Tofacitinib onveiliger dan TNF-α-remmer bij reumatoïde artritis

Tofacitinib is a relatively new oral drug for the treatment of rheumatoid arthritis. The ORAL surveillance study shows in a direct comparison that more patients with RA develop a 'major adverse cardiovascular event' (MACE) or malignancy during treatment with tofacitinib than during treatment with a tumor necrosis factor (TNF) inhibitor. The reliability of the study, the generalisability and interpretation of the results, as well as their implication for daily practice are discussed here

Is active sacroiliitis on MRI associated with radiographic damage in axial spondyloarthritis? Real-life data from the ASAS and DESIR cohorts

Objectives. To assess any association between bone marrow oedema on MRI of the sacroiliac joints (MRI-SIJ) according to local readings in daily practice and the development of structural damage on radiographs of the SIJ (X-SIJ) in axial spondyloarthritis (axSpA). Methods. Patients with axSpA from the Assessment of the SpondyloArthritis international Society (ASAS) and DEvenir des Spondylarthopathies Indifférenciées Récentes (DESIR) multicentre cohorts were included. MRI-SIJ and X-SIJ were obtained at baseline, and X-SIJ at follow-up after a mean 4.6 years (ASAS) and 5.1 years (DESIR). All images were scored by local readers. Structural damage in the X-SIJ was defined according to the modified New York criteria. The percentage of structural net progression (number of 'progressors' minus the number of 'regressors' divided by the total number of patients) was assessed and the effect of bone marrow oedema on MRI-SIJ on X-SIJ damage evaluated by multivariable logistic regression. Results. In total, 125 (ASAS-cohort) and 415 (DESIR-cohort) patients had baseline MRI-SIJ and complete X-SIJ data available. According to local readings, progression and 'improvement' in X-SIJ was seen in both the ASAS- and DESIR-cohort, yielding a net progression that was higher in the former than in the latter (19.2% and 6.3%). In multivariable analysis, baseline bone marrow oedema on MRI-SIJ was strongly associated with X-SIJ structural progression in both ASAS (odds ratio = 3.2 [95% CI: 1.3; 7.9]), and DESIR (odds ratio = 7.6 [95% CI: 4.3; 13.2]). Conclusion. Inflammation on MRI-SIJ is associated with future radiographic progression according to local readings despite an expected increased imprecision invoked by local readings

Validation and reliability of translation of the ASAS Health Index in a Colombian Spanish-speaking population with spondyloarthritis

To validate a Spanish language translation of the ASAS Heath-Index (ASAS-HI) testing, its reliability, construct validity, and responsiveness in Colombian patients with spondyloarthritis. Translation was done following a forward-backward procedure. Patients fulfilling the Assessment of Spondyloarthritis international Society (ASAS) criteria for either axial or peripheral spondyloarthritis (SpA) participated. Test-retest reliability was assessed by intra-class correlation coefficient (ICC) in patients without treatment changes. In patients who required a therapeutic intervention, responsiveness was assessed using the standardized response mean (SRM). Construct validity was evaluated by Spearman correlation. Internal consistency (Cronbach’s α) and discriminative ability of the ASAS-HI were assessed. Fifty patients were included: 54% male, mean (SD) age 44.8 (13.1), symptom duration 15.8 (9.7) years, Bath Ankylosing Spondylitis Disease Index (BASDAI) 4.6 (2.2), Bath Ankylosing Spondylitis Functioning Index (BASFI) 4.7 (2.5), Ankylosing Spondylitis Disease Activity Score with C-Reactive Protein (ASDAS-CRP) 2.2 (1.0). Axial SpA was established in 44 patients (ankylosing spondylitis (AS) = 30, non-radiographic axial SpA (nr-axSpA) = 14) and peripheral SpA in 6 patients. The score of the ASAS-HI was 8.2 (5.1). The test-retest reliability was good with an ICC of 0.84. SRM was 2.58 (1.75–3.37) in 10 patients with any intervention and 2.94 (2.13–4.24) for 7 patients starting TNF blockers. Construct validity showed a good correlation between ASAS-HI and pain, BASDAI, BASFI, and Ankylosing Spondylitis Disease Activity Score (ASDAS) (r ≥ 0.60). A high internal consistency was found with a Cronbach’s α of 0.91. ASAS-HI discriminated well between patients with different stages of disease activity (BASDAI and ASDAS). Those with higher disease activity had higher ASAS-HI scores. The Spanish language translation of the ASAS-HI has proven to be psychometrically valid for Colombian patients with SpA. This version is available to evaluate the state of health and functioning in these patients and can be used in clinical practice

