LAUSR

Background Filgotinib (FIL), an oral, selective Janus kinase 1 (JAK1) inhibitor, significantly improved the signs and symptoms of rheumatoid arthritis (RA) in the phase 3 FINCH2 study in bDMARD-IR patients with active RA.1 Objectives To evaluate the efficacy and safety of FIL by geography and race in FINCH2. Methods FINCH2 enrolled 449 bDMARD-IR patients with active RA, who were randomized in a 1:1:1 manner to receive FIL 200 mg, FIL 100 mg, or placebo (PBO) on a background of csDMARDs for 24 weeks. In this prespecified subgroup analysis, patient and disease characteristics and treatment effects were analyzed by race and geographic region (Region 1: AU, BE, FR, DE, IS, IT, NL, KR, ES, CH, UK, US; Region 2: HU, CZ, PL; Region 3: AR, PR, MX; Region 4: JP). Results 448 patients received ≥1 dose of study drug; they were 80.4% female, with a mean [SD] age of 56 [12.2] years, and 23.4% had received ≥3 prior bDMARDs). Baseline characteristics were similar across regions and race. The primary endpoint and all key secondary endpoints were met in the primary analysis.1 Efficacy and safety parameters by geography and race are shown below. There were 2 MACE (white/Region 1, 1 FIL 100/1 PBO), 4 cases of uncomplicated herpes zoster (2 black/1 white/1 Asian; 3 Region 1/1 Region 4, 2 FIL 200/2 FIL 100), and 1 VTE (retinal vein occlusion, white/Region 1/FIL 200), but no cases of DVT/PE, opportunistic infection, active tuberculosis, malignancy, gastrointestinal perforation, or death.Table 1 Week 24 key efficacy and safety measures by geographic region. Regimen N1= ACR20;%2 DAS28(CRP) <2.6;%2 CFB HAQ-DI TEAE;% SAE;% Region 1 FIL 200 111 67‡ 31† –0.7 (0.6)‡ 73 5 FIL 100 110 48* 24 –0.6 (0.7)* 66 6 PBO 110 32 14 –0.4 (0.6) 70 5 Region 2 FIL 200 12 75 25 –0.7 (0.7) 58 0 FIL 100 12 75 33 –0.6 (0.5) 75 17 PBO 11 46 9 –0.5 (0.6) 73 0 Region 3 FIL 200 12 67 17 –1.2 (0.6) 42 8 FIL 100 16 81 38 –1.0 (0.7) 44 0 PBO 14 64 14 –0.8 (0.6) 36 0 Region 4 FIL 200 12 92‡ 50† –0.7 (0.5)‡ 75 0 FIL 100 15 60* 27 –0.5 (0.7)† 60 0 PBO 13 15 0 –0.1 (0.6) 77 0 1n’s for HAQ-DI at week 24 were different. 2Nonresponder imputation. *p<0.05,†p<0.01, ‡p<0.001 vs PBO. CFB, change from baseline as mean (SD); SAE, serious adverse events; TEAE, treatment-emergent adverse events.Table 2 Week 24 key efficacy and safety measures by race. Regimen N1= ACR20;%2 DAS28(CRP) <2.6;%2 CFB HAQ-DI TEAE;% SAE;% White FIL 200 110 67‡ 30* –0.7 (0.6)† 71 5 FIL 100 109 49* 25 –0.5 (0.6) 63 6 PBO 97 34 16 –0.5 (0.6) 66 4 Black FIL 200 14 57 21 –0.7 (0.6)* 57 0 FIL 100 12 67 17 –0.6 (0.7) 67 8 PBO 21 38 14 –0.2 (0.5) 67 0 Asian FIL 200 15 93‡ 47† –0.8 (0.6)‡ 73 0 FIL 100 20 60† 30* –0.6 (0.7)† 65 0 PBO 15 13 0 –0.1 (0.5) 80 7 1n’s for HAQ-DI at week 24 were different. 2Nonresponder imputation. *p<0.05,†p<0.01, ‡p<0.001 vs PBO. CFB, change from baseline as mean (SD); SAE, serious adverse events; TEAE, treatment-emergent adverse events. Conclusion FIL demonstrated consistent safety and efficacy in bDMARD-IR patients with RA regardless of geography or race. References [1] Genovese MC, et al. ACR 2018. Abstract L06. Disclosure of Interests Jacques-Eric Gottenberg Grant/research support from: Bristol-Myers Squibb, Grant/research support from: Bristol-Myers Squibb, Consultant for: Bristol-Myers Squibb, Lilly, Pfizer, Sanofi-Genzyme, UCB Pharma, Consultant for: Bristol-Myers Squibb, Eli Lilly, UCB, Sanofi-Genzyme, Pfizer, Mark C. Genovese Grant/research support from: Sanofi/Genzyme, Genentech/Roche, RPharm, Consultant for: Sanofi/Genzyme, Genentech/Roche, RPharm, Kenneth Kalunian Grant/research support from: Gilead Sciences, Inc., Neelufar Mozaffarian Shareholder of: Gilead, Employee of: Gilead, Beatrix Bartok Shareholder of: Gilead, Employee of: Gilead, Franziska Matzkies Shareholder of: Gilead, Employee of: Gilead, Jie Gao Shareholder of: Gilead, Employee of: Gilead, Ying Guo Shareholder of: Gilead, Employee of: Gilead, David Walker: None declared, 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., Kurt de Vlam Consultant for: Pfizer Inc, Consultant for: Johnson & Johnson