IntroductionAxial spondyloarthritis (axSpA) is a chronic inflammatory disease that typically affects people in their second and third decades of life, which are important years for establishing a ...professional career. We aim to study outcomes of work participation (WP) and their associations with demographic and clinical confounders, in addition to prevalence of negative workplace experiences in axSpA.MethodsIn total, 770 patients with axSpA participated in the multicentre, observational ATTENTUS–axSpA survey in Germany. Demographic information, clinical parameters and patient-related outcomes (including disease activity and function) with a focus on WP were prospectively recorded.ResultsA high prevalence of negative workplace experiences was reported among the 770 patients analysed. Overall, 23.4% of patients were not employed and 6.5% received disability pensions. Current work cessation was prevalent in 120 patients, and 28 of those were out of work for 10 years or longer. Of the 590 currently employed patients, 31.9% reported absenteeism and 35.9% reported presenteeism for >1 month within the past year. Multivariate logistic regression identified low disease activity (Bath Ankylosing Spondylitis Disease Activity Index), better physical function (Bath Ankylosing Spondylitis Functional Index) and better global functioning (Assessment of SpondylAarthritis International Society–Health Index) as the main predictors for unimpaired WP (n=242). Importantly, biological treatment, disease duration, age, sex, education level and body mass index were not reliable predictors.DiscussionDespite improvements in pharmacological treatment options, we still observed substantially impaired WP in patients with axSpA. These data emphasise the high unmet need for targeted strategies to provide improved medical and social care.
IntroductionTo identify facilitators and barriers towards vaccination in general and specifically against pneumococci, influenza and SARS-CoV-2 in patients with rheumatic musculoskeletal diseases ...(RMD).MethodsBetween February and April 2021, consecutive patients with RMD were asked to complete a structured questionnaire on general knowledge about vaccination, personal attitudes and perceived facilitators and barriers towards vaccination. General facilitators (n=12) and barriers (n=15) and more specific ones for vaccination against pneumococci, influenza and SARS-CoV-2 were assessed. Likert scales had four response options: from 1 (completely disagree) to 4 (completely agree). Patient and disease characteristics, their vaccination records and attitudes towards vaccination against SARS-CoV-2 were assessed.Results441 patients responded to the questionnaire. Knowledge about vaccination was decent in ≥70% of patients, but <10% of patients doubted its effectiveness. Statements on facilitators were generally more favourable than on barriers. Facilitators for SARS-CoV-2 vaccination were not different from vaccination in general. Societal and organisational facilitators were more often named than interpersonal or intrapersonal facilitators. Most patients indicated that recommendations of their healthcare professional would encourage them to be vaccinated—without preference for general practitioner or rheumatologists. There were more barriers towards SARS-CoV-2 vaccination than to vaccination in general. Intrapersonal issues were most frequently reported as a barrier. Statistically significant differences in response patterns to nearly all barriers between patients classified as definitely willing, probably willing and unwilling to receive SARS-CoV-2 vaccines were noted.DiscussionFacilitators towards vaccination were more important than barriers. Most barriers against vaccination were intrapersonal issues. Societal facilitators identified support strategies in that direction.
Introduction
Baricitinib, an orally available small-molecule inhibitor of Janus kinase (JAK)1 and JAK2, is indicated to treat active moderate-to-severe rheumatoid arthritis (RA).
Objective
This ...systematic review described the real-world clinical characteristics of baricitinib-treated patients with RA, prescription patterns, effectiveness, drug persistence, patient-reported outcomes (PROs; physical function, pain, health-related quality of life HRQoL), patient global assessment (PGA), and safety of baricitinib.
Methods
A PRISMA systematic review of real-world studies was conducted to identify relevant literature published between January 2016 and September 2022 using MEDLINE®, EMBASE®, and evidence-based medicine review databases. Websites or online repositories of the American College of Rheumatology and the European Alliance of Associations for Rheumatology were searched manually to include relevant abstracts from conferences held between January 2016 and November 2022.
Results
A total of 11,472 records were identified by searching online databases. Seventy studies were included in the study, of which 40 were abstracts. Most patients were older (51–71 years), female, and with mean RA duration of 4–19 years. Baricitinib was mostly used after the failure of one or more bDMARDs, and 4 mg dosing was prevalent in patients with RA (range 22–100%). Clinical effectiveness of baricitinib was reported in real-world settings regardless of prior biologic/targeted synthetic disease-modifying antirheumatic drug (DMARD) use and concomitant conventional synthetic DMARD use. Achievement of Clinical Disease Activity Index (CDAI) remission was reported in 8.7–60% of patients at week 12 and CDAI low disease activity (LDA) in 20.2–81.6% at week 24. The proportion of patients attaining Simple Disease Activity Index (SDAI) remission was reported in 12% at week 4 to 45.4% at 24 weeks. Drug persistence was high, similar, or equal to anti-tumor necrosis factor drugs. No new safety signals were identified.
