PT - JOURNAL ARTICLE AU - Claudia Kedor AU - Joachim Listing AU - Jan Zernicke AU - Anja Weiß AU - Frank Behrens AU - Norbert Blank AU - Joerg Christoph Henes AU - Joern Kekow AU - Andrea Rubbert-Roth AU - Hendrik Schulze-Koops AU - Eva Seipelt AU - Christof Specker AU - Eugen Feist TI - Canakinumab for Treatment of Adult-Onset Still’s Disease to Achieve Reduction of Arthritic Manifestation (CONSIDER): phase II, randomised, double-blind, placebo-controlled, multicentre, investigator-initiated trial AID - 10.1136/annrheumdis-2020-217155 DP - 2020 Aug 01 TA - Annals of the Rheumatic Diseases PG - 1090--1097 VI - 79 IP - 8 4099 - http://ard.bmj.com/content/79/8/1090.short 4100 - http://ard.bmj.com/content/79/8/1090.full SO - Ann Rheum Dis2020 Aug 01; 79 AB - Background Inhibition of interleukin (IL)-1 represents a promising treatment option in adult-onset Still's disease (AOSD).Objective To investigate the efficacy and safety of canakinumab in patients with AOSD and active joint involvement by means of a multicentre, double-blind, randomised, placebo-controlled trial.Methods Patients with AOSD and active joint involvement (tender and swollen joint counts of ≥4 each) were treated with canakinumab (4 mg/kg, maximum 300 mg subcutaneous every 4 weeks) or placebo. The primary endpoint was the proportion of patients with a clinically relevant reduction in disease activity at week 12 as determined by the change in disease activity score (ΔDAS28>1.2).Results At enrolment, patients had high active disease with a mean DAS28(ESR) of 5.4 in the canakinumab and 5.3 in the placebo group, respectively. In the intention-to-treat analysis, 12 patients (67%) in the canakinumab group and 7 patients (41%) in the placebo group fulfilled the primary outcome criterion (p=0.18). In the per-protocol analysis, significantly higher American College of Rheumatology (ACR) 30% (61% vs 20%, p=0.033), ACR 50% (50% vs 6.7%, p=0.009) and ACR 70% (28% vs 0%, p=0.049) response rates were observed in the canakinumab group compared with the placebo group. Two patients in the canakinumab group experienced a serious adverse event.Conclusion Although the study was terminated prematurely and the primary endpoint was not achieved, treatment with canakinumab led to an improvement of several outcome measures in AOSD. The overall safety findings were consistent with the known profile of canakinumab. Thus, our data support indication for IL-1 inhibition with canakinumab in AOSD.