Patterns and predictors of change in outcome measures in clinical trials in scleroderma: an individual patient meta-analysis of 629 subjects with diffuse cutaneous systemic sclerosis.

Arthritis and Rheumatism
Peter A MerkelScleroderma Clinical Trials Consortium

Abstract

To examine the range and responsiveness to change of clinical outcome measures and study predictors of clinical response in patients with diffuse cutaneous systemic sclerosis (dcSSc) in the context of clinical trials. Data were combined from 629 patients with dcSSc who participated in 7 multicenter clinical therapeutic trials. Trials used common outcome measures: modified Rodnan skin thickness score (MRSS), Health Assessment Questionnaire disability index (HAQ DI), patient's global assessment of disease activity, pulmonary function tests (forced vital capacity, diffusing capacity for carbon monoxide), hand span, and oral aperture. The combined database included 629 patients (82% women, mean ± SD age 46.5 ± 11.8 years, mean ± SD disease duration 19.4 ± 15.9 months). Outcomes tended to improve during trials for patients with more severe disease at study entry and to worsen for patients with less severe disease at entry. Disease duration was mildly negatively predictive of change in MRSS at 6 months (r = -0.27, P < 0.001), and substantial bidirectional variation in change in MRSS and HAQ DI score was seen across the spectrum of disease duration. Sixty-three percent of patients with "early" disease (disease duration <18 months) had...Continue Reading

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Citations

Nov 14, 2012·Nature Reviews. Rheumatology·Zsuzsanna H McMahan, Laura K Hummers
Feb 22, 2013·Annals of the Rheumatic Diseases·Giuseppina AbignanoFrancesco Del Galdo
Sep 15, 2007·Arthritis Research & Therapy·Marco Matucci-CerinicJames R Seibold
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Jul 2, 2014·Annals of the Rheumatic Diseases·Britta MaurerUNKNOWN EUSTAR co-authors
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