期刊
JOURNAL OF CROHNS & COLITIS
卷 10, 期 11, 页码 1259-1266出版社
OXFORD UNIV PRESS
DOI: 10.1093/ecco-jcc/jjw152
关键词
Crohn's disease; anti-TNF-alpha antibody; immunomodulator
资金
- Eisai Corporation [EC]
- Abbvie GK [AGK]
- Mitsubishi Tanabe Pharma [MTP]
- EC
- AGK
- MTP
- Jannsen Pharma
- Ajinomoto Pharma [AP]
- Astellas Pharma [AsP]
- Otsuka Pharmaceutical Corporation [OPC]
- Takeda Pharmaceutical Corporation [TPO]
- Zeria Pharmaceutical Corporation [ZPO]
- Kyorin Pharmaceutical Corporation
- Diichi Sankyo Corporation
- Ono Pharmaceutical Corporation
- Gene Care Research Institute
- AsP
- Asahi Kasei Kuraray Corporation
- Chugai Pharmaceutical Corporation
- TPO
- AP
- OPC
- Kyowa Hakko Kirin Corporation
- Jimro Corporation
- ZPO
- UCB Japan Corporation
- Dainippon Sumitomo Pharma
- Toray Industries
- Bristol-Meyers KK
The efficacy of azathioprine for Crohn's disease under adalimumab treatment remains obscure. 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 naive 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. 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]. 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 naive to both medications.
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