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Measuring the Functional Abilities of Children Aged 3-6 Years Old with Observational Methods and Computer Tools
Published on: June 20, 2020
Subcutaneous mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma
Atul Gupta1, Isabelle Pouliquen2, Daren Austin2
1King's College Hospital NHS Foundation Trust, King's College London, London, UK.
Insights
Mepolizumab subcutaneous therapy in children aged 6-11 with severe eosinophilic asthma showed comparable pharmacokinetics and pharmacodynamics to adults. This anti-interleukin-5 treatment demonstrated significant reductions in blood eosinophil counts.
Area of Science:
- Pharmacology
- Pediatric Asthma
- Immunotherapy
Background:
- Limited data exists on anti-interleukin-5 therapy for children under 12 with asthma.
- Severe eosinophilic asthma in children requires effective treatment options.
Purpose of the Study:
- To assess the pharmacokinetics and pharmacodynamics of mepolizumab in children aged 6-11 with severe eosinophilic asthma.
- To compare mepolizumab's profile in this pediatric group to adult data.
Main Methods:
- An open-label, multinational study involving 36 children aged 6-11 with severe eosinophilic asthma.
- Mepolizumab was administered subcutaneously at 40mg or 100mg every 4 weeks for 12 weeks, based on body weight.
- Pharmacokinetic and pharmacodynamic parameters, including blood eosinophil counts, were monitored.
Main Results:
- Mepolizumab exposure in children was comparable to adults, with higher exposures and lower clearance than predicted.
- Blood eosinophil counts decreased significantly by 83-89% at week 12.
- The treatment was well-tolerated, with no new safety concerns identified.
Conclusions:
- Subcutaneous mepolizumab in children aged 6-11 with severe eosinophilic asthma achieves bodyweight-adjusted drug exposure within twofold of adult targets.
- The therapy resulted in marked reductions in blood eosinophil counts, similar to adult outcomes.
- Mepolizumab demonstrated a positive clinical profile in this pediatric population.
Objectives:
There are no published reports for anti-interleukin-5 therapy in children <12 years with asthma. The primary objective of this study was to characterize the pharmacokinetics and pharmacodynamics of mepolizumab following subcutaneous (SC) administration in children 6 to 11 years-of-age with severe eosinophilic asthma.
Hypothesis:
Mepolizumab SC pharmacokinetics and pharmacodynamics in children with severe eosinophilic asthma are comparable with adults.
Study Design:
Multinational, nonrandomised, open-label (NCT02377427).
Patient Selection:
Children 6 to 11 years-of-age with severe eosinophilic asthma (blood eosinophil count ≥150 cells/µL at screening or ≥300 cells/µL <12 months of screening) and ≥2 exacerbations in the prior year.
Methodology:
Children received mepolizumab SC 40 mg (bodyweight <40 kg) or 100 mg (≥40 kg) every 4 weeks for 12 weeks.
Results:
Thirty-six children received mepolizumab (40 mg, n = 26; 100 mg, n = 10). Mepolizumab exposures were higher and apparent clearance lower than predicted based on prior existing data. Derived mepolizumab exposures normalized to mean bodyweight for the 40 mg and 100 mg dose groups were 454 μg * day/mL and 675 μg * day/mL, respectively. At week 12, blood eosinophils were reduced by 89% and 83% from baseline to 42 and 55 cells/µL, respectively. Mepolizumab was well tolerated; no new safety signals were observed compared with previous adult/adolescent studies.
Conclusion:
In children 6 to 11 years-of-age with severe eosinophilic asthma, mepolizumab SC 40 or 100 mg provided bodyweight-adjusted drug exposure within twofold of target adult exposure as well as marked reductions to blood eosinophil counts similar to adults, and although not designed to evaluate efficacy outcomes, demonstrated a positive clinical profile.
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