title: Adalimumab for the treatment of Japanese patients with intestinal Behçet's disease.
abstract: OBJECTIVE
  Behçet's disease is a chronic, relapsing inflammatory disease that can involve the mouth, skin, eyes, genitals, and intestines. Active intestinal Behçet's disease can be complicated by gastrointestinal (GI) bleeding and perforation. We performed a multicenter, open-label, uncontrolled study to evaluate the efficacy and safety of adalimumab, a fully human monoclonal antibody against tumor necrosis factor α, in patients with intestinal Behçet's disease who were refractory to corticosteroid and/or immunomodulator therapies.
  
  
  METHODS
  The study was conducted at 12 sites in Japan, from November 2010 through October 2012. Twenty patients were given 160 mg adalimumab at the start of the study and 80 mg 2 weeks later, followed by 40 mg every other week for 52 weeks; for some patients, the dose was increased to 80 mg every other week. A composite efficacy index, combining GI symptom and endoscopic assessments, was used to evaluate efficacy. The primary efficacy end point was the percentage of patients with scores of 1 or lower for GI symptom and endoscopic assessments at week 24. Secondary end points included complete remission and resolution of non-GI Behçet's-related symptoms.
  
  
  RESULTS
  Nine patients (45%) had GI symptom and endoscopic assessment scores of 1 or lower at week 24 of treatment, and 12 patients (60%) had these scores by week 52. Four patients (20%) achieved complete remission at weeks 24 and 52. Individual global GI symptom and endoscopic scores improved for most patients at weeks 24 and 52. Two thirds of patients with oral aphthous ulcers, skin symptoms, and genital ulcers, and 88% of patients with erythema nodosum had complete resolution of these conditions at week 52. A total of 9 of 13 patients (69%) taking steroids at baseline were able to taper (n = 1) or completely discontinue steroids (n = 8) during the study. No new safety signals were observed.
  
  
  CONCLUSIONS
  Adalimumab is a potentially effective treatment for intestinal Behçet's disease in Japanese patients who are refractory to conventional treatments. ClinicalTrials.gov number: NCT01243671.
authors.affiliation: Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tanida
authors.affiliation: Keio University School of Medicine, Tokyo, Japan.
authors.forename: Nagamu
authors.initials: N
authors.lastname: Inoue
authors.affiliation: Kitasato University East Hospital, Kanagawa, Japan.
authors.forename: Kiyonori
authors.initials: K
authors.lastname: Kobayashi
authors.affiliation: Keio University School of Medicine, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Naganuma
authors.affiliation: Fukuoka University Chikushi Hospital, Fukuoka, Japan.
authors.forename: Fumihito
authors.initials: F
authors.lastname: Hirai
authors.affiliation: Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Bunei
authors.initials: B
authors.lastname: Iizuka
authors.affiliation: Osaka City University Hospital, Osaka, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Watanabe
authors.affiliation: Kurume University School of Medicine, Kurume, Japan.
authors.forename: Keiichi
authors.initials: K
authors.lastname: Mitsuyama
authors.affiliation: Osaka Medical College, Osaka, Japan.
authors.forename: Takuya
authors.initials: T
authors.lastname: Inoue
authors.affiliation: Yokohama City University Graduate School of Medicine, Yokohama, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Ishigatsubo
authors.affiliation: Toho University Medical Center Sakura Hospital, Chiba, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Suzuki
authors.affiliation: Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Nagahori
authors.affiliation: IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Motoya
authors.affiliation: Hyogo College of Medicine, Hyogo, Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Nakamura
authors.affiliation: AbbVie, North Chicago, Illinois.
authors.forename: Vipin
authors.initials: V
authors.lastname: Arora
authors.affiliation: AbbVie, North Chicago, Illinois.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Robinson
authors.affiliation: AbbVie, North Chicago, Illinois.
authors.forename: Roopal B
authors.initials: RB
authors.lastname: Thakkar
authors.affiliation: Kitasato University Kitasato Institute Hospital, Tokyo, Japan. Electronic address: thibi@insti.kitasato-u.ac.jp.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
mesh_terms: D000068879:Adalimumab / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D001528:Behcet Syndrome / Q000188:drug therapy* / Q000473:pathology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000068879:Adalimumab
keywords: Anti-TNF Agent; Autoimmunity; Endoscopy; Japan