Safety and efficacy of filgotinib for Japanese patients with RA and inadequate response to MTX: FINCH 1 52-week results and FINCH 4 48-week results

Abstract

Objective To present safety and efficacy of the JAK1 preferential inhibitor filgotinib in Japanese patients with prior inadequate response (IR) to methotrexate (MTX) from a 52-week randomised controlled parent study (PS) and long-term extension (LTE) through June 2020. Methods The PS (NCT02889796) randomised MTX-IR patients to filgotinib 200 (FIL200) or 100 mg (FIL100), adalimumab (ADA) 40 mg, or placebo; all took stable background MTX. At week (W) 24, placebo patients were rerandomised to FIL200 or FIL100. The primary endpoint was W12 American College of Rheumatology 20% improvement (ACR20); safety was assessed by adverse event (AE) reporting. For the LTE (NCT03025308), eligible filgotinib patients continued FIL200/FIL100; ADA patients were rerandomised (blinded) to FIL200 or FIL100; all continued MTX. Results 114/147 Japanese patients completed the PS; 115 enrolled in LTE; 103 remained on study in June 2020. In the PS, AEs were consistent with the overall population, and W24 efficacy was maintained or improved through W52, comparable with the overall population. LTE AE incidences were similar between doses; filgotinib efficacy was consistent from baseline to W48 and similar between PS ADA and filgotinib patients. Conclusion Among MTX-IR Japanese patients, filgotinib maintained efficacy over 1 year; LTE safety was consistent with the PS.

Long-Term Safety, Efficacy, and Patient-Centered Outcomes of Filgotinib in the Treatment of Rheumatoid Arthritis: Current Perspectives

“… 12–18 , 20 , 21 , 33–35 However, the response rates among bDMARD-IR patients were lower relative to those observed among the MTX-IR and MTX-naïve populations. 14 , 16 , 20 , 33–35 …”

“…24 It is important to note that for the LTEs, patients were rerandomized from active comparators (MTX, ADA, and csDMARDs) to filgotinib by study design rather than for safety, efficacy, or tolerability. 20 , 33 More evidence is needed for the tolerability of filgotinib in real-world settings.…”

“…24 Patients who had been assigned to filgotinib continued their originally assigned filgotinib dosage while those who had been assigned to control groups in the parent trials were rerandomized (blinded) to filgotinib 200 or 100 mg once daily. 20 , 21 , 33 Overall, the FINCH clinical trials have been conducted internationally across 34 countries beginning in 2016, with FINCH 4 currently ongoing, with projected completion in 2025. 24 Patients received their LTE treatment in FINCH 4 for ≤6 years.…”

“…4,5,7,10,11 Filgotinib, an orally administered medication, has been extensively studied for the treatment of moderate-to-severe RA in a series of Phase 2b and 3 clinical trials: DARWIN 1, 2, and 3 and FINCH 1, 2, 3, and 4. [12][13][14][15][16][17][18][19][20][21][22] The Phase 2b DARWIN trials were filgotinib dosefinding studies, while the Phase 3 FINCH trials assessed the safety and efficacy of the treatment modality. [23][24][25][26][27][28][29] The DARWIN and FINCH trials both required an RA diagnosis defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA and an ACR functional class I-III.…”

Focus on Filgotinib in Rheumatoid Arthritis: A Trial-Based Review

“…Disease activity measured as DAS28(CRP)<2.6 was reported for 81% of patients treated with FIL 200 mg and 74% of patients in the FIL 100 mg arm. 19 …”