improvement in axial PsA (axPsA) symptoms, but have not shown efficacy in treating ankylosing spondylitis (AS), suggesting differences in axPsA processes and treatments. In a post hoc, pooled analysis of patients with investigator- and imaging-confirmed sacroiliitis in two phase 3, randomized, placebo-controlled studies (DISCOVER-1 and DISCOVER-2), patients treated with guselkumab, an IL-23p19 inhibitor, had greater axial symptom improvements compared with placebo. Confirmatory imaging at baseline was restricted to the sacroiliac (SI) joints, occurred prior to/at screening, and was locally read. Methods The STAR study will prospectively assess efficacy outcomes in PsA patients with magnetic resonance imaging (MRI)-confirmed axial inflammation. Eligible, biologic-naïve patients with PsA (N = 405) for ≥ 6 months and active disease (≥ 3 swollen and ≥ 3 tender joints, C-reactive protein [CRP] ≥ 0.3 mg/dL) despite prior non-biologic disease-modifying antirheumatic drugs, apremilast, and/or nonsteroidal anti-inflammatory drugs will be randomized (1:1:1) to guselkumab every 4 weeks (Q4W); guselkumab at week (W) 0, W4, then every 8 weeks (Q8W); or placebo with crossover to guselkumab at W24, W28, then Q8W. Patients will have Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4, spinal pain component score (0–10 visual analog scale) ≥ 4, and screening MRI-confirmed axial involvement (positive spine and/or SI joints according to centrally read Spondyloarthritis Research Consortium of Canada [SPARCC] score ≥ 3 in ≥ 1 region). The primary endpoint is mean change from baseline in BASDAI at W24; multiplicity controlled secondary endpoints at W24 include AS Disease Activity Score employing CRP (ASDAS), Disease Activity Index for PsA (DAPSA), Health Assessment Questionnaire – Disability Index (HAQ-DI), Investigator’s Global Assessment of skin disease (IGA), and mean changes from baseline in MRI SI joint SPARCC scores. Centrally read MRIs of spine and SI joints (scored using SPARCC) will be obtained at W0, W24, and W52, with readers blinded to treatment group and timepoint. Treatment group comparisons will be performed using a Cochran-Mantel-Haenszel or chi-square test for binary endpoints and analysis of covariance, mixed model for repeated measures, or constrained longitudinal data analysis for continuous endpoints. Discussion This study will evaluate the ability of guselkumab to reduce both axial symptoms and inflammation in patients with active PsA. Trial registration This trial was registered at ClinicalTrials.gov, NCT04929210, on 18 June 2021. Protocol version: Version 1.0 dated 14 April 2021.

In patients with axial spondyloarthritis (axSpA), pain, functional and structural impairments, reduced mobility and potential deformity of the axial skeleton are the most prominent health concerns. Limitations in physical function and spinal mobility are caused by both inflammation and structural damage, and therefore restrictions to physical function must be monitored throughout a patient's life. Consequently, the assessment of physical function is recommended as a key domain in the Assessment of Spondyloarthritis International Society-OMERACT Core Outcome Set. However, in comparison with disease activity, physical function seems to be a relatively neglected target of intervention in patients with axSpA, even though physical function is a major contributor to costs and disability in this disease. This Review aims to reacquaint rheumatologists with the targets for physical function, physical activity and performance by giving guidance on determinants of physical function and how physical function can be examined in patients with axSpA.

Spondyloarthritis (SpA) is one of the most complex rheumatological diseases to diagnose and treat because, in the early stages of the disease, the inflammatory low back pain is often difficult to identify, and patients are diagnosed when they already have advanced structural processes. There is an urgent need to establish healthcare models that allow optimization of the management of these patients. The objective of this work is to propose a care model that is adaptable to the factual realities of Latin America. A systematic search of the literature terms (MeSH) was performed to search associated terms. Taking the model of the REAL-PANLAR project as an example and incorporating some related literature, a model of centers of excellence for SpA in Latin America is proposed that can be reasonably established and implemented. This model proposes 3 types of centers of excellence for SpA according to the level of complexity of each institution, and its criteria are defined based on indicators of structure, processes, and results. This is the first effort in Latin America to try to standardize the care of patients with spondyloarthritis. Key Points • The unmet needs in Latin America in the care of SpondyloArthritis (SpA), demand solutions that facilitate the rapid and assertive access of patients to specialized centers such as Center of Excellence in SpA. • This project facilitates the standardization of high-quality care for patients with SpA, starting from its diagnosis and up to clinical follow-up. • Due to standardization of care, better clinical and safety outcomes are achieved for patients, as well as patient-reported outcomes. • By standardized models of care, will be achieved a reduction in the progress of this pathology and optimization in the use of high-complexity services and high-cost therapies, improving cost-efficiency for public health systems in each country.

Diagnosing peripheral spondyloarthritis (pSpA) remains a significant challenge due to the lack of specific disease biomarkers and the overlap with other SpA subtypes, mainly psoriatic arthritis (PsA), which represents a diagnostic challenge particularly in the absence of skin psoriasis (PsAsine psoriase). This narrative review aimed to compare the epidemiology, genetic susceptibility, pathophysiology, classification criteria, disease phenotype and burden, and therapeutic guidelines between patients diagnosed with pSpA and those with PsAsine psoriase,to determine if the two entities should be considered jointly or distinctly. Globally, pSpA appears to be more inclusive compared with PsAsine psoriase. Areas of similarities include age of onset, number of joints involved and prevalence of axial involvement. However, patients with pSpA have a male gender predominance, a higher prevalence of HLA-B27, enthesitis and involvement of large joints of the lower limbs, whereas patients with PsAsine psoriasehave a higher prevalence HLA-Cw6, dactylitis and involvement of hand distal interphalangeal joints. Therefore, the difference between pSpA and PsAsine psoriasegoes beyond semantics. The few dissimilarities should drive scientific efforts to reach a better characterisation of pSpA as an individual disease. Accordingly, randomised clinical trials should target patients with well-defined pSpA to identify effective therapies in this population.

ObjectivesTo investigate the associations between MRI detected vertebral corner inflammation (VCI) and vertebral corner fat deposition (VCFD) on whole spine low-dose CT scan (ldCT) detected syndesmophyte formation and growth.MethodsPatients from the Sensitive Imaging in Ankylosing Spondylitis cohort underwent MRI (baseline, 1 year and 2 years) and ldCT (baseline and 2 years). MR images were scored by three readers for VCI and VCFD, MRI patterns were defined by presence of VCI and/or VCFD over 2 years. LdCT images were scored by two central readers for presence and size of syndesmophytes and change was calculated for new or new/grown syndesmophytes. Multilevel generalised estimated equations were used to test the associations between VCI and VCFD and syndesmophyte development.ResultsFifty radiographic patients with axial spondyloarthritis were included (mean age 49 years, 86% male, 78% HLA-B27+). Absence of both VCI and VCFD protected against syndesmophyte development (ORs 0.36–0.37). Presence of VCI and/or VCFD increased the risk of syndesmophyte development (ORs 1.73–2.60). Out of all corners with a new or new/grown syndesmophyte, 47% of corners according to reader 1 and 44% according to reader 2 had neither VCI nor VCFD preceding the bone formation.ConclusionsVCI and VCFD were positively associated with syndesmophyte development. This has been shown for the first time for syndesmophytes detected on ldCT and also in the thoracic spine. However, almost half of all bone formation occurred in corners without VCI or VCFD, suggesting the presence of these lesions in yearly MRIs does not fully clarify the development of syndesmophytes.

