Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial

Nagamu Inoue, Kiyonori Kobayashi, Makoto Naganuma, Fumihito Hirai, Morio Ozawa, Dilek Arikan, Bidan Huang, Anne M. Robinson, Roopal B. Thakkar, Toshifumi Hibi

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background/Aims: Intestinal Behçet's disease (BD) is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671). Methods: Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs) were examined. The efficacy was assessed on the basis of marked improvement (MI) and complete remission (CR) using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments. Results: Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years). No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively. Conclusions: This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity.

Original languageEnglish
Pages (from-to)395-401
Number of pages7
JournalIntestinal Research
Volume15
Issue number3
DOIs
Publication statusPublished - 2017

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Intestinal Diseases
Phase III Clinical Trials
Safety
Therapeutics
Symptom Assessment
Incidence
Patient Safety
Adalimumab
Clinical Trials

Keywords

  • Behçet's disease
  • Biological products
  • Endoscopy
  • Intestinal
  • Ulcer

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial. / Inoue, Nagamu; Kobayashi, Kiyonori; Naganuma, Makoto; Hirai, Fumihito; Ozawa, Morio; Arikan, Dilek; Huang, Bidan; Robinson, Anne M.; Thakkar, Roopal B.; Hibi, Toshifumi.

In: Intestinal Research, Vol. 15, No. 3, 2017, p. 395-401.

Research output: Contribution to journalArticle

Inoue, Nagamu ; Kobayashi, Kiyonori ; Naganuma, Makoto ; Hirai, Fumihito ; Ozawa, Morio ; Arikan, Dilek ; Huang, Bidan ; Robinson, Anne M. ; Thakkar, Roopal B. ; Hibi, Toshifumi. / Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial. In: Intestinal Research. 2017 ; Vol. 15, No. 3. pp. 395-401.
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abstract = "Background/Aims: Intestinal Beh{\cc}et's disease (BD) is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671). Methods: Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs) were examined. The efficacy was assessed on the basis of marked improvement (MI) and complete remission (CR) using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments. Results: Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years). No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0{\%} and 40.0{\%} of patients showed MI, respectively, and 20.0{\%} and 15.0{\%} of patients showed CR, respectively. Conclusions: This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity.",
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AU - Arikan, Dilek

AU - Huang, Bidan

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