Adalimumab for the treatment of japanese patients with intestinal behçet's disease

Satoshi Tanida, Nagamu Inoue, Kiyonori Kobayashi, Makoto Naganuma, Fumihito Hirai, Bunei Iizuka, Kenji Watanabe, Keiichi Mitsuyama, Takuya Inoue, Yoshiaki Ishigatsubo, Yasuo Suzuki, Masakazu Nagahori, Satoshi Motoya, Shiro Nakamura, Vipin Arora, Anne M. Robinson, Roopal B. Thakkar, Toshifumi Hibi

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Background & Aims: Behçet's disease is a chronic, relapsing inflammatory disease that can involve the mouth, skin, eyes, genitals, and intestines. Active intestinal Behçet's disease can be complicated by gastrointestinal (GI) bleeding and perforation. We performed a multicenter, open-label, uncontrolled study to evaluate the efficacy and safety of adalimumab, a fully human monoclonal antibody against tumor necrosis factor α, in patients with intestinal Behçet's disease who were refractory to corticosteroid and/or immunomodulator therapies. Methods: The study was conducted at 12 sites in Japan, from November 2010 through October 2012. Twenty patients were given 160 mg adalimumab at the start of the study and 80 mg 2 weeks later, followed by 40 mg every other week for 52 weeks; for some patients, the dose was increased to 80 mg every other week. A composite efficacy index, combining GI symptom and endoscopic assessments, was used to evaluate efficacy. The primary efficacy end point was the percentage of patients with scores of 1 or lower for GI symptom and endoscopic assessments at week 24. Secondary end points included complete remission and resolution of non-GI Behçet's-related symptoms. Results: Nine patients (45%) had GI symptom and endoscopic assessment scores of 1 or lower at week 24 of treatment, and 12 patients (60%) had these scores by week 52. Four patients (20%) achieved complete remission at weeks 24 and 52. Individual global GI symptom and endoscopic scores improved for most patients at weeks 24 and 52. Two thirds of patients with oral aphthous ulcers, skin symptoms, and genital ulcers, and 88% of patients with erythema nodosum had complete resolution of these conditions at week 52. A total of 9 of 13 patients (69%) taking steroids at baseline were able to taper (n= 1) or completely discontinue steroids (n= 8) during the study. No new safety signals were observed. Conclusions: Adalimumab is a potentially effective treatment for intestinal Behçet's disease in Japanese patients who are refractory to conventional treatments. ClinicalTrials.gov number: NCT01243671.

Original languageEnglish
Pages (from-to)940-948
Number of pages9
JournalClinical Gastroenterology and Hepatology
Volume13
Issue number5
DOIs
Publication statusPublished - 2015 May 1

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Intestinal Diseases
Symptom Assessment
Therapeutics
Adalimumab
Steroids
Oral Ulcer
Aphthous Stomatitis
Safety
Erythema Nodosum
Skin
Immunologic Factors
Ulcer
Intestines
Mouth
Japan
Adrenal Cortex Hormones
Tumor Necrosis Factor-alpha

Keywords

  • Anti-TNF Agent
  • Autoimmunity
  • Endoscopy
  • Japan

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Adalimumab for the treatment of japanese patients with intestinal behçet's disease. / Tanida, Satoshi; Inoue, Nagamu; Kobayashi, Kiyonori; Naganuma, Makoto; Hirai, Fumihito; Iizuka, Bunei; Watanabe, Kenji; Mitsuyama, Keiichi; Inoue, Takuya; Ishigatsubo, Yoshiaki; Suzuki, Yasuo; Nagahori, Masakazu; Motoya, Satoshi; Nakamura, Shiro; Arora, Vipin; Robinson, Anne M.; Thakkar, Roopal B.; Hibi, Toshifumi.

In: Clinical Gastroenterology and Hepatology, Vol. 13, No. 5, 01.05.2015, p. 940-948.

Research output: Contribution to journalArticle

Tanida, S, Inoue, N, Kobayashi, K, Naganuma, M, Hirai, F, Iizuka, B, Watanabe, K, Mitsuyama, K, Inoue, T, Ishigatsubo, Y, Suzuki, Y, Nagahori, M, Motoya, S, Nakamura, S, Arora, V, Robinson, AM, Thakkar, RB & Hibi, T 2015, 'Adalimumab for the treatment of japanese patients with intestinal behçet's disease', Clinical Gastroenterology and Hepatology, vol. 13, no. 5, pp. 940-948. https://doi.org/10.1016/j.cgh.2014.08.042
Tanida, Satoshi ; Inoue, Nagamu ; Kobayashi, Kiyonori ; Naganuma, Makoto ; Hirai, Fumihito ; Iizuka, Bunei ; Watanabe, Kenji ; Mitsuyama, Keiichi ; Inoue, Takuya ; Ishigatsubo, Yoshiaki ; Suzuki, Yasuo ; Nagahori, Masakazu ; Motoya, Satoshi ; Nakamura, Shiro ; Arora, Vipin ; Robinson, Anne M. ; Thakkar, Roopal B. ; Hibi, Toshifumi. / Adalimumab for the treatment of japanese patients with intestinal behçet's disease. In: Clinical Gastroenterology and Hepatology. 2015 ; Vol. 13, No. 5. pp. 940-948.
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AU - Tanida, Satoshi

