THU0168 A MATCHING-ADJUSTED INDIRECT COMPARISON (MAIC) OF UPADACITINIB VERSUS TOFACITINIB IN CSDMARD-IR PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS (RA)

Christopher Edwards,Patrick Tang,Jordan Cammarota,Ella Du,Ruta Sawant,Alan Friedman,Vishvas Garg,Keith Betts

doi:10.1136/annrheumdis-2019-eular.7189

Christopher Edwards, Patrick Tang + Show 6 more

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https://doi.org/10.1136/annrheumdis-2019-eular.7189

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Abstract

Background Upadacitinib (UPA), a JAK1 selective inhibitor, is being investigated as monotherapy and combination therapy with DMARDs for the treatment of moderate-to-severe RA. To date, no head-to-head trials have compared the effectiveness of UPA with tofacitinib (TOFA). Objectives To compare the efficacy of UPA 15 mg monotherapy and combination therapy with TOFA 5 mg combination therapy using MAICs. Methods Two MAICs were conducted. MAIC is an indirect comparison technique that utilizes individual patient data (IPD) for one treatment and aggregate data for the other treatment to provide comparative evidence after balancing differences in patient characteristics. The first MAIC used IPD from the SELECT-MONOTHERAPY trial of UPA monotherapy vs. methotrexate (MTX) and published data from the Oral Standard trial1 of TOFA+MTX vs. MTX. The second used IPD from the SELECT-COMPARE trial of UPA+MTX vs. adalimumab (ADA)+MTX and published data from the ORAL Strategy trial2 of TOFA+MTX vs. ADA+MTX. UPA monotherapy was not compared to TOFA monotherapy based on feasibility analysis and trial selection criteria. Patients in the UPA trials were re-weighted based on age, gender, race, swollen joint count 66/28, tender joint count 68/28, C-reactive protein (CRP), and patient’s global assessment, to match the baseline characteristics in each comparator trial. After matching, ACR20/50/70 and clinical remission (SDAI(CRP)≤3.3, CDAI≤2.8, DAS28-ESR/CRP Results After matching, baseline characteristics were balanced across the trial populations. At month 3, UPA monotherapy patients experienced significantly greater improvement in ACR70 compared to TOFA+MTX with a mean difference in difference (DD) of 9.9% (p Conclusion The results from MAICs indicate that treatment with UPA 15 mg when used as monotherapy or in combination with MTX appears to produce improved outcomes at 3/6 months as compared to TOFA 5 mg+MTX (mono: ACR70 and combination: ACR50, SDAI, CDAI and DAS28-ESR remission).

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