AB0448 SAFETY AND EFFICACY OF FILGOTINIB IN JAPANESE PATIENTS ENROLLED IN A GLOBAL PHASE 3 TRIAL OF PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS AND INADEQUATE RESPONSE OR INTOLERANCE TO BIOLOGIC DMARDS

Background Filgotinib (FIL), an oral, selective inhibitor of Janus kinase 1 (JAK1), has demonstrated efficacy in a phase 3 study in bDMARD-IR patients with active rheumatoid arthritis (RA). Objectives We report results of Japanese patients enrolled in the FINCH2 study (ClinicalTrials.gov Identifier: NCT02873936) of FIL in patients with RA and an inadequate response or intolerance to ≥1 bDMARDs. Methods FINCH2 (ClinicalTrials.gov: NCT02873936) was a 24-week, randomized, placebo-controlled, phase 3 trial conducted globally at 114 sites, including at sites in Japan, from July 2016–June 2018. Male and female adults with moderately-to-severely active RA and inadequate response/intolerance to ≥1 prior bDMARDs were randomized 1:1:1 to oral doses of FIL 200 mg, FIL 100 mg, or placebo (PBO) once daily (QD) for 24 weeks; patients continued background therapy with conventional synthetic DMARDs. Results Primary and all key secondary endpoints were met for both global (N=448, Genovese, 2018) and Japanese patient populations (n=40; FIL 200 mg, n=12; FIL 100 mg, n=15; and PBO, n=13). ACR20 response rates, HAQ-DI LS mean changes from baseline, and the percentage of Japanese patients with DAS28(CRP) ≤3.2 at week 12 are shown in Table 1. In Japanese patients, treatment-emergent adverse event (AE) rates were similar for FIL 200 mg, FIL 100 mg, and PBO (75%, 60%, and 77%, respectively) and there were no serious AEs; there was 1 case of uncomplicated herpes zoster (FIL 200 mg); and no venous thrombotic events, opportunistic infection/active TB, malignancy, GI perforation, or death. Conclusion In this phase 3 study in bDMARD-IR patients with active RA, treatment with FIL over a 24-week period was associated with significant improvements in signs and symptoms of RA, with a safety and efficacy profile in Japanese patients consistent with that in the global population. Thus, FIL may provide a novel treatment option for patients who continue to have active RA despite prior biologic therapy. References [1] Genovese MC, et al. ACR 2018. Abstract L06. Disclosure of Interests Tsutomu Takeuchi Grant/research support from: Astellas Pharma Inc, Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd., AbbVie GK, Asahikasei Pharma Corp., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Eisai Co., Ltd., AYUMI Pharmaceutical Corporation, Nipponkayaku Co. Ltd., Novartis Pharma K.K., Grant/research support from: AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, Teijin, Grant/research support from: Astellas Pharma Inc., Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., AbbVie GK, Asahi Kasei Pharma Corp., Taisho Toyama Pharmaceutical Co., Ltd., SymBio Pharmaceuticals Ltd., Janssen Pharmaceutical K.K., Celltrion Inc., Nipponkayaku Co. Ltd., and UCB Japan, Consultant for: Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Abbivie GK, Nipponkayaku Co.Ltd, Janssen Pharmaceutical K.K., Astellas Pharma Inc., Taiho Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Taisho Toyama Pharmaceutical Co. Ltd., GlaxoSmithKline K.K., UCB Japan Co. Ltd., Consultant for: AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, Teijin, Consultant for: Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Asahi Kasei Medical K.K., AbbVie GK, Daiichi Sankyo Co., Ltd., Bristol Myers Squibb, and Nipponkayaku Co. Ltd., Speakers bureau: Astellas Pharma Inc., Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., AbbVie GK, Asahi Kasei Pharma Corp., Taisho Toyama Pharmaceutical Co., Ltd., SymBio Pharmaceuticals Ltd., Janssen Pharmaceutical K.K., Celltrion Inc., Nipponkayaku Co. Ltd., and UCB Japan, Speakers bureau: AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, Teijin, Speakers bureau: AbbVie GK., Bristol–Myers K.K., Chugai Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Astellas Pharma Inc, Diaichi Sankyo Co. Ltd., Eisai Co. Ltd., Sanofi K.K., Teijin Pharma Ltd., Takeda Pharmaceutical Co. Ltd., Novartis Pharma K.K., Tsukasa Matsubara Consultant for: Nichi-Iko Pharmaceutical Co., Ltd, Pfizer Japan Inc., Speakers bureau: Astellas Pharma Inc, SE ...