Conclusion
Baricitinib demonstrated effectiveness in the real-world setting with a consistent safety profile observed in clinical studies. Better persistence rates for baricitinib compared to bDMARDs with improvement in PROs were reported, although baricitinib-treated patients had RA with poor prognostic characteristics.
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.
To investigate the impact of MRCT on physical function and mobility including range of motion (RoM) and kinematics (RoK).
Single-center interventional, observational trial.
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.
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
V2 were noted for BASFI, BASMI, and all other assessments (
< 0.001), and also for ES measures of RoK (all
< 0.003) and RoM (all
< 0.04), while a positive trend was seen for flexion and extension (RoM). There was no significant effect of changes in medication (all
> 0.05).
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.
Ethical Committee: Ruhr-Universität (reference-number: 19-6735-BR).
In this review article four clinical comparative studies in axial spondylarthritis (axSpA) are presented and discussed. SURPASS as the only head-to-head study investigated the effect of adalimumab ...biosimilar disease-modifying antirheumatic drug (bsDMARD) or secukinumab on radiographic progression over a time period of 2 years. Overall, the radiographic progression of the spine was low and no significant difference between adalimumab bsDMARD or secukinumab was noted. The three other studies were not constructed as direct head-to-head studies but compared the efficacy of non-steroidal antirheumatic drugs (NSARD) with and without simultaneous treatment with biological DMARDs (bDMARD). The CONSUL study showed no statistically significant difference in the delay of radiographic progression of the spine over 2 years in radiographic axSpA (r-axSpA) patients, who underwent either combined treatment with golimumab and celecoxib or treatment with golimumab alone over 2 years. The ESTHER study showed that patients with early axSpA active inflammatory lesions, which were detected by whole-body magnetic resonance imaging (MRI), showed a significantly greater improvement under treatment with etanercept than those treated with sulfasalazine. The INFAST study showed that patients with early active axSpA who received a combined treatment of infliximab and naproxen, achieved a clinical remission twice as frequently as those who only received naproxen. Therefore, for the endpoint of radiological progression no difference could be shown in the inhibition of radiological progression between the mechanisms of action investigated. The comparative data for the endpoint of clinical efficacy showed that patients with bDMARDs showed a clearly better response to treatment than patients with NSAR or conventional synthetic DMARDs (csDMARD).
ObjectivesTo determine if there were differences in the Assessment of SpondyloArthritis international Society Health Index (ASAS HI) scores between patients classified as radiographic axial ...spondyloarthritis (r-axSpA) and non-radiographic axSpA (nr-axSpA), and to identify factors associated with higher ASAS HI scores in both disease phenotypes.MethodsThis study was an ancillary analysis of the ASAS HI international validation project performed in 23 countries. Patients were included if they were ≥18 years of age and diagnosed with axSpA. Univariable and multivariable analysis were performed to determine if ASAS HI scores differed between the axSpA phenotypes, and to identify other variables associated with ASAS HI scores. We also tested for potential interactions between the axSpA phenotype and significant variables identified through the multivariable regression.ResultsA total of 976 patients were included, with 703 having r-axSpA and 273 nr-axSpA. Patients with r-axSpA reported higher (worse) ASAS HI scores compared with those with nr-axSpA (6.8 (4.4) vs 6.0 (4.0), p=0.02), but the axSpA phenotype was not associated with ASAS HI scores in the multivariable regression (β: −0.19, 95% CI: −0.56 to 0.19). Female gender, having worse physical function (Bath Ankylosing Spondylitis Functional Index), disease activity (Ankylosing Spondylitis Disease Activity Score) and anxiety and depressive symptoms (Hospital Anxiety and Depression Scale) were associated with higher ASAS HI scores. No interactions were found to be significant.ConclusionOverall health and functioning are similarly affected in patients with r-axSpA and nr-axSpA. Female patients, having worse physical function, disease activity, anxiety and depressive symptoms were independently associated with higher ASAS HI scores.
