4.6 Article

Adalimumab Monotherapy and a Combination with Azathioprine for Crohn's Disease: A Prospective, Randomized Trial

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

  1. Eisai Corporation [EC]
  2. Abbvie GK [AGK]
  3. Mitsubishi Tanabe Pharma [MTP]
  4. EC
  5. AGK
  6. MTP
  7. Jannsen Pharma
  8. Ajinomoto Pharma [AP]
  9. Astellas Pharma [AsP]
  10. Otsuka Pharmaceutical Corporation [OPC]
  11. Takeda Pharmaceutical Corporation [TPO]
  12. Zeria Pharmaceutical Corporation [ZPO]
  13. Kyorin Pharmaceutical Corporation
  14. Diichi Sankyo Corporation
  15. Ono Pharmaceutical Corporation
  16. Gene Care Research Institute
  17. AsP
  18. Asahi Kasei Kuraray Corporation
  19. Chugai Pharmaceutical Corporation
  20. TPO
  21. AP
  22. OPC
  23. Kyowa Hakko Kirin Corporation
  24. Jimro Corporation
  25. ZPO
  26. UCB Japan Corporation
  27. Dainippon Sumitomo Pharma
  28. Toray Industries
  29. Bristol-Meyers KK

向作者/读者索取更多资源

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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