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]

Tadakazu Hisamatsu, Takayuki Matsumoto, Kenji Watanabe, Hiroshi Nakase, Satoshi Motoya, Naoki Yoshimura, Tetsuya Ishida, Shingo Kato, Tomoo Nakagawa, Motohiro Esaki, Masakazu Nagahori, Toshiyuki Matsui, Yuji Naito, Takanori Kanai, Yasuo Suzuki, Masanori Nojima, Mamoru Watanabe, Toshifumi Hibi, Akira Andoh, Toshifumi AshidaKatsuya Endo, Yutaka Endo, Hiroshi Fujita, Mikihiro Fujiya, Ken Haruma, Sakiko Hiraoka, Ichiro Hirata, Yutaka Honda, Hideki Iijima, Bunei Iizuka, Kentaro Ikeya, Takuya Inoue, Syuji Inoue, Yo Ishiguro, Shunji Ishihara, Hiroaki Ito, Ryuichi Iwakiri, Takashi Kagaya, Hiroshi Kashida, Jun Kato, Takehiko Katsurada, Fukunori Kinjyo, Kiyonori Kobayashi, Mayumi Kodama, Reiko Kunisaki, Koichi Kurahara, Takafumi Kurokami, Lee Kyouwon, Koichiro Matsuda, Kazuhiro Matsueda, Keiichi Mitsuyama, Yuji Mizokami, Shiro Nakamura, Masafumi Nomura, Atsuhiro Ogawa, Kazuichi Okazaki, Kazuaki Otsuka, Hirotake Sakuraba, Masayuki Saruta, Makoto Sasaki, Takayuki Shirai, Tomoaki Suga, Kazuhito Sugimura, Toshiro Sugiyama, Fuminao Takeshima, Hiroyuki Tamaki, Shinji Tanaka, Satoshi Tanida, Keiichi Tominaga, Taku Tomizawa, Syojiro Yamamoto, Masaki Yamashita, Atsushi Yoshida

Research output: Contribution to journalArticlepeer-review

9 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 and Colitis
Volume13
Issue number9
DOIs
Publication statusPublished - 2019 Sep 1

Keywords

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

ASJC Scopus subject areas

  • Gastroenterology

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