The possibility of detection of structural damage on magnetic resonance imaging (MRI) of sacroiliac joints raises the question of whether MRI can substitute radiographs for diagnostic evaluation and to a further extent for classification of axial spondyloarthritis (axSpA). In this viewpoint, we will argue that it is time to replace conventional radiographs with MRI for the assessment of structural changes in sacroiliac joints. This message is based on current data on the following questions: (1) How reliable are conventional radiographs in the diagnosis of axSpA overall and radiographic axSpA in particular? (2) How does T1-weighted MRI compare to radiographs in the detection of sacroiliitis? (3) Are there now other (better) MRI sequences than T1-weighted, which might be more suitable for the detection of structural lesions? (4) Which MRI sequences should be performed for the diagnostic evaluation of the sacroiliac joints? (5) Do we have data to define sacroiliitis based on structural changes detected by MRI?

Although the pathogenesis of spondyloarthritis (SpA) has still not been elucidated our options to treat SpA have definitely improved in the last decades. There are two main types of SpA: (i) axial spondyloarthritis (axSpA), also covering the classical ankylosing spondylitis (AS) which is largely equivalent to radiographic (r)-axSpA but different from non-radiographic (nr)-axSpA, and (ii) peripheral SpA (pSpA) also covering psoriatic arthritis (PsA) as the main subtype. The subtype nr-axSpA has historically developed because the approval of drugs for AS did not cover forms without structural changes in the sacroiliac joints which is mandatory in the 1984 New York criteria. The definitions for axSpA are based on the 2009 Assessments in AxSpA International Society (ASAS) classification criteria. Several biologic disease modifying anti-rheumatic drugs (bDMARDs) such as the tumor necrosis factor alpha inhibitors (TNFi) and the interleukin-17-inhibitors (IL-17i) are approved mostly for the whole spectrum of SpA including axSpA and PsA but L-17i does not work in inflammatory bowel disease (IBD). Targeted synthetic (ts) DMARDs cover mainly the janus kinase (JAK)-inhibitors which have recently been developed to inhibit inflammation in several rheumatic and other immune mediated diseases such as IBD. Indeed, the physiologic mechanism of JAK-mediated signal transduction has been recognized as an important target because the inhibition of its actions was shown to successfully work as a therapeutic mechanism. There are now 4 small molecule JAK inhibitors (JAKi) that currently play a role in rheumatology with variable selectivity for the four different JAK isoforms: tofacitinib, baricitinib, upadacitinib and filgotinib. In this review, we summarize current clinical trial data and evaluate the use of the JAK1 selective inhibitor upadacitinib in the treatment of axSpA, including nr-axSpA and r-axSpA. Even though the efficacy and safety of upadacitinib over shorter periods of time has been convincing to date, long-term trials are needed to fully establish its performance and also evaluate the safety at higher doses, and its use in PsA.

Background Accumulating evidence supports the role of monocytes and neutrophils in radiographic axSpA (r-axSpA). Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor for both leukocyte lineages and a pro-inflammatory cytokine activating myeloid cells and promoting osteoclastogenesis. It acts through the JAK-STAT pathway. We measured serum GM-CSF and markers of bone metabolism in patients with r-axSpA before and after anti-TNF treatment. Methods Patients with active r-axSpA despite treatment with NSAIDs, all eligible for treatment with a biologic agent, were recruited. Healthy donors were sampled as controls. Serum was collected before (baseline) and after 4–6 months (follow-up) of anti-TNF treatment and the following molecules were measured with ELISA: GM-CSF, sclerostin (SOST), and dickkopf-1 (Dkk-1). Results Twelve r-axSpA patients (7 males, 5 females, median age 37 years) with a median disease duration of 1 year and 16 age- and sex-matched controls were included. At baseline, patients had mean BASDAI 6.3±2 and ASDAS 3.2±0.7, which decreased to 4.1±1.7 and 2.2±0.6 at follow-up, respectively. At baseline, r-axSpA patients had significantly higher mean serum levels of GM-CSF (150 vs 62pg/ml, p=0.049), significantly lower Dkk-1 (1228 vs 3052pg/ml, p=0.001), but similar levels of SOST (369 vs 544pg/ml, p=0.144) compared to controls. Anti-TNF treatment did not affect GM-CSF, Dkk-1, or SOST levels. Spearman correlation analysis showed that GM-CSF correlated positively with ASDAS at baseline (r=0.61, p=0.039), while no correlations were identified between bone markers (Dkk-1, SOST) on one hand and GM-CSF or disease activity indices on the other. Conclusions GM-CSF is increased in patients with active AS and strongly correlates with disease activity. TNF inhibition does not affect GM-SCF levels, despite improving disease activity. GM-CSF may represent an important pathway responsible for residual inflammation during TNF blockade, but also a potential target of JAK inhibitors, explaining their efficacy in r-axSpA.

Objectives The primary objective was to compare the clinical characteristics of SpA patients with and without root joint disease (RJD+ and RJD–). The secondary objectives were to compare the prevalence of RJD across various SpA subtypes and in different world regions, and to compare the SpA axial severity and SpA burden between RJD+ and RJD–. Methods This is a post hoc analysis of the Assessment of Spondyloarthritis International Society PerSpA study (PERipheral involvement in SpondyloArthritis), which included 4465 patients with SpA [axial (axSpA), peripheral (pSpA), PsA, IBD, reactive and juvenile] according to the rheumatologist’s diagnosis. RJD was defined as the ‘ever’ presence of hip or shoulder involvement related to SpA, according to the rheumatologist. Patient characteristics were compared between RJD+ and RJD–. Multivariable stepwise binary logistic regression analyses were conducted to identify factors associated with ‘RJD’, ‘hip’ and ‘shoulder’ involvement. Results RJD was significantly associated with the SpA main diagnosis (highest in pSpA), a higher prevalence of HLA-B27 positivity, enthesitis, tender and swollen joints, CRP, conventional synthetic DMARDs, loss of lumbar lordosis and occiput-wall distance >0. RJD was more prevalent in Asia, and occurred in 1503 patients (33.7%), with more hip (24.2%) than shoulder (13.2%) involvement. Hip involvement had a distinct phenotype, similar to axSpA (including younger age at onset, HLA-B27 positivity), whereas shoulder involvement was associated with features of pSpA (including older age at onset). Conclusion RJD+ SpA patients had a distinctive clinical phenotype compared with RJD–. Hip involvement, based on the rheumatologist’s diagnosis, was more prevalent than shoulder involvement and was clinically distinct.