How do clinical and socioeconomic factors impact on work disability in early axial spondyloarthritis? Five-year data from the DESIR cohort

OBJECTIVES: To investigate the impact of clinical and socioeconomic factors on work disability (WD) in early axial spondyloarthritis (axSpA). METHODS: Patients from the DESIR cohort with a clinical diagnosis of axSpA were studied over 5 years. Time to WD and potential baseline and time-varying predictors were explored, with a focus on socioeconomic (including ethnicity, education, job-type, marital/parental status) and clinical (including disease activity, function, mobility) factors. Univariable analyses, collinearity and interaction tests guided subsequent multivariable time-varying Cox survival analyses. RESULTS: From 704 patients eligible for this study, the estimated incidence of WD among those identified as at risk (n = 663, 94%), and across the five years of DESIR, was 0.05 (95% CI 0.03, 0.06) per 1000 person-days. Significant differences in baseline socioeconomic factors, including lower educational status and clinical measures, including worse disease activity, were seen in patients developing WD over follow-up, compared with those who never did. In the main multivariable model, educational status was no longer predictive of WD, whereas the AS disease activity score (ASDAS) and the BASFI were significantly and independently associated with a higher hazard of WD [HR (95%CI) 1.79 (1.27, 2.54) and 1.42 (1.22, 1.65), respectively]. CONCLUSION: WD was an infrequent event in this early axSpA cohort. Nevertheless, clinical factors were among the strongest predictors of WD, over socioeconomic factors, with worse disease activity and function independently associated with a higher hazard of WD. Disease severity remains a strong predictor of adverse work outcome even in early disease, despite substantial advances in therapeutic strategies in axSpA

Systematic review of rheumatoid arthritis clinical studies: Suboptimal statistical analysis of radiological data

Introduction: The distribution of progression scores in rheumatoid arthritis is highly skewed, requiring advanced statistical analysis techniques, with different techniques resulting in different outcomes. Methods: Three databases were searched to identify rheumatoid arthritis clinical trials and observational studies that described radiographic analysis techniques, comparing at least two groups. Results: Of 5980 identified papers, 225 were eligible for data extraction. Parametric techniques (t-tests, ANOVA or linear regression) were used in 39 studies, of which 18% took the skewed distribution into account. In 53 studies, continuous data was categorized and analyzed with binomial or ordinal methods (chi-square tests or logistic regression). Two studies treated the outcome as a ‘count’ outcome variable (applying a Poisson). Conclusion: There is large heterogeneity in the analysis strategy of radiographic progression in recent rheumatoid arthritis clinical trials and observational studies, with the majority of studies applying simple, suboptimal or inappropriate methods

Determinants of the patient global assessment of well-being in early axial spondyloarthritis: 5-year longitudinal data from the DESIR cohort

OBJECTIVES: To investigate the determinants of patient well-being over time, and the influence of age, gender and education in patients with early axial spondyloarthritis (axSpA). METHODS: Five-year data from DESIR, a cohort of early axSpA, were analysed. The outcome was the BAS-G over 5 years. Generalized estimating equations (GEE) were used to test the relationship between potential explanatory variables from five outcome domains (disease activity, physical function, spinal mobility, structural damage and axial inflammation) and BAS-G over time. Longitudinal relationships were analysed using an autoregressive GEE model. Age, gender and educational level were tested as effect modifiers or confounders. RESULTS: A total of 708 patients were included. Higher BASDAI questions on fatigue [β (95% CI): 0.17 (0.13, 0.22)], back pain [0.51 (0.46, 0.56)], peripheral joint pain [0.08 (0.04, 0.12)] and severity of morning stiffness [0.08 (0.03-0.13)], and higher BASFI [0.14 (0.08, 0.19)] were associated with a higher BAS-G. In the autoregressive model, the same variables except for morning stiffness were associated with a worsening in BAS-G. Age, gender and educational level were neither effect modifiers nor confounders. CONCLUSION: A higher level of back pain is associated with a worsening of patient well-being, as are, though to a lesser extent, higher levels of fatigue, peripheral joint pain and physical disability. Age, gender and educational level do not have an impact on these relationships