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Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial
BACKGROUND/AIMS: Intestinal Behçet's disease (BD) is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671)....
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Korean Association for the Study of Intestinal Diseases
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5478765/ https://www.ncbi.nlm.nih.gov/pubmed/28670237 http://dx.doi.org/10.5217/ir.2017.15.3.395 |
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author | Inoue, Nagamu Kobayashi, Kiyonori Naganuma, Makoto Hirai, Fumihito Ozawa, Morio Arikan, Dilek Huang, Bidan Robinson, Anne M. Thakkar, Roopal B. Hibi, Toshifumi |
author_facet | Inoue, Nagamu Kobayashi, Kiyonori Naganuma, Makoto Hirai, Fumihito Ozawa, Morio Arikan, Dilek Huang, Bidan Robinson, Anne M. Thakkar, Roopal B. Hibi, Toshifumi |
author_sort | Inoue, Nagamu |
collection | PubMed |
description | BACKGROUND/AIMS: Intestinal Behçet's disease (BD) is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671). METHODS: Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs) were examined. The efficacy was assessed on the basis of marked improvement (MI) and complete remission (CR) using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments. RESULTS: Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years). No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively. CONCLUSIONS: This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity. |
format | Online Article Text |
id | pubmed-5478765 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Korean Association for the Study of Intestinal Diseases |
record_format | MEDLINE/PubMed |
spelling | pubmed-54787652017-07-01 Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial Inoue, Nagamu Kobayashi, Kiyonori Naganuma, Makoto Hirai, Fumihito Ozawa, Morio Arikan, Dilek Huang, Bidan Robinson, Anne M. Thakkar, Roopal B. Hibi, Toshifumi Intest Res Original Article BACKGROUND/AIMS: Intestinal Behçet's disease (BD) is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671). METHODS: Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs) were examined. The efficacy was assessed on the basis of marked improvement (MI) and complete remission (CR) using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments. RESULTS: Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years). No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively. CONCLUSIONS: This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity. Korean Association for the Study of Intestinal Diseases 2017-07 2017-06-12 /pmc/articles/PMC5478765/ /pubmed/28670237 http://dx.doi.org/10.5217/ir.2017.15.3.395 Text en © Copyright 2017. Korean Association for the Study of Intestinal Diseases. http://creativecommons.org/licenses/by-nc/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Inoue, Nagamu Kobayashi, Kiyonori Naganuma, Makoto Hirai, Fumihito Ozawa, Morio Arikan, Dilek Huang, Bidan Robinson, Anne M. Thakkar, Roopal B. Hibi, Toshifumi Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial |
title | Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial |
title_full | Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial |
title_fullStr | Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial |
title_full_unstemmed | Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial |
title_short | Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial |
title_sort | long-term safety and efficacy of adalimumab for intestinal behçet's disease in the open label study following a phase 3 clinical trial |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5478765/ https://www.ncbi.nlm.nih.gov/pubmed/28670237 http://dx.doi.org/10.5217/ir.2017.15.3.395 |
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