Efficacy and Safety of Infliximab in Intestinal Behcet's Disease: A Multicenter, Phase 3 Study (BEGIN).

ABSTRACT:

Background/aims

To date, there is no prospective study that specifically investigated the efficacy of infliximab in intestinal Behçet's disease (BD). This study evaluated the efficacy of infliximab in patients with moderate-to-severe active intestinal BD that are refractory to conventional therapies.

Methods

This phase 3, interventional, open-label, single-arm study evaluated clinical outcomes of infliximab treatment in patients with moderate-to-severe intestinal BD. The coprimary endpoints were clinical response, decrease in disease activity index for intestinal BD (DAIBD) score ≥20 from weeks 0 to 8 for the induction therapy and week 32 for the maintenance therapy.

Results

A total of 33 patients entered the induction therapy and were treated with infliximab 5 mg/kg

SUBMITTER: Cheon JH 

PROVIDER: S-EPMC10502498 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature