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Changing the outcome measures, changing the results? The urgent need of a specific disease activity score to adult-onset Still’s disease
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  1. Piero Ruscitti1,
  2. Tanja A Stamm2,
  3. Roberto Giacomelli1
  1. 1Department of Clinical Sciences and Applied Biotechnology, University of L'Aquila, L'Aquila, Abruzzo, Italy
  2. 2Section for Outcomes Research, Center for Medical Statistics, Informatics and Intelligent System, Medical University of Vienna, Vienna, Austria
  1. Correspondence to Dr Roberto Giacomelli, Department of Clinical Sciences and Applied Biotechnology, University of L'Aquila, L'Aquila 67100, Abruzzo, Italy; roberto.giacomelli{at}cc.univaq.it

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We read with great interest the article by Kedor et al1 on the efficacy of canakinumab, an interleukin (IL)−1β antagonist, on patients with adult-onset Still’s disease (AOSD). In this multicentre, double-blind, randomised, placebo-controlled trial, 36 patients with active joint involvement were enrolled1; this is the largest clinical trial performed on AOSD so far. Moreover, the results of this trial are of considerable interest in this field, considering the challenge of arranging prospective studies on a rare disease. Despite the improvement of many articular secondary measures, the primary outcome, the proportion of patients with a clinically relevant reduction of the articular manifestation measured by change in disease activity score (ΔDAS28(ESR) >1.2) at week 12, did not achieve statistical significance.1 Apparently, this finding seems to be in contrast with the strong scientific rationale, which is behind the study, of inhibiting IL-1β in AOSD and with the confirmed efficacy of canakinumab reported in …

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