Intestinal Research 2017; 15(3): 395-401  
Long-term safety and efficacy of adalimumab for intestinal Behçet’s disease in the open label study following a phase 3 clinical trial
Nagamu Inoue1, Kiyonori Kobayashi2, Makoto Naganuma3, Fumihito Hirai4, Morio Ozawa5, Dilek Arikan6, Bidan Huang6, Anne M. Robinson6, Roopal B. Thakkar6, Toshifumi Hibi7
1Center for Preventive Medicine, Keio University Hospital, Tokyo, 2Department of Gastroenterology, Kitasato University Hospital, Kanagawa, 3Division of Gastroenterology & Hepatology, Department of Internal Medicine, Keio University School of Medicine, 4IBD Center, Fukuoka University Chikushi Hospital, Fukuoka, 5AbbVie GK, Tokyo, Japan, 6AbbVie Inc., North Chicago, IL, USA, 7Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan
Correspondence to: Nagamu Inoue, Center for Preventive Medicine, Keio University Hospital, Shinanomachi 35, Shinjuku-ku, Tokyo 160-8582, Japan.  Tel: +81-3-3353-1211, Fax: +81-3-5315-4356, E-mail: nagamu@z6.keio.jp
Received: January 28, 2017; Revised: May 24, 2017; Accepted: May 25, 2017; Published online: July 30, 2017.
© Korean Association for the Study of Intestinal Diseases. All rights reserved.

Abstract
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. (Intest Res 2017;15:395-401)
Keywords: Biological products; Endoscopy; Ulcer; Behçet’s disease, intestinal


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