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Clinical Trial
. 2021 Jun;80(6):727-738.
doi: 10.1136/annrheumdis-2020-219213. Epub 2021 Jan 15.

Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial

René Westhovens  1   2 , William F C Rigby  3 , Désirée van der Heijde  4 , Daniel W T Ching  5 , William Stohl  6 , Jonathan Kay  7   8 , Arvind Chopra  9 , Beatrix Bartok  10 , Franziska Matzkies  10 , Zhaoyu Yin  10 , Ying Guo  10 , Chantal Tasset  11 , John S Sundy  10   12 , Angelika Jahreis  10 , Neelufar Mozaffarian  13 , Osvaldo Daniel Messina  14   15 , Robert Bm Landewé  16   17 , Tatsuya Atsumi  18 , Gerd R Burmester  19   20
Affiliations
Clinical Trial

Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial

René Westhovens et al. Ann Rheum Dis. 2021 Jun.

Abstract

Objectives: To investigate efficacy and safety of the Janus kinase-1 inhibitor filgotinib in patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure.

Methods: This 52-week, phase 3, multicentre, double-blind clinical trial (NCT02886728) evaluated once-daily oral filgotinib in 1252 patients with RA randomised 2:1:1:2 to filgotinib 200 mg with MTX (FIL200 +MTX), filgotinib 100 mg with MTX (FIL100 +MTX), filgotinib 200 mg monotherapy (FIL200), or MTX. The primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 24.

Results: The primary endpoint was achieved by 81% of patients receiving FIL200+ MTX versus 71% receiving MTX (p<0.001). A significantly greater proportion treated with FIL100+ MTX compared with MTX achieved an ACR20 response (80%, p=0.017) at week 24. Significant improvement in Health Assessment Questionnaire-Disability Index was seen at week 24; least-squares mean change from baseline was -1.0 and -0.94 with FIL200+MTX and FIL100+MTX, respectively, versus -0.81 with MTX (p<0.001, p=0.008, respectively). Significantly higher proportions receiving FIL200+MTX (54%) and FIL100+MTX (43%) achieved DAS28(CRP) <2.6 versus MTX (29%) (p<0.001 for both) at week 24. Hierarchical testing stopped for comparison of ACR20 for FIL200 monotherapy (78%) versus MTX (71%) at week 24 (p=0.058). Adverse event rates through week 52 were comparable between all treatments.

Conclusions: FIL200+MTX and FIL100+MTX both significantly improved signs and symptoms and physical function in patients with active RA and limited or no prior MTX exposure; FIL200 monotherapy did not have a superior ACR20 response rate versus MTX. Filgotinib was well tolerated, with acceptable safety compared with MTX.

Keywords: antirheumatic agents; arthritis; rheumatoid; therapeutics.

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Conflict of interest statement

