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Postmarketing surveillance of tocilizumab for rheumatoid arthritis in Japan: interim analysis of 3881 patients

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Title: Postmarketing surveillance of tocilizumab for rheumatoid arthritis in Japan: interim analysis of 3881 patients
Authors: Koike, Takao Browse this author →KAKEN DB
Harigai, Masayoshi Browse this author
Inokuma, Shigeko Browse this author
Ishiguro, Naoki Browse this author
Ryu, Junnosuke Browse this author
Takeuchi, Tsutomu Browse this author
Takei, Syuji Browse this author
Tanaka, Yoshiya Browse this author
Ito, Kyoko Browse this author
Yamanaka, Hisashi Browse this author
Issue Date: Dec-2011
Publisher: BMJ Publishing Group
Journal Title: Annals of the Rheumatic Diseases
Volume: 70
Issue: 12
Start Page: 2148
End Page: 2151
Publisher DOI: 10.1136/ard.2011.151092
Abstract: Objective: An interim analysis of an all-patient postmarketing surveillance programme in Japan to investigate the safety of tocilizumab for the treatment of rheumatoid arthritis (RA) in the real world. Methods: This analysis included 3881 patients. Patients received 8 mg/kg of tocilizumab every 4 weeks, and were observed for 28 weeks. Data on baseline characteristics and adverse events (AE) were collected. Results: Total and serious AE were reported as 167 and 27 events/100 patient-years, respectively. The most frequent AE and serious AE were infections. Logistic regression analysis identified the following risk factors for the development of serious infection: concurrent or medical history of respiratory disorders; prednisolone dose at baseline ≥ 5 mg/day; and age ≥ 65 years. Twenty-five patients died, and the standardised mortality ratio, with the Japanese general population in 2008 as reference, was 1.66, similar to the results from the Japanese cohort study for RA patients. Conclusions: Tocilizumab is acceptably safe in the real clinical setting. Tocilizumab needs to be used with consideration of the benefit-risk balance to avoid serious infections in elderly patients and those on high doses of corticosteroids or with a concurrent or medical history of respiratory disorders.
Rights: This article has been accepted for publication in Annals of the Rheumatic Diseases 2011;70:2148-2151 following peer review and can also be viewed on the journal's website at
Type: article
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 小池 隆夫

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