SAT0142 MATCHING ADJUSTED INDIRECT COMPARISON OF FILGOTINIB VS. TOFACITINIB IN MODERATE-TO-SEVERE ACTIVE RHEUMATOID ARTHRITIS PATIENTS WITH INADEQUATE RESPONSE TO METHOTREXATE. (2nd June 2020)

• Record Type: Journal Article
• Authors: Gharaibeh, M.; Smith, N.; Jeyakumar, S.; Mark, E.; Shreay, S.
• Is Part Of: Annals of the rheumatic diseases. Volume 79(2020)Supplement 1
• Page Start: 1009
• Page End: 1010
• Publication Date: 2020-06-02
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2020-eular.6108
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: Filgotinib (FILG) is a JAK1 inhibitor that has been investigated in combination with methotrexate (MTX) for the treatment of moderate-to-severe rheumatoid arthritis (RA). To date, no head-to-head trial has compared the efficacy of FILG versus tofacitinib (TOFA). Objectives: To compare the efficacy of FILG 200 mg + MTX with TOFA 5 mg + MTX using matching adjusted indirect comparison (MAIC). Methods: MAIC technique uses individual patient data (IPD) from one trial and aggregate data from the other to enable comparison of outcomes after matching on baseline characteristics [1]. An anchored MAIC was conducted using IPD from the FINCH-1 trial of FILG 200 mg + MTX vs adalimumab (ADA) 40 mg + MTX and published data from ORAL STRATEGY [2] trial of TOFA 5 mg + MTX vs ADA 40 mg + MTX. Patients in the FINCH-1 trial were reweighted based on age, sex, race, tender joint count 28, swollen joint count 28, C-reactive protein and patient's global assessment to match baseline characteristics of the comparator. After matching, Wald tests were used to test for significant differences in ACR 20/50/70 and clinical remission outcomes (SDAI≤3.3, CDAI≤2.8, DAS28(CRP)<2.6, Boolean) between FILG + MTX vs TOFA 5 mg + MTX relative to ADA 40 mg + MTX. Results: After matching, baseline characteristics were balanced across the trial populations [Table 1 ]. FILG 200 mg + MTX patients experienced significantly greater improvement in 12 week ACR50 and ACR70 outcomes compared to TOFA 5 mg + MTX with a mean difference in difference (DD) of 13.5% (p < .05) and 8.3% (p < .05) respectively, as well as numerical improvements on other ACR outcomes at 12, 24 and 52 weeks [Figure 1 ]. At 24 weeks, FILG 200 mg + MTX patients experienced significantly greater improvement in DAS28(CRP) clinical remission compared to TOFA 5 mg + MTX with DD of 10.1% (p < .05) [Figure 2 ] as well as numerical improvements on other efficacy outcomes. At 52 weeks, FILG 200 mg + MTX patients experienced significantly greater improvement in DAS28(CRP) clinical remission compared to TOFA 5 mg + MTX with DD of 13.2% (p < .05) [Figure 2 ] as well as numerical improvements on other efficacy outcomes. Conclusion: In this MAIC, compared to TOFA 5 mg + MTX, FILG 200 mg + MTX appears to produce improved efficacy outcomes (ACR20/50/70, DAS28(CRP), SDAI, CDAI and Boolean Remission) at weeks 12, 24 and 52. References: [1]Signorovitch JE, et al. "Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research." Value in Health 15.6 (2012): 940-947 [2]Fleischmann R, et al. "Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy)." The Lancet 390.10093 (2017): 457-468 Acknowledgments: The study was funded by Gilead Sciences Inc Disclosure of Interests: Mahdi Gharaibeh Shareholder of: Gilead Sciences Inc, Employee of: Gilead Sciences, Amgen, Nate Smith Consultant of: Gilead Sciences Inc, Sushanth Jeyakumar Consultant of: Gilead Sciences, Ejim Mark Shareholder of: Gilead Sciences Inc, Employee of: Gilead Sciences, Novartis, Sanatan Shreay Shareholder of: Gilead Sciences, Employee of: Gilead Sciences