TY - JOUR
T1 - Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors
T2 - Post hoc analysis of FINCH 3
AU - Aletaha, Daniel
AU - Westhovens, René
AU - Gaujoux-Viala, Cecile
AU - Adami, Giovanni
AU - Matsumoto, Alan
AU - Bird, Paul
AU - Messina, Osvaldo Daniel
AU - Buch, Maya H.
AU - Bartok, Beatrix
AU - Yin, Zhaoyu
AU - Guo, Ying
AU - Hendrikx, Thijs
AU - Burmester, Gerd R.
N1 - Funding Information:
Competing interests DA reports grants or research support from AbbVie, Merck Sharp & Dohme, Novartis, and Roche; serving as a consultant for Janssen; serving on a speaker’s bureau for Bristol-Myers Squibb, Merck Sharp & Dohme and UCB; and serving as a consultant and on a speaker’s bureau for AbbVie; Amgen; Celgene; Eli Lilly; Medac; Merck; Novartis; Pfizer; Roche; Sandoz; and Sanofi/ Genzyme. RW reports grant/research support from and serving as a consultant for Celltrion; Galapagos; and Gilead Sciences, Inc. CG-V reports serving as a consultant and on a speaker’s bureau for AbbVie; Amgen; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB. GA reports serving as a consultant for Amgen and Theramex. AM reports grants or research support from AbbVie; Bristol-Myers Squibb; Eli Lilly; Galapagos; Gilead Sciences, Inc.; GlaxoSmithKline; Janssen; Novartis; Pfizer; Sanofi; UCB; and Regeneron; and serving as a consultant for AbbVie; Gilead Sciences, Inc; GlaxoSmithKline; and Novartis. PB reports serving as a consultant and on a speaker’s bureau for AbbVie, Celgene, Eli Lilly, Janssen, Novartis and Pfizer. ODM reports serving on a speaker’s bureau for Amgen, Pfizer and Americas Health Foundation. MHB reports grants or research support from Pfizer, Roche and UCB; and serving as a consultant for AbbVie; Eli Lilly; Gilead Sciences, Inc; Serono; Sandoz; and Sanofi. BB, ZY and YG are employees and shareholders of Gilead Sciences, Inc. TH is an employee and shareholder of Galapagos BV. GRB reports serving as a consultant and on a speaker’s bureau for AbbVie; Eli Lilly; Pfizer; and Gilead Sciences, Inc.
Publisher Copyright:
© 2021 BMJ Publishing Group. All rights reserved.
PY - 2021/8/12
Y1 - 2021/8/12
N2 - Objective This analysis evaluated efficacy and safety of filgotinib, a Janus-associated kinase 1-preferential inhibitor, in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) with multiple poor prognostic factors (PPFs). Methods This was a post hoc analysis of the phase III, randomised, double-blind, active-controlled, FINCH 3 study (clinicaltrials.gov NCT02886728). Patients received once-daily oral filgotinib 200 or 100 mg plus once-weekly oral MTX ≤20 mg (FIL200 + MTX and FIL100 + MTX), filgotinib 200 mg monotherapy (FIL200), or oral MTX monotherapy (MTX-mono) for up to 52 weeks. PPFs investigated were seropositivity for rheumatoid factor or anticyclic citrullinated peptide antibodies, high-sensitivity C reactive protein (CRP) ≥4 mg/L, Disease Activity Score in 28 joints with CRP (DAS28(CRP)) >5.1, and presence of erosions. Filgotinib efficacy and safety in patients with all four PPFs at baseline were explored versus MTX-mono within this subgroup and compared informally with the overall population. Results Of 1249 patients in FINCH 3, 510 (40.8%) had all PPFs. Efficacy of FIL200 + MTX among these patients was comparable to the overall population, with higher rates of 20%/50%/70% improvement from baseline by American College of Rheumatology criteria, DAS28(CRP) <2.6, and remission; greater improvement in physical function and pain; and better inhibition of structural damage relative to MTX-mono. FIL100 + MTX and FIL200 were not consistently more efficacious versus MTX-mono. Safety of filgotinib in patients with PPFs was comparable to the overall population; no new safety signals were observed. Conclusion FIL200 + MTX efficacy and safety in patients with multiple PPFs were similar to the overall population.
AB - Objective This analysis evaluated efficacy and safety of filgotinib, a Janus-associated kinase 1-preferential inhibitor, in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) with multiple poor prognostic factors (PPFs). Methods This was a post hoc analysis of the phase III, randomised, double-blind, active-controlled, FINCH 3 study (clinicaltrials.gov NCT02886728). Patients received once-daily oral filgotinib 200 or 100 mg plus once-weekly oral MTX ≤20 mg (FIL200 + MTX and FIL100 + MTX), filgotinib 200 mg monotherapy (FIL200), or oral MTX monotherapy (MTX-mono) for up to 52 weeks. PPFs investigated were seropositivity for rheumatoid factor or anticyclic citrullinated peptide antibodies, high-sensitivity C reactive protein (CRP) ≥4 mg/L, Disease Activity Score in 28 joints with CRP (DAS28(CRP)) >5.1, and presence of erosions. Filgotinib efficacy and safety in patients with all four PPFs at baseline were explored versus MTX-mono within this subgroup and compared informally with the overall population. Results Of 1249 patients in FINCH 3, 510 (40.8%) had all PPFs. Efficacy of FIL200 + MTX among these patients was comparable to the overall population, with higher rates of 20%/50%/70% improvement from baseline by American College of Rheumatology criteria, DAS28(CRP) <2.6, and remission; greater improvement in physical function and pain; and better inhibition of structural damage relative to MTX-mono. FIL100 + MTX and FIL200 were not consistently more efficacious versus MTX-mono. Safety of filgotinib in patients with PPFs was comparable to the overall population; no new safety signals were observed. Conclusion FIL200 + MTX efficacy and safety in patients with multiple PPFs were similar to the overall population.
KW - antirheumatic agents
KW - arthritis
KW - rheumatoid
KW - therapeutics
UR - http://www.scopus.com/inward/record.url?scp=85113194953&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85113194953&partnerID=8YFLogxK
U2 - 10.1136/rmdopen-2021-001621
DO - 10.1136/rmdopen-2021-001621
M3 - Article
C2 - 34385364
AN - SCOPUS:85113194953
SN - 2056-5933
VL - 7
JO - RMD Open
JF - RMD Open
IS - 2
M1 - e001621
ER -