THU0210 Malignancy Data in Tofacitinib-Treated Japanese Patients with Rheumatoid Arthritis. (15th July 2016)

• Record Type: Journal Article
• Authors: Tanaka, Y.; Takeuchi, T.; Yamanaka, H.; Sugiyama, N.; Yoshinaga, T.; Togo, K.; Geier, J.; Boy, M.; Connell, C.A.
• Is Part Of: Annals of the rheumatic diseases. Volume 75(2016)Supplement 2
• Page Start: 263
• Page End: 263
• Publication Date: 2016-07-15
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2016-eular.1849
• Languages: English
• ISSNs: 0003-4967

Abstract

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 data 1 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. References: 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