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Efficacy and safety of canakinumab in patients with adult-onset Still’s disease: Results from an open-label phase III study in Japan

Year: 2026

Type: article

Abstract: OBJECTIVES: To evaluate the efficacy and safety of canakinumab 4 mg/kg every 4 weeks administered subcutaneously in Japanese adult-onset Still's disease patients. METHODS: Fourteen participants were included in this open-label, single-arm, active-treatment study. The primary endpoint was the adapted ACR30 response, with a predefined 95% CI lower limit requirement of 40% at Week 8. Secondary endpoints included glucocorticoid tapering from Weeks 8 to 28; adapted ACR30/50/70/90/100 responses over time; and the systemic feature score over time. RESULTS: The primary endpoint was not met [6/11 patients (54.5%); 95% CI: 20.6-88.5; one-sided P = 0.249]. From Weeks 8 to 28, 6/11 patients (54.5%) successfully tapered oral glucocorticoids. At Week 28, among the 11 patients assessed, 70% achieved adapted ACR30 and adapted ACR50, 60% achieved adapted ACR70 and adapted ACR90, and 40% achieved adapted ACR100. At Week 28, the mean (SD) change from baseline in the systemic feature score was -4.3 (2.06). All 14 patients had at least one treatment-emergent adverse event. Six participants (42.9%) had serious adverse events. Three patients had serious infections; all were considered treatment-related and all recovered. CONCLUSION: Although the primary endpoint was not met, the Week 28 analysis showed that canakinumab treatment led to improvements in various efficacy outcome measures in Japanese patients with adult-onset Still's disease, with no unexpected safety signals.

Source: Modern Rheumatology

DOI: 10.1093/mr/roag026