Adalimumab induction and maintenance therapy achieve clinical remission and response in Chinese patients with Crohn's disease

Autor: Kai-Chun Wu, Zhi Hua Ran, Xiang Gao, Minhu Chen, Jie Zhong, Jian-Qiu Sheng, Michael A Kamm, Simon Travis, Kori Wallace, Nael M Mostafa, Marisa Shapiro, Yao Li, Roopal B Thakkar, Anne M Robinson
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Zdroj: Intestinal Research, Vol 14, Iss 2, Pp 152-163 (2016)
Druh dokumentu: article
ISSN: 1598-9100
2288-1956
DOI: 10.5217/ir.2016.14.2.152
Popis: Background/AimsThis was a Phase 2 study (NCT02015793) to evaluate the pharmacokinetics, safety, and efficacy of adalimumab in Chinese patients with Crohn's disease (CD).MethodsThirty, adult Chinese patients with CD (CD Activity Index [CDAI] 220–450; high-sensitivity [hs]-C-reactive protein [CRP] ≥3 mg/L) received double-blind adalimumab 160/80 mg or 80/40 mg at weeks 0/2, followed by 40 mg at weeks 4 and 6. An open-label extension period occurred from weeks 8–26; patients received 40 mg adalimumab every other week. Serum adalimumab concentration and change from baseline in fecal calprotectin (FC) were measured during the double-blind period. Clinical remission (CDAI
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