Real-world Pattern of Biologic Use in Patients With Inflammatory Bowel Disease: Treatment Persistence, Switching, and Importance of Concurrent Immunosuppressive Therapy

Abstract

Background and aims Medication persistence, defined as the time from drug initiation to discontinuation of therapy, has been suggested as a proxy for real-world therapeutic benefit and safety. This study seeks to compare the persistence of biologic drugs among patients with inflammatory bowel disease (IBD). Methods Patients with newly diagnosed IBD were included in a retrospective study using Truven MarketScan database. Treatment persistence and switching was compared among biologic medications including infliximab, adalimumab, certolizumab, golimumab, and vedolizumab. Predictors for discontinuation and switching were evaluated using time-dependent proportional hazard regression. Results In total, 5612 patients with Crohn’s disease (CD) and 3533 patients with ulcerative colitis (UC) were included in this analysis. Less than half of the patients continued using their initial biologic treatment after 1 year (48.48% in CD cohort; 44.78% in UC cohort). In the first year, adalimumab had the highest persistence and lowest switching rates for both CD (median survival time: 1.04 years) and UC (median survival time: 0.84 years). In subsequent years, infliximab users were more likely to persist in the use of biologic. Combination therapy with immunomodulators significantly decreased the risk of discontinuation, especially when immunomodulator therapy was started more than 30 days before the biologic (hazard ratio [HR], 0.22; CI, 0.16, 0.32). The major predictors for noncompliance included infection and hospitalization. Conclusion Overall, the persistence profiles of biologics suggest a high rate of dissatisfaction or adverse disease outcomes resulting in discontinuation and switching to a different agent. Early initiation of immunomodulators will substantially increase the persistence of biologic treatment.

Persistence, Dose Titration, and Health Care Resource Utilization Among Crohn’s Disease Patients Treated With Ustekinumab: A Real-World Analysis in the United States

“…A realworld study of TNF-inhibitors (ADA, CZP, IFX) reported that 38-45% of CD patients discontinued their anti-TNF therapy within 12 months [19]. Another recently published real-world study reported that only 48.5% of the CD [34]. The present UST study found that most CD patients were persistent, and 83.6% remained persistent 1 year after initiation of UST.…”

“…Further studies comparing UST to other biologics are needed to assess persistence rates over more extended follow-up periods. The most common reasons for discontinuation of biologic treatment among CD patients include disease progression, loss of response, and infection events [34]. The high real-world persistence we found in the current study suggests effectiveness of UST 1 year after initiation.…”

Editorial: calcineurin inhibitors as a bridge to vedolizumab for severe ulcerative colitis

“…Vedolizumab was discontinued in 72% at 2 years. This is consistent with large real‐world data for other biologics . In this refractory population, the majority of discontinuation is explained by need for colectomy.…”

Impact of immunomodulator use on treatment persistence in patients with ulcerative colitis: A claims database analysis

“…As the analysis focused on persistence during maintenance in patients who had completed the induction phase of biologic therapy without switching or discontinuing treatment, differences in the duration of induction between the two biologics were not considered to be relevant. [27][28][29][30][31][32][33] The risk of hospitalization would not be expected to increase in the combination subgroups given that there were no significant differences in treatment persistence among the three subgroups. 25,26 Our results indicate that in UC, step-up from a single-agent IM to biologic/IM combination treatment (in the Bio + prior IM subgroup) may be better maintained over the long term than biologic monotherapy if infliximab is chosen.…”

“…These findings are consistent with previous data. [27][28][29][30][31][32][33] The risk of hospitalization would not be expected to increase in the combination subgroups given that there were no significant differences in treatment persistence among the three subgroups. A previous US claims analysis has shown an increase in hospitalizations for UC patients without therapeutic persistence to infliximab.…”