Work

Safety and effectiveness of canakinumab in Japanese patients with cryopyrin-associated periodic syndrome: final results from a post-marketing surveillance in Japan

Year: 2025

Type: article

Abstract: OBJECTIVES: To assess the real-world safety and effectiveness of canakinumab, a monoclonal anti-interleukin-1β antibody, in patients with cryopyrin-associated periodic syndrome (CAPS) in a real-world setting in Japan. METHODS: All patients with CAPS who received canakinumab treatment after drug approval in Japan were registered in a post-marketing all-patient surveillance with 2-year observation period and a follow-up period of up to 5 years. RESULTS: Of 93 patients in the safety analysis set, the proportion of patients with any adverse drug reactions (ADRs) and any serious ADRs was 33.33% and 4.30%, respectively. The most common ADRs were infections and infestations (21.51%). Of 70 new and 18 continuing patients (roll-over from a previous clinical trial) in the effectiveness analysis set, the proportion of responders among new and continuing patients, who achieved both clinical and serological remissions, was 78.57% and 83.33%, respectively, at Week 24. Most responders remained without relapse after the remission until Week 104 (98.11% of new and 100% of continuing patients). Clinical symptoms related to auditory, joint, visual, renal, and central nervous system maintained or improved in the majority of patients. CONCLUSIONS: Canakinumab was well-tolerated and effective during long-term treatment for patients with CAPS in the real-world setting.

Source: Modern Rheumatology

DOI: 10.1093/mr/roaf104

Authors: Chihiro Kato, Takayoshi Sasajima, Ryuta Nishikomori

Institutions: Novartis (Japan), Kurume University

Language: English

Topic: Inflammasome and immune disorders

Subfield: Molecular Biology

Field: Biochemistry, Genetics and Molecular Biology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $3,208