EARLY VERSUS DELAYED INITIATION OF VEDOLIZUMAB IN ULCERATIVE COLITIS: TREATMENT RESPONSE IN THE REAL WORLD (RALEE). (22nd January 2022)

• Record Type: Journal Article
• Authors: Cleveland, Noa; Candela, Ninfa; Carter, John; Kuharic, Maja; Qian, Joyce; Tang, Lily; Turpin, Robin; Rubin, David
• Is Part Of: Inflammatory bowel diseases. Volume 28(2022)Supplement 1
• Page Start: S105
• Page End: S106
• Publication Date: 2022-01-22
• Subjects: Inflammatory bowel diseases -- Periodicals; Colitis, Ulcerative -- Periodicals; Crohn Disease -- Periodicals; Inflammatory Bowel Diseases -- Periodicals; 616.344
• DOI: 10.1093/ibd/izac015.171
• Languages: English
• ISSNs: 1078-0998

Abstract

Abstract: BACKGROUND: Pivotal trials in ulcerative colitis (UC) have indicated that earlier intervention with a biologic is associated with greater likelihood of treatment response. However, in real-world clinical practice, patients with newly diagnosed UC are often prescribed conventional therapies, such as immunomodulators (IM), corticosteroids (CS), and/or 5-aminosalicylates (5-ASA) before biologic treatment, which may result in suboptimal clinical outcomes and high costs. RALEE is an observational study investigating the impact of early versus delayed initiation of vedolizumab (VDZ) on clinical and economic outcomes in patients with inflammatory bowel disease, using administrative data sets. Here, we report the impact on treatment response in patients with UC. METHODS: Using the MarketScan Commercial Claims and Encounters database and the MarketScan Medicare Supplemental database, we identified adult patients diagnosed with UC between 2017 and 2018 who had ≥ 1 claim for VDZ and continuous enrollment for ≥ 12 months before and after their initial UC diagnosis. Patients were excluded if they received VDZ, anti-tumor necrosis factor therapy, or other biologic therapy in the 12 months before their initial UC diagnosis. Five post-diagnosis treatment pathways were predefined: (1) EARLY VDZ, VDZ within 30 days of initial UC diagnosis; (2) DELAYED VDZ 1, IM (not 5-ASA) before VDZ; (3) DELAYED VDZ 2, CS with IM before VDZ; (4) DELAYED VDZ 3, 5-ASA with CS before VDZ; or (5) DELAYED VDZ 4, 5-ASA with CS and IM before VDZ. Response was defined as no occurrence of the following events within 60 days after VDZ initiation: new concomitant use of CS, inflammatory bowel disease-related surgery, increased administration of VDZ, VDZ treatment discontinuation, or treatment switch. Response was evaluated with logistic regression (backwards selection) with EARLY VDZ as the reference group. RESULTS: We identified 136, 315 patients with UC, of whom 1, 342 received VDZ and met the selection criteria. The median age of patients was 43 years; 51.0% of patients were male and 96.4% were commercially insured. The proportion of patients with response to VDZ was higher for EARLY VDZ (88.8%) than any of the DELAYED VDZ treatment pathways (70.1–79.8%) (Figure 1). Delayed initiation of VDZ (DELAYED VDZ 1, 2, and 4 ) was associated with a significantly lower likelihood of response than EARLY VDZ (Figure 2). CONCLUSION: This analysis demonstrates that patients with UC are more likely to respond to therapy if initiated on VDZ within 30 days of diagnosis than if initiation is delayed by use of IM, CS, and/or 5-ASA. These findings are consistent with clinical guidelines that recommend use of VDZ for induction of remission in patients with moderately to severely active UC. Further analyses of remission, healthcare resource utilization, and associated direct medical costs are underway.