Gut Liver.  2023 Sep;17(5):777-785. 10.5009/gnl220278.

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

• Cheon JH
• Kim HS
• Han DS
• Kim SK
• Shin SJ
• Kim JS
• Ye BD
• Song GA
• Lee Y
• Kim Y
• Lee Y
• Kim WH
• BEGIN Study Group

• KMID: 2546060
• DOI: http://doi.org/10.5009/gnl220278

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 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<0.001). Thirty-one (93.9%) continued to receive 5 mg/kg infliximab every 8 weeks during the maintenance therapy. The mean change in the DAIBD score after the maintenance therapy was statistically significant (61.5±38.5; 95% confidence interval, 46.0 to 77.1; p<0.001, from weeks 0 to 32). The proportion of patients who maintained a clinical response was 92.3% at week 32. No severe adverse reactions occurred during the induction and maintenance therapies.
Conclusions
This study provided evidence that infliximab 5 mg/kg induction and maintenance therapies are efficacious and well-tolerated in patients with moderate-to-severe active intestinal BD. (ClinicalTrials.gov identifier: NCT02505568)

Keyword

Infliximab; Tumor necrosis factor-alpha; Behcet syndrome; Intestinal diseases; Clinical efficacy