S17 Treatment Patterns Among Moderate-to-Severe Ulcerative Colitis Patients in TARGET-IBD

Abstract

Background: The treatment paradigm for Ulcerative Colitis (UC) is becoming increasingly complex with more treatment options available. There is a growing need to discern patterns of UC treatments in real-world settings. The objectives of this study were to identify a real-world moderate-to-severe UC patient population and estimate the risk of treatment modification (i.e. drug switching, dose escalation, treatment augmentation) among patients initiating advanced or conventional therapies. Methods: TARGET-IBD, a non-interventional cohort of IBD patients enrolled from one of 34 participating academic and community-based gastroenterology US sites, was used to identify the study population. Enrolled patients consented to the collection of up to 3 years of retrospective and 5 years prospective data. Patients were considered moderate to severe if they were ever hospitalized due to UC, received advanced treatments (biologics or Janus kinase inhibitor [JAKi]), an immunomodulator (IMM), or took corticosteroids for >2 months of the year prior to enrollment. To assess treatment modification, patients had to initiate an advanced treatment, or conventional therapy (IMM and 5-aminosalicylic acids) 3 years prior to or after enrollment and have a follow-up duration of at least 1 day. The incidence proportion was defined as the number of patients that experienced a treatment modification in the study period divided by the number of patients at risk. Kaplan Meier curves and cumulative incidence functions were produced for both treatment classes. Fine Gray sub-distribution hazard regression models were used to estimate the unadjusted and multivariable-adjusted hazard rate ratios for treatment modification, with 95% confidence intervals. Results: Out of 1,854 adult UC patients enrolled in TARGET-IBD, 1,332 patients met criteria for moderate to severe UC, of which 1,096 (82%) used an advanced treatment by the date of enrollment. Compared to patients on conventional therapies, patients on advanced treatments were younger (39 vs 50 years old), less likely to be on Medicare (11.6% vs 18.6%), and disproportionately treated at academic sites (70% vs 56%). A total of 660 patients initiated advanced (n=366, 55.5%) or conventional (n=294, 44.5%) therapy during the observation periods and were evaluated for treatment modification. The incidence proportion of treatment modification was lower in patients with advanced treatment compared patients with conventional therapy [47.6% (95% CI = 41.3, 53.8) vs 64.8% (95% CI = 58.3, 71.2), respectively]. Kaplan Meier curve showed that the probability of treatment modification increased with time on treatment for both groups, but was significantly more likely for patients on conventional therapies (median survival = 11.3, 95% CI = 8.80, 13.19) compared to that of patients on advanced treatments (median survival = 13.0, 95% CI = 9.72, 16.90). Both univariate and multivariable models showed that use of an advanced treatment was associated with decreased likelihood of treatment modification (HR = 0.73, 95% CI = 0.56, 0.95). Conclusion(s): In this large, real-world cohort analysis, moderate-to-severe UC patients initiating advanced treatments were significantly less likely to experience treatment modifications than those receiving conventional therapies. This study highlights the importance of therapy selection for patients with moderate-to-severe UC and the need for additional, more efficacious, and durable treatments.