PMID- 28670237
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 1598-9100 (Print)
IS  - 2288-1956 (Electronic)
IS  - 1598-9100 (Linking)
VI  - 15
IP  - 3
DP  - 2017 Jul
TI  - Long-term safety and efficacy of adalimumab for intestinal Behcet's disease in 
      the open label study following a phase 3 clinical trial.
PG  - 395-401
LID - 10.5217/ir.2017.15.3.395 [doi]
AB  - BACKGROUND/AIMS: Intestinal Behcet'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.
FAU - Inoue, Nagamu
AU  - Inoue N
AD  - Center for Preventive Medicine, Keio University Hospital, Tokyo, Japan.
FAU - Kobayashi, Kiyonori
AU  - Kobayashi K
AD  - Department of Gastroenterology, Kitasato University Hospital, Kanagawa, Japan.
FAU - Naganuma, Makoto
AU  - Naganuma M
AD  - Division of Gastroenterology & Hepatology, Department of Internal Medicine, Keio 
      University School of Medicine, Fukuoka, Japan.
FAU - Hirai, Fumihito
AU  - Hirai F
AD  - IBD Center, Fukuoka University Chikushi Hospital, Fukuoka, Japan.
FAU - Ozawa, Morio
AU  - Ozawa M
AD  - AbbVie GK, Tokyo, Japan.
FAU - Arikan, Dilek
AU  - Arikan D
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Huang, Bidan
AU  - Huang B
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Robinson, Anne M
AU  - Robinson AM
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Thakkar, Roopal B
AU  - Thakkar RB
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Hibi, Toshifumi
AU  - Hibi T
AD  - Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, 
      Kitasato University, Tokyo, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT01243671
PT  - Journal Article
DEP - 20170612
PL  - Korea (South)
TA  - Intest Res
JT  - Intestinal research
JID - 101572802
PMC - PMC5478765
OTO - NOTNLM
OT  - Behcet's disease, intestinal
OT  - Biological products
OT  - Endoscopy
OT  - Ulcer
COIS- Conflict of interest: F.H. has received personal fees for lectures from AbbVie GK 
      and his institution has received funding from AbbVie GK. D.A., B.H., A.M.R., and 
      R.B.T. are employees of AbbVie Inc., and M.O. is an employee of AbbVie GK, and 
      they may hold AbbVie stock or options. T.H. has received personal fees from 
      Ajinomoto Pharmaceuticals Co. Ltd., Asahi Kasei Medical Co., Ltd., AstraZeneca 
      Pharmaceuticals, Janssen Pharmaceutical K.K., JIMRO Co., Ltd., Kyorin 
      Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Mitsubishi Tanabe 
      Pharma Corporation, UCB Japan Co., Ltd., UMN Pharma Inc., and Zeria 
      Pharmaceutical Co., Ltd. The remaining authors disclose no conflicts of interest.
EDAT- 2017/07/04 06:00
MHDA- 2017/07/04 06:01
PMCR- 2017/07/01
CRDT- 2017/07/04 06:00
PHST- 2017/01/28 00:00 [received]
PHST- 2017/05/24 00:00 [revised]
PHST- 2017/05/25 00:00 [accepted]
PHST- 2017/07/04 06:00 [entrez]
PHST- 2017/07/04 06:00 [pubmed]
PHST- 2017/07/04 06:01 [medline]
PHST- 2017/07/01 00:00 [pmc-release]
AID - 10.5217/ir.2017.15.3.395 [doi]
PST - ppublish
SO  - Intest Res. 2017 Jul;15(3):395-401. doi: 10.5217/ir.2017.15.3.395. Epub 2017 Jun 
      12.