AU - Inoue, Nagamu

AU - Kobayashi, Kiyonori

AU - Naganuma, Makoto

AU - Hirai, Fumihito

AU - Iizuka, Bunei

AU - Watanabe, Kenji

AU - Mitsuyama, Keiichi

AU - Inoue, Takuya

AU - Ishigatsubo, Yoshiaki

AU - Suzuki, Yasuo

AU - Nagahori, Masakazu

AU - Motoya, Satoshi

AU - Nakamura, Shiro

AU - Arora, Vipin

AU - Robinson, Anne M.

AU - Thakkar, Roopal B.

AU - Hibi, Toshifumi

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N2 - Background & Aims: Behçet's disease is a chronic, relapsing inflammatory disease that can involve the mouth, skin, eyes, genitals, and intestines. Active intestinal Behçet's disease can be complicated by gastrointestinal (GI) bleeding and perforation. We performed a multicenter, open-label, uncontrolled study to evaluate the efficacy and safety of adalimumab, a fully human monoclonal antibody against tumor necrosis factor α, in patients with intestinal Behçet's disease who were refractory to corticosteroid and/or immunomodulator therapies. Methods: The study was conducted at 12 sites in Japan, from November 2010 through October 2012. Twenty patients were given 160 mg adalimumab at the start of the study and 80 mg 2 weeks later, followed by 40 mg every other week for 52 weeks; for some patients, the dose was increased to 80 mg every other week. A composite efficacy index, combining GI symptom and endoscopic assessments, was used to evaluate efficacy. The primary efficacy end point was the percentage of patients with scores of 1 or lower for GI symptom and endoscopic assessments at week 24. Secondary end points included complete remission and resolution of non-GI Behçet's-related symptoms. Results: Nine patients (45%) had GI symptom and endoscopic assessment scores of 1 or lower at week 24 of treatment, and 12 patients (60%) had these scores by week 52. Four patients (20%) achieved complete remission at weeks 24 and 52. Individual global GI symptom and endoscopic scores improved for most patients at weeks 24 and 52. Two thirds of patients with oral aphthous ulcers, skin symptoms, and genital ulcers, and 88% of patients with erythema nodosum had complete resolution of these conditions at week 52. A total of 9 of 13 patients (69%) taking steroids at baseline were able to taper (n= 1) or completely discontinue steroids (n= 8) during the study. No new safety signals were observed. Conclusions: Adalimumab is a potentially effective treatment for intestinal Behçet's disease in Japanese patients who are refractory to conventional treatments. ClinicalTrials.gov number: NCT01243671.

AB - Background & Aims: Behçet's disease is a chronic, relapsing inflammatory disease that can involve the mouth, skin, eyes, genitals, and intestines. Active intestinal Behçet's disease can be complicated by gastrointestinal (GI) bleeding and perforation. We performed a multicenter, open-label, uncontrolled study to evaluate the efficacy and safety of adalimumab, a fully human monoclonal antibody against tumor necrosis factor α, in patients with intestinal Behçet's disease who were refractory to corticosteroid and/or immunomodulator therapies. Methods: The study was conducted at 12 sites in Japan, from November 2010 through October 2012. Twenty patients were given 160 mg adalimumab at the start of the study and 80 mg 2 weeks later, followed by 40 mg every other week for 52 weeks; for some patients, the dose was increased to 80 mg every other week. A composite efficacy index, combining GI symptom and endoscopic assessments, was used to evaluate efficacy. The primary efficacy end point was the percentage of patients with scores of 1 or lower for GI symptom and endoscopic assessments at week 24. Secondary end points included complete remission and resolution of non-GI Behçet's-related symptoms. Results: Nine patients (45%) had GI symptom and endoscopic assessment scores of 1 or lower at week 24 of treatment, and 12 patients (60%) had these scores by week 52. Four patients (20%) achieved complete remission at weeks 24 and 52. Individual global GI symptom and endoscopic scores improved for most patients at weeks 24 and 52. Two thirds of patients with oral aphthous ulcers, skin symptoms, and genital ulcers, and 88% of patients with erythema nodosum had complete resolution of these conditions at week 52. A total of 9 of 13 patients (69%) taking steroids at baseline were able to taper (n= 1) or completely discontinue steroids (n= 8) during the study. No new safety signals were observed. Conclusions: Adalimumab is a potentially effective treatment for intestinal Behçet's disease in Japanese patients who are refractory to conventional treatments. ClinicalTrials.gov number: NCT01243671.

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