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

BACKGROUNDFilgotinib has been approved for the treatment of rheumatoid arthritis (RA) in adults who respond inadequately to disease-modifying antirheumatic 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 withan inadequate response to methotrexateor other DMARDs. METHODSA systematic literature search was conducted to identify articles in PubMed, MEDLINE, EMBASE, and Cochrane Library from inceptionto 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). RESULTSFour 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. CONCLUSIONSFilgotinib is effective in the treatment of RA, and the 200 mg dose has a more beneficialprofile thanthe 100 mg dose.