Objectives Antibodies against anti-CD74 are related to axial spondyloarthritis (axSpA). The objectives were (i) to study IgA anti-CD74 in radiographic (r)-axSpA patients in the Backbone cohort and to calculate the sensitivity and specificity of anti-CD74, (ii) to study the fluctuation of IgA anti-CD74 levels in prospectively collected samples, and (iii) to explore the relation between IgA anti-CD74 and radiographic spinal changes. Methods IgA anti-CD74 was analysed by ELISA in 155 patients with r-axSpA and age- and sex-matched controls. BASDAI, ASDAS, BASFI and BASMI were assessed and spinal radiographs were scored for r-axSpA-related changes with mSASSS. Previously donated samples, before inclusion in the Backbone study, were identified in the Medical Biobank of Northern Sweden. Results A total of 155 patients comprising 69% men and 31% women, age [mean (s.d.)] 55.5 (11.4) years and 152 (98.1%) HLA-B27 positive, were included. The plasma level of IgA anti-CD74 was significantly higher in the patients [median (interquartile range), 12.9 (7.9–17.9) U/ml] compared with controls [10.9 (7.2–14.6) U/ml, P = 0.003]. IgA anti-CD74 was above the cut-off level of 20 U/ml in 36/155 (23.2%) patients and in 15/151 (9.9%) controls (P = 0.002). Multivariable logistic regression analyses revealed ≥1 syndesmophyte associated with IgA anti-CD74 (odds ratio 5.64; 95% CI: 1.02, 35.58; P = 0.048) adjusted for hsCRP, smoking, BMI, sex and age. No distinct pattern of IgA anti-CD74 over time was revealed. Conclusion Plasma levels of IgA anti-CD74 were increased in r-axSpA and independently associated with radiographic spinal changes, which suggests that IgA anti-CD74 could play a role in the pathogenies of r-axSpA.

Proof-of-concept trial to determine the effects of tumor necrosis factor inhibitor (TNFi) therapy on osteoblastic activity at sites of inflammatory and structural lesions in patients with radiographic axial spondyloarthritis (SpA), using fluorine 18-labeled NaF (Sixteen patients with clinically active radiographic axial SpA were prospectively enrolled to receive TNFi treatment and undergoOverall, 11 male and 5 female patients (mean age ± SD 38.6 ± 12.0 years) were followed up for a mean duration of 4.6 months (range 3-6).Anti-TNF antibody treatment led to a significant decrease in osteoblastic activity within 3-6 months, especially, but not solely, at sites of inflammation. Larger data sets are needed for confirmation of the antiosteoblastic effects of TNFi for the prevention of radiographic progression in axial SpA.

ObjectivesThe effect of different modes of immunosuppressive therapy in autoimmune inflammatory rheumatic diseases (AIRDs) remains unclear. We investigated the impact of immunosuppressive therapies on humoral and cellular responses after two-dose vaccination.MethodsPatients with rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis treated with TNFi, IL-17i (biological disease-modifying antirheumatic drugs, b-DMARDs), Janus-kinase inhibitors (JAKi) (targeted synthetic, ts-DMARD) or methotrexate (MTX) (conventional synthetic DMARD, csDMARD) alone or in combination were included. Almost all patients received mRNA-based vaccine, four patients had a heterologous scheme. Neutralising capacity and levels of IgG against SARS-CoV-2 spike-protein were evaluated together with quantification of activation markers on T-cells and their production of key cytokines 4 weeks after first and second vaccination.Results92 patients were included, median age 50 years, 50% female, 33.7% receiving TNFi, 26.1% IL-17i, 26.1% JAKi (all alone or in combination with MTX), 14.1% received MTX only. Although after first vaccination only 37.8% patients presented neutralising antibodies, the majority (94.5%) developed these after the second vaccination. Patients on IL17i developed the highest titres compared with the other modes of action. Co-administration of MTX led to lower, even if not significant, titres compared with b/tsDMARD monotherapy. Neutralising antibodies correlated well with IgG titres against SARS-CoV-2 spike-protein. T-cell immunity revealed similar frequencies of activated T-cells and cytokine profiles across therapies.ConclusionsEven after insufficient seroconversion for neutralising antibodies and IgG against SARS-CoV-2 spike-protein in patients with AIRDs on different medications, a second vaccination covered almost all patients regardless of DMARDs therapy, with better outcomes in those on IL-17i. However, no difference of bDMARD/tsDMARD or csDMARD therapy was found on the cellular immune response.

\(\bf Hintergrund\) Patienten mit entzündlich rheumatischen Erkrankungen haben aufgrund ihrer Autoimmunerkrankung, aber auch bedingt durch die immunsuppressive Medikation ein erhöhtes Infektrisiko. Obwohl Impfungen in der Primärprophylaxe von Infektionen bekanntermaßen effektiv sind, ist die Impfrate in Deutschland generell zu niedrig. Wegen des zuletzt zunehmenden, teils epidemieartigen Auftretens von Masern ist die Lebendimpfung gegen Masern in Deutschland seit Kurzem gesetzlich vorgeschrieben. \(\bf Fragestellung\) Wie viele Patienten mit entzündlich rheumatischen Erkrankungen sind aktuell ausreichend gegen Masern geschützt? \(\bf Methode\) Patienten mit entzündlich rheumatischen Erkrankungen des Rheumazentrums Ruhrgebiet wurden zwischen Dezember 2017 und Oktober 2018 prospektiv und konsekutiv eingeschlossen. Dabei wurden Daten zu Erkrankung und Therapie auf Ebene von Substanzklassen sowie die Impf- und Infektanamnese erhoben. Alle Angaben zu Impfungen wurden im Impfpass kontrolliert. Antikörpertiter gegen Masern wurden mit ELISA bestimmt. Als Schwellenwert für einen ausreichenden Schutz gegen Masern wurden 150 mIU/ml festgelegt. \(\bf Ergebnis\) Von 975 Patienten konnten 540 (55,4 %) einen Impfausweis vorlegen. Bei 201 Patienten mit Ausweis (37,2 %) lagen dokumentierte Impfungen seit Geburt vor. Insgesamt hatten 45 von 267 nach 1970 geborene Patienten (16,9 %) einen suffizienten Impfschutz gegen Masern. Die anamnestischen Angaben zu einer Masernerkrankung in der Kindheit differenzierten nicht zwischen Patienten mit und ohne protektiven Masern-IgG-Antikörpern. Protektive Masern-IgG-Antikörper wurden bei 901 Patienten von 928 Patienten mit Messung der Masern-IgG-Antikörperspiegel (97,1 %) nachgewiesen. Die unterschiedlichen Wirkprinzipien der aktuellen immunsuppressiven Therapie hatten darauf keinen Einfluss. \(\bf Diskussion\) Diese Daten zeigen, dass mindestens 2,9 % der Patienten keinen ausreichenden Schutz gegen Masern haben. Interessanterweise hatte die Mehrheit der nach 1970 geborenen Patienten protektive Antikörper trotz fehlenden Impfschutzes gegen Masern. Die Anstrengungen sowohl im primär- als auch im fachärztlichen Bereich sollten dringend verstärkt werden, um eine adäquate Infektionsprophylaxe bei besonders gefährdeten Patienten gewährleisten zu können. \(\bf Background\) Patients with inflammatory rheumatic diseases have an increased risk of infections due to the autoimmune disease but also due to the immunosuppressive medication. Although vaccinations are known to be effective in the primary prophylaxis of infections, the vaccination rate in Germany is generally too low. Due to the recently increasing, sometimes epidemic-like occurrence of measles, the administration of live vaccine against measles has recently become required by law. \(\bf Objective\) How many patients with inflammatory rheumatic diseases are currently sufficiently protected against measles? \(\bf Method\) Between December 2017 and October 2018 patients with inflammatory rheumatic diseases at the Ruhrgebiet Rheumatism Center were prospectively and consecutively included. Data on the disease and treatment at the level of substance classes, patient history of vaccination and infections were collated. All information on vaccinations were controlled in the vaccination certificate. Antibodies against measles were determined using ELISA. The threshold for sufficient protection against measles was set at 150 mIU/ml. \(\bf Results\) Out of 975 patients 540 (55.4%) could present a vaccination certificate. In 201 patients with a certificate (37.2%) vaccination had been documented since birth. Overall, 45 out of 267 patients born after 1970 (16.9%) had sufficient protection against measles. The patient history of measles in childhood showed no differences between patients with and without protective measles IgG antibodies. Protective measles IgG antibodies were detected in 901 out of 928 patients with measurement of the measles IgG antibody level (97.1%). The different principles of action of the current immunosuppressive treatments had no influence on this. \(\bf Conclusion\) These data show that at least 2.9% of the patients did not have sufficient protection against measles. Interestingly, the majority of patients born after 1970 had protective antibodies despite the lack of vaccination against measles. The efforts in primary and also in the specialist medical care should be urgently strengthened in order to be able to guarantee an adequate infection prophylaxis in particularly endangered patients.

