Changes in Patient-Reported Outcomes With Vedolizumab Therapy in Patients With Inflammatory Bowel Diseases (IBD)

Abstract

Introduction: Patient-reported outcomes (PROs) are important measures to assess response in patients with IBD. Vedolizumab (VDZ) is a gut-selective monoclonal antibody that specifically binds α 4β7 integrin and blocks gut lymphocyte trafficking, and is approved for use in moderate to severe Crohn's disease (CD) and ulcerative colitis (UC) patients who are naïve or have previously been exposed to tumor necrosis factor antagonists (anti-TNFs). Less is known about the real-world experience of patients on VDZ for changes in PROs. Methods: We performed a prospective cohort study investigating changes in PROs within the CCFA Partners cohort. All patients with CD or UC initiating VDZ from 2014 to present who had at least 6 months of follow-up were included. We stratified by biologic anti-TNF naïve (BN) or biologic anti-TNF exposed (BE) status. Outcomes included the short inflammatory bowel diseases questionnaire (SIBDQ); PRO measurement information system (PROMIS) assessing anxiety, depression, fatigue, social satisfaction, sleep disturbance, and pain interference; and the short CD activity index (sCDAI) as a measure of clinical remission. Bivariate analyses were performed to describe differences by BN or BE status; PRO changes were analyzed. Results: VDZ was initiated in 348 patients with CD and 169 with UC. The majority of CD (54%) and UC patients (65%) were managed in private practice settings (Table 1). A total of 20 (6%) CD patients and 32 (19%) UC patients were BN. CD patients who were BE had higher rates of prior surgery (67%) than BN patients (37%, p=0.01); BE UC patients had higher rates of prior hospitalization (72%) than BN patients (28%, p < 0.01). In the overall IBD population, corticosteroid-free remission (CSFR) rates as defined by sCDAI at 6-12 months improved from 20% to 45% in BN patients (difference 25%, p=0.03) vs improvement of 24% to 30% in BE patients (difference 6%, p=0.13). BN patients experienced greater improvements in PROs than BE patients, with significant improvement in social satisfaction (p=0.03) (Table 2). Multiple PRO domains met minimally clinically important differences at follow-up for BN patients.Table: No Caption availableTable: No Caption availableConclusion: VDZ was predominantly used in individuals with prior BE in this real-world cohort. CSFR rates and social satisfaction were significantly improved in BN patients after VDZ. Trends toward minimally clinically important differences in multiple additional PRO domains were also noted in BN patients.