title: Adalimumab Monotherapy and a Combination with Azathioprine for Crohn's Disease: A Prospective, Randomized Trial.
abstract: OBJECTIVE
  The efficacy of azathioprine for Crohn's disease under adalimumab treatment remains obscure.
  
  
  METHODS
  In an open-labelled prospective study, we evaluated the efficacy of adalimumab with and without azathioprine in patients with active Crohn's disease, who were naïve to biologics and thiopurines. The patients were randomly assigned to subcutaneous administration of adalimumab [monotherapy group] or to exactly the same schedule of adalimumab with azathioprine [25-100mg daily] [combination group] for 52 Weeks. The primary endpoint was clinical remission at WWeek 26. We also evaluated the score for simple endoscopic severity of Crohn's disease before the therapy and at WWeeks 26 and 52.
  
  
  RESULTS
  A total of 176 patients were randomized to either the monotherapy group [n = 85] or to the combination group [n = 91]. Eighteen patients [21.2%] from the monotherapy group and 7 patients [7.7%] from the combination group withdrew owing to active disease, and 15 patients [16.5%] from the combination group and 1 patient [1.2%] from the monotherapy group withdrew due to side effects of the medications. Non-responder imputation analysis revealed that the remission rate at WWeek 26 did not differ between the monotherapy group and the combination group [71.8% vs 68.1%; OR 0.84, p = 0.63]. The rate of endoscopic improvement at WWeek 26 was significantly higher in the combination group [84.2%, n = 57] than in the monotherapy group [63.8%, n = 58] [p = 0.019].
  
  
  CONCLUSIONS
  The clinical efficacy of a combination of adalimumab and azathioprine at WWeek 26 did not differ from that of adalimumab monotherapy in patients with Crohn's disease naïve to both medications.
authors: Division of Gastroenterology, Department of Medicine, Iwate Medical University, Morioka, Japan.
authors: Takayuki
authors: T
authors: Matsumoto
authors: Inflammatory Bowel Disease Centre, Sapporo Kosei General Hospital, Sapporo, Japan.
authors: Satoshi
authors: S
authors: Motoya
authors: Division of Gastroenterology, Osaka City General Hospital, Osaka, Japan.
authors: Kenji
authors: K
authors: Watanabe
authors: Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo, Japan.
authors: Tadakazu
authors: T
authors: Hisamatsu
authors: Department of Gastroenterology and Hepatology, Endoscopic Medicine, Kyoto University, Kyoto, Japan.
authors: Hiroshi
authors: H
authors: Nakase
authors: Department of Medicine, Division of Gastroenterology, Tokyo Yamate Medical Centre, Tokyo, Japan.
authors: Naoki
authors: N
authors: Yoshimura
authors: Department of Gastroenterology, Oita Red Cross Hospital, Oita, Japan.
authors: Tetsuya
authors: T
authors: Ishida
authors: Department of Gastroenterology and Hepatology, Saitama Medical Centre, Saitama Medical University, Kawagoe, Japan.
authors: Shingo
authors: S
authors: Kato
authors: Department of Gastroenterology and Nephrology [Ka], Graduate School of Medicine, Chiba University, Chiba, Japan.
authors: Tomoo
authors: T
authors: Nakagawa
authors: Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors: Motohiro
authors: M
authors: Esaki
authors: Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.
authors: Masakazu
authors: M
authors: Nagahori
authors: Department of Gastroenterology, Fukuoka University Chikushi Hospital, Chikushino, Japan.
authors: Toshiyuki
authors: T
authors: Matsui
authors: Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors: Yuji
authors: Y
authors: Naito
authors: Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.
authors: Takanori
authors: T
authors: Kanai
authors: Department of Internal Medicine, Toho University Sakura Medical Centre, Sakura, Japan.
authors: Yasuo
authors: Y
authors: Suzuki
authors: Centre for Translational Research, Institute of Medical Science Hospital, University of Tokyo, Tokyo, Japan.
authors: Masanori
authors: M
authors: Nojima
authors: Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.
authors: Mamoru
authors: M
authors: Watanabe
authors: Centre for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
authors: Toshifumi
authors: T
authors: Hibi
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001379:Azathioprine / Q000008:administration & dosage / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents; D000068879:Adalimumab; D001379:Azathioprine
keywords: Crohn’s disease; anti-TNF-alpha antibody; immunomodulator