P2645 - TNFi Cyclers vs MOA Switchers in a Real-World Population of TNFi-Experienced Patients with Ulcerative Colitis: A Propensity Score Adjusted Analysis

Navneet Upadhyay, MS, PhD¹, Amita Ketkar, PhD², Can Mert, MS³, Alexandra Wallem, PharmD¹, Simin K Baygani, MS¹, Tariku J Beyene, PhD², Deborah A. Fisher, MD, MHS⁴, Tracey Quimbo, MPH², Raven Perez, MPH², Taylor Tassoul, BS², Michael Grabner, PhD², Casey Chapman, MD^5
1Eli Lilly and Company, Indianapolis, IN; ²Carelon Research, Wilmington, DE; ³HaaPACS GmbH, Schriesheim, Baden-Wurttemberg, Germany; ⁴Eli Lilly and Company, Raleigh, NC; ⁵GI Alliance, Baton Rouge, LA

Introduction: Tumor Necrosis Factor Inhibitors (TNFi) are widely used as first-line (1L) advanced therapy for ulcerative colitis (UC). Patients with inadequate response (IR) to the initial TNFi may switch to a different TNFi (TNFi Cyclers) or a non-TNFi (mechanism-of-action [MOA] switchers). To address limited existing evidence, this study compared the real-world outcomes of 2L TNFi vs. non-TNFi initiation among patients with UC who had received 1L TNFi therapy.

Methods: We included adult patients with ≥2 claims with ICD-10-CM diagnoses for UC from the Healthcare Integrated Research Database (HIRD®) between 01/01/2015 and 06/30/2022. 1L TNFi users were identified by ≥1 medical or pharmacy claim for a TNFi approved for UC. The start of 2L therapy (“index date”) was identified by ≥1 claim for a TNFi approved for UC that is different than 1L advanced therapy, or ≥1 claim for non-TNFi approved for UC, between 1L end date and end of study period. The main study outcome was IR to treatment, a composite outcome of: switch/add alternative advanced therapy, augment with conventional therapy, dose escalation, glucocorticoid IV use or increase in oral dosage, UC-related hospitalization, and UC-related surgeries. We used multivariable logistic regression with trimmed inverse probability treatment weighting (IPTW) to calculate the odds of IR in 2L TNFi cyclers vs MOA switchers. Multivariable adjusted Cox Proportional Hazard models were used to assess the hazards of each individual IR criterion.

Results: A total of 933 2L patients were included in the study, 45.2% female, median age of 42 years. For the weighted cohorts (2L TNFi N=281, 2L non-TNFi N=640), the IR rates for the TNFi and non-TNFi groups were 61.9% and 49.4%, respectively (Table 1). Based on the multivariable regression model, patients who received 2L TNFi had statistically significant higher odds of IR compared to those who received non-TNFi as 2L (OR 1.76, 95% CI: 1.31-2.37, p< 0.01). IR was most often due to switch or initiation of non-index advanced therapy (30% for 2L TNFi, 15% for 2L non-TNFi). Mean time to IR among patients with IR at 1 year was 139 days (TNFi) and 150 days (non-TNFi) with adjusted hazard ratio 1.48 (95% CI: 1.23-1.79, p< 0.01).

Discussion: Study results suggest that patients with UC who initially were treated with a TNFi as 1L advanced therapy have higher odds of an inadequate response when they subsequently use a second TNFi therapy. In contrast, switching to an alternate MOA as a 2L therapy yields better clinical outcomes.


Disclosures:


Navneet Upadhyay, MS, PhD¹, Amita Ketkar, PhD², Can Mert, MS³, Alexandra Wallem, PharmD¹, Simin K Baygani, MS¹, Tariku J Beyene, PhD², Deborah A. Fisher, MD, MHS⁴, Tracey Quimbo, MPH², Raven Perez, MPH², Taylor Tassoul, BS², Michael Grabner, PhD², Casey Chapman, MD⁵. P2645 - TNFi Cyclers vs MOA Switchers in a Real-World Population of TNFi-Experienced Patients with Ulcerative Colitis: A Propensity Score Adjusted Analysis, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.