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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.Physical function is an important contributor towards a patient’s quality of life, but is often neglected in management strategies for axial spondyloarthritis (axSpA). This Review provides guidance on determinants and assessments of physical function in axSpA.

Background In spondyloarthritides (SpA) and fibromyalgia (FM), patients suffer from generalized pain. The impact of FM on PRO validated in SpA has not been systematically studied. Objective Study the performance of PROs developed for SpA in patients with primary (p) FM without chronic inflammatory-rheumatic disease vs. SpA without and with concomitant (c) FM. Methods Patients with pFM, axSpA or PsA and indication for treatment adaptation were prospectively included. Standardized PROs were assessed: BASDAI, ASDAS-CRP, DAPSA, patient´s global assessment, BASFI, LEI, MASES, SPARCC Enthesitis Score and FIQ. Results 300 patients were included (100/diagnosis). More males were found in axSpA vs. PsA and pFM group (67, 33 and 2/100, respectively), while 12 axSpA (axSpA+) and 16 PsA (PsA+) patients had cFM. pFM patients showed significantly higher scores in all assessments vs. axSpA or PsA, with exception of ASDAS-CRP (3.3 ± 0.6 in FM vs. 3.1 ± 1.0 in axSpA) and duration of low lumbar morning stiffness. Similar results were also found in the subanalysis of female patients only. In addition, patients with axSpA + or PsA + showed no differences to patients with pFM, while significantly higher scores were found for FM, axSpA + and PsA + for almost all FIQ items compared to axSpA- or PsA-. Conclusions PROs originally developed for axSpA or PsA need to be interpreted differently in the presence or absence of cFM. ASDAS-CRP and duration of lumbar morning stiffness were not affected by cFM. FM-specific questionnaires also showed high scores in patients with SpA with cFM but not in those without.

Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disease characterized by inflammation and new bone formation in the axial skeleton. AxSpA is considered a spectrum of disease that includes two subtypes identified by the Assessment in SpondyloArthritis International Society classification criteria, namely, radiographic (r-axSpA usually referred to as ankylosing spondylitis) and non-radiographic axSpA (nr-axSpA). Although the burden of disease appears similar between the two classified subtypes, the degree of inflammation, as assessed by magnetic resonance imaging and C-reactive protein, and the degree of new bone formation are significantly higher in r-axSpA than in nr-axSpA. Nevertheless, axSpA is considered one disease with different courses. International guidelines for the management of axSpA have outlined treatment goals focused on control of signs and symptoms, inflammation, prevention of progressive structural damage, preservation of physical function, normalization of social participation and improvement of quality of life. The pathogenesis of axSpA has not been completely elucidated to date. A strong link between human leukocyte antigen B27 and axSpA, however, has been identified, and the success of anti-tumour necrosis factor and anti-interleukin (IL)-17A therapy has highlighted some of the key pro-inflammatory cytokines involved. The anti-IL-17A monoclonal antibody secukinumab is approved for the treatment of ankylosing spondylitis and nr-axSpA in the European Union and United States. In this narrative review, we discuss data for secukinumab in axSpA from randomized controlled trials, including MEASURE trials in AS and PREVENT in nr-axSpA, and real-world evidence.

Selenium (Se) is an essential micronutrient for antioxidant defense. Selenoproteins are involved in metabolic and signaling pathways of autoimmune and autoinflammatory diseases. Copper (Cu) and zinc (Zn) are integral components of key enzymes and regulatory proteins. Trace element (TE) dysregulations have potential relevance as disease biomarkers. In this study, we compare TE status and TE profiles between patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA), and relate the results to markers of inflammation, remission, and healthy controls. Serum TE was measured using total reflection X-ray fluorescence. The Se transporter SELENOP and extracellular glutathione peroxidase (GPx3) were determined by ELISA and enzymatic assay, respectively. Both groups of patients (axSpA; n = 84, and PsA; n = 76) displayed TE deficiency compared to healthy European adults. Serum Cu, Se, Zn, SELENOP, and GPx3 levels were not different between the groups. The serum Cu and Cu-Zn ratio correlated positively with C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). An inverse correlation of serum Se, Zn, and SELENOP with CRP was observed in axSpA, but not in PsA. On average, all TE, including the inflammation-responsive Cu levels, were below reference ranges, indicating a TE deficiency in both groups. Increasing CRP was associated with low SELENOP levels, suggesting personalized Se substitution as indicated to maintain systemic Se supply and protect from ferroptotic cell loss under inflammatory conditions.

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.

