# A91 OUTCOMES OF PATIENTS WITH PRIOR BIOLOGIC INTOLERANCE ARE BETTER THAN THOSE WITH BIOLOGIC FAILURE IN CLINICAL TRIALS OF INFLAMMATORY BOWEL DISEASE

## TL;DR

Patients with biologic intolerance had better outcomes than those with biologic failure in IBD trials, especially in ulcerative colitis.

## Contribution

The study shows that biologic intolerance is associated with better treatment outcomes compared to biologic failure in IBD.

## Key findings

- Biologic-intolerant UC patients had higher clinical response, remission, and endoscopic improvement than biologic-failure patients.
- In CD, biologic intolerance was linked to higher odds of clinical response after adjusting for confounders.
- Outcomes for biologic-intolerant UC patients were similar to biologic-naïve patients.

## Abstract

Inflammatory bowel disease (IBD) trials often stratify patients by prior biologic exposure, including prior biologic failure or intolerance.

This study aimed to assess clinical outcomes in IBD patients with prior biologic failure versus intolerance treated with ustekinumab or vedolizumab.

A post-hoc analysis of ulcerative colitis (UC) and Crohn’s disease (CD) clinical trials for ustekinumab (UNITI, UNIFI) and vedolizumab (GEMINI-1, GEMINI-2) was performed. Clinical response, clinical remission, and endoscopic improvement (for UC) were compared among biologic naïve, biologic-failure, and biologic intolerant patients. Statistical analyses, including chi-square tests and logistic regression, were performed.

1178 UC and 1439 CD patients received either ustekinumab or vedolizumab. In UC, biologic intolerant patients exhibited higher clinical response (54.7% vs. 38.8%, aOR 1.87 [95% CI 0.93-3.73]), clinical remission (25.0% vs. 11.0%, aOR 2.84 [95% CI 1.47-5.49]), and endoscopic improvement (40.6% vs. 24.8%, aOR 2.76 [95% CI 1.28-5.94]) compared to biologic failure, with outcomes similar to biologic naïve patients. In biologic-intolerant CD patients, clinical response was similar between prior biologic failure and intolerance (34.2% vs 32.8%), but after adjustment for potential confounders, biologic intolerance was associated with higher odds of clinical response (aOR: 1.67, 95% CI 1.09-2.55), with no significant difference observed for clinical remission (aOR: 1.48, 95% CI 0.88-2.49).

Improved treatment outcomes were generally observed in patients with biologic intolerance compared to failure, especially in UC, where outcomes were similar to biologic naïve patients. Future clinical trials should meticulously differentiate prior biologic failure versus intolerance to mitigate potential bias.

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