Competing interests: RW reports grant/research support from and serving as a consultant for Celltrion, Galapagos, and Gilead Sciences. WFCR reports serving as a consultant for Gilead Sciences. DvdH reports serving as a consultant for AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Cyxone, Daiichi Sankyo, Eisai, Eli Lilly and Co., Galapagos, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and UCB Pharma; and is director of Imaging Rheumatology BV. DWTC reports receiving grants from AbbVie, Gilead Sciences, Pfizer, and Sanofi; and serving as a consultant for AbbVie and Pfizer. WS reports receiving consulting fees from Janssen Research and Development, and research support from GlaxoSmithKline. JK reports research grants paid to his institution from AbbVie, Genentech, Gilead Sciences, Pfizer, and UCB; and has received personal fees from AbbVie, Alvotech,Suisse AG, Amgen, Boehringer Ingelheim GmbH, Celltrion Healthcare Co., Janssen Biotech, Merck Sharp & Dohme Corp., Mylan, Novartis AG, Pfizer, Samsung Bioepis, Sandoz, and UCB. AC reports no conflicts of interest. BB, FM, ZY, and YG are shareholders and employees of Gilead Sciences. CT is a shareholder and employee of Galapagos NV. JSS is a shareholder and former employee of Gilead Sciences; and current employee and shareholder of Pandion Therapeutics. NM is a shareholder and former employee of Gilead Sciences, and current employee of Ichnos Sciences. AJ is a shareholder and former employee of Gilead Sciences. ODM reports serving on a speaker’s bureau for Americas Health Foundation, Amgen, and Pfizer. RBML reports serving as a consultant for AbbVie, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Co., Galapagos NV, Novartis, Pfizer and UCB. TA reports grant/research support from AbbVie, Alexion, Astellas, Bristol-Myers Squibb, Chugai Pharmaceutical Co., Daiichi Sankyo Co., Eli Lilly Japan K.K., Mitsubishi Tanabe Pharma Co., and Pfizer; and has served as a consultant for AbbVie, Chugai, Daiichi Sankyo Co., Eli Lilly Japan K.K., Gilead Sciences, Pfizer, and UCB Japan Co.; and has served on a speakers bureau for AbbVie, Astellas, Bristol-Myers Squibb Co., Chugai Pharmaceutical Co., Daiichi Sankyo Co., Eisai Co., Eli Lilly Japan K.K., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co., Pfizer, Takeda Pharmaceutical Co., and UCB Japan Co. GRB reports serving as a consultant and on a speaker’s bureau for AbbVie, Eli Lilly and Co., Pfizer, and Gilead Sciences.

Figures

Figure 1
Figure 1
Study flow and patient disposition through 24 and 52 weeks. *Three patients were randomised (1 to FIL 200 mg+MTX and 2 to MTX monotherapy) but not dosed. FIL, filgotinib; MTX, methotrexate; QD, once daily; QW, once weekly.
Figure 2
Figure 2
Primary, key secondary, and other secondary efficacy outcomes: (A) proportion of patients who achieved ACR20 over time; (B) change from baseline in HAQ-DI at week 24 and week 52; (C) proportion of patients achieving DAS28(CRP) <2.6 at week 24 and week 52. ###p<0.001; ##p<0.01; #p<0.05. The difference between filgotinib 200 mg and MTX for ACR20 at week 24 was not significant (p=0.058). ***Exploratory p<0.001; **exploratory p<0.01; *exploratory p<0.05, for supportive analysis without adjustment for multiplicity. an=372, 190, 185, and 370 for FIL200+MTX, FIL100+MTX, FIL200, and MTX, respectively. bn=332, 169, 171, and 307 for FIL200+MTX, FIL100+MTX, FIL200, and MTX, respectively. Error bars represent 95% CI for proportions of patients and SD for mean. For HAQ-DI, p values are based on least-squares mean difference versus MTX. Supporting values for (A) are shown in online supplemental table S3. ACR20, 20% improvement in American College of Rheumatology criteria; DAS28(CRP), 28-joint Disease Activity Score with C-reactive protein; FIL, filgotinib; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate.
Figure 3
Figure 3
Change in modified total Sharp/van der Heijde score (mTSS) and components from baseline at (A) week 24 and (B) week 52. ***Exploratory p<0.001; **exploratory p<0.01; *exploratory p<0.05; for supportive analysis without adjustment for multiplicity. Error bars represent 95% CI. For mTSS, week 24 includes only data from campaign A and week 52 includes data from campaign A and B. Week 52 n values are not provided for mTSS change from baseline, as the analysis included both campaign A (through week 24) and campaign B (through week 52 including re-reading of baseline and week 24). ES, erosion score; FIL, filgotinib; JSN, joint space narrowing; LSM, least-squares mean; MTX, methotrexate.
Figure 4
Figure 4
Proportion of patients achieving (A) ACR50 at weeks 24 and 52; (B) ACR70 at weeks 24 and 52; (C) remission at week 24; and (D) remission at week 52. ***Exploratory p<0.001; **exploratory p<0.01; *exploratory p<0.05; for supportive analysis without adjustment for multiplicity. ACR50/70, 50%/70% improvement in American College of Rheumatology criteria; CDAI, Clinical Disease Activity Index; FIL, filgotinib; MTX, methotrexate; SDAI, Simple Disease Activity Index.
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