Bruce E. Sands, MD, FACG1, Chenglong Han, MD, PhD2, Christopher Gasink, MD3, Zou Bin, PhD4, Targan Stephen, MD5, William J. Sandborn, MD, FACG6, Brian G. Feagan, MD, MSc, FACG7
1Icahn School of Medicine at Mount Sinai, New York, NY; 2Janssen Global Services, LLC, Malvern, PA; 3Janssen Scientific Affairs, LLC, Horsham, PA; 4Janssen Research & Development, LLC, Spring House, PA; 5Cedars-Sinai Medical Center, Los Angeles, CA; 6University of California San Diego, La Jolla, CA; 7Robarts Clinical Trials, London, ON, Canada
Introduction: The IM-UNITI study evaluated the safety and efficacy of subcutaneous (SC) ustekinumab (UST) maintenance therapy in patients with moderately to severely active Crohn’s disease (CD) who completed induction treatment with UST. Previously, we reported the effects of UST on health-related quality of life (HRQoL) through Wk44. Here, we evaluated HRQoL through Wk140 in patients who entered the long-term extension of the IM-UNITI study.
Methods: Patients who completed the safety and efficacy evaluation at Wk44 of the maintenance study were eligible to continue their regimen in the extension study (placebo [PBO], UST 90 mg q12w, or UST 90 mg q8w). All patients who were treated in the extension study were included in this analysis of Inflammatory Bowel Disease Questionnaire (IBDQ) and SF-36 data according to the treatment they received during the extension study. The IBDQ is a 32-item questionnaire with 4 dimensions: bowel symptoms, systemic symptoms, emotional function, and social function. The total score ranges from 32 to 224, higher scores indicate better quality of life, and a change ≥16 points was defined as clinically meaningful. For SF-36, a change ≥5 points was defined as clinically meaningful.
Results: For patients who entered the extension, mean total IBDQ scores and SF-36 scores at maintenance baseline were comparable across treatment groups (Table). Patients who received UST maintained the improvement in IBDQ and SF-36 that was achieved by maintenance baseline through Wk140, and those who received PBO generally worsened. Through Wk140, 26.5% of patients receiving PBO, 61.5% of patients receiving UST 90 mg q12w, and 59.3% of patients receiving UST 90 mg q8w had ≥16-point improvements from induction baseline in IBDQ score. In addition, 10.9%, 51.6%, and 54.2%, respectively, had ≥5-point improvements in SF-36 physical component summary scores, and 8.7%, 43.8%, and 43.7%, respectively, had ≥5-point improvements in SF-36 mental component summary scores during the same period.
Discussion: In patients who entered the long-term extension of the IM-UNITI study, those who received SC UST maintenance generally maintained improvements in IBDQ and SF-36 scores that were achieved through IV induction, and those who received PBO gradually lost these improvements.
Citation: Bruce E. Sands, MD, FACG; Chenglong Han, MD, PhD; Christopher Gasink, MD; Zou Bin, PhD; Targan Stephen, MD; William J. Sandborn, MD, FACG; Brian G. Feagan, MD, MSc, FACG. P0498 - USTEKINUMAB MAINTAINED CLINICALLY MEANINGFUL IMPROVEMENT IN HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH MODERATE TO SEVERE CROHN’S DISEASE: RESULTS FROM THE IM-UNITI LONG-TERM EXTENSION. Program No. P0498. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.