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SAT0211 Effectiveness and Safety of Tocilizumab in Biologics Naïve RA Patients – PMS for Investigating Success in Achieving Clinical and Functional Remission and Sustaining Efficacy with Tocilizumab in Biologics-Naïve RA Patients (First Bio) Study
  1. T. Mimori1,
  2. T. Atsumi2,
  3. M. Harigai3,
  4. N. Nishimoto4,
  5. T. Sumida5,
  6. T. Takeuchi6,
  7. Y. Tanaka7,
  8. H. Yamanaka8,
  9. A. Nakasone9,
  10. N. Takagi9,
  11. N. Ishiguro10
  1. 1Kyoto University, Kyoto
  2. 2Hokkaido University, Sapporo
  3. 3Tokyo Medical and Dental University
  4. 4Tokyo Medical University, Tokyo
  5. 5University of Tsukuba, Tsukuba
  6. 6Keio University, Tokyo
  7. 7University of Occupational and Environment Health, Kitakyushu
  8. 8Institute of Rheumatology, Tokyo Women's Medical University
  9. 9Chugai Pharmaceutical, Tokyo
  10. 10Nagoya University Hospital, Nagoya, Japan

Abstract

Background The all-patient registry PMS (PMS7901) of tocilizumab (TCZ) followed 7901 RA patients for 28 wk which showed that patients with a high probability of remission and a low probability of developing serious infection were most likely to be early and less advanced RA and had not received biologics previously.

Objectives To evaluate overall effectiveness and safety of TCZ in biologics-naïve RA patients in real clinical setting.

Methods FIRST Bio was a 52-wk, postmarketing surveillance with biologics-naïve RA patients who met the ACR/EULAR 2010 classification criteria, experienced inadequate response or were intolerant to one or more DMARDs. Patients received 8mg/kg of TCZ-IV every 4 wk with or without DMARDs. A paired t-test was used to detect statistically significant differences in disease activities compared with the baseline.

Results Overall, 839 patients were observed. Patients in the FIRST Bio study had shorter mean disease duration and lower percentage of less advanced Steinbrocker's stage and class than those in the PMS7901 (Table). At Wk 52, 72.3% patients continued to receive TCZ-IV with a total 718.4 patient-years. The mean CDAI improved from 23.3 at baseline to 6.6 at Wk 52 (p<0.0001). DAS28-ESR also improved from 5.2 at baseline to 2.1 at Wk 52 (p<0.0001). At Wk 52, the rate of CDAI remission was 36.8% and that of Boolean was 33.1%. The Boolean remission rate at Wk 24 was better in FIRST Bio (27.7%) than in PMS7901 (15.1%) (Table). The mean HAQ score improved from 1.0 at baseline to 0.5 at Wk 52 (p<0.0001), and in 65.1% patients, the HAQ score decreased to <0.5 at Wk 52. The incidence (events/100 patient-years) of total adverse events (AEs) and serious AEs (SAEs) was 75.7 and 18.1, respectively. Infections were the most frequent AEs (17.8) and SAEs (5.8). Malignancies and gastrointestinal tract perforation were reported in 0.8 and 0.3, respectively. Six patients died. The incidence of SAEs and serious infections were lower in FIRST Bio than in PMS7901 (Table). The mean dose of concomitant MTX decreased from 9.1 mg/wk at baseline to 6.4 mg/wk at Wk 52. The mean dose of concomitant glucocorticoid also decreased from 5.4 mg/day at baseline to 2.6 mg/day at Wk 52.

Table 1

Conclusions The FIRST Bio study revealed that in real clinical settings, TCZ showed high effectiveness and safety in patients with less advanced RA who did not receive biologics previously.

Disclosure of Interest T. Mimori Grant/research support from: Asahi Kasei, Astellas, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Mitsubishi Tanabe, MDS, Nippon Kayaku, Nippon Shinyaku, Santen and Takeda, Speakers bureau: Astellas, Bristol-Myers Squibb, Chugai, Mitsubishi Tanabe and Taisho Toyama, T. Atsumi Grant/research support from: Chugai, Eisai, Bristol-Myers Squibb, Astellas, Daiichi Sankyo, Mitsubishi Tanabe, Speakers bureau: Astellas, Mitsubishi Tanabe, M. Harigai Grant/research support from: AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe, Santen, Takeda and UCB, Consultant for: Bristol-Myers Squibb, Chugai and Janssen, Speakers bureau: AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi Tanabe, Ono, Santen, Takeda, UCB and Pfizer, N. Nishimoto Grant/research support from: Chugai and Eisai, Consultant for: Chugai, T. Sumida Consultant for: Chugai, Speakers bureau: Chugai, T. Takeuchi Consultant for: AbbVie, Asahi Kasei, Asahi Kasei Medical, Astellas, Astra Zeneca, Bistol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen, Mitsubishi Tanabe, Novartis, Pfizer, Santen, SymBio, Takeda, Taishyo Toyama and Teijin, Speakers bureau: AbbVie, Asahi Kasei, Asahi Kasei Medical, Astellas, Astra Zeneca, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Janssen, Mitsubishi Tanabe, Novartis, Pfizer, Santen, SymBio, Takeda, Taishyo Toyama and Teijin, Y. Tanaka Consultant for: Abbvie, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi Tanabe and MSD, Speakers bureau: Abbvie, Actelion, Astellas, Astra Zeneca, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, GlaxoSmithKline, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Ono, Otsuka, Pfizer, Quintiles, Santen and UCB, H. Yamanaka Consultant for: AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Mitsubishi Tanabe, Nippon Kayaku, Pfizer, Takeda, Teijin and UCB, Speakers bureau: AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Mitsubishi Tanabe, Nippon Kayaku, Pfizer, Takeda, Teijin and UCB, A. Nakasone Employee of: Chugai, N. Takagi Employee of: Chugai, N. Ishiguro Consultant for: AbbVie, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi Tanabe, Pfizer and Takeda, Speakers bureau: AbbVie, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi Tanabe, Pfizer and Takeda

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