Comparison of the Persistence of Anti-TNF Agents and Ustekinumab in Patients with Crohn’s Disease: A Study Based on the Korean National Database

Abstract

Background: Biologics play an important role in the treatment of moderate to severe Crohn’s disease (CD). Ustekinumab was approved for such patients in the Republic of Korea on 1 December 2018. Therefore, we need to compare the efficacy of ustekinumab and anti-TNF inhibitors. Methods: We compared one-year persistence rates between anti-TNF inhibitors and ustekinumab in moderate-to-severe CD patients using Korean National Health Insurance Service data from 1 December 2016 to 30 November 2021. We also analysed the risk factors for the non-persistence of biologics. Results: The one-year persistence rates with index therapy in bio-naïve and bio-experienced patients were 87.7% and 69.7% for infliximab (p < 0.001), 85.1% and 72.8% for adalimumab (p < 0.001), and 92.1% and 89.8% for ustekinumab (p = 0.333), respectively. The risk factors for non-persistence were older age, non-use of an immune modulator, and previous biologic exposure in both the infliximab and adalimumab groups. The one-year persistence rate of ustekinumab was higher than that of anti-TNF inhibitors in bio-naïve patients (hazard ratio [HR] 0.53; 95% confidence interval [CI] 0.35–0.81; p = 0.003) and bio-experienced patients (HR 0.32; 95% CI 0.22–0.45; p < 0.001). Conclusions: Ustekinumab was superior in bio-naïve CD patients compared to anti-TNF inhibitors. However, the follow-up time was relatively short; further studies should continuously collect and analyse data.