FRI0210 Real-world hawk study: long-term safety and effectiveness of adalimumab with higher-dose methotrexate in japanese patients with early rheumatoid arthritis

Background TNF inhibitors are first-line biologic therapy used in combination with MTX for treatment of RA. However, in Japan, limited real-world data exist on this combination with relatively higher doses of MTX (>8 to ≤16 mg/week). Objectives The HAWK study was designed to assess real-world, long-term safety and effectiveness of the TNF inhibitor ADA with MTX (≥12 mg/week) in Japan. Week 52 results are presented. Methods This multicenter, prospective, observational study, enrolled biologic-naive, early (≤2 years) RA patients with DAS28-CRP>3.2 despite MTX therapy for ≥3 months. Eligible patients received ADA + MTX (≥12 mg/week at beginning of ADA) for 104 weeks. Primary endpoint was DAS28-CRP Results As of April 15, 2016, 346 patients were enrolled (safety set 301; effectiveness set 293). Effectiveness set comprised 73% women; mean (±SD) age, 54.3 (13.9) years; duration of RA, 12.1 (6.2) months; MTX dosage, 13.4 (1.8) mg/week; DAS28-CRP, 4.5 (0.9); and mTSS, 7.7 (10.0) at baseline. At week 52, DAS28-CRP Conclusions Results show that ADA with MTX (≥12 mg/week at the beginning) displayed a consistent safety profile and was effective with a DAS28-CRP remission rate of 77% in routine clinical practice. The ADR rate of 26% was similar to a previous, short-term (28 weeks) postmarketing surveillance report (1). References Koike et al. Mod Rheumatol 2014; 24:390–8. Acknowledgements This study (NCT01736189) was funded by AbbVie GK and Eisai Co., Ltd. AbbVie participated in the collection, analysis, and interpretation of the data, and in the drafting, review, and approval of the abstract. AbbVie GK and Eisai Co., Ltd. provided funding to EPS Corporation for data analysis and to Cactus Communications for editorial assistance. Disclosure of Interest Y. Tanaka Grant/research support from: Mitsubishi-Tanabe, Takeda, Daiichi-Sankyo, Chugai, Bristol-Myers, MSD, Astellas, Abbvie, Eisai, Consultant for: Abbvie, Chugai, Daiichi-Sankyo, Bristol-Myers, Mitsubishi Tanabe, Astellas, Takeda, Pfizer, Teijin, Asahi-kasei, YL Biologics, Sanofi, Janssen, Eli Lilly, GlaxoSmithKline, T. Mimori Grant/research support from: Acterion, Ayumi, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi Tanabe, Speakers bureau: Chugai, Mitsubishi Tanabe, H. Yamanaka Grant/research support from: MSD, Ayumi, AbbVie, Eisai, Ono, Astellas, Daiichi-Sankyo, Taisyo-Toyama, Takeda, Tanabe-Mitsubishi, Chugai, Teijin Pharma, Torii, Nippon Shinyaku, Pfizer, UCB. Nippon Kayaku, YL biologics, Bayer, Bristol-Meyers, Consultant for: MSD, Ayumi, AbbVie, Eisai, Ono, Astellas, Daiichi-Sankyo, Taisyo-Toyama, Takeda, Tanabe-Mitsubishi, Chugai, Teijin Pharma, Torii, Nippon Shinyaku, Pfizer, UCB, Nippon Kayaku, YL biologics, Bayer, Bristol-Meyers, R. Nakajima Employee of: AbbVie GK, K. Morita Employee of: AbbVie GK, J. Kimura Employee of: AbbVie GK, T. Takeuchi Grant/research support from: AbbVie, Astellas, Bristol-Myers, Chugai, Daiichi Sankyo, Eisai, Janssen, Mitsubishi Tanabe, Nippon Shinyaku, Pfizer, Sanofi, Santen, Takeda, Teijin, Consultant for: AstraZeneca, Eli Lilly, Novartis, Mitsubishi Tanabe, Asahi Kasei Medical, Speakers bureau: AbbVie, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi Tanabe, Pfizer, Takeda