Safety and tolerability of sifalimumab, an anti-interferon-α monoclonal antibody, in Japanese patients with systemic lupus erythematosus: A multicenter, phase 2, open-label study

• Published in: Modern rheumatology Vol. 30; no. 1; pp. 93 - 100
• Main Authors: Takeuchi, Tsutomu, Tanaka, Yoshiya, Matsumura, Ryutaro, Saito, Kazuyoshi, Yoshimura, Mitsuhiro, Amano, Koichi, Atsumi, Tatsuya, Suematsu, Eiichi, Hayashi, Nobuya, Wang, Liangwei, Tummala, Raj
• Format: Journal Article
• Language: English
• Published: United States Taylor & Francis 02-01-2020
• Subjects: Dose escalation; intravenous; safety; sifalimumab; subcutaneous; systemic lupus erythematosus; subcutaneous; systemic lupus erythematosus; intravenous; Dose escalation; safety; sifalimumab
• ISSN: 1439-7595; 1439-7609
• DOI: 10.1080/14397595.2019.1583832

Objectives: To evaluate the safety of sifalimumab in Japanese patients with systemic lupus erythematosus (SLE).
Methods: This phase 2, open-label study consisted of a 52-week initial stage (Stage I) and a long-term extension (Stage II). In Stage I, sequential cohorts of patients received ascending doses of sifalimumab (intravenous [IV] 1.0, 3.0, and 10.0 mg/kg or subcutaneous 100 mg every 2 weeks; IV 600 and 1200 mg every 6 weeks). In Stage II, patients enrolled before June 2012 received the same dose of sifalimumab as during Stage I for up to 157 weeks or sifalimumab 600 mg IV every 4 weeks if they enrolled later. The safety of sifalimumab was assessed by adverse events (AEs).
Results: Thirty patients enrolled in Stage I and 21 patients entered Stage II. The majority of patients experienced AEs (96.7% in Stage I and 100% in Stage II); most were mild or moderate in severity. Serious AEs occurred in 30.0% and 57.1% of patients in Stage I and II, respectively; most were instances of SLE flares. The proportion of patients in Stage I and II who had AEs leading to discontinuation was 10.0% and 28.6%, respectively.
Conclusion: Sifalimumab was well tolerated in Japanese patients with SLE.
Trial registration:
ClinicalTrials.gov identifier: NCT01031836.