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

DIAMOND study group

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2 Citations (Scopus)

Abstract

BACKGROUND: 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. METHODS: 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. RESULTS: 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 <0.001]. Kaplan-Meier analyses revealed significantly earlier dropout in the combination group [log-rank test, p = 0.001]. Multivariable analysis revealed low body weight to be a risk for dropout due to adverse effects in the combination group. CONCLUSIONS: Combination of azathioprine with adalimumab resulted in dropout in the early stage of the study due to side effects of azathioprine, in comparison with late dropout due to active CD in the adalimumab monotherapy group.

Original languageEnglish
Pages (from-to)1097-1104
Number of pages8
JournalJournal of Crohn's & colitis
Volume13
Issue number9
DOIs
Publication statusPublished - 2019 Sep 19

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Azathioprine
Crohn Disease
Randomized Controlled Trials
Kaplan-Meier Estimate
Therapeutics
Monoclonal Antibodies
Body Weight
Safety
Adalimumab

Keywords

  • Adalimumab
  • anti-TNF-alpha antibody
  • Crohn’s disease
  • thiopurine

ASJC Scopus subject areas

  • Gastroenterology

Cite this

@article{3cfa89e57dc341e6908d421d16bce69c,
title = "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",
abstract = "BACKGROUND: 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. METHODS: 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. RESULTS: 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 <0.001]. Kaplan-Meier analyses revealed significantly earlier dropout in the combination group [log-rank test, p = 0.001]. Multivariable analysis revealed low body weight to be a risk for dropout due to adverse effects in the combination group. CONCLUSIONS: Combination of azathioprine with adalimumab resulted in dropout in the early stage of the study due to side effects of azathioprine, in comparison with late dropout due to active CD in the adalimumab monotherapy group.",
keywords = "Adalimumab, anti-TNF-alpha antibody, Crohn’s disease, thiopurine",
author = "{DIAMOND study group} and Tadakazu Hisamatsu and Takayuki Matsumoto and Kenji Watanabe and Hiroshi Nakase and Satoshi Motoya and Naoki Yoshimura and Tetsuya Ishida and Shingo Kato and Tomoo Nakagawa and Motohiro Esaki and Masakazu Nagahori and Toshiyuki Matsui and Yuji Naito and Takanori Kanai and Yasuo Suzuki and Masanori Nojima and Mamoru Watanabe and Toshifumi Hibi",
year = "2019",
month = "9",
day = "19",
doi = "10.1093/ecco-jcc/jjz030",
language = "English",
volume = "13",
pages = "1097--1104",
journal = "Journal of Crohn's and Colitis",
issn = "1873-9946",
publisher = "Elsevier",
number = "9",

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TY - JOUR

T1 - Concerns and Side Effects of Azathioprine During Adalimumab Induction and Maintenance Therapy for Japanese Patients With Crohn's Disease

T2 - A Subanalysis of a Prospective Randomised Clinical Trial [DIAMOND Study

AU - DIAMOND study group

AU - Hisamatsu, Tadakazu

AU - Matsumoto, Takayuki

AU - Watanabe, Kenji

AU - Nakase, Hiroshi

AU - Motoya, Satoshi

AU - Yoshimura, Naoki

AU - Ishida, Tetsuya

AU - Kato, Shingo

AU - Nakagawa, Tomoo

AU - Esaki, Motohiro

AU - Nagahori, Masakazu

AU - Matsui, Toshiyuki

AU - Naito, Yuji

AU - Kanai, Takanori

AU - Suzuki, Yasuo

AU - Nojima, Masanori

AU - Watanabe, Mamoru

AU - Hibi, Toshifumi

PY - 2019/9/19

Y1 - 2019/9/19

N2 - BACKGROUND: 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. METHODS: 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. RESULTS: 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 <0.001]. Kaplan-Meier analyses revealed significantly earlier dropout in the combination group [log-rank test, p = 0.001]. Multivariable analysis revealed low body weight to be a risk for dropout due to adverse effects in the combination group. CONCLUSIONS: Combination of azathioprine with adalimumab resulted in dropout in the early stage of the study due to side effects of azathioprine, in comparison with late dropout due to active CD in the adalimumab monotherapy group.

AB - BACKGROUND: 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. METHODS: 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. RESULTS: 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 <0.001]. Kaplan-Meier analyses revealed significantly earlier dropout in the combination group [log-rank test, p = 0.001]. Multivariable analysis revealed low body weight to be a risk for dropout due to adverse effects in the combination group. CONCLUSIONS: Combination of azathioprine with adalimumab resulted in dropout in the early stage of the study due to side effects of azathioprine, in comparison with late dropout due to active CD in the adalimumab monotherapy group.

KW - Adalimumab

KW - anti-TNF-alpha antibody

KW - Crohn’s disease

KW - thiopurine

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U2 - 10.1093/ecco-jcc/jjz030

DO - 10.1093/ecco-jcc/jjz030

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C2 - 30753377

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VL - 13

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JO - Journal of Crohn's and Colitis

JF - Journal of Crohn's and Colitis

SN - 1873-9946

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