SAT0142 MATCHING ADJUSTED INDIRECT COMPARISON OF FILGOTINIB VS. TOFACITINIB IN MODERATE-TO-SEVERE ACTIVE RHEUMATOID ARTHRITIS PATIENTS WITH INADEQUATE RESPONSE TO METHOTREXATE

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.Table 1.Baseline Characteristics of FINCH-1 vs ORAL STRATEGYCHARACTERISTICBEFORE MATCHINGAFTER MATCHINGORAL STRATEGYFILG 200 + MTX (N=475)ADA + MTX (N=325)FILG 200 + MTX (ESS=340)ADA + MTX (ESS=233)TOFA 5mg + MTX BID (N=376)ADA + MTX BID (N=386)Sex – Female, %79.8%81.8%83.0%83.0%83.0%83.0%Age (year), mean (SD)51.8 (12.8)53.3 (12.9)50.0 (13.4)50.7 (13.4)50.0 (13.4)50.7 (13.4)Race – White, %65.7%70.5%76.0%76.0%76.0%76.0%Tender Joint Count 28, mean (SD)15.0 (6.4)14.6 (6.3)15.6 (6.5)15.2 (6.7)15.6 (6.5)15.2 (6.7)Swollen Joint Count 28, mean (SD)11.2 (5.2)11.2 (5.0)11.8 (5.7)11.0 (5.4)11.8 (5.7)11.0 (5.4)C-Reactive Protein (mg/L), mean (SD)16.1 (21.0)14.6 (18.0)18.7 (21.9)16.7 (21.3)18.7 (21.9)16.7 (21.3)Patient global assessment baseline, mean (SD)67.1 (19.2)67.0 (19.1)61.7 (22.0)60.2 (23.5)61.7 (22.0)60.2 (23.5)ESS = effective sample size; SD = standard deviationFigure 1.ACR20/50/70 relative to ADA 40 mg+ MTX of FILG 200 mg + MTX vs TOFA 5 mg + MTX * p < .05Figure 2.Clinical Remission outcomes relative to ADA 40 mg+ MTX of FILG 200 mg + MTX vs TOFA 5 mg + MTX * p < .05Conclusion: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.