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-naïve, 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 <2.6 at week 52. Secondary endpoints included CDAI, SDAI, HAQ-DI and inhibition of structural joint damage using the mTSS. ADRs and dosage of ADA and MTX were recorded.
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 <2.6 and low disease activity (<3.2) were achieved in 77% and 92% patients, respectively. Remission rates in CDAI (≤2.8), SDAI (≤3.3), and HAQ-DI (≤0.5) were 49%, 51%, and 82%, respectively. Although average MTX dosage was decreased (≤2 mg/week), unchanged, and increased (≥2 mg/week) from baseline in 19.6%, 78.9%, and 1.4% patients over 52 weeks, respectively, there was no significant difference in disease activity improvement across these MTX dosage groups at week 52 (p=0.350). Structural remission rate at week 52 was 86% (ΔmTSS ≤0.5) (Figure). A total 110 ADRs occurred in 80 (26.6%) patients, 23 were serious in 21 (7.0%) patients (Table).
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).
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