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Mod Rheumatol. 2019 Feb 21:1-8. doi: 10.1080/14397595.2019.1583832. [Epub ahead of print]

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.

Author information

1
a Division of Rheumatology, Department of Internal Medicine , Keio University School of Medicine , Tokyo , Japan.
2
b First Department of Internal Medicine , School of Medicine, University of Occupational and Environmental Health Japan , Kitakyushu , Japan.
3
c Department of Allergy , National Hospital Organization, Chiba-East Hospital , Chiba , Japan.
4
d Department of Internal Medicine , National Hospital Organization, Kanazawa Medical Center , Ishikawa , Japan.
5
e Department of Rheumatology and Clinical Immunology , Saitama Medical Center, Saitama Medical University , Saitama , Japan.
6
f Department of Rheumatology, Endocrinology and Nephrology , Hokkaido University Hospital , Hokkaido , Japan.
7
g Department of Internal Medicine and Rheumatology , National Hospital Organization, Kyushu Medical Center , Fukuoka , Japan.
8
h Department of Research and Development , AstraZeneca K.K , Osaka , Japan.
9
i 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.

KEYWORDS:

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

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