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Published on: August 9, 2019
CDP571, a humanized anti-tumor necrosis factor-alpha monoclonal antibody in pediatric Crohn's disease
Petar Mamula1, Stanley A Cohen, George D Ferry
1Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, USA. mamula@email.chop.edu
Insights
This study found CDP571 to be safe and well-tolerated in pediatric Crohn's disease patients. Treatment showed early signs of efficacy, with most patients responding within two weeks.
Area of Science:
- Pediatric Gastroenterology
- Immunology
- Pharmacokinetics
Background:
- Crohn's disease is a chronic inflammatory bowel disease affecting children.
- Limited treatment options exist for pediatric Crohn's disease.
- CDP571 is an investigational biologic therapy.
Purpose of the Study:
- To assess the safety of CDP571 in pediatric Crohn's disease patients.
- To evaluate the pharmacokinetics and immunogenicity of CDP571.
- To determine the preliminary efficacy of CDP571.
Main Methods:
- Open-label, single-dose (10 mg/kg) infusion of CDP571 in pediatric patients (6-17 years).
- Monitoring of adverse events, plasma concentrations, and clinical laboratory values.
- Assessment of disease activity using the Pediatric Crohn's Disease Activity Index (PCDAI).
Main Results:
- Twenty patients enrolled; 14 reported mild to moderate adverse events.
- CDP571 exhibited a plasma half-life of approximately 2 weeks.
- Early treatment response (PCDAI reduction >10) observed by Week 2 in 13/20 patients.
Conclusions:
- CDP571 demonstrated a favorable safety profile in pediatric Crohn's disease.
- The drug was well-tolerated, with manageable adverse events.
- Preliminary efficacy suggests potential therapeutic benefit in this population.
Objectives:
The objectives of this study were to evaluate the safety, pharmacokinetics, and immunogenicity of CDP571 in pediatric patients with Crohn's disease.
Methods:
A single dose of CDP571, 10 mg/kg, was administered by infusion to pediatric patients (aged 6-17 years) with Crohn's disease in a 12-week open-label study. Adverse events were monitored during infusion and throughout the study. Plasma concentrations of CDP571 and standard clinical and laboratory values were assessed. Changes in disease activity were monitored using the Pediatric Crohn's Disease Activity Index (PCDAI).
Results:
Twenty patients were enrolled and stratified by age: 6 to 13 (n = 9) and 14 to 17 years (n = 11). Fourteen patients experienced adverse events, which were mainly mild or moderate in intensity. The plasma concentration profile was consistent with a half-life of approximately 2 weeks. At Week 4, 4 patients in the 6- to 13-year-old group and 2 patients in the 14- to 17-year-old group had detectable anti-CDP571 antibodies. By Week 2, 7 patients in the 6- to 13-year-old group and 6 patients in the 14- to 17-year-old group had responded to treatment (reduction in PCDAI score >10 points).
Conclusion:
In conclusion, CDP571 was well tolerated among pediatric patients with Crohn's disease.
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