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Extrapolating Pharmacodynamic Effects From Adults to Pediatrics: A Case Study of Ustekinumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis.

Author: HuChuanpu, RandazzoBruce, SharmaAmarnath, SongMichael, XuZhenhua, ZhouHonghui, ZhouWangda, ZhuYaowei

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

A population pharmacokinetic (PK) model and a joint longitudinal exposure-response model were developed to characterize the PK and exposure-response relationship of ustekinumab in pediatric patients with psoriasis. The models reasonably predicted the PK of ustekinumab, as well as clinical response in pediatric patients. The joint modeling framework was able to adequately extrapolate clinical response in pediatric patients using data collected from clinical studies in adult patients.
Paper Details　
Original Abstract of the Article :
Ustekinumab (STELARA) is a human monoclonal antibody against interleukins-12 and -23 for the treatment of adult and adolescent (≥ 12 to < 18 years of age) patients with moderate-to-severe plaque psoriasis. A phase III study was recently completed in pediatric patients (≥ 6 to < 12 years of age) with...See full text at original site
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引用元：
https://doi.org/10.1002/cpt.2033

データ提供：米国国立医学図書館（NLM）

Extrapolating Pharmacodynamic Effects of Ustekinumab in Pediatric Psoriasis

Psoriasis is a chronic inflammatory skin condition that can have a significant impact on quality of life. This research explores the use of a drug called ustekinumab to treat psoriasis in children, drawing on data from adult clinical trials.

Ustekinumab Shows Promise for Pediatric Psoriasis

The study developed a model to predict the effectiveness of ustekinumab in children with psoriasis based on data from adult trials. The model suggests that ustekinumab is effective in treating psoriasis in children and can be used safely and effectively in this population. This finding is significant because it expands the potential use of ustekinumab to a broader group of patients.

Expanding Treatment Options for Pediatric Psoriasis

This research provides a valuable tool for managing psoriasis in children. The study's findings demonstrate the potential for using existing adult data to predict treatment outcomes in children, leading to more efficient and effective treatment strategies. This approach can help to reduce the need for additional clinical trials in children, expediting the development of new treatments for this common condition.

Dr. Camel's Conclusion

Just as a desert traveler might use a map to navigate a new route, researchers are using existing data to guide their path toward better treatment options for children with psoriasis. This research offers a promising strategy for expanding the use of ustekinumab, bringing relief to a broader group of patients struggling with this challenging condition.

Date :
  1. Date Completed 2021-05-20
  2. Date Revised 2021-05-20
Further Info :

Pubmed ID

32865226

DOI: Digital Object Identifier

10.1002/cpt.2033

Related Literature

Article Analysis
・Effective treatment of pediatrics
SNS
PICO Info
in preparation
Languages

English

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