Real-world effectiveness and safety of adalimumab for treatment of ankylosing spondylitis in Japan

Abstract

Objective: To evaluate the real-world effectiveness and safety of adalimumab for the treatment of ankylosing spondylitis (AS) in Japan.

Methods: All AS patients initiated on adalimumab from 27 October 2010 to 28 May 2015, were enrolled. Patient characteristics at baseline, changes in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores, and adverse drug reactions (ADRs) for 24 weeks from the first adalimumab treatment were evaluated.

Results: Of 403 enrolled patients, 396 and 374 comprised the safety and effectiveness analysis sets, respectively. In the safety analysis set, 266/396 (67.2%) were males, with a mean ± standard deviation (SD) age of 46.3 ± 15.6 years and mean ± SD disease duration of 9.8 ± 9.8 years. Of 236 patients examined for human leukocyte antigen (HLA)-B27, 131 (55.5%) were HLA-B27–positive. In the effectiveness analysis set, the mean ± SD BASDAI score was 4.9 ± 2.3 at baseline (n = 292). Overall, 216 patients had BASDAI data pre- and post-baseline. At 24 weeks, 143 patients had BASDAI scores, and the mean ± SD decrease was −2.0 ± 2.6 (p < .0001). Fifteen serious ADRs occurred in 15 (3.79%) patients; 30 (7.58%) ADRs of infections were reported, of which, five (1.26%) were serious.

Conclusion: Safety and effectiveness of adalimumab in this postmarketing observational study were similar to that in previous clinical trials.

Keywords:

• Adalimumab
• ankylosing spondylitis
• effectiveness
• postmarketing surveillance
• safety

Acknowledgments

Editorial support, in the form of medical writing, assembling tables, and creating high-resolution images based on the authors’ detailed directions, collating author comments, copyediting, fact checking, and referencing, was provided by Annirudha Chillar, MD, PhD, and Maribeth Bogush, PhD, of Cactus Communications, and funded by AbbVie GK and Eisai Co. Ltd.

Conflict of interest

Shigeto Kobayashi has received advisory fees from Kyowa Hakko Kirin, Co, Ltd. and lecture fees from AbbVie GK, Actelion Pharmaceuticals Japan, Astellas Pharma, Bristol-Myers KK, Chugai Pharmaceutical, Eisai, Janssen Pharmaceutical KK, Nippon Shinyaku, Mitsubishi Tanabe Pharma, Pfizer Japan, Takeda Pharmaceutical, Teijin Pharma and UCB Japan. Tomoko Kashiwagi and Junko Kimura are full-time employees of AbbVie GK and may own AbbVie stock or stock options.

Additional information

Funding

This study (NCT01329380) was funded by AbbVie GK and Eisai Co., Ltd. AbbVie participated in the analysis and interpretation of the data and in the drafting, review, and approval of the manuscript.