Date: Friday, November 6, 2020
Session Title: RA – Treatments Poster I: RA Treatments & Their Safety
Session Type: Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Filgotinib (FIL) is an oral, potent, selective JAK 1 inhibitor. FINCH 3 assessed FIL efficacy and safety in methotrexate (MTX)-naïve patients (pts) with rheumatoid arthritis (RA); week (W)24 primary outcome results were previously presented.1 These analyses report FINCH 3 (NCT02886728) results through W52.
Methods: This global, phase 3, double-blind, active-controlled study randomized MTX-naïve pts with moderately to severely active RA 2:1:1:2 to oral FIL 200 mg once daily + MTX ≤20 mg weekly, FIL 100 mg + MTX, FIL 200 mg monotherapy (mono) + placebo (PBO), or PBO + MTX up to W52. Comparisons at W52 were not adjusted for multiplicity. Safety was assessed from adverse events and laboratory abnormalities.
Results: Of 1249 treated pts, 975 received study drug through W52. FIL efficacy was sustained up to W52. Treatment with FIL + MTX or FIL mono increased proportions of pts achieving ACR20/50/70 and clinical disease remission by DAS28(CRP) < 2.6 (FIL 200 mg + MTX, 53%; FIL mono, 46%), CDAI, SDAI, and Boolean criteria; improved HAQ-DI; and halted radiographic progression vs MTX alone (Table 1 and Figure). Safety was consistent with W24 data (Table 2).
Conclusion: Efficacy of FIL 200 mg + MTX, FIL 100 mg + MTX, and FIL 200 mg mono was sustained through W52, with faster onset1 and consistently numerically greater efficacy for FIL 200 vs 100 mg. No new safety signals were observed.
- Westhovens, et al. Ann Rheum Dis. 2019;78(Suppl2):259–60.
To cite this abstract in AMA style:Westhovens R, Rigby W, van der Heijde D, Ching D, Stohl W, Kay J, Chopra A, Bartok B, Matzkies F, Yin Z, Guo Y, Tasset C, Sundy J, Jahreis A, Mozaffarian N, Messina O, Landewé R, Atsumi T, Burmester G. Efficacy and Safety of Filgotinib in Methotrexate-Naïve Patients with Rheumatoid Arthritis: 52-Week Results [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-filgotinib-in-methotrexate-naive-patients-with-rheumatoid-arthritis-52-week-results/. Accessed June 17, 2021.
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