Concerns and Side Effects of Azathioprine During Adalimumab Induction and Maintenance Therapy for Japanese Patients With Crohn's Disease: A Subanalysis of a Prospective Randomised Clinical Trial [DIAMOND Study]

Combining a thiopurine with the human anti-tumour necrosis factor-α monoclonal antibody adalimumab for Crohn's disease [CD] treatment is controversial with regard to efficacy and safety. By conducting a subanalysis of a multicentre, randomised, prospective, open-label trial [the DIAMOND study,...

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Bibliographic Details
Published in:Journal of Crohn's and colitis 2019-09, Vol.13 (9), p.1097-1104
Main Authors: Hisamatsu, Tadakazu, Matsumoto, Takayuki, Watanabe, Kenji, Nakase, Hiroshi, Motoya, Satoshi, Yoshimura, Naoki, Ishida, Tetsuya, Kato, Shingo, Nakagawa, Tomoo, Esaki, Motohiro, Nagahori, Masakazu, Matsui, Toshiyuki, Naito, Yuji, Kanai, Takanori, Suzuki, Yasuo, Nojima, Masanori, Watanabe, Mamoru, Hibi, Toshifumi
Format: Article
Language:English
Subjects:
Adalimumab - administration & dosage
Adalimumab - therapeutic use
Adolescent
Adult
Aged
Anti-Inflammatory Agents - administration & dosage
Anti-Inflammatory Agents - therapeutic use
Azathioprine - administration & dosage
Azathioprine - adverse effects
Azathioprine - therapeutic use
Crohn Disease - drug therapy
Drug Therapy, Combination - adverse effects
Female
Humans
Immunosuppressive Agents - administration & dosage
Immunosuppressive Agents - adverse effects
Immunosuppressive Agents - therapeutic use
Japan
Kaplan-Meier Estimate
Male
Middle Aged
Patient Dropouts - statistics & numerical data
Prospective Studies
Risk Factors
Sex Factors
Treatment Outcome
Young Adult
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Summary:Combining a thiopurine with the human anti-tumour necrosis factor-α monoclonal antibody adalimumab for Crohn's disease [CD] treatment is controversial with regard to efficacy and safety. By conducting a subanalysis of a multicentre, randomised, prospective, open-label trial [the DIAMOND study, UMIN registration number 000005146], we studied the risk of discontinuation of thiopurine in combination with adalimumab. In the preceding DIAMOND study, we analysed the: [i] timing and reasons for dropout in the monotherapy group and combination group; [ii] risk factors for dropout in the combination group. There was no significant difference in the dropout rate up to Week 52 between the monotherapy group and combination group [p = 0.325]. The main reason for study dropout was active CD in the monotherapy group, whereas it was adverse effects in the combination group [Fisher's exact test, p
ISSN:1873-9946
1876-4479
DOI:10.1093/ecco-jcc/jjz030