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Clinical and epidemiological research
Concise report
Postmarketing surveillance of tocilizumab for rheumatoid arthritis in Japan: interim analysis of 3881 patients
  1. Takao Koike1,2,
  2. Masayoshi Harigai2,3,
  3. Shigeko Inokuma2,4,
  4. Naoki Ishiguro2,5,
  5. Junnosuke Ryu2,6,
  6. Tsutomu Takeuchi2,7,
  7. Syuji Takei2,8,
  8. Yoshiya Tanaka2,9,
  9. Kyoko Ito2,10,
  10. Hisashi Yamanaka2,11
  1. 1Hokkaido University Graduate School of Medicine, Hokkaido, Japan
  2. 2Postmarketing Surveillance Committee of the Japan College of Rheumatology, Tokyo, Japan
  3. 3Tokyo Medical and Dental University Graduate School, Tokyo, Japan
  4. 4Japanese Red Cross Medical Center, Tokyo, Japan
  5. 5Nagoya University Graduate School of Medicine, Aichi, Japan
  6. 6Nihon University School of Medicine, Tokyo, Japan
  7. 7Keio University, Tokyo, Japan
  8. 8Kagoshima University, Kagoshima, Japan
  9. 9University of Occupational and Environmental Health, Japan, Kitakyushu, Japan
  10. 10Chugai Pharmaceutical Co. Ltd., Tokyo, Japan
  11. 11Tokyo Women's Medical University, Tokyo, Japan
  1. Correspondence to Takao Koike, Department of Medicine II, Hokkaido University Graduate School of Medicine N-15 W-7, Kita-ku, Sapporo 060–8638, Japan; tkoike{at}med.hokudai.ac.jp

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.

This paper is freely available online under the BMJ Journals unlocked scheme, see http://ard.bmj.com/info/unlocked.dtl

https://doi.org/10.1136/ard.2011.151092

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    Footnotes

    • Funding This study was funded by Chugai Pharmaceutical Co, Ltd. Data were collected and analysed by Chugai according to the prespecified protocol. Medical writing and editorial assistance were also provided by Chugai following a face-to-face meeting with all authors during which the data, its interpretation and the content of the paper were discussed.

    • Competing interests TK, MH, SI, NI, JR, TT, ST, YT and HY are all members of the Postmarketing Surveillance Committee of the Japan College of Rheumatology. The Committee was created in response to a request for assistance from the Ministry of Health, Labour and Welfare (MLHW) of Japan. The role of the committee is to provide independent advice to Chugai Pharmaceutical Co Ltd on conducting the PMS programme mandated by the MHLW and on the results thereof. Participation on this committee is not compensated for. It is the belief of the first author that this position does not constitute a conflict of interest. The doctors participated in the review and analysis of the PMS data in their capacity as committee members and are so listed. TK, MH, NI, JR, TT and YT have received research grants, consultant fees, and/or speakers' bureau honoraria from Chugai Pharmaceutical Co Ltd. HY is a member of the advisory board and has received research grants, consultant fees and speakers' bureau honoraria from Chugai Pharmaceutical Co Ltd and Roche. KI is a full-time employee of Chugai Pharmaceutical Co Ltd.

    • Patient consent Obtained.

    • Ethics approval This postmarketing surveillance was initiated after the synopsis was submitted to MHLW in advance. Approval has been obtained from each ethics committee in the hospitals that participated in the surveillance.

    • Provenance and peer review Not commissioned; externally peer reviewed.