Efficacy and safety of filgotinib in patients with rheumatoid arthritis and inadequate response to disease-modifying antirheumatic drugs (DMARDs): a meta-analysis of randomized controlled trials

Background: Filgotinib has been approved for the treatment of rheumatoid arthritis (RA) in adults who respond inadequately to disease-modifying anti-rheumatic drugs (DMARDs) in Europe and Japan. Several randomized controlled trials (RCTs) have investigated its efficacy and safety in adult patients with RA. This meta-analysis aimed to study the efficacy and safety of filgotinib in patients with RA with an inadequate response to methotrexate or other DMARDs. Methods: A systematic literature search was conducted to identify articles in PubMed, MEDLINE, EMBASE, and Cochrane Library from inception to December 1, 2021. Outcomes of interest included ACR20/50/70 responses, DAS28-CRP <= 3.2, SF-36 PCS Score, FACIT-fatigue, SDAI,CDAI, and HAQ-DI, which were assessed after treatment. The safety outcomes included treatment-emergent adverse events (TEAEs) and serious TEAEs. Odds ratios (ORs) with 95% confidence intervals (CI) were pooled for categorical variables, and the mean difference with 95%CI were pooled for continuous variables. We used Review Manager 5.3 for the standard meta-analysis. This study followed the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Results: Four RCTs comparing filgotinib (200 and 100 mg once daily) with placebo were identified. Compared with placebo, 200 and 100 mg filgotinib was more effective in achieving ACR20/50/70 responses and other outcomes at weeks 12 and 24 (P < 0.05), with no significant difference in safety outcomes (P > 0.05). Filgotinib 200 mg performed better than filgotinib 100 mg in terms of ACR20/50 responses, DAS28-CRP <= 3.2, SDAI, and CDAI at weeks 12 and 24, and caused fewer serious TEAEs than the 100 mg dose. Conclusions: Filgotinib is effective in the treatment of RA, and the 200 mg dose has a more beneficial profile than the 100 mg dose.