دورية أكاديمية
Safety and effectiveness of adalimumab in the treatment of ulcerative colitis: results from a large-scale, prospective, multicenter, observational study
| العنوان: | Safety and effectiveness of adalimumab in the treatment of ulcerative colitis: results from a large-scale, prospective, multicenter, observational study |
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| المؤلفون: | Haruhiko Ogata, Takashi Hagiwara, Takeshi Kawaberi, Mariko Kobayashi, Toshifumi Hibi |
| المصدر: | Intestinal Research, Vol 19, Iss 4, Pp 419-429 (2021) |
| بيانات النشر: | Korean Association for the Study of Intestinal Diseases, 2021. |
| سنة النشر: | 2021 |
| المجموعة: | LCC:Medicine LCC:Diseases of the digestive system. Gastroenterology |
| مصطلحات موضوعية: | adalimumab, japanese, postmarketing surveillance, real-world study, ulcerative colitis, Medicine, Diseases of the digestive system. Gastroenterology, RC799-869 |
| الوصف: | 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. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 1598-9100 2288-1956 |
| العلاقة: | http://www.irjournal.org/upload/pdf/ir-2020-00033.pdfTest; https://doaj.org/toc/1598-9100Test; https://doaj.org/toc/2288-1956Test |
| DOI: | 10.5217/ir.2020.00033 |
| الوصول الحر: | https://doaj.org/article/16eafc1f18b44bb5807f25b33c87e516Test |
| رقم الانضمام: | edsdoj.16eafc1f18b44bb5807f25b33c87e516 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 15989100 22881956 |
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| DOI: | 10.5217/ir.2020.00033 |