Intest Res.  2017 Jul;15(3):395-401. 10.5217/ir.2017.15.3.395.

Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial

Affiliations
  • 1Center for Preventive Medicine, Keio University Hospital, Tokyo, Japan. nagamu@z6.keio.jp
  • 2Department of Gastroenterology, Kitasato University Hospital, Kanagawa, Japan.
  • 3Division of Gastroenterology & Hepatology, Department of Internal Medicine, Keio University School of Medicine, Fukuoka, Japan.
  • 4IBD Center, Fukuoka University Chikushi Hospital, Fukuoka, Japan.
  • 5AbbVie GK, Tokyo, Japan.
  • 6AbbVie Inc., North Chicago, IL, USA.
  • 7Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.

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.

Keyword

Biological products; Endoscopy; Ulcer; Behçet's disease, intestinal

MeSH Terms

Adalimumab*
Biological Products
Endoscopy
Humans
Incidence
Ulcer
Adalimumab
Biological Products
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