SAT0194 Long Term Safety for Tocilizumab in Real-World Setting; 3 Year Follow-Up Postmarketing Surveillance of 5573 Patients with Rheumatoid Arthritis in Japan: Table 1.
Authors: K. Yamamoto, H. Goto, K. Hirao, A. Nakajima, H. Origasa, A. Nakasone, N. Takagi, K. Totsuka
Journal: Annals of the Rheumatic Diseases (2015)

<h3>Objectives</h3> To evaluate the long-term safety of tocilizumab (TCZ) for the treatment of rheumatoid arthritis (RA) in a real-world clinical setting in Japan. <h3>Methods</h3> In this long-term extension of the single-arm, observational postmarketing surveillance of TCZ, patients who received at least 1 dose of intravenous TCZ (8 mg/kg) between April 2008 and August 2010 were observed for 3 years. Patient characteristics and the incidences of mortality, serious infection, malignancy, GI perforation and serious cardiac dysfunction were evaluated. Data were summarized as the proportion (95% CI) of patients experiencing each event or as incidence rates presented as the number of patients per 100 patient-years (PY). <h3>Results</h3> In total, 5573 patients were enrolled, with a total observation of 15,106 PY. The mean and median treatment duration was 2.1and 2.9 years, respectively. The overall mortality rate during the observation period was 2.58% (144/5573 patients). The most common cause of death was infection (28.47%). The standardized mortality ratio (SMR) in comparison with the general Japanese population was 1.27 (95% CI, 1.08–1.50), which is comparable to the SMR reported in a large observational cohort of Japanese patients with RA (all-patient mortality between 1.46 [95% CI, 1.32–1.60] and 1.90 [95% CI, 1.75–2.07]).<sup>1</sup> The incidence rate of malignancy during the observation period was 2.24% (0.83/100 PY), and the standardized incidence ratio (SIR) was 0.79 (95% CI, 0.66–0.95), which was stable over time. Only malignant lymphoma had a significantly higher incidence compared to the general Japanese population, with a SIR of 3.13 (95% CI, 1.82–5.39) which is comparable to that of all RA patients compared with the general population (SIR, 6.07; 95% CI, 3.71–9.37).<sup>2</sup> There was no increase in rate of any AEs with prolonged observation, while incidence of fatal events, serious infection, GI perforation and serious cardiac dysfunction decreased over time (Table 1). <h3>Conclusions</h3> The safety profile of TCZ was consistent over time with respect to mortality, serious infections, malignancy, gastrointestinal perforation, and serious cardiac dysfunction. These data confirm the long-term safety of TCZ use in patients with RA in a real-world clinical setting in Japan. <h3>References</h3> Nakajima et al. Scand J Rheumatol. 2010;39:360–7, Yamada et al. Rheumatol Int. 2011;31:1487–92 <h3>Disclosure of Interest</h3> K. Yamamoto Grant/research support from: AbbVie, Astellas, BMS, Daiichi-Sankyo, Mitsubishi-Tanabe, Pfizer, Sanofi, Santen, Takeda and Teijin, Consultant for: AbbVie, Astellas, BMS, Boehringer Ingelheim, Chugai, Eisai, Ono, Pfizer, Santen, Taisho Toyama and UCB, Speakers bureau: AbbVie, Asahi Kasei, Astellas, BMS, Chugai, Daiichi-Sankyo, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Santen, Taisho Toyama, Takeda, Teijin and UCB., H. Goto Consultant for: Chugai, K. Hirao Grant/research support from: BIOTRONIK, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Japan Lifeline and MSD, Consultant for: BIOTRONIK, Boehringer-Ingelheim and Chugai, Speakers bureau: Bayer, BIOTRONIK, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Japan Lifeline and MSD, A. Nakajima Consultant for: AbbVie, Astellas, Chugai, Mitsubishi-Tanabe, Ono, Pfizer Santen and Takeda, H. Origasa Consultant for: Chugai, Astellas and UCB, A. Nakasone Employee of: Chugai, N. Takagi Employee of: Chugai, K. Totsuka Consultant for: Bayer, Chugai, Eiken Chemical, Kyorin and Toyama Chemical