Treatment Persistence Among Anti-TNF-Experienced Patients With Ulcerative Colitis Switching to Ustekinumab or Cycling to Another Anti-TNF Agent
AIBD 2023
Background:
Anti-TNF agents are often used as first-line biologic therapy in ulcerative colitis (UC). If the initial anti-TNF fails, switching to a different class of biologics or cycling to another anti-TNF agent may be necessary. Ustekinumab is a recently approved anti-interleukin 12/23 antibody for treatment of UC. This study compared real-world persistence in anti-TNF-experienced patients with UC who switched to ustekinumab or cycled to another anti-TNF agent.
Methods:
Adults with UC that discontinued treatment with an anti-TNF, and then switched to ustekinumab or cycled to another anti-TNF (index date) between 10/21/2019 and 03/02/2022 were selected from the IQVIA PharMetrics® Plus database. Patients had ≥12 months of continuous insurance eligibility before the first observed 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 was defined as no therapy gaps of >120 days (ustekinumab, infliximab) or >60 days (adalimumab, golimumab) between days of supply. Composite endpoints were persistence while on monotherapy (no immunomodulators/non-index biologics/advanced therapies) and persistence while being corticosteroid-free (< 14 consecutive days of corticosteroids supply after day 90 post-index). Endpoints were assessed at 12 months after the maintenance phase start using weighted Kaplan-Meier analyses and weighted Cox proportional hazards models adjusted for baseline gastroesophageal reflux disease, anal/rectum hemorrhage, and the baseline anti-TNF agent.
Results:
After weighting, there were 182 patients who switched to ustekinumab (mean age: 40.9; 47.4% female) and 129 patients who cycled to a different anti-TNF (mean age: 40.8; 47.7% female). In the cycle cohort, the index agent cycled to was infliximab for 53.3%, adalimumab for 40.1% and golimumab for 6.6%. At 12 months after maintenance phase start, 78.7% of the switch cohort and 63.8% of the cycle cohort persisted on the index biologic; persistence was 2.11 times higher in the switch cohort versus the cycle cohort (hazard ratio [HR]: 2.11; 95% confidence interval [CI]: 1.29-3.47; p-value: 0.0031). Moreover, 73.9% of the switch cohort and 49.1% of the cycle cohort persisted on the index biologic while on monotherapy; persistence while on monotherapy was 2.40 times higher in the switch cohort versus the cycle cohort (HR: 2.40; 95% CI: 1.57-3.65; p-value: < 0.001). Finally, 57.0% of the switch cohort and 48.3% of the cycle cohort were persistent and corticosteroid-free; the rate of being persistent and corticosteroid-free trended 31% higher in the switch cohort relative to the cycle cohort but was not statistically significant (HR: 1.31; 95% CI: 0.90-1.89; p-value 0.1607).
Conclusions:
After discontinuation of an anti-TNF, persistence on biologic therapy was better among patients with UC who switched to ustekinumab compared to those who cycled to a different anti-TNF. These findings may inform treatment strategies for patients on the first anti-TNF agent who require treatment adjustment.