To assess the association of demographic and clinical factors with the clinical decision of tapering biologic disease modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) in daily practice.All RA patients receiving bDMARDs were documented by 14 rheumatologists when presenting in 9 specialized private practices. Statistical analyses employed multivariable logistic models for dose reduction with the covariates age, gender, disease duration until bDMARD start, smoking status, disease activity, comorbidity, functional capacity, radiographic damage, concomitant methotrexate (MTX) treatment, rheumatoid factor positivity, and glucocorticoid use. In the multivariable model (MVM), missing values were imputed.Data of 586 RA patients on bDMARD treatment were available, 171 of which (29%) received a reduced dose. The highest rates of patients with dose reduction were seen for rituximab (67%) and infliximab (50%). The degree of dose reduction was most prominent for rituximab (57%). In the MVM, 6/11 covariates were significantly associated with dose reduction: age (odds ratio (OR) 1.03, 95% confidence interval (CI) 1.01-1.05; P = 0.002), time between disease onset and bDMARD start (OR 1.03, 95% CI 1.01-1.06; P = 0.015), DAS 28 2.6 (OR 1.55, 95% CI 1.01-2.37; P = 0.045), MTX therapy (OR 1.52, 95% CI 1.03-2.25; P = 0.036), comorbidity (OR 1.20, 95% CI 1.01-1.42; P = 0.036), and glucocorticoid dose (OR 0.82, 95% CI 0.76-0.89; P 0.001).DAS 28 remission, concomitant MTX, and lower glucocorticoid doses were positively associated with dose tapering of bDMARDs in RA patients. While this could be expected, the reason for the association with age, comorbidity, and the time between disease onset and bDMARD start is less clear. Key points • In rheumatology practice, tapering of biologic disease modifying antirheumatic drugs is feasible in nearly 30% of patients with rheumatoid arthritis. • The degree of dose reduction may exceed 50% of the recommended dose. • In a multivariable model, concomitant methotrexate is positively associated with dose tapering of biologic disease modifying antirheumatic drugs.

Background and aimStriving for harmonisation of specialty training and excellence of care in rheumatology, the European League Against Rheumatism (EULAR) established a task force to develop points to consider (PtCs) for the assessment of competences during rheumatology specialty training.MethodsA systematic literature review on the performance of methods for the assessment of competences in rheumatology specialty training was conducted. This was followed by focus groups in five selected countries to gather information on assessment practices and priorities. Combining the collected evidence with expert opinion, the PtCs were formulated by the multidisciplinary task force, including rheumatologists, medical educationalists, and people with rheumatic and musculoskeletal diseases. The level of agreement (LoA) for each PtC was anonymously voted online.ResultsFour overarching principles and 10 PtCs were formulated. The overarching principles highlighted the importance of assessments being closely linked to the rheumatology training programme and protecting sufficient time and resources to ensure effective implementation. In the PtCs, two were related to overall assessment strategy (PtCs 1 and 5); three focused on formative assessment and portfolio (PtCs 2–4); three focused on the assessment of knowledge, skills or professionalism (PtCs 6–8); one focused on trainees at risk of failure (PtC 9); and one focused on training the trainers (PtC 10). The LoA (0–10) ranged from 8.75 to 9.9.ConclusionThese EULAR PtCs provide European guidance on assessment methods throughout rheumatology training programmes. These can be used to benchmark current practices and to develop future strategies, thereby fostering continuous improvement in rheumatology learning and, ultimately, in patient care.

Objectives The efficacy and safety of certolizumab pegol (CZP), an Fc-free, PEGylated anti-TNF, in axial spondyloarthritis (axSpA) has been established in clinical trial settings. We report CZP effectiveness and safety in European clinical practice in patients with axSpA, including radiographic (r-) and non-radiographic (nr-) axSpA. Methods CIMAX (NCT02354105), a European non-interventional multicentre prospective study, observed CZP treatment response and safety over 12 months in a real-world axSpA cohort. The primary outcome was change from baseline in BASDAI to week 52, with additional outcomes pertaining to effectiveness and safety. Patients who received ≥1 dose CZP were followed up for adverse events, and those with baseline and ≥1 post-baseline BASDAI assessment were included in effectiveness analyses. Results A total of 672 patients (r-axSpA: 469; nr-axSpA: 201; unconfirmed diagnosis: 2) from 101 sites received ≥1 dose of CZP, of whom 564 (r-axSpA: 384; nr-axSpA: 179; unconfirmed: 1) were included in the effectiveness analyses. The mean baseline BASDAI was 6.1 in the overall axSpA population and r-axSpA and nr-axSpA subpopulations. At week 52, the mean (s.d.) change in BASDAI was −2.9 (2.3; n = 439); for r-axSpA and nr-axSpA, it was −2.9 (2.2; n = 301) and −2.8 (2.4; n = 137), respectively (P Conclusion Improvements observed in signs and symptoms of axSpA following one year of CZP treatment in real-world clinical practice were similar to those from previous randomized clinical trials, with no new safety concerns.

Objective Chronic inflammatory back pain (IBP) is frequently reported in axial SpA (axSpA) but also in the general population. We evaluated a recently proposed two-step referral system for early recognition of axSpA in primary care and compare it with other combinations of symptoms and SpA-related items. Methods Consecutive chronic back pain patients ≤45 years of age answered a questionnaire and were seen by a primary care physician who decided whether HLA-B27 needed to be determined. They were then referred to a rheumatologist who made the diagnosis. Generally sticking to the two-step system with HLA-B27 as an additional option, combinations with a sensitivity ≥90% and a likelihood ratio >4 were compared. Results A total of 326 patients were included, 46 of whom were diagnosed with axSpA (14.1%). The sensitivity of the strategy was 87%, the specificity was 56.8% and the positive and negative predictive values were 24.8% and 96.4%, respectively. A ‘good response to NSAIDs’, ‘morning stiffness >30 min’ and ‘elevated C-reactive protein’ performed best, with a sensitivity of 91%, specificity of 67%, positive predictive value of 31% and negative predictive value of 98%. On that basis, only three patients had to be seen by a rheumatologist to diagnose one. Conclusion The earlier proposed referral system worked well but was outperformed by other combinations with high sensitivity and better specificity, which deserve to be prospectively studied.

