Efficacy and safety of filgotinib in patients with rheumatoid arthritis: week 156 interim results from a long-term extension study.

BACKGROUND

Janus kinase inhibitors are an effective option for achieving sustained remission or low disease activity in patients with rheumatoid arthritis (RA) following inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs. Filgotinib is a Janus kinase 1-preferential inhibitor available in two doses for moderate-to-severe RA. We report the long-term efficacy and safety of filgotinib.

METHODS

In the ongoing long-term extension study FINCH 4 (NCT03025308), patients continue filgotinib 200 mg or 100 mg from FINCH 1, 2 or 3 or receive filgotinib 200 mg or 100 mg de novo. Efficacy assessments up to week 156 include American College of Rheumatology 20% response (ACR20), Disease Activity Score 28 using C-reactive protein of <2.6, Clinical Disease Activity Index of ≤2.8, Simplified Disease Activity Index of ≤3.3 and Boolean remission (1.0 and 2.0) with non-responder imputation.

RESULTS

In patients with an inadequate response to methotrexate, 60.2% and 54.6% receiving de novo filgotinib 200 mg and 100 mg had an ACR20 at week 156, respectively, as did 67.3% and 59.5% of those who continued filgotinib 200 mg and 100 mg. At week 156, Boolean remission 1.0 was achieved by 18.8% and 15.4% of patients treated with de novo filgotinib 200 mg and 100 mg, respectively, and by 21.1% and 18.5% when Boolean 2.0 criteria were applied. Similar efficacy data were seen in patients from FINCH 2 and 3. Safety data were consistent with the known safety profile of filgotinib.

CONCLUSION

In FINCH 4, filgotinib 200 mg and 100 mg (continuous or de novo) demonstrated sustained efficacy up to week 156 in patients enrolled from FINCH 1, 2 or 3, with no unexpected safety results.

Informations de copyright

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: MHB reports consultancy fees from AbbVie, Boehringer Ingelheim, CESAS Medical, Galapagos, Gilead and Pfizer (all paid to host institution); speaker fees from AbbVie (paid to host institution); and grant/research support from Gilead (paid to host institution). DA reports consultancy fees, speaker fees and grant/research support from AbbVie, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Sandoz and Sanofi. BGC reports consultancy fees from AbbVie, Celltrion, Eli Lilly, Galapagos, Gilead, Janssen and Roche-Chugai; and speaker fees from AbbVie, Celltrion, Eli Lilly, Galapagos, Janssen, Pfizer and Roche-Chugai. YT reports speaker fees and/or honoraria from AbbVie, Asahi Kasei, AstraZeneca, Boehringer Ingelheim, BMS, Chugai, Eli Lilly, Eisai, Gilead, GSK, Pfizer, Taisho and Taiho; and research grants from Asahi Kasei, Chugai, Eisai, Mitsubishi Tanabe and Taisho. RC reports consultancy fees from AbbVie, Accord, Eli Lilly, Fresenius Kabi, Galapagos, MSD, Novartis, Pfizer and UCB; and speaker fees from AbbVie, Amgen, BMS, Celltrion, Eli Lilly, Fresenius Kabi, Galapagos, Janssen, MSD, Novartis, Pfizer and UCB. HS-K reports consultancy fees and speaker fees from AbbVie, Eli Lilly, Galapagos and Pfizer. TT reports consultancy fees from AbbVie, Astellas Pharma, Eli Lilly Japan and Gilead; and speaker fees and/or honoraria from AbbVie, Astellas Pharma, Eisai, Eli Lilly Japan, Gilead and Pfizer Japan. J-EG reports consultancy fees from AbbVie, BMS, Eli Lilly, Galapagos, Gilead, MSD, Novartis and Pfizer; and grant/research support from AbbVie, BMS, Lilly and Pfizer. RB reports consultancy fees from AstraZeneca, Galapagos, Janssen, Novartis and Pfizer; speaker fees from AbbVie, Amgen, BMS, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche and Sanofi; and grant/research support from AbbVie and Roche. PV reports consultancy fees from Celltrion, Eli Lilly, Galapagos, Gilead, Nordic Pharma and Sidekick Health; speaker fees from AbbVie, Eli Lilly, Galapagos and Roularta; and grant/research support from Galapagos and Pfizer. AZ-S has no disclosures of interest to report. FDL is a former employee of, and shareholder in, Galapagos. EVEO reports consultancy fees from Galapagos and Janssen and is a shareholder in UCB. VR is a former employee of Galapagos and current employee of GSK Vaccines. PE reports consultancy fees from AbbVie, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead and Novartis; speaker fees from AbbVie, Boehringer Ingelheim, Eli Lilly, Gilead, Novartis and Samsung; and grant/research support from AbbVie, BMS, Eli Lilly and Samsung.