THU0210 Malignancy Data in Tofacitinib-Treated Japanese Patients with Rheumatoid Arthritis
Authors: Y. Tanaka, T. Takeuchi, H. Yamanaka, N. Sugiyama, T. Yoshinaga, K. Togo, J. Geier, M. Boy, C.A. Connell
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). <h3>Objectives</h3> 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. <h3>Methods</h3> 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 data<sup>1</sup> 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. <h3>Results</h3> 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). <h3>Conclusions</h3> 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. <h3>References</h3> Cancer Information Service, National Cancer Center, Japan http://ganjoho.jp/en/professional/statistics/table_download.html (accessed Feb 24, 2015) <h3>Acknowledgement</h3> 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. <h3>Disclosure of Interest</h3> 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