KMID : 1188320230170050777
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Gut and Liver 2023 Volume.17 No. 5 p.777 ~ p.785
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Efficacy and Safety of Infliximab in Intestinal Behcet¡¯s Disease: A Multicenter, Phase 3 Study (BEGIN)
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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
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Abstract
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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 ¡Ã20 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¡¾40.1 at week 0 to 40.3¡¾36.4 at week 8, with a significant mean change of 50.5¡¾36.4 (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¡¾38.5; 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)
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KEYWORD
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Infliximab, Tumor necrosis factor-alpha, Behcet syndrome, Intestinal diseases, Clinical efficacy
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