S770 Health-Related Quality of Life With Ustekinumab vs Adalimumab for Induction and Maintenance Therapy in Biologic-Naïve Patients With Moderate-To-Severe Crohn’s Disease: IBDQ in the SEAVUE Study

Introduction: Crohn’s disease (CD) impacts physical and mental well-being, which can negatively affect health-related quality of life (HRQoL). The Inflammatory Bowel Disease Questionnaire (IBDQ), a disease-specific measure of HRQoL, was used to assess the effects of ustekinumab (UST) and adalimumab (ADA) on HRQoL in biologic-naïve patients with CD enrolled in the SEAVUE study. Methods: SEAVUE was a multicenter, randomized, blinded, parallel-group, active-controlled study in biologic-naïve adults with CD Activity Index (CDAI) scores ≥220/≤450. Patients were randomized 1:1 to UST (∼6mg/kg IV at baseline then 90mg SC every 8 weeks) or ADA (160/80mg SC at baseline/Week 2, then 40mg SC every 2 weeks) per US-approved regimens. Dose modification was not allowed. Using the IBDQ, which includes an overall score and 4 dimension scores (bowel symptoms, systemic symptoms, emotional function, and social function), we evaluated improvement in HRQoL from baseline through 1 year in these patients. Results: Among 386 patients randomized to UST or ADA, baseline demographics and disease characteristics were balanced between groups (median CD duration, 2.58 years; CDAI, 289.5; Simple Endoscopic Score for CD, 8.0). Baseline mean [standard deviation] IBDQ scores were similar between the treatment groups (IBDQ: 116.6 [30.7] UST, 121.9 [31.6] ADA; bowel symptoms: 37.4 [9.6] UST, 39.2 [9.5] ADA; emotional function: 44.0 [13.0] UST, 45.6 [13.3] ADA; systemic symptoms: 15.0 [5.1] UST, 16.1 [5.5] ADA; social function: 20.4 [7.4] UST, 20.9 [7.7] ADA). In both groups, improvements in the overall IBDQ and dimension scores were observed as early as Week 8 (data not shown) and increased through Week 52 (Table 1). At Week 52, mean improvement from baseline in overall IBDQ score was 50 points with UST and 43 points with ADA, and a ≥16-point improvement from baseline in IBDQ score was achieved by 67% of patients in the UST group and 63% of patients in the ADA group. Conclusion: UST and ADA similarly improved the IBDQ overall and dimension scores through Week 52 in biologic-naïve patients with moderate-to-severe CD. These results are consistent with those previously reported in biologic-naïve patients with CD1 or ulcerative colitis2 and provide further evidence of the benefit of effective treatment in improving the HRQoL of patients with inflammatory bowel disease.Table 1

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