Efficacy and Safety of Infliximab in Intestinal Behçet’s Disease: A Multicenter, Phase 3 Study (BEGIN)

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 therapie...

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Published in:Gut and liver 2023-09, Vol.17 (5), p.777
Main Authors: Jae Hee Cheon, Hyun-soo Kim, Dong Soo Han, Sung Kook Kim, Sung Jae Shin, Joo Sung Kim, Byong Duk Ye, Geun Am Song, Youngja Lee, Youngdoe Kim, Yoosun Lee, Won Ho Kim
Format: Article
Language:Korean
Subjects:
Behcet syndrome
Clinical efficacy
Infliximab
Intestinal diseases
Tumor necrosis factor-alpha
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Summary: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 intravenously at weeks 0, 2, and 6. The mean DAIBD score changed from 90.8±40.1 at week 0 to 40.3±36.4 at week 8, with a significant mean change of 50.5±36.4 (95% confidence interval, 37.5 to 63.4; p
ISSN:1976-2283