Tsutomu Takeuchi1, Yoshiya Tanaka2, Ryutaro Matsumura3, Kazuyoshi Saito2, Mitsuhiro Yoshimura4, Koichi Amano5, Tatsuya Atsumi6, Eiichi Suematsu7, Nobuya Hayashi8, Liangwei Wang9, Raj Tummala9. 1. Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. 2. First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan. 3. Department of Allergy, National Hospital Organization, Chiba-East Hospital, Chiba, Japan. 4. Department of Internal Medicine, National Hospital Organization, Kanazawa Medical Center, Ishikawa, Japan. 5. Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan. 6. Department of Rheumatology, Endocrinology and Nephrology, Hokkaido University Hospital, Hokkaido, Japan. 7. Department of Internal Medicine and Rheumatology, National Hospital Organization, Kyushu Medical Center, Fukuoka, Japan. 8. Department of Research and Development, AstraZeneca K.K, Osaka, Japan. 9. AstraZeneca, Gaithersburg, MD, USA.
Abstract
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.
RCT Entities:
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.