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Efficacy and Safety of Infliximab in Intestinal Behçet'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, YoungJa; Kim, Youngdoe; Lee, Yoosun; Kim, Won Ho.
Afiliación
  • Cheon JH; Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
  • Kim HS; Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
  • Han DS; Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.
  • Kim SK; Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.
  • Shin SJ; Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.
  • Kim JS; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
  • Ye BD; Department of Gastroenterology, University of Ulsan College of Medicine, Seoul, Korea.
  • Song GA; Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea.
  • Lee Y; Medical Affairs, Janssen Korea, Seoul, Korea.
  • Kim Y; Medical Affairs, Janssen Korea, Seoul, Korea.
  • Lee Y; Medical Affairs, Janssen Korea, Seoul, Korea.
  • Kim WH; Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
Gut Liver ; 17(5): 777-785, 2023 09 15.
Article en En | MEDLINE | ID: mdl-36578194
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).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Síndrome de Behçet / Enfermedades Intestinales Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Límite: Humans Idioma: En Revista: Gut Liver Año: 2023 Tipo del documento: Article Pais de publicación: Corea del Sur
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Síndrome de Behçet / Enfermedades Intestinales Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Límite: Humans Idioma: En Revista: Gut Liver Año: 2023 Tipo del documento: Article Pais de publicación: Corea del Sur