Functional disability in axial spondyloarthritis is related to the structural progression caused by the disease, thus largely contributing to its global burden and still representing a major challenge in management. Diagnosis at an early inflammatory stage of the disease is the hallmark for a better disease control and management. The natural history of axial spondyloarthritis is now better understood with imaging studies and long-term follow-up data, with some predictive factors for structural progression being identified. Non-steroidal anti-inflammatory drugs are still considered as the first line treatment for axial spondyloarthritis, however, their impact on structural progression is conflicting. Recent data on biologic disease-modifying anti-rheumatic drugs, such as tumor necrosis factor inhibitors have shown significant retardation of radiographic damage after several years of treatment, while first data with interleukin-17 inhibitors were also positive. Novel emerging drugs are being evaluated with promising results on halting disease progression. This review summarizes the predictors of radiographic progression in patients with axial spondyloarthritis as well as the current evidence on the effect of available treatments on structural progression.

Objective There is currently no diagnostic test for PMR. A characteristic pattern of extracapsular inflammation as assessed by contrast-enhanced MRI (ceMRI) has recently been described in the pelvis of patients with PMR. We aimed to evaluate the performance of inflammatory ceMRI signals at predefined pelvic sites as a diagnostic test for PMR. Methods Pelvic MRI scans of patients with pelvic girdle pain (n = 120), including 40 patients with an expert diagnosis of PMR and 80 controls with other reasons for pelvic pain were scored by three blinded radiologists, who evaluated the degree of contrast enhancement at 19 predefined tendinous and capsular pelvic structures. Different patterns of involvement were analysed statistically. Results The frequency of bilateral peritendinitis and pericapsulitis including less common sites, such as the proximal origins of the m. rectus femoris and m. adductor longus, differed significantly between PMR cases and controls: 13.4 ± 2.7 vs 4.0 ± 2.3. A cut-off of ≥10 inflamed sites discriminated well between groups (sensitivity 95.8%, specificity 97.1%). Bilateral inflammation of the insertion of the proximal m. rectus femoris or adductor longus tendons together with ≥3 other bilaterally inflamed sites performed even better (sensitivity 100%, specificity 97.5%). Conclusion This study confirms that a distinctive MRI pattern of pelvic inflammation (bilateral peritendinitis and pericapsulitis and the proximal origins of the m. rectus femoris and m. adductor longus) is characteristic for PMR. The high sensitivity and specificity of the set of anatomical sites evaluated suggests their clinical usefulness as a confirmatory diagnostic test.

Secukinumab, an anti-interleukin (IL)-17A monoclonal antibody, has demonstrated low radiographic progression over 4 years in patients with ankylosing spondylitis (AS). An adalimumab (tumor necrosis factor [TNF] inhibitor) biosimilar, GP2017 (SDZ-ADL; Sandoz), has been approved by the European Medicines Agency (July 2018) for use in all same indications as adalimumab, including AS. Adalimumab has also shown low long-term radiographic progression in patients with AS. Direct comparison of radiographic progression in AS between IL-17A and TNF inhibitors has not been studied. SURPASS is the first head-to-head, Phase IIIb, randomized, biologic-controlled study in AS to compare effects of secukinumab versus SDZ-ADL on spinal radiographic progression. Overall, 858 biologic-naive patients with AS with elevated high-sensitivity C-reactive protein (≥ 5 mg/L) and/or at least one syndesmophyte in the cervical/lumbar spine at baseline (without total ankylosis) were randomized (1:1:1) to subcutaneous (sc) secukinumab (300 or 150 mg) or SDZ-ADL (40 mg). Secukinumab will be administered at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks until week 100. SDZ-ADL will be administered every 2 weeks from baseline until week 102. Patients and investigators will be unblinded to drug but blinded to secukinumab doses. Spinal X-rays will be obtained at baseline, and weeks 52 and 104, sacroiliac joint (SIJ) X-rays at baseline and week 104, and magnetic resonance imaging (MRI) of SIJs and spine at baseline, weeks 16, 52, and 104. The primary endpoint is to demonstrate superiority of secukinumab (300 or 150 mg) treatment versus SDZ-ADL regarding proportion of patients with no radiographic progression (change from baseline in modified Stoke Ankylosing Spondylitis Spinal Score [mSASSS] ≤ 0.5) at week 104. Secondary endpoints include change from baseline in mSASSS, proportion of patients with syndesmophyte at baseline who develop no new syndesmophytes, reduction of osteitis on MRI of SIJs and spine (Berlin method). Assessment of SpondyloArthritis International Society (ASAS) 20/40 responses, ASAS partial remission, and AS Disease Activity Score (ASDAS) inactive disease (ASDAS

Objective To evaluate the effect of ixekizumab on self-reported functioning and health in patients with active nonradiographic axial spondyloarthritis (SpA). Methods COAST-X was a randomized, controlled trial conducted in patients with nonradiographic axial SpA over 52 weeks. Participants were randomized at a ratio of 1:1:1 to receive 80 mg of ixekizumab subcutaneously every 4 weeks or 2 weeks or placebo for 52 weeks. Self-reported functioning and health end points included the Medical Outcomes Study Short Form 36 (SF-36) health survey, Assessment of Spondyloarthritis International Society (ASAS) health index, and European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) health-utility descriptive system. Results Compared to placebo, ixekizumab treatment resulted in improvement of SF-36 physical component summary scores from baseline, with a score of 4.7 improving to 8.9 with ixekizumab therapy every 4 weeks (P < 0.05) and a score of 9.3 with ixekizumab therapy every 2 weeks (P < 0.01); the greatest improvements were observed in the domains of physical functioning, role-physical, and bodily pain at weeks 16 and 52. A higher proportion of patients receiving ixekizumab therapy every 2 weeks reported >= 3 improvements based on the ASAS health index from baseline to weeks 16 and 52 (P < 0.05). Significantly more patients receiving ixekizumab every 4 weeks reported improvements in "good health status" on the ASAS health index (ASAS score of

Inflammatory back pain (IBP) is a major criterion in identifying axial spondyloarthritis. Whether socioeconomic issues impact prevalence of IBP assessed using standardized questionnaires has not been assessed. We determined IBP prevalence and performance of IBP questionnaires in a low-income, low-literacy population.Individuals were interviewed in Fortaleza, Brazil, for the prevalence of IBP using Calin's, Berlin, and ASAS IBP questionnaires; monthly family income (US dollars), literacy (/≤8 school years [SYs]), and smoking habit (present/absent) were registered.Two hundred nineteen individuals were included (mean age, 38.2 ± 12.9 years), 110 (50.2%) men, 58 (26.4%) White, and 38 (17.3%) smokers. Overall, 152 (69.4%) declaredUS $720 (mean local income) earnings, and 64 (29.2%) had ≤8 SYs. Chronic back pain was declared by 134 (61%) with 32 (14.6%), 25 (11.9%), and 63 (28.3%) fulfilling ASAS, Berlin, and Calin's IBP criteria, respectively. Chronic back pain or IBP prevalence was similar regardless of ethnicity, smoking habit, income, or literacy with IBP prevalence higher among women (p = 0.006).This is the first report on IBP prevalence in a low-income, low-literacy population. Chronic back pain was highly prevalent with almost 15% having IBP using ASAS criteria. Inflammatory back pain prevalence looked similar using ASAS and Berlin criteria; values were higher using Calin's criteria. Literacy or income did not influence IBP prevalence in this population, which was higher among women. The higher prevalence of IBP using Calin's criteria in this population should be taken into account as it might impact studies aiming to determine prevalence of axial spondyloarthritis in clinical studies in this scenario.

