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

Tsutomu Takeuchi, Yoshiya Tanaka, Ryutaro Matsumura, Kazuyoshi Saito, Mitsuhiro Yoshimura, Koichi Amano, Tatsuya Atsumi, Eiichi Suematsu, Nobuya Hayashi, Liangwei Wang, Raj Tummala

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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.

Original languageEnglish
JournalModern Rheumatology
DOIs
Publication statusPublished - 2019 Jan 1

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Systemic Lupus Erythematosus
Interferons
Monoclonal Antibodies
Safety
sifalimumab

Keywords

  • Dose escalation
  • intravenous
  • safety
  • sifalimumab
  • subcutaneous
  • systemic lupus erythematosus

ASJC Scopus subject areas

  • Rheumatology

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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. / Takeuchi, Tsutomu; Tanaka, Yoshiya; Matsumura, Ryutaro; Saito, Kazuyoshi; Yoshimura, Mitsuhiro; Amano, Koichi; Atsumi, Tatsuya; Suematsu, Eiichi; Hayashi, Nobuya; Wang, Liangwei; Tummala, Raj.

In: Modern Rheumatology, 01.01.2019.

Research output: Contribution to journalArticle

Takeuchi, Tsutomu ; Tanaka, Yoshiya ; Matsumura, Ryutaro ; Saito, Kazuyoshi ; Yoshimura, Mitsuhiro ; Amano, Koichi ; Atsumi, Tatsuya ; Suematsu, Eiichi ; Hayashi, Nobuya ; Wang, Liangwei ; Tummala, Raj. / 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. In: Modern Rheumatology. 2019.
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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.",
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AU - Takeuchi, Tsutomu

AU - Tanaka, Yoshiya

AU - Matsumura, Ryutaro

AU - Saito, Kazuyoshi

AU - Yoshimura, Mitsuhiro

AU - Amano, Koichi

AU - Atsumi, Tatsuya

AU - Suematsu, Eiichi

AU - Hayashi, Nobuya

AU - Wang, Liangwei

AU - Tummala, Raj

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AB - 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.

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