|
KMID : 1188320230170050777
|
|
Gut and Liver
2023 Volume.17 No. 5 p.777 ~ p.785
|
|
|
Efficacy and Safety of Infliximab in Intestinal Behcet’s Disease: A Multicenter, Phase 3 Study (BEGIN)
|
|
Cheon Jae-Hee
Kim Hyun-Soo
Han Dong-Soo
Kim Sung-Kook
Shin Sung-Jae
Kim Joo-Sung
Ye Byong-Duk
Song Geun-Am
Lee Young-Ja
Kim Young-Doe
Lee Yoo-Sun
Kim Won-Ho
|
|
|
Abstract
|
|
|
Background/Aims: To date, there is no prospective study that specifically investigated the efficacy of infliximab in intestinal Behcet’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
|
|
|
FullTexts / Linksout information
|
|
|
|
|
Listed journal information
|
|
|
|
|