Background: In the FINCH 3 study, filgotinib (FIL)—a potent, selective, oral small molecule Janus kinase 1 inhibitor1—in combination with methotrexate (MTX), demonstrated significant improvements in the signs and symptoms of rheumatoid arthritis (RA) vs MTX alone in patients (pts) who were MTX-naïve.2 For pts with RA, rapid control of pain and fatigue along with maintenance of physical function and health-related quality of life (HRQoL) are important outcomes of their care.3 Thus, patient-reported outcomes (PROs) can provide physicians with evidence to guide treatment decisions beyond the guideline-recommended treatment targets of reducing immune inflammation to prevent joint damage, physical disability, and mortality.4
Objectives: To evaluate the rate and magnitude of change in PROs assessing functional status, pain, HRQoL, and fatigue from FINCH 3.
Methods: In the FINCH 3 study (NCT02886728), pts with active RA who were MTX-naïve received FIL 200 mg daily + MTX, FIL 100 mg + MTX, FIL 200 mg (+ placebo [PBO]), or MTX (+ PBO) for up to 52 weeks. PROs were recorded prospectively and included HAQ-DI (functional status) and VAS pain scale (day 1, week [W]2, W4, W8, W12, W16, W20, W24, W30, W36, W44, W52), SF-36 (HRQoL), and FACIT-Fatigue (day 1, W4, W12, W24, W36, W52). The least squares mean of the change from baseline (CFB) at each time point up to W52 and p values (each FIL arm vs MTX) were analysed using a mixed-effects model for repeated measures. For HAQ-DI, the proportion of pts who achieved the minimum clinically important difference (MCID; reduction ≥0.22) between each FIL arm and MTX was analysed using logistic regression analysis. P values for the comparisons of PROs were not adjusted for multiplicity, except for HAQ-DI CFB at W24 for FIL 200 mg + MTX and FIL 100 mg + MTX vs MTX.
Results: Of the 1249 pts randomised and treated (FIL 200 mg + MTX, n = 416; FIL 100 mg + MTX, n = 207; FIL 200 mg, n = 210; MTX, n = 416), 1025 (82.1%) completed the study. Compared with MTX alone, a nominally significantly greater CFB in functional status and pain from W2 to W24 was observed in all FIL arms; the benefit was sustained from W30 to W52 (Fig 1). By W2, a nominally significantly greater proportion of pts achieved the HAQ-DI MCID or greater (≥0.22) in all FIL arms (FIL 200 mg + MTX: 61.9%, p <0.001; FIL 100 mg + MTX: 58.5%, p <0.001; FIL 200 mg: 53.9%, p = 0.004) compared with MTX (42.2%). By W8, ≥72% of pts in all FIL arms vs 63% of pts in the MTX arm achieved the HAQ-DI MCID; a numerically greater proportion of pts in FIL arms vs MTX achieved HAQ-DI MCID through W52. SF-36 physical component summary and FACIT-Fatigue scores were nominally significantly improved with FIL treatment vs MTX alone at various time points (Fig 2A, B). Improvements in SF-36 mental component summary scores were nominally significant for pts in all FIL arms vs MTX alone as early as W4, and the CFB reached at W12 for FIL arms was generally sustained up to W52 (Fig 2A).
Conclusion: For pts with moderate to severe RA who were MTX-naïve, FIL—with or without concomitant MTX—led to more rapid and sustained improvements in functional status, pain, fatigue, and HRQoL, compared with MTX alone.
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Disclosure of Interests: Rieke Alten Grant/research support from: Pfizer, Galapagos, Galapagos NV, Gilead, Gilead Sciences, Inc., Novartis, Consultant of: Pfizer, Speakers bureau: Pfizer, William Rigby Consultant of: Gilead Sciences, Inc., Alena Pechonkina Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Zhaoyu Yin Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Ken Hasegawa Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Thijs Hendrikx Shareholder of: Galapagos (share/warrant holder), Employee of: Galapagos, Tatsuya Atsumi Grant/research support from: Eli Lily Japan K.K., Alexion Pharmaceuticals, Inc., Bristol-Myers Squibb Co., AbbVie Inc., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Astellas Pharma Inc., Consultant of: Gilead Sciences, Inc., Eli Lilly Japan K.K., UCB Japan Co. Ltd., AbbVie Inc., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Speakers bureau: Eli Lilly Japan K.K., UCB Japan Co. Ltd., Bristol-Myers Squibb Co., AbbVie Inc., Eisai Co. Ltd., Otsuka Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Takeda Pharmaceutical Co., Ltd., Astellas Pharma Inc., Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead
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