PT  - JOURNAL ARTICLE
AU  - Yuko Kaneko
AU  - Hideto Kameda
AU  - Kei Ikeda
AU  - Tomonoti Ishii
AU  - Kosaku Murakami
AU  - Hyota Takamatsu
AU  - Yoshiya Tanaka
AU  - Takayuki Abe
AU  - Tsutomu Takeuchi
TI  - Tocilizumab in patients with adult-onset still’s disease refractory to glucocorticoid treatment: a randomised, double-blind, placebo-controlled phase III trial
AID  - 10.1136/annrheumdis-2018-213920
DP  - 2018 Dec 01
TA  - Annals of the Rheumatic Diseases
PG  - 1720--1729
VI  - 77
IP  - 12
4099  - http://ard.bmj.com/content/77/12/1720.short
4100  - http://ard.bmj.com/content/77/12/1720.full
SO  - Ann Rheum Dis2018 Dec 01; 77
AB  - Objective To evaluate the efficacy and safety of tocilizumab, an interleukin-6 receptor antibody, in patients with adult-onset Still’s disease.Methods In this double-blind, randomised, placebo-controlled phase III trial, 27 patients with adult-onset Still’s disease refractory to glucocorticoids were randomised to tocilizumab at a dose of 8 mg/kg or placebo given intravenously every 2 weeks during the 12-week, double-blind phase. Patients received open-label tocilizumab for 40 weeks subsequently. The primary outcome was American College of Rheumatology (ACR) 50 response at week 4. The secondary outcomes included ACR 20/50/70, systemic feature score, glucocorticoid dose and adverse events at each point.Results In the full analysis set, ACR50 response at week 4 was achieved in 61.5% (95% CI 31.6 to 86.1) in the tocilizumab group and 30.8% (95% CI 9.1 to 61.4) in the placebo group (p=0.24). The least squares means for change in systemic feature score at week 12 were –4.1 in the tocilizumab group and –2.3 in the placebo group (p=0.003). The dose of glucocorticoids at week 12 decreased by 46.2% in the tocilizumab group and 21.0% in the placebo group (p=0.017). At week 52, the rates of ACR20, ACR50 and ACR70 were 84.6%, 84.6% and 61.5%, respectively, in both groups. Serious adverse events in all participants who received one dose of tocilizumab were infections, aseptic necrosis in the hips, exacerbation of adult-onset Still’s disease, drug eruption and anaphylactic shock.Conclusion The study suggests that tocilizumab is effective in adult-onset Still’s disease, although the primary endpoint was not met and solid conclusion was not drawn.