S908 PRA023 Improved Health-Related Quality of Life as Measured by IBDQ-32 in a Phase 2 Trial in Patients with Moderately to Severely Active Ulcerative Colitis

Introduction: PRA023 is a humanized monoclonal antibody against tumor necrosis factor–like cytokine 1A (TL1A) in development for inflammatory bowel diseases. In ARTEMIS-UC, a phase 2, double-blind, placebo-controlled study of PRA023 in adults with moderately to severely active ulcerative colitis (UC), a significantly greater proportion of patients receiving PRA023 achieved clinical remission. This post hoc analysis assessed the impact of PRA023 on health-related quality of life using the Inflammatory Bowel Disease Questionnaire (IBDQ-32). Methods: Adults with a modified Mayo score of 4 to 9, centrally read endoscopy subscore of ≥2, rectal bleeding subscore of ≥1, and history of insufficient response, loss of response, and/or intolerance to conventional and/or advanced therapies were stratified by prior biologic exposure and genetic-based diagnostic status and randomized 1:1 to placebo or intravenous PRA023 (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10). IBDQ outcomes measures include IBDQ response (score of ≥16 points from baseline), IBDQ remission (total score ≥170), and mean change from baseline in total and domain scores after 12 weeks of induction therapy. Score changes from baseline were compared between treatment groups, and the impact of prior advanced therapy exposure on IBDQ remission was assessed. Results: Of 135 patients enrolled, 60/67 (89.6%) in the placebo arm and 68/68 (100%) in the PRA023 arm completed the 12-week induction period. Baseline characteristics were similar between the treatment groups. Significantly greater proportions of patients in the PRA023 group achieved IBDQ response (82.4% PRA023 vs 49.3% placebo, ∆33.1%, P< 0.0001) and IBDQ remission (51.5% PRA023 vs 19.4% placebo, ∆32.1%, P=0.0001) at week 12. Prior advanced therapy use did not affect the placebo-adjusted proportion of patients experiencing IBDQ remission in those who received PRA023 (Δ34.4% vs Δ30.0%, respectively, for prior and no prior advanced therapy). The total IBDQ score and all IBDQ domain subscores (bowel symptoms, systemic symptoms, emotional function, and social function) were significantly improved after 12 weeks of PRA023 induction treatment compared to placebo (Table 1). Conclusion: PRA023 significantly improved quality-of-life measures in patients with moderately to severely active UC, regardless of prior advanced therapy use. The greatest benefits were reported in the bowel symptoms and emotional function domains. Table 1. - IBDQ Outcomes with PRA023 Induction Therapy IBDQ outcomes Placebo PRA023 % Difference vs placebo (95% CI) P value IBDQ response (%, n/N)†‡ 49.3 (33/67) 82.4 (56/68) 33.1 (17.2–46.8) < 0.0001 IBDQ remission (%, n/N)‡ 19.4 (13/67) 51.5 (35/68) 32.1 (16.0–45.9) 0.0001 Prior advanced therapy 18.8 (6/32) 53.1 (17/32) 34.4 (10.9–53.1) - No prior advanced therapy 20.0 (7/35) 50.0 (18/36) 30.0 (7.8–48.4) - Change in IBDQ scores from BL, mean±SD Total score 20.8±37.59 48.6±34.85 26.8 (14.6–38.9) < 0.0001 Bowel symptoms subscore 7.1±12.27 17.2±11.79 9.4 (5.3–13.4) < 0.0001 Systemic symptoms subscore 3.0±5.97 7.0±6.56 4.0 (2.0–6.0) 0.0002 Emotional function subscore 6.6±14.59 16.1±13.25 8.9 (4.3–13.5) 0.0002 Social function subscore 4.1±7.74 8.2±7.38 4.4 (2.0–6.8) 0.0004 †Prespecified secondary endpoint.‡Nonresponder imputation was applied to response and remission endpoints.Abbreviations: BL, baseline; IBDQ, Inflammatory Bowel Disease Questionnaire. P values are nominal except IBDQ response.

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