Objectives To evaluate the inhibition of progression of structural joint damage through week 48 in patients with moderately to severely active RA receiving upadacitinib as monotherapy or in combination with MTX. Methods Radiographic progression was assessed in two phase 3 randomized controlled trials. MTX-naïve patients were randomized to upadacitinib 15 or 30 mg once daily or MTX monotherapy (SELECT-EARLY, n = 945), while MTX inadequate responders (IRs) were randomized to upadacitinib 15 mg once daily or adalimumab 40 mg every other week or placebo added to background MTX (SELECT-COMPARE, n = 1629). The mean changes from baseline in modified total Sharp score (mTSS), joint space narrowing and erosion scores were determined. Data were analysed both by linear extrapolation for missing data imputation and treatment switching and as observed. Results In patients naïve or with limited exposure to MTX (SELECT-EARLY), mean changes from baseline to week 48 in mTSS were 0.03 for upadacitinib 15 mg, 0.14 for upadacitinib 30 mg and 1.00 for MTX based on linear extrapolation (P Conclusion Upadacitinib monotherapy or in combination with background MTX was effective in inhibiting the progression of structural joint damage through week 48 in MTX-naïve and MTX-IR patients with RA. Trial registration ClinicalTrials.gov (https://clinicaltrials.gov), NCT02706873 and NCT02629159

Objective ACHILLES aimed to demonstrate efficacy of secukinumab on Achilles’ tendon enthesitis in spondyloarthritis (SpA) patients. Methods Patients ≥18 years (n = 204) with active PsA or axial SpA and heel enthesitis were randomized 1:1 to secukinumab 150/300 mg or placebo up to week 24, and thereafter placebo patients were switched to secukinumab. Results At week 24, a higher, yet statistically non-significant (P = 0.136), proportion of patients in secukinumab vs placebo reported resolution of Achilles tendon enthesitis in affected foot (42.2% vs 31.4%; odds ratio [OR] = 1.63; 95% CI: 0.87, 3.08). Proportion of patients reporting resolution of enthesitis based on Leeds Enthesitis Index was higher with secukinumab vs placebo (33.3% vs 23.5%; OR = 1.65; 95% CI: 0.85, 3.25) at week 24. Mean change from baseline in heel pain at week 24 was higher in secukinumab patients vs placebo (−2.8 [3.0] vs −1.9 [2.7]). Greater improvements with secukinumab were observed in heel enthesopathy activity and global assessment of disease activity. Imaging evaluation by local reading confirmed heel enthesitis on MRI at screening for all patients. Based on central reading, 56% presented with bone marrow oedema and/or tendinitis; according to Heel Enthesitis MRI Scoring System (HEMRIS) post hoc analysis, 76% had signs of entheseal inflammation while 86% had entheseal inflammation and/or structural changes. Conclusion A substantial proportion of patients showed no signs of inflammation on the centrally read MRIs despite a clinical diagnosis of heel enthesitis, thus highlighting that the discrepancy between the clinical and imaging assessments of enthesitis requires further investigation. Although ACHILLES did not meet the primary end point, the study reported clinically meaningful improvements in patient-related outcomes. Trial registration clinicaltrials.gov, NCT02771210

ObjectiveEvaluate the effect of upadacitinib on pain outcomes in patients with active psoriatic arthritis (PsA) or ankylosing spondylitis (AS) across 3 randomised trials (SELECT-PsA 1 and 2 for PsA; SELECT-AXIS 1 for AS).MethodsPatients were randomised to upadacitinib 15 mg once daily or placebo (all 3 studies), or adalimumab 40 mg every other week (SELECT-PsA 1 only). Pain outcomes included proportion of patients achieving ≥30%, ≥50% and ≥70% reduction from baseline in patient global assessment of pain and other end points.ResultsA higher proportion of patients receiving upadacitinib versus placebo achieved ≥30%, ≥50% and ≥70% reduction in pain end points as early as week 2; these improvements with upadacitinib were generally sustained or increased through year 1 (PsA 1/2 studies: 64%/48%, 58%/42% and 38%/22%, respectively; SELECT-AXIS 1 study: 76%, 72% and 54%). Results were similar with adalimumab in PsA 1 (59%, 49% and 32%). Patients who switched from placebo to upadacitinib 15 mg were able to reach a similar level of improvement as the continuous upadacitinib groups by year 1 (PsA 1/2 studies: 46%–60%, 35%–49% and 15%–34%; AS study: 83%, 72% and 46%). Results were similar with other pain end points.ConclusionRapid and sustained improvements in pain outcomes across several end points were consistently shown with upadacitinib over 1 year in patients with active PsA or AS who had either inadequate response to prior non-biologic or biologic disease-modifying antirheumatic drugs (PsA studies) or were biologic-naïve with inadequate response to non-steroidal anti-inflammatory drugs (AS study).

Rheumatoid arthritis (RA) is associated with systemic osteoporosis, which leads to severe disability and low quality of life. Current therapies target osteoclasts to reduce bone degradation, but more treatment options would be required to promote bone protection by acting directly on osteoblasts (OB). Recently, the local production of dopamine in inflamed joints of RA has been observed. Thus, in this project, we aimed to determine the implication of the neurotransmitter dopamine in the bone formation process in RA. Dopamine receptors (DR) in the human bone tissue of RA or osteoarthritis (OA) patients were examined by immunohistochemistry. DR in isolated human osteoblasts (OB) was analyzed by flow cytometry, and dopamine content was evaluated by ELISA. Osteoclasts (OC) were differentiated from the PBMCs of healthy controls (HC) and RA patients. Isolated cells were treated with specific dopamine agonists. The effect of dopamine on mineralization was evaluated by Alizarin red staining. Cytokine release in supernatants was measured by ELISA. Osteoclastogenesis was evaluated with TRAP staining. OC markers were analyzed via real-time PCR and bone resorption via staining of resorption pits with toluidine blue. All DR were observed in bone tissue, especially in the bone remodeling area. Isolated OB maintained DR expression, which allowed their study in vitro. Isolated OB expressed tyrosine hydroxylase, the rate-limiting enzyme for dopamine production, and contained dopamine. The activation of D2-like DR significantly increased bone mineralization in RA osteoblasts and increased osteoclastogenesis but did not alter the expression of OC markers nor bone resorption. DR were found in the bone remodeling area of human bone tissue and dopamine can be produced by osteoblasts themselves, thus suggesting a local autocrine/paracrine pathway of dopamine in the bone. D2-like DRs are responsible for bone mineralization in osteoblasts from RA patients without an increase in bone resorption, thus suggesting the D2-like DR pathway as a possible future therapeutic target to counteract bone resorption in arthritis.