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  < 0.001) while synovitis was visible in both but was more prevalent in RA (synovitis-score axSpA/RA: 0.02vs0.1; p  < 0.001). BME was found in 8 (13.6%) vertebral corner vs. 9 (18.8%), in 2 (3.4%) facet joints vs. 7 (14.6%) and in 1 (1.7%) spinous processes vs. 9 (18.8%) in patients with RA/r-axSpA. In contrast, more patients with RA (30.5% vs6.3%) showed erosive osteochondrosis with endplate BME ( p  = 0.002). Conclusion While involvement of upper cervical inflammation was typically present in RA, r-axSpA patients showed more BME in lower CS segments, vertebral corners, facet joints and spinous processes. Neck pain is linked to upper and lower inflammatory and structural lesions of the CS in both diseases.

Background: Radiographic axial spondyloarthritis (r-axSpA), formerly known as ankylosing spondylitis (AS), is a chronic, inflammatory rheumatic disease associated with symptoms such as inflammatory back pain, morning stiffness, and arthritis. First-line recommendations for patients with AS include treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for reducing pain and stiffness. Objectives: The objective of our study is to evaluate the efficacy and short-term NSAID-sparing effect of secukinumab in patients with AS currently treated with NSAIDs. Design: We assessed the clinical Assessment of SpondyloArthritis International Society (ASAS20) response to secukinumab and evaluated the extent to which the use of concomitant NSAID can be reduced between weeks 4 and 12 in r-axSpA patients treated with secukinumab 150 mg compared with placebo. Methods: ASTRUM was a prospective 24-week randomized controlled trial of adult patients with active r-axSpA [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ⩾4] who had a documented inadequate response to ⩾2 NSAIDs. Patients were randomized (1:1:1) to initiate treatment with subcutaneous secukinumab 150 mg from either week 0 (group 1), week 4 (group 2), or week 16 (group 3). From week 4 onward, tapering of NSAIDs was allowed in all groups. Results: This study included 211 patients (n = 71, 70, and 70 in groups 1, 2, and 3, respectively). ASAS20 response at week 12 for pooled groups 1 and 2 versus group 3 was 51.1% versus 44.3% (p = 0.35). A higher proportion of patients in groups 1 and 2 achieved ASAS40 and BASDAI50 and showed improvements in other secondary clinical outcomes as compared to group 3 at week 16. More patients in groups 1 and 2 versus group 3 stopped their NSAID intake from baseline through week 16. Conclusion: Treatment with secukinumab improved clinical outcomes and showed a short-term NSAID-sparing effect in patients with r-axSpA, even though the primary endpoint was not met. Trial registration: ClinicalTrials.gov; NCT02763046, EudraCT 2015-004575-74.

ObjectivesTo compare the spondyloarthritis (SpA) specific universal health utility estimation from the ASAS health index (U-ASAS-HI) with the generic EuroQol-5D-3L (EQ-5D-3L) utility among SpA subtypes and to understand the contribution of health-, personal- and country-level factors to the U-ASAS-HI.MethodsAncillary analysis of the ASAS-PERipheral involvement in SpondyloArthritis (PerSpA) study including patients who completed both ASAS-HI and EQ-5D-3L. Correlations between U-ASAS-HI and EQ-5D-3L were tested overall and by subtype (axial SpA, peripheral SpA and psoriatic arthritis (PsA)). Health and contextual determinants of U-ASAS-HI were evaluated using multivariable linear mixed-effects models with country as level.Results4158 patients were included, mean age 44 (SD:13) and 61% male. Mean U-ASAS-HI was 0.44 (SD:0.30) and mean EQ-5D-3L was 0.71 (SD:0.21), with numerically minor differences between subtypes. Correlations between U-ASAS-HI and EQ-5D-3L were consistently strong between subgroups (range 0.74–0.76). Linear mixed-effects modelling showed health outcomes, including disease activity (axial spondyloarthritis disease activity score; β=−0.030, 95% CI −0.038 to −0.021), physical function (bath ankylosing spondylitis functional index; β=−0.044, 95% CI −0.048 to −0.041), anxiety/depression (EQ-5D-3L q5; β=−0.147, 95% CI −0.160 to −0.134) and fibromyalgia (fibromyalgia rapid screening tool; β=−0.068, 95% CI −0.083 to −0.053) were strong predictors of lower U-ASAS-HI. Additionally, female gender, PsA subtype, axial involvement, fatigue and having no employment were associated with lower U-ASAS-HI while older age and university education were associated with higher U-ASAS-HI. The random-effects model indicated an intraclass correlation coefficient of 6% in total variance attributable to differences between countries.ConclusionThe universal U-ASAS-HI captures the broad range of aspects relevant to valuing SpA health states across SpA subtypes. The lower absolute values of U-ASAS-HI reflect the wider disutility associated with SpA.

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 < 0.001), and also for ES measures of RoK (all p < 0.003) and RoM (all p < 0.04), while a positive trend was seen for flexion and extension (RoM). There was no significant effect of changes in medication (all 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).

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.