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THU0210 Malignancy Data in Tofacitinib-Treated Japanese Patients with Rheumatoid Arthritis
  1. Y. Tanaka1,
  2. T. Takeuchi2,
  3. H. Yamanaka3,
  4. N. Sugiyama4,
  5. T. Yoshinaga4,
  6. K. Togo4,
  7. J. Geier5,
  8. M. Boy5,
  9. C.A. Connell5
  1. 1University of Occupational and Environmental Health, Kitakyushu
  2. 2Keio University
  3. 3Tokyo Women's Medical University
  4. 4Pfizer Japan Inc, Tokyo, Japan
  5. 5Pfizer Inc, Groton, United States

Abstract

Background Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA).

Objectives To evaluate age- and sex-standardised incidence rates (ASRs) for malignancy (excluding non-melanoma skin cancer [NMSC]) in Japanese RA (JRA) patients (pts) in the tofacitinib clinical programme.

Methods Malignancy data were pooled from 2 Phase (P)2, 1 P3 and 1 open-label long-term extension RA studies conducted in Japan (April 2014 data-cut). Cumulative ASRs were calculated (6-month intervals). Crude incidence rates and standardised incidence ratios (SIRs) were calculated for tofacitinib clinical trials in Japan and Japan Medical Data Center (JMDC) RA sub-populations. General population data1 were used to calculate ASRs and SIRs. Three sets of criteria for malignancy events (A, B and C) were defined for sensitivity analysis for the JMDC claims data. Compared with Malignancy criteria A, Malignancy criteria B and C included a more restricted definition of malignancy events in order to exclude possible false diagnoses of malignancy.

Results Of 556 tofacitinib-treated JRA pts (1705 patient-years [pt-yrs] of exposure); 22 pts had malignancies. Overall, post-tofacitinib exposure in JRA pts, cumulative ASR (95% confidence interval [CI]) for malignancy (excluding NMSC) was 1.34 (0.46–2.21) pts with events/100 pt-yrs of exposure, and the SIR (95% CI) was 2.13 (1.33–3.22) which overlapped with the SIRs for several JMDC cohorts (Figure).

Conclusions SIRs for malignancies (excluding NMSC) in tofacitinib-treated JRA pts were comparable with JMDC RA sub-populations. Ongoing post-marketing surveillance will further evaluate malignancy among JRA pts treated with tofacitinib.

  1. Cancer Information Service, National Cancer Center, Japan http://ganjoho.jp/en/professional/statistics/table_download.html (accessed Feb 24, 2015)

Acknowledgement Previously presented (Tanaka Y et al. Arthritis Rheumatol 2015; 67 (S10): 571) and reproduced with permission from Arthritis Rheumatol. This study was funded by Pfizer Inc. Editorial support was provided by S Johnson of Complete Medical Communications, and funded by Pfizer Inc.

Disclosure of Interest Y. Tanaka Consultant for: Mitsubishi-Tanabe Pharma Corporation, Abbott Japan, Eisai, Chugai Pharma, Janssen Pharma, Santen, Astellas Pharma, Daiichi-Sankyo, GlaxoSmithKline, Astra Zeneca, Actelion Pharma, Eli Lilly Japan, Nippon Kayaku, UCB Japan, Ono, and Novartis Pharma, Pfizer Inc, Speakers bureau: Mitsubishi-Tanabe Pharma Corporation, Abbott Japan, Eisai, Chugai Pharma, Janssen Pharma, Santen, Astellas Pharma, Daiichi-Sankyo, GlaxoSmithKline, Astra Zeneca, Actelion Pharma, Eli Lilly Japan, Nippon Kayaku, UCB Japan, Ono, and Novartis Pharma, Pfizer Inc, T. Takeuchi Consultant for: Pfizer Inc, Speakers bureau: Pfizer Inc, H. Yamanaka Consultant for: Pfizer Inc, Speakers bureau: Pfizer Inc, N. Sugiyama Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, T. Yoshinaga Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, K. Togo Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, J. Geier Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, M. Boy Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, C. Connell Shareholder of: Pfizer Inc, Employee of: Pfizer Inc

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