Adalimumab monotherapy and a combination with azathioprine for Crohn's disease

A prospective, randomized trial

DIAMOND study group

Research output: Contribution to journalArticle

50 Citations (Scopus)

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- 100 mg 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.

Original languageEnglish
Pages (from-to)1259-1266
Number of pages8
JournalJournal of Crohn's and Colitis
Volume10
Issue number11
DOIs
Publication statusPublished - 2016

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Azathioprine
Crohn Disease
Adalimumab
Biological Products
Appointments and Schedules
Prospective Studies
Therapeutics

Keywords

  • Anti-TNF-alpha antibody
  • Crohn's disease
  • Immunomodulator

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Adalimumab monotherapy and a combination with azathioprine for Crohn's disease : A prospective, randomized trial. / DIAMOND study group.

In: Journal of Crohn's and Colitis, Vol. 10, No. 11, 2016, p. 1259-1266.

Research output: Contribution to journalArticle

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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 na{\"i}ve 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- 100 mg 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 na{\"i}ve to both medications.",
keywords = "Anti-TNF-alpha antibody, Crohn's disease, Immunomodulator",
author = "{DIAMOND study group} and Takayuki Matsumoto and Satoshi Motoya and Kenji Watanabe and Tadakazu Hisamatsu and Hiroshi Nakase 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 and Akira Andoh and Toshifumi Ashida and Katsuya Endo and Yutaka Endo and Hiroshi Fujita and Mikihiro Fujiya and Ken Haruma and Sakiko Hiraoka and Ichiro Hirata and Yutaka Honda and Hideki Iijima and Bunei Iizuka and Kentaro Ikeya and Takuya Inoue and Shuji Inoue and Yo Ishiguro and Shunji Ishihara and Hiroaki Ito and Ryuichi Iwakiri and Takashi Kagaya and Hiroshi Kashida and Jun Kato and Takehiko Katsurada and Fukunori Kinjyo and Kiyonori Kobayashi and Mayumi Kodama and Reiko Kunisaki and Koichi Kurahara and Takafumi Kurokami and Lee Kyouwon and Koichiro Matsuda and Kazuhiro Matsueda",
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T1 - Adalimumab monotherapy and a combination with azathioprine for Crohn's disease

T2 - A prospective, randomized trial

AU - DIAMOND study group

AU - Matsumoto, Takayuki

AU - Motoya, Satoshi

AU - Watanabe, Kenji

AU - Hisamatsu, Tadakazu

AU - Nakase, Hiroshi

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

AU - Andoh, Akira

AU - Ashida, Toshifumi

AU - Endo, Katsuya

AU - Endo, Yutaka

AU - Fujita, Hiroshi

AU - Fujiya, Mikihiro

AU - Haruma, Ken

AU - Hiraoka, Sakiko

AU - Hirata, Ichiro

AU - Honda, Yutaka

AU - Iijima, Hideki

AU - Iizuka, Bunei

AU - Ikeya, Kentaro

AU - Inoue, Takuya

AU - Inoue, Shuji

AU - Ishiguro, Yo

AU - Ishihara, Shunji

AU - Ito, Hiroaki

AU - Iwakiri, Ryuichi

AU - Kagaya, Takashi

AU - Kashida, Hiroshi

AU - Kato, Jun

AU - Katsurada, Takehiko

AU - Kinjyo, Fukunori

AU - Kobayashi, Kiyonori

AU - Kodama, Mayumi

AU - Kunisaki, Reiko

AU - Kurahara, Koichi

AU - Kurokami, Takafumi

AU - Kyouwon, Lee

AU - Matsuda, Koichiro

AU - Matsueda, Kazuhiro

PY - 2016

Y1 - 2016

N2 - 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- 100 mg 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.

AB - 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- 100 mg 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.

KW - Anti-TNF-alpha antibody

KW - Crohn's disease

KW - Immunomodulator

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U2 - 10.1093/ecco-jcc/jjw152

DO - 10.1093/ecco-jcc/jjw152

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EP - 1266

JO - Journal of Crohn's and Colitis

JF - Journal of Crohn's and Colitis

SN - 1873-9946

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