Treatment Persistence Among Anti-Tumor Necrosis Factor–experienced Patients With Ulcerative Colitis Switching to a Biologic With a Different Mode of Action or Cycling to Another Anti–Tumor Necrosis Factor Agent

Purpose

In ulcerative colitis (UC), anti–tumor necrosis factor (TNF) agents often are first-line biologic therapy. Switching to a biologic with a different mode of action (ustekinumab and vedolizumab) or cycling to another anti–TNF agent (adalimumab, infliximab, and golimumab) is necessary if an initial anti–TNF fails. This study compared real-world persistence in patients with UC who switched to a biologic with a different mode of action or cycled with another anti–TNF after nonresponse to an anti–TNF.

Methods

Adults with UC treated with an anti–TNF, who switched or cycled (index date) between October 21, 2019, and March 02, 2022, were selected from the IQVIA PharMetrics® Plus database. Patients had ≥12 months of continuous insurance eligibility before the first anti–TNF without UC-indicated biologics or advanced therapies. During the 12 months before the index date (baseline period), patients had no other immune disorders and discontinued the first anti–TNF. Baseline characteristics were balanced using inverse probability of treatment weights. Persistence on the index biologic was defined as no therapy exposure gaps >120 days (ustekinumab, vedolizumab, and infliximab) or >60 days (adalimumab and golimumab) between days of supply. Composite end points were persistence while corticosteroid-free (<14 consecutive days of corticosteroid supply after day 90 post-index) and persistence while on monotherapy (no immunomodulators/nonindex biologics/advanced therapies). End points were assessed with weighted Kaplan-Meier and Cox proportional hazards models 12 months after the maintenance phase started.

Findings

The switch cohort included 488 patients (mean age: 41.4 years; 44.9% female), and the cycle cohort included 129 patients (mean age: 40.7 years; 43.8% female). At 12 months after the maintenance phase started, the proportions of persistent patients (switch cohort: 79.6%; cycle cohort: 64.9%) and persistent patients on monotherapy (switch cohort: 74.6%; cycle cohort: 48.0%) were significantly higher in the switch versus cycle cohort; the proportions of persistent patients while corticosteroid-free was also higher in the switch (60.1%) versus cycle cohort (49.3%) but was not significant. In the switch cohort, the rate of persistence was 1.92 times higher (hazard ratio [HR] = 1.92; 95% CI, 1.31−2.82), the rate of persistence while on monotherapy was 2.56 times higher (HR = 2.56; 95% CI, 1.86−3.53), and the rate of persistence and being corticosteroid-free was 1.31 times higher (HR = 1.31; 95% CI, 0.98−1.77) than in the cycle cohort.

Implications

Patients with UC who switched from an anti–TNF agent to a biologic with a different mode of action were more persistent on treatment than patients who cycled to another anti–TNF agent. Findings may aid physicians whose patients experience treatment failure on the first anti–TNF agent.