Takayuki Matsumoto1, Satoshi Motoya2, Kenji Watanabe3, Tadakazu Hisamatsu4, Hiroshi Nakase5, Naoki Yoshimura6, Tetsuya Ishida7, Shingo Kato8, Tomoo Nakagawa9, Motohiro Esaki10, Masakazu Nagahori11, Toshiyuki Matsui12, Yuji Naito13, Takanori Kanai14, Yasuo Suzuki15, Masanori Nojima16, Mamoru Watanabe11, Toshifumi Hibi17. 1. Division of Gastroenterology, Department of Medicine, Iwate Medical University, Morioka, Japan. 2. Inflammatory Bowel Disease Centre, Sapporo Kosei General Hospital, Sapporo, Japan. 3. Division of Gastroenterology, Osaka City General Hospital, Osaka, Japan. 4. Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo, Japan. 5. Department of Gastroenterology and Hepatology, Endoscopic Medicine, Kyoto University, Kyoto, Japan. 6. Department of Medicine, Division of Gastroenterology, Tokyo Yamate Medical Centre, Tokyo, Japan. 7. Department of Gastroenterology, Oita Red Cross Hospital, Oita, Japan. 8. Department of Gastroenterology and Hepatology, Saitama Medical Centre, Saitama Medical University, Kawagoe, Japan. 9. Department of Gastroenterology and Nephrology [Ka], Graduate School of Medicine, Chiba University, Chiba, Japan. 10. Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 11. Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan. 12. Department of Gastroenterology, Fukuoka University Chikushi Hospital, Chikushino, Japan. 13. Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan. 14. Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan. 15. Department of Internal Medicine, Toho University Sakura Medical Centre, Sakura, Japan. 16. Centre for Translational Research, Institute of Medical Science Hospital, University of Tokyo, Tokyo, Japan. 17. Centre for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Abstract
BACKGROUND AND AIMS: 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]. CONCLUSION: 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.
RCT Entities:
BACKGROUND AND AIMS: 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]. CONCLUSION: 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: A N Ananthakrishnan; A Sakuraba; E L Barnes; J Pekow; L Raffals; M D Long; R S Sandler Journal: Aliment Pharmacol Ther Date: 2017-05-03 Impact factor: 8.171
Authors: Christopher Andrew Lamb; Nicholas A Kennedy; Tim Raine; Philip Anthony Hendy; Philip J Smith; Jimmy K Limdi; Bu'Hussain Hayee; Miranda C E Lomer; Gareth C Parkes; Christian Selinger; Kevin J Barrett; R Justin Davies; Cathy Bennett; Stuart Gittens; Malcolm G Dunlop; Omar Faiz; Aileen Fraser; Vikki Garrick; Paul D Johnston; Miles Parkes; Jeremy Sanderson; Helen Terry; Daniel R Gaya; Tariq H Iqbal; Stuart A Taylor; Melissa Smith; Matthew Brookes; Richard Hansen; A Barney Hawthorne Journal: Gut Date: 2019-09-27 Impact factor: 23.059