Outcomes of Patients With Prior Biologic Intolerance Are Better Than Those With Biologic Failure in Clinical Trials of Inflammatory Bowel Disease.

ABSTRACT:

Background and aims

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 vs intolerance treated with ustekinumab or vedolizumab.

Methods

A post-hoc analysis of ulcerative colitis (UC) and Crohn's disease (CD) clinical trials for ustekinumab (UNITI and UNIFI) and vedolizumab (GEMINI-1 and 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.

Results

A total of 1178 UC and 143

SUBMITTER: Samnani S 

PROVIDER: S-EPMC11945295 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature