Objectives: The alternative ASDAS (altASDAS) is an index that can be used when patient global assessment is unavailable. Our aim was to test the truth and discrimination aspects according to... Show moreObjectives: The alternative ASDAS (altASDAS) is an index that can be used when patient global assessment is unavailable. Our aim was to test the truth and discrimination aspects according to OMERACT filter 2.0 of the altASDAS in an external cohort. Methods: Cohorts from the COAST trials of ixekizumab (COAST-V, -W, -X; 16-week primary endpoint) enrolling radiographic/non-radiographic axial SpA patients were pooled. The ASDAS [original formula with patient global assessment (PGA)] and altASDAS were calculated. Truth was assessed by agreement with the continuous ASDAS [intraclass correlation coefficients (ICCs)] and ASDAS disease activity (DA) states (weighted kappa), Bland-Altman plots [mean difference (MD) and 95% limits of agreement (LoA)] and Pearson's correlations between altASDAS/ASDAS and other constructs. Discrimination was tested by the ability of altASDAS to distinguish high/low DA according to nocturnal pain >6/10 as an external anchor and agreement (kappa) with ASDAS in major improvement (MI) and clinically important improvement (CII). Results: A total of 958 patients were included. For truth, agreement with ASDAS was very good (ICC = 0.99, kappa = 0.91), MD with ASDAS was 0.03 (95% LoA -0.31-0.24) and correlation coefficients of altASDAS with related constructs were within a prespecified 0.3-wide band around those between ASDAS and the same construct. For discrimination, the altASDAS discriminated between DA states and agreed with ASDAS response (kappa MI = 0.91, CII = 0.93). Conclusions: The altASDAS was truthful and discriminative in an external cohort and as such has been fully validated to be used in cases when PGA is unavailable. Show less
Nikiphorou, E.; Boonen, A.; Fautrel, B.; Richette, P.; Landewe, R.; Heijde, D. van der; Ramiro, S. 2021
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... Show moreObjectives: 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. Show less
Essers, I.; Boonen, A.; Busch, M.; Heijde, D. van der; Keszei, A.P.; Landewe, R.; ... ; Tubergen, A. van 2016
