Gene Expression Signature for Prediction of Golimumab Response in a Phase 2a Open-label Trial of Patients With Ulcerative Colitis

Golimumab, a tumor necrosis factor (TNF) antagonist, is an effective treatment for patients with moderate-to-severe ulcerative colitis (UC). However, more than 50% of initial responders lose their response to the drug within the first year of therapy. A gene expression signature identified in colon biopsies collected before treatment was associated with response to infliximab, and was subsequently refined to associate with mucosal healing in response to golimumab. We performed a phase 2a open label study of 103 golimumab-treated patients with moderate-to-severe UC to test whether the baseline gene expression signature could be used to predict which patients would achieve mucosal healing, clinical response, and clinical remission at weeks 6 and 30 of treatment.

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