AB0435 Effects of Prior Use of BIOLOGICS on the Safety and Effectiveness of Abatacept Administered with or without Methotrexate in Japanese Patients with Rheumatoid Arthritis: Sub-Analysis of the Abatacept All-Cases Post-Marketing Surveillance
Authors: M. Harigai, N. Ishiguro, S. Inokuma, T. Mimori, J. Ryu, Y. Takasaki, S. Takei, T. Takeuchi, Y. Tanaka, H. Yamanaka, M. Watanabe, T. Koike
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Background</h3> The result of post-marketing surveillance (PMS) of 3985 patients reported previously<sup>1</sup> indicated that prior use of biologics, with or without concomitant methotrexate (MTX), was associated with the safety and effectiveness of ABT. <h3>Objectives</h3> To assess the independent effects of prior biologic therapy and concomitant MTX on the safety and effectiveness of ABT in a sub-analysis of the Japanese PMS data. <h3>Methods</h3> ABT-naïve patients who were registered and observed for 24 weeks in the PMS were first divided into subgroups according to concomitant MTX (MTX+ vs MTX−) and then subdivided into biologic-naïve and -experienced groups. Safety and effectiveness were analysed in each subgroup. Disease Activity Score (DAS) 28 (C-reactive protein [CRP]) was calculated at baseline, weeks 4, 12 and 24. Multivariate logistic regression analyses of safety and effectiveness were performed. <h3>Results</h3> The MTX− group included 321 biologic-naïve and 986 biologic-experienced patients (mean age: 65.4 vs 64.3 y; mean duration of illness: 10.7 vs 12.0 y). The MTX+ group included 858 biologic-naïve and 1717 biologic-experienced patients (mean age: 60.6 vs 59.3 y; mean duration of illness: 7.7 vs 10.4 y). The proportion of patients with comorbidities or past medical history between biologic-naïve and -experienced did not differ significantly in MTX+/− groups. The mean MTX dose in biologic-naïve vs -experienced patients was 7.20 vs 7.05 mg/week, respectively. The frequency of adverse drug reactions (ADRs) in biologic-naïve vs -experienced groups were 14.3% vs 17.8%, respectively, in the MTX− group, and 14.6% vs 15.2%, respectively, in the MTX+ group. The corresponding frequency of serious ADRs were 1.2% vs 3.3% (MTX−) and 2.3% vs 2.4% (MTX+). The mean change in DAS28 (CRP) at week 24 in biologic-naïve vs -experienced patients was −1.61 vs −0.93, respectively, in the MTX– group and −1.64 vs −1.08, respectively, in the MTX+ group. Multivariate logistic regression analysis showed that body weight &lt;40 kg, history/presence of respiratory disorders, and concomitant use of prednisolone &gt;5 mg/day were risk factors for serious infections. Steinbrocker9s functional class, duration of illness and the number of prior biologics were significant predictors for achieving disease remission or low disease activity. <h3>Conclusions</h3> In this 24-week surveillance of ABT-treated patients with RA, biologic-naïve patients experienced fewer serious ADRs and showed greater improvements in disease activity than biologic-experienced patients. <h3>References</h3> Koike T, et al. Arthritis Rheum 2013;65(10 Suppl.):S598 <h3>Disclosure of Interest</h3> M. Harigai Grant/research support: Abbvie, Astellas, Bristol-Myers, Chugai, Eisai, Mitsubishi-Tanabe, Santen, Takeda, and UCB, Consultant for: Bristol-Myers, Chugai, Elli-Lilly, and Janssen, Speakers bureau: Abbvie, Astellas, Bristol-Myers, Chugai, Eisai, Mitsubishi-Tanabe, Pfizer, Takeda, and UCB, N. Ishiguro Grant/research support: Astellas and Bristol-Myers, Consultant for: Abbvie, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Pfizer, and Takeda, Speakers bureau: Abbvie, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Pfizer, and Takeda, S. Inokuma Speakers bureau: Abbvie, Asahi Kasei Pharma, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, GlaxoSmithKline, Kyorin, Mitsubishi-Tanabe, Pfizer, Santen, Taiho, Taisho-Toyama, Takeda, and Teijin, T. Mimori Grant/research support: Asahi-Kasei, Astellas, Bristol-Myers, Chugai, Eisai, Mitsubishi-Tanabe, Pfizer, Santen, and Takeda, Speakers bureau: Bristol-Myers, Chugai, and Mitsubishi-Tanabe, J. Ryu: None declared, Y. Takasaki Grant/research support: Abbvie, Astellas, AstraZeneca, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, MSD, Nippon Kayaku, Pfizer, Santen, and Shionogi, Consultant for: Actelion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, GlaxoSmithKline, Mitsubishi-Tanabe, Nippon Kayaku, Novartis, Otsuka, Pfizer, Santen, and UCB, Speakers bureau: Abbvie, Actelion, Astellas, Chugai, Daiichi-Sankyo, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Santen, and UCB, S. Takei Grant/research support: Bristol-Myers, Chugai, Eisai, and Takeda, Speakers bureau: Abbvie, Asahi Kasei, Astellas, Chugai, Eisai, Novartis, Pfizer, Takeda, and Teijin, T. Takeuchi Grant/research support: Abbott, Abbvie, Asahi Kasei, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, Sanofi-Aventis, Santen, Taisho-Toyama, Takeda, and Teijin, Consultant for: Abbvie, Asahi Kasei, AstraZeneca, Daiichi-Sankyo, Eli Lilly, Mitsubishi-Tanabe, and Novartis, Speakers bureau: Abbott, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, and Takeda, Y. Tanaka Grant/research support: Abbvie, Astellas, Bristol-Myers, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, and MSD, Consultant for: Abbvie, Actelion, Astellas, AstraZeneca, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, GlaxoSmithKline, Janssen, Mitsubishi-Tanabe, Nippon Kayaku, Novartis, Ono, Otsuka, Pfizer, Quintiles Transnational, Santen, and UCB, Speakers bureau: Abbvie, Actelion, Astellas, AstraZeneca, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, GlaxoSmithKline, Janssen, Mitsubishi-Tanabe, Nippon Kayaku, Otsuka, Pfizer, Quintiles Transnational, Santen, and UCB, H. Yamanaka Grant/research support: Abbvie, Abbott, Astellas, AstraZeneca, Bristol-Myers, Chugai, Eisai, Mitsubishi-Tanabe, Pfizer, Takeda, and UCB, Consultant for: Abbott, Abbvie, Astellas, AstraZeneca, Bristol-Myers, Chugai, Eisai, Mitsubishi-Tanabe, Pfizer, Takeda, and UCB, Speakers bureau: Abbott, Abbvie, Astellas, Chugai, Eisai, Mitsubishi-Tanabe, Pfizer, Takeda, and UCB, M. Watanabe Employee of: Bristol-Myers K.K., T. Koike Speakers bureau: Abbvie, Astellas, Bristol-Myers, Chugai, Eisai, Mitsubishi-Tanabe, Pfizer, Santen, Taisho-Toyama, Takeda, Teijin, and UCB <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.1987