Dose Escalation of Biologics in Biologic-Naïve Patients With Ulcerative Colitis: Outcomes From the ODESSA-UC Study.

Background: Dose escalation of biologics may regain treatment response in patients with ulcerative colitis (UC). However, dose escalation rates and associated outcomes and costs are not well characterized in biologic-naïve patients receiving antitumor necrosis factor-alpha (anti-TNF-α) treatments, such as infliximab or adalimumab or vedolizumab. Methods: ODESSA-UC, a retrospective cohort study investigating dose escalation in patients with UC who had received first-line biologics, used data from IBM MarketScan databases. Adults with UC and ≥1 claim for an index drug (adalimumab, infliximab, or vedolizumab) were eligible. A Cox proportional hazards model was used to evaluate the adjusted rate of dose escalation. Logistic regression was used to evaluate the odds of experiencing adverse outcomes (corticosteroid use, infection, sepsis, or inflammatory bowel disease-related hospitalization) and incurring index drug costs. Results: A year after the start of maintenance, a lower proportion of patients experienced dose escalation with vedolizumab (22.3%) than adalimumab (43.0%). The dose escalation risk was significantly higher for infliximab (hazard ratio [HR], 1.894; 95% confidence interval [CI], 1.486-2.413) and adalimumab (HR, 2.120; 95% CI, 1.680-2.675) than for vedolizumab. The odds of experiencing an adverse outcome after dose escalation were higher for anti-TNF-α treatments than for vedolizumab (odds ratio, 2.052; 95% CI, 1.200-3.507). Index drug costs after dose escalation were lowest for vedolizumab. Conclusions: Patients with UC receiving vedolizumab had a lower risk of dose escalation and lower subsequent costs than patients receiving anti-TNF-α treatments. Our study demonstrates the possible clinical and economic implications of dose escalation.