POS0286 INCIDENCE OF MALIGNANCIES IN JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS: DATA FROM A LARGE JAPANESE NATIONAL REGISTRY

Background: Patients (pts) with rheumatoid arthritis (RA) have an increased risk of some malignancies vs the general population, and this can vary by region/race.1,2 Data on the epidemiology and impact of biological (b)DMARDs and targeted synthetic (ts)DMARDs, such as Janus kinase (JAK) inhibitors, on the incidence of malignancies in Japanese pts with RA are limited. The National Database of Rheumatic Diseases in Japan (NinJa) is one of the largest RA registries in Japan. Objectives: To evaluate the incidence of malignancies in Japanese pts with RA using NinJa registry data. Methods: This retrospective observational study analysed NinJa registry data for Japanese pts with RA aged ≥18 years with ≥1 data entry between 2013 (first JAK inhibitor approval for RA in Japan) and 2018. The overall cohort included all pts with RA, and two sub-cohorts were analysed: pts exposed and unexposed to bDMARDs (exposure defined as ≥1 bDMARD reported in database). Crude incidence rates (IRs) for malignancies (including non-melanoma skin cancer) were calculated as the number of events per 100 pt-years of follow-up (time between start of follow-up or the date of first bDMARD exposure [for bDMARD-exposed pts] and end of observation period, or withdrawal from database). The most recent data for incidence of malignancy in the Japanese general population (2013–2017 data from the National Cancer Center, Japan) were used to calculate standardised incidence ratios (SIRs) and age- and sex-adjusted standardised rates (ASRs) for malignancies. Cross-sectional (per calendar year) and cumulative analyses were performed for the overall cohort. Cumulative rates were calculated for sub-cohorts, and all cumulative analyses were repeated excluding pts exposed to JAK inhibitors (ie ≥1 JAK inhibitor reported in database). Results: Data were collected for 26 607 Japanese pts with RA from 2013–2018. In the cross-sectional analysis (Table 1), the SIR and ASR for malignancies in all pts with RA were generally consistent from 2013–2018. In the cumulative analysis, the SIR (95% CI) for malignancies from 2013–2018 was 0.97 (0.91, 1.03) in all pts with RA, and 0.93 (0.82, 1.04) and 0.99 (0.92, 1.07) in pts exposed and unexposed to bDMARDs, respectively (Figure 1). Adjusting for age/sex, the cumulative ASR (95% CI) for malignancies from 2013–2018 was 0.83 (0.76, 0.90) in all pts with RA, and 0.82 (0.69, 0.95) and 0.86 (0.77, 0.96) in pts exposed and unexposed to bDMARDs, respectively (Figure 1). In all cohorts, the cumulative SIR and ASR were similar when pts exposed to JAK inhibitors were excluded (Figure 1). Conclusion: The incidence of malignancies in Japanese pts with RA, registered in the NinJa database from 2013–2018, was similar to that in the Japanese general population. The SIR and ASR for malignancies were comparable in pts exposed and unexposed to bDMARDs. In all cohorts, rates did not increase when pts exposed to JAK inhibitors were included. References: [1] Dougados et al. Ann Rheum Dis 2014; 73: 62-68. [2] Parikh-Patel et al. Cancer Causes Control 2009; 20: 1001-1010. Acknowledgements: Study sponsored by Pfizer Inc. Medical writing support was provided by Christina Viegelmann, CMC Connect, and funded by Pfizer Inc. Disclosure of Interests: Toshihiro Matsui Speakers bureau: Astellas, Ayumi, Chugai, Daiichi-Sankyo, Eli Lilly, Ono, Pfizer Inc, Takeda, Tanabe-Mitsubishi, Consultant of: Pfizer Inc, Grant/research support from: Chugai, Naonobu Sugiyama Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Shigeyuki Toyoizumi Employee of: Pfizer R&D Japan, Fujio Matsuyama Consultant of: Pfizer Inc, Employee of: CRECON Medical Assessment Inc, Tatsunori Murata Consultant of: Pfizer Inc, Employee of: CRECON Medical Assessment Inc, Yukitomo Urata Speakers bureau: Asahi Kasei, Chugai, Eli Lilly, Pfizer Inc, Consultant of: AbbVie, Asahi Kasei, Chugai, Pfizer Inc, Kimito Kawahata Speakers bureau: Pfizer Inc, Consultant of: Pfizer Inc, Grant/research support from: Pfizer Inc, Shigeto Tohma Speakers bureau: Astellas, Ayumi, Chugai, Ono, Pfizer Inc, Takeda, Consultant of: Pfizer Inc