Investigators Test Anti-TNF Therapies to Treat Ulcerative Colitis and Crohn

Andres Yarur, MD

Real world data is needed to better understand the clinical effectiveness of second-line (2L) anti-TNF treatment post first-line (1L; biologic-naive) vedolizumab (VDZ) and 1L anti-TNF use in patients with ulcerative colitis (UC) or Crohn’s disease (CD).

During the American College of Gastroenterology’s Annual Scientific Meeting (ACG 2019), a team of investigators presented data from a multi-country, multi-center retrospective study, led by Andres Yarur, MD, involved both ulcerative colitis and Crohn’s disease patients treated with 1 L anti-TNF or 2L anti-TNF after discontinuation of 1L vedolizumab for any reason between 2014-2018.

A total of 579 anti-TNF patients (1L: 497 [UC: 224; CD: 273]; 2L: 82 [UC: 58; CD: 24]) from 36 sites in Canada, Greece, and the US were included in the study. Anti-TNF therapies included adalimumab, infliximab, golimumab, and certolizumab pegol.

Proportions of patients in each cohort were: adalimumab (1L: 41.4%; 2L:19.5%), infliximab (1L: 52.7%; 2L: 79.3%), golimumab (1L: 4.8%; 2L: 1.2%), and certolizumab pegol (1L: .8%; 2L: 0.0%).

The index date was defined as the data of 1L treatment initiation.

The investigators collected data on the clinical effectiveness of the treatment from 1L or 2L treatment initiation to earliest of death, chart abstraction date. They also estimated the cumulative rates of treatment persistence, clinical response, and clinical remission using the Kaplan-Meier method for ulcerative colitis and Crohn’s disease—separately and combined—over 6 months.

Clinical response and remission were assessed using pre-defined hierarchical algorithms of standard disease measures reported in the medical records and P-values were generated using the log-rank test.

The investigators found that the cumulative rates of treatment persistence (1L: 83.9%; 2L: 83.6%), clinical response (1L: 49.5%; 2L: 65.6%) and clinical remission (1L: 29.5%; 2L: 31.4%), were similar between 1L and 2L patients at the 6-month mark.

The results were similar when the data was stratified by ulcerative colitis and Crohn’s disease. However, due to a small sample size, the investigators said larger studies are warranted in the future.

“Cumulative rates of [treatment] persistence, clinical response and clinical remission were comparable between 1L anti-TNF patients and those who switched to a 2L anti-TNF following the discontinuation of 1L VDZ,” the authors wrote. “Results suggest that 1L VDZ may not impact the effectiveness of subsequent anti-TNF [treatment] in real-world clinical practice.”

The study, “Clinical Effectiveness of First-Line Anti-TNF Therapies and Second-Line Anti-TNF Therapy Post-Vedolizumab Discontinuation in Patients With Ulcerative Colitis or Crohn’s Disease,” was presented Tuesday, October 29, 2019, at the American College of Gastroenterology Annual Scientific Meeting (ACG 2019) in San Antonio, Texas.