Journal article
Adalimumab induction and maintenance therapy achieve clinical remission and response in Chinese patients with Crohn's disease.
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
Intestinal Research | Korean Association for the Study of Intestinal Diseases | Published : 2016
Abstract
This was a Phase 2 study (NCT02015793) to evaluate the pharmacokinetics, safety, and efficacy of adalimumab in Chinese patients with Crohn's disease (CD). Methods: Thirty, 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 < 150), response (decrease in CDAI ≥7..
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Funding Acknowledgements
AbbVie funded the study. AbbVie participated in the study design, data collection, data management, data analysis, review and approval of the publication. All authors were involved in the design of the analyses reported in the manuscript, interpretation of the data, and critical review and revision of each draft of the manuscript. All authors had access to relevant data and approved the content of the manuscript for submission. Medical writing support was provided by Adebusola A. Ajibade, PhD, of AbbVie Inc.