Most patients with ulcerative colitis treated with ustekinumab who enter the maintenance phase after 12 months remain persistent to the treatment.

A team, led by Maryia Zhdanava, Analysis Group, described the real-world persistence of ustekinumab among patients with ulcerative colitis attaining the maintenance phase.

Treatment of Ulcerative Colitis

Biologics and small molecule therapies have proven top efficacy in controlling disease activity in patients with ulcerative colitis.

In the study, presented during the Crohn’s and Colitis Congress 2023 in Denver, the investigators examined data from 778 patients with ulcerative colitis from the Komodo Health’s comprehensive dataset for first claims of ustekinumab between October 10, 2019 and August 13, 2021. Patients had at least 12 months of continuous insurance eligible prior to the index date with at least 1 claim of a diagnosis of ulcerative colitis at baseline or on the index date.

The participants also persisted with ulcerative colitis to their first subcutaneous ustekinumab claim.

The investigators defined persistence to ustekinumab as the absence of a therapy exposure gap of greater than 120 days between days of supply or the end of follow-up. The team sought composite endpoints of persistence while being corticosteroid-free and persistence while on a monotherapy. The persistence endpoints were described following the maintenance phase until the earlier of 12 months, the end of insurance eligibility, or data.

They also assessed persistence outcomes in all patients and specifically in patients without prior biologic/advanced therapy exposure using Kaplan-Meier curves.

The Assessment

Of the 778 patients included in the trial, 30.3% (n = 236) were bio-naïve. The mean follow-up time was 13.5 months overall, but 12.7 months for the bio-naïve patient population.

At the 12 month maintenance mark, 73.2% of the entire study and 75.5% of bio-naïve were persistent to ustekinumab.

The results also show of the patients who were persistent and corticosteroid-free between the index data and the start of the maintenance phase, 47% of all patients and 55.1% of bio-naïve patients remained persistent and corticosteroid-free 12 months following their first maintenance claim.

The subanalysis of patients who were persistent on monotherapy at the beginning of the maintenance phase showed that 63.6% of all patients and 68.1% of bio-naïve patients remained persistent on monotherapy at 12 months.

“In this study, 12 months after their first ustekinumab maintenance claim for UC, most patients who attained the maintenance phase were persistent to treatment, around half of patients who were also corticosteroid-free at the start of the maintenance phase remained persistent and corticosteroid-free, and most patients who were persistent on monotherapy at the start of the maintenance phase remained persistent on monotherapy,” the authors wrote.

The study, “REAL-WORLD USTEKINUMAB PERSISTENCE IN PATIENTS WITH ULCERATIVE COLITIS ATTAINING THE MAINTENANCE PHASE,” was published online by the Crohn’s and Colitis Congress.