Inflamm Bowel Dis. 2023 Sep 1;29(9):1421-1430. doi: 10.1093/ibd/izac260.

Julian Panés ¹, Edward V Loftus ², Peter D R Higgins ³, James O Lindsay ⁴, Wen Zhou ⁵, Xuan Yao ⁵, Dapo Ilo ⁵, Charles Phillips ⁵, Jacinda Tran ⁶, Yuri Sanchez Gonzalez ⁵, Séverine Vermeire ⁷

Author information

¹Inflammatory Bowel Disease Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.

²Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.

³Department of Medicine, University of Michigan, Ann Arbor, MI, USA.

⁴Department of Gastroenterology, Royal London Hospital, Barts Health NHS Trust, London, United Kingdom.

⁵AbbVie Inc, North Chicago, IL, USA.

⁶AbbVie and the Comparative Health Outcomes, Policy, and Economics Institute, University of Washington, Seattle, WA, USA.

⁷Department of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.

Abstract

Background: We evaluated the health-related quality of life (HRQoL) benefits of upadacitinib (UPA) induction and maintenance treatment in a phase 3 study of patients with ulcerative colitis (UC) across a broad range of patient-centered outcomes.

Methods: Patients received UPA 45 mg once daily or placebo as induction treatment for 8 weeks. Patients who achieved clinical response were rerandomized to receive once daily UPA 15 mg, 30 mg, or placebo as maintenance treatment for 52 weeks. The percentages of patients reporting a clinically meaningful within-person change from baseline in the Ulcerative Colitis Symptoms Questionnaire, Inflammatory Bowel Disease Questionnaire, Work Productivity and Impairment Questionnaire, 36-Item Short Form Survey, and European Quality of Life-5 Dimension 5 Levels were evaluated at weeks 2 and 8 of induction and at weeks 0 and 52 of maintenance.

Results: Significant improvements from baseline in all HRQoL measures except the Work Productivity and Impairment Questionnaire-absenteeism were achieved with UPA (P < .001) vs placebo as early as week 2 of induction. These improvements were sustained at week 52 with significantly more patients treated with either 15 mg or 30 mg UPA vs placebo achieving meaningful within-person change in the Ulcerative Colitis Symptoms Questionnaire; Inflammatory Bowel Disease Questionnaire; overall work impairment, presenteeism, and activity impairment; both 36-Item Short Form Survey Physical and Mental Component Summaries; and European Quality of Life-5 Dimension 5 Levels (P < .001).

Conclusions: Induction treatment with UPA 45 mg significantly improved HRQoL measures. A significantly higher percentage of patients who responded to induction treatment with UPA maintained clinically meaningful improvements consistently across a wide range of HRQoL outcomes after 52 weeks of maintenance therapy with UPA (15 mg and 30 mg) compared with placebo. (ClinicalTrials.gov, Numbers: NCT02819635, NCT03653026).