Rheumatoid arthritis (RA) is a chronic rheumatic disease with a clear sex-bias. Recent data indicated a role for dopamine in RA pathogenesis, while dopaminergic pathways can be modulated by estrogens. As defined mechanism of action of dopamine on B cell function in RA are unclear, we aimed to elucidate this, with special focus on sex-differences. Healthy controls (HC, n = 64) and RA patients (n = 61) were recruited. Expression of D1–D5 dopamine receptors (DRs) was investigated by flow cytometry on peripheral blood mononuclear cells (PBMCs). D1-like DRs were stimulated in vitro to assess effects on B cell activation and proliferation. Secretion of cytokines and dopamine content were measured by ELISA. All DRs were expressed on PBMCs of HC and RA patients. Dopamine content in PBMCs, and frequency of D1DR expressing B cells were significantly higher in RA females (p 1DR on RA B cells correlated positively with disease duration and severity only in women. Combined B cell and D1-like DR stimulation induced higher IL-8 and CCL-3 secretion from PBMCs of female RA patients compared to HC. These results indicate sex-specific differences in dopaminergic pathway in RA, with a proinflammatory feature of the D1DR pathway in women.

Objective: In active early rheumatoid arthritis (RA), glucocorticoids are often used for bridging, due to the delayed action of methotrexate. This study was undertaken to compare the effect of 3 bridging strategies, including high-dose and low-dose prednisolone, on radiographic and clinical outcomes. Methods: Adult RA patients from 1 rheumatology hospital and 23 rheumatology practices who presented with moderate/high disease activity were randomized (1:1:1) to receive 60 mg prednisolone (high-dose prednisolone [HDP]) or 10 mg prednisolone (low-dose prednisolone [LDP]) daily (tapered to 0 mg within 12 weeks) or placebo. The 12-week intervention period was followed by 40 weeks of therapy at the physicians' discretion. The primary outcome measure was radiographic change at 1 year measured using the total modified Sharp/van der Heijde score (SHS). Disease activity was assessed with the Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28-ESR). Results: Of 395 randomized patients (HDP, n = 132; LDP, n = 131; placebo, n = 132), 375 (95%) remained in the modified intention-to-treat analysis. Mean ± SD changes in SHS scores in the 3 groups after 1 year were comparable: mean ± SD 1.0 ± 2.0 units in the HDP group, 1.1 ± 2.2 units in the LDP group, and 1.1 ± 1.5 units in the placebo group. The primary analysis showed no superiority of HDP compared to placebo (estimated difference of the mean change −0.04 [95% confidence interval (95% CI) −0.5, 0.4]). At week 12, the mean DAS28-ESR differed: −0.6 (95% CI −1.0, −0.2) for HDP versus placebo; –0.8 (95% CI −1.2, −0.5) for LDP versus placebo. At week 52, there was no significant difference in DAS28-ESR between the 3 groups (range 2.6–2.8). Serious adverse events occurred similarly often. Conclusion: Short-term glucocorticoid bridging therapy at a high dose showed no benefit with regard to progression of radiographic damage at 1 year.

Background Axial spondyloarthritis including ankylosing spondylitis (AS) is characterized by chronic inflammation and new bone formation in the axial skeleton. On the other hand, bone loss, osteoporosis and an increased risk of vertebral fractures is known to frequently occur in AS. In the MEASURE 1 study, the clinically efficacious interleukin-17A inhibitor secukinumab was shown to have limited radiographic progression through 4 years in patients with active AS. Here we present a post hoc analysis to evaluate the effect of secukinumab on bone mineral density (BMD) and bone turnover biomarkers over 2 years in this study. Methods BMD was measured by dual-energy X-ray absorptiometry at the lumbar spine, total hip, and femoral neck. Spinal radiographs performed at baseline and Week 104 were assessed by modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) and analyzed in relation to BMD change, considering baseline syndesmophytes. Bone turnover biomarkers were assessed at baseline and at Weeks 52 or 104. Results Among 104 patients included in this analysis, 66% were male, with a mean (SD) age of 40.4 (12.3) years. In postmenopausal women and men ≥50 years of age (T-score), the proportion of patients having normal BMD at baseline and Week 104 were 54.5%/54.5% (lumbar spine), 31.6%/55.6% (total hip), and 42.1%/44.4% (femoral neck). Similarly, at baseline, the proportion of patients with osteopenia/osteoporosis was 31.8%/13.6% (lumbar spine), 57.9%/10.5% (total hip), 42.1%/15.8% (femoral neck), and 36.4%/9.1% (lumbar spine), 44.4%/0% (total hip) and 55.6%/0% (femoral neck) at Week 104, respectively. In premenopausal women and men Conclusion The high proportion of AS patients with diminished BMD was confirmed in this study. An increase of BMD in the lumbar spine after 2 years of secukinumab treatment in patients with AS was found that was probably unrelated to radiographic progression. No relevant effects of secukinumab on bone turnover biomarkers were documented. Trial registration MEASURE 1 (post hoc analysis) Clinicaltrials.gov, NCT01358175; Registered, 23 May 2011.

ObjectivesTo investigate pregnancy outcomes in women with axial spondyloarthritis (axSpA) under different pharmacological treatments in comparison with matched controls.MethodsUsing health insurance data from 2006 to 2019, pregnancy outcomes of women with axSpA were compared with those of age-matched and calendar year-matched controls without axSpA. Women with axSpA were further stratified by treatment prior to delivery and pregnancy outcomes compared. Adjusted ORs (aORs) with 95% CIs were calculated using generalised estimating equation analyses.ResultsA total of 1021 pregnancy outcomes in patients with axSpA were identified (928 deliveries, 80 abortions, 13 ectopic pregnancies) and compared with 10 210 pregnancy outcomes in controls (9488 deliveries, 615 abortions, 147 ectopic pregnancies). Compared with controls, women with axSpA showed higher odds of elective caesarean section (aOR 1.52; 1.25 to 1.85).Among women with axSpA, the risk of preterm birth was higher under non-steroidal anti-inflammatory drugs (NSAIDs) treatment (aOR 2.22; 1.09 to 4.52) than without any anti-inflammatory treatment. The risks of preterm birth (aOR 4.01; 1.93 to 8.34) and small-for-gestational-age (aOR 3.22; 1.34 to 7.73) were increased under NSAIDs treatment in combination with conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs), steroids or analgesics. Non-significant increased risks of small-for-gestational-age (aOR 1.68; 0.43 to 6.57) and preterm birth (aOR 1.56; 0.51 to 4.83) were found under biological DMARDs.ConclusionsWomen with axSpA have significantly increased odds of caesarean section compared with matched controls. Risks of preterm birth and small-for-gestational-age vary by type of anti-inflammatory treatment.

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.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.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.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.

