An analysis of safety data from seven placebo-controlled clinical trials has been conducted to characterise the safety of the JAK-1 preferential inhibitor Jyseleca (filgotinib) in patients with moderately to severely active rheumatoid arthritis, receiving treatment over a median of 1,6 years. In conclusion the analysis shows that the safety and tolerability of filgotinib 200 and 100 mg were similar, with lower incidence of infections with filgotinib 200 mg.
Previous studies have shown that filgotinib was generally well tolerated in previous trials and had safety similar to active comparators methotrexate and adalimumab up to 52 weeks.
This integrated analysis of safety data adds additional insights:
1. Winthrop KL, Tanaka Y, Takeuchi T, Kivitz A, Matzkies F, Genovese MC, Jiang D, Chen K, Bartok B, Jahreis A, Besuyen R, Burmester GR, Gottenberg JE. Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years. Ann Rheum Dis. 2022 Feb;81(2):184-192. doi: 10.1136/annrheumdis-2021-221051. Epub 2021 Nov 5. PMID: 34740884; PMCID: PMC8762003.