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- still's disease, adult-onset
- biological therapy
- interleukin 1 receptor antagonist protein
- outcome assessment, health care
We would like to thank Ruscitti et al1 for their interest in our recent publication, in which we presented the results of the Canakinumab for treatment of adult onset Still‘s disease to achieve reduction ofarthritic manifestation (CONSIDER) trial. In this study, we investigated the efficacy of canakinumab for the treatment of patients with adult-onset Still’s disease (AOSD) with articular involvement (tender and swollen joint counts≥4 each) by means of a multicentre, double-blind, randomised, placebo-controlled trial.2 Patients were randomised to receive either canakinumab 4 mg/kg body weight (maximum 300 mg) every 4 weeks or placebo. According to the study goal, the primary endpoint was defined as the proportion of patients with a clinically relevant reduction in Disease Activity Score (DAS 28 >1.2) at week 12.
Since no controlled studies existed in this indication at that time of the study initiation, we were not able to base our statistical considerations on known facts of response rates to placebo or any immunosuppressive regimen. After careful consideration, our sample size calculation indicated that it requires a total of n=68 randomised patients to show a significant difference between the groups. …
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