지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2021.10
- 수록면
- 419 - 429 (11page)
- DOI
- 10.5217/ir.2020.00033
이용수
초록· 키워드
오류제보하기
Background/Aims: Adalimumab has been shown to induce and maintain clinical remission in patients with moderate to severe ulcerative colitis (UC). However, no large-scale population-based studies have been performed in Japan. This study was conducted to evaluate the safety and effectiveness of adalimumab in clinical practice in Japanese patients with UC.Methods: In this 52-week, prospective, multicenter, single-cohort, noninterventional, observational, postmarketing surveillance study, patients with moderate to severe UC received an initial subcutaneous injection of adalimumab 160 mg, followed by 80 mg at 2 weeks, and then 40 mg every other week. Safety assessments were the incidence of adverse drug reactions (ADRs) and serious ADRs. Effectiveness assessments were clinical remission, corticosteroid-free remission, mucosal healing, and change in C-reactive protein (CRP) levels from baseline.Results: Of 1,593 registered patients, 1,523 (male, 57.6%; mean age, 41.8 years) and 1,241 patients were included in the safety and effectiveness populations, respectively. ADRs were reported in 18.1% and serious ADRs in 4.9% of patients. Clinical remission was achieved in 49.7% of patients at week 4, increasing to 74.4% at week 52. Corticosteroid-free remission rates increased over time, from 10.4% at week 4 to 53.1% at week 52. More than 60% of patients demonstrated mucosal healing at weeks 24 and 52. Mean CRP levels (mg/dL) decreased from 1.2 at baseline to 0.6 at week 4 and 0.3 at week 52.Conclusions: This large real-world study confirmed the safety and effectiveness of adalimumab in patients with UC in Japan. No new safety concerns were identified.
목차
등록된 정보가 없습니다.
참고문헌 (39)
참고문헌 신청
Matsuoka K / 2018 / Evidence-based clinical practice guidelines for inflammatory bowel disease / J Gastroenterol 53:305~353
Ordás I / 2012 / Ulcerative colitis / Lancet 380:1606~1619
Suzuki Y / 2017 / Four-year maintenance treatment with adalimumab in Japanese patients with moderately to severely active ulcerative colitis / J Gastroenterol 52:1031~1040
Molodecky NA / 2012 / Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review / Gastroenterology 142:46~54
Wee Khoon Ng / 2016 / Changing epidemiological trends of inflammatory bowel disease in Asia / Intestinal research 14(2):111~119
Ordás I / 2012 / Ulcerative colitis / Lancet 380:1606~1619
Suzuki Y / 2017 / Four-year maintenance treatment with adalimumab in Japanese patients with moderately to severely active ulcerative colitis / J Gastroenterol 52:1031~1040
Molodecky NA / 2012 / Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review / Gastroenterology 142:46~54
Wee Khoon Ng / 2016 / Changing epidemiological trends of inflammatory bowel disease in Asia / Intestinal research 14(2):111~119
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