ObjectivePatients with axial spondyloarthritis (axSpA) suffer from clinical symptoms like morning stiffness and back pain. Mobility of patients with axSpA is often impaired. The aim of this study is ...to compare the performance of patients with axSpA regarding mobility measures including performance-based tests and objective electronic assessments with the Epionics SPINE device (ES) at different times of the day compared with healthy controls (HC).MethodsObservational trial, consecutive inpatients with axSpA (n=100) and 20 HCs were examined in the morning (V1: before 10:00 am) and in the afternoon (V2: after 02:00 pm) by the Bath Ankylosing Spondylitis Metrology Index (BASMI), the AS physical performance index (ASPI), the Short Physical Performance Battery (SPPB) and ES measurements, including range of motion (RoM) and range of kinematics (RoK).ResultsThe assessments of patients with axSpA performed in the morning clearly differed from those in the afternoon, especially regarding performance-based tests. Significant improvements were seen for BASMI (4.0±3.8 to 3.8±1.9; p<0.001), ASPI (36.2±18.3 to 28.8±11.9 s; p<0.001), SPPB (10.1±1.5 to 10.7±1.4 points; p<0.001) and for ES measures of speed (RoK; p<0.018) but not for RoM, except for lateral flexion (13.3±7.4 to 14.7±8.2°; p=0.002). This time of assessment-related variability was not observed in HC.ConclusionThe spinal mobility of patients with axSpA was worse in the morning but significantly improved in the afternoon. This was captured best by performance-based measures and was not seen in HC. The diurnal variation of mobility has implications for clinical studies, suggesting that the time of assessments needs to be standardised.
Introduction
To evaluate the effect of upadacitinib vs. placebo on health-related quality of life (HRQoL) and work productivity in patients with active non-radiographic axial spondyloarthritis ...(nr-axSpA) enrolled in the SELECT-AXIS 2 phase 3 randomized controlled trial.
Methods
Adult patients with active nr-axSpA and an inadequate response to non-steroidal anti-inflammatory drugs were randomized 1:1 to receive upadacitinib 15 mg once daily or placebo. Mean changes from baseline in measures of HRQoL (Ankylosing Spondylitis QoL ASQoL, Assessment of SpondyloArthritis international Society Health Index ASAS HI, Short-Form 36 Physical Component Summary SF-36 PCS score) and Work Productivity and Activity Impairment (WPAI) were assessed through 14 weeks based on mixed-effects repeated measures or analysis of covariance models. The proportions of patients with improvements ≥ minimum clinically important differences (MCID) were assessed in HRQoL measures at week 14 using non-responder imputation with multiple imputation.
Results
At week 14, upadacitinib- vs. placebo-treated patients reported greater improvements from baseline in ASQoL and ASAS HI (ranked,
P
< 0.001) and in SF-36 PCS and WPAI overall work impairment (nominal
P
< 0.05). Improvements were observed as early as week 2 in ASAS HI. Greater proportions of upadacitinib vs. placebo-treated patients reported improvements ≥ MCID in ASQoL (62.6 vs. 40.9%), ASAS HI (44.8 vs. 28.8%), and SF-36 PCS (69.3 vs. 52.0%), with numbers needed to treat < 10 for all (nominal
P
≤ 0.01). Improvements ≥ MCID were consistently observed irrespectively of prior exposure to tumor necrosis factor inhibitors.
Conclusions
Upadacitinib provides clinically meaningful improvements in HRQoL and work productivity in patients with active nr-axSpA.
Clinical Registration Number
NCT04169373, SELECT-AXIS 2.
ObjectiveThe objective of this study is to build a structural model visualising and quantifying the interrelationships of different disease outcomes with the Assessment of SpondyloArthritis ...International Society Health Index (ASAS HI) in patients with axial spondyloarthritis (axSpA).MethodsCross-sectional data collected at month 72 of the Devenir des Spondylarthropathies Indifferénciées Récentes cohort was analysed. Combining prior knowledge and observed data, probabilistic Bayesian network modelling was used to study how the interplay of different disease outcomes affects the ASAS HI, which measures disease-specific overall functioning and health. Disease outcomes comprised, among others, the Ankylosing Spondylitis (AS) Disease Activity Score (ASDAS) and the Bath AS Functional Index (BASFI).ResultsData of 384 patients were analysed. The obtained structure suggests that ASAS HI is determined by both patient-reported physical function (BASFI) and disease activity (ASDAS). The parameters of the structural model show that an increase of ASDAS or BASFI by 1 unit corresponds to an increase of ASAS HI by 0.70 or 1.25 units, respectively. Moreover, the model suggests that disease activity has an indirect impact on ASAS HI via BASFI. No relationship between spinal mobility or structural damage and ASAS HI was found.ConclusionsThis is the first structural model developed to better understand the construct and the interplay between clinically relevant outcomes related to ASAS HI in axSpA patients. It shows that disease activity and physical function have a strong impact on ASAS HI, confirming it to be a valid construct of overall functioning and health in axSpA patients.
