P658 Comparative Efficacy and Safety of Upadacitinib Versus Tofacitinib as Induction Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: A Matching-Adjusted Indirect Comparison

Abstract Background Upadacitinib (UPA) and tofacitinib (TOFA) are Janus kinase (JAK) inhibitors approved for the treatment of patients (pts) with moderately to severely active ulcerative colitis (UC), but evidence on their comparative efficacy safety is limited. This study conducted a placebo (PBO)-anchored matching-adjusted indirect comparison (MAIC) induction outcomes between UPA TOFA. Methods Pts received oral 45 mg once daily or PBO 8 weeks in phase 3 studies U-ACHIEVE Induction (NCT02819635) U-ACCOMPLISH (NCT03653026), TOFA 10 twice OCTAVE 1 2 trials (NCT01458951, NCT01465763). MAIC was bio-naïve bio-failure pts. These included clinical remission per full Mayo score (FMS; FMS ≤2 no subscore >1), response (decrease from baseline ≥3 points ≥30%, decrease rectal bleeding [RBS] ≥1 an absolute RBS 0 1), endoscopic improvement (EI; [ES] 1). The overall population used assess (ER; ES 0) including any adverse events (AEs), serious AEs (SAEs) discontinuation (DC) due AEs. Baseline characteristics age, gender, extent duration disease, FMS, corticosteroid use were weighted match reported pts primary outcomes, plus weight, C-reactive protein, haemoglobin ER outcomes. Numbers needed treat/harm (NNT/NNH) calculated as inverse difference proportions achieving efficacy/safety Results data 961 977 ER/safety respectively, 1,139 A greater proportion receiving vs groups achieved remission, response, EI (p <0.05, Table PBO-adjusted differences 14.6%, 23.0%, 25.1%, 8.5%, 27.7%, 14.3% bio-failed also higher (8.6% difference, p < 0.001). SAEs not statistically different pts, DC lower 0.05, 2). NNT/NNH analysis showed favorable benefit-risk profile Conclusion UC similar during compared based MAIC, suggesting JAK class.