To study the knowledge of patients with chronic inflammatory rheumatic diseases (CIRD) about biosimilars (bsDMARDs), assess patients' satisfaction after being educated about switching of bsDMARDs by rheumatologists compared to nurse specialists, and to explore the impact of multiple switches on patient satisfaction.Adult patients with CIRD who underwent a non-medical switch from the adalimumab bsDMARDs GP2017 to the adalimumab bsDMARDs MSB 11022 were 1:1 randomized with randomly selected block sizes into two groups in which information about multiple switching of bsDMARDs was provided by either a nurse specialist or a rheumatologist. Validated outcome tools and standardized parameters for disease activity and function were assessed at baseline and 12 weeks after the switch. The primary endpoint was to evaluate whether satisfaction with care differs when education about switching is provided by rheumatologists or nurse specialists. Secondary endpoints were patients' knowledge about bsDMARDs and the efficacy and safety of switching in routine care. Patients' satisfaction with care was assessed by the Leeds Satisfaction Questionnaire. A structured questionnaire was used to assess the patient's knowledge.A total of 102 patients was randomized, with 40 educated by rheumatologists (39.2%) and 62 by nurse specialists (60.8%). Patients had moderate to low disease activity and limited impairment of physical function without progression on follow-up, implying that switching did not affected disease activity. Almost half of the patients (n = 50, 49%) had undergone one and 52 multiple switches (51%), respectively. Less than one-third of patients were able to correctly answer questions on manufacturing, effectiveness, clinical trial evidence, and cost of bsDMARDs. Patients were generally satisfied with the education - irrespective of whether the information had been provided by nurses or rheumatologists. No relevant differences in the outcomes assessed were observed. Efficacy and safety results were consistent with previously published data.Patient satisfaction after education about bsDMARDs and multiple switching by nurses and rheumatologists was equally good. Multiple switches had no negative impact on patient satisfaction, and outcomes after switching of bsDMARDs did not significantly worsen. Patients' knowledge about bsDMARDS was limited.

Objectives To determine quantitative SI joint MRI lesion cut-offs that optimally define a positive MRI for inflammatory and structural lesions typical of axial SpA (axSpA) and that predict clinical diagnosis. Methods The Assessment of SpondyloArthritis international Society (ASAS) MRI group assessed MRIs from the ASAS Classification Cohort in two reading exercises where (A) 169 cases and 7 central readers; (B) 107 cases and 8 central readers. We calculated sensitivity/specificity for the number of SI joint quadrants or slices with bone marrow oedema (BME), erosion, fat lesion, where a majority of central readers had high confidence there was a definite active or structural lesion. Cut-offs with ≥95% specificity were analysed for their predictive utility for follow-up rheumatologist diagnosis of axSpA by calculating positive/negative predictive values (PPVs/NPVs) and selecting cut-offs with PPV ≥ 95%. Results Active or structural lesions typical of axSpA on MRI had PPVs ≥ 95% for clinical diagnosis of axSpA. Cut-offs that best reflected a definite active lesion typical of axSpA were either ≥4 SI joint quadrants with BME at any location or at the same location in ≥3 consecutive slices. For definite structural lesion, the optimal cut-offs were any one of ≥3 SI joint quadrants with erosion or ≥5 with fat lesions, erosion at the same location for ≥2 consecutive slices, fat lesions at the same location for ≥3 consecutive slices, or presence of a deep (i.e. >1 cm depth) fat lesion. Conclusion We propose cut-offs for definite active and structural lesions typical of axSpA that have high PPVs for a long-term clinical diagnosis of axSpA for application in disease classification and clinical research.

The last decade witnessed the ascendancy of rheumatology to become one of the most dynamic and progressive across the fields of medicine. During the COVID-19 pandemic our discipline emerged at the forefront of molecular medicine with the rapid uptake of immune-modulatory therapeutics and depth of immune pathogenesis understanding contributing fundamentally to the COVID-19 response. The European Alliance of Associations for Rheumatology (EULAR) played a fundamental and vital role in this response in guiding rheumatic and musculoskeletal disease (RMD) therapeutics, vaccine use and even treatment innovations in the context of COVID-19 itself. Given this remarkable contribution, it is timely to reflect on EULAR—what is it and for what does it stand? At its core, EULAR represents people with RMDs, including their national societies, health professionals in rheumatology and scientific societies of rheumatology across the European nations. Our mission is to reduce the burden of RMDs on individuals and society and improve the treatment and prevention of RMDs. In this message from the new EULAR President and Steering Group, we present the most relevant activities of EULAR, its strategic aims and the concept of the EULAR family, a fantastic team of people working together across the three pillars of medical, health professional and patient societies.

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-CoV‑2 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-CoV‑2 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.Die SARS-CoV-2-Pandemie hält die meisten Länder der Welt anhaltend in Atem. In Deutschland liegt die Prävalenz von SARS-CoV-2-Infektionen zwar noch unter 2 %, die Zahlen steigen aber seit Wochen auch in Deutschland wieder an. Die rheumatologische Versorgung wurde durch die 1. Welle der Pandemie vorübergehend beeinträchtigt. Wir berichten über die Infektionssituation in der größten deutschen Rheumaspezialklinik, dem Rheumazentrum Ruhrgebiet, weil es hier vor Kurzem während der 2. Welle erstmals zum Auftreten von mehreren SARS-CoV-2-Infektionen an einem Wochenende gekommen ist, was zu einer erheblichen Unruhe bei vielen Beteiligten führte. Die Situation konnte durch konsequentes Testen von Patienten und Mitarbeitern mit dem Antigenschnelltest aufgeklärt und die Lage beruhigt werden. Letztlich waren nur wenige Getestete positiv, und die Verläufe bei den Patienten blieben bis jetzt blande. Dies zeigt auch die Effektivität der seit April konsequent durchgeführten hygienischen Schutzmaßnahmen.

The ASAS Health Index (ASAS HI) was developed to assess global functioning in patients with axial spondyloarthritis (axSpA). Influencing factors have not been studied to date, especially the influence of inflammation and structural changes in the spine has remained unclear to date.To find out whether and to what degree do axial inflammation, radiographic damage and other clinical features influence global functioning of patients with axSpA.Patient reported outcomes (ASAS HI, pain, BASDAI, BASFI, EQ-5D and SF-36) were assessed, spinal mobility by BASMI and depression by SF-36 scores. Axial inflammation was quantified using the MRI Berlin score and structural damage as detected by conventional radiographs by the modified Stokes AS Spinal Score (mSASSS). Correlation and regression analyses were performed to analyze the association between global functioning and other variables.A total of 191 axSpA patients with different degrees of global functioning and disease activity was included, 60.2% had r-axSpA. Syndesmophytes were found in 38.5% of patients - with a median mSASSS score of 3.8 (IQR 1.0-18.7) in r-axSpA and 0.0 (IQR 0.0-1.2) in nr-axSpA patients. The mean MRI score was 2.3 (IQR 0.5-7.6). ASAS HI values correlated significantly with BASMI, BASDAI, BASFI, BMI and MRI scores. However, no significant correlation was found for mSASSS and CRP. Regression analyses revealed that global functioning was significantly influenced by disease activity, physical function, obesity and depression but not by structural damage or spinal inflammation as detected MRI.Our study shows that global functioning is strongly associated with physical function, body weight and depression in patients with axSpA but not with spinal inflammation and structural damage. This may be explained by the relatively low mSASSS of these well treated patients.