Background Mepolizumab is approved for severe eosinophilic asthma in adults and, in some regions, adolescents (12 – 17 years old). Efficacy results in children (6 – 11 years old) have yet to be compared to data from adults and adolescents.
Methods Asthma exacerbation incidence and asthma control questionnaire (ACQ-5) responder rates were taken from adult/adolescents in double-blind, placebo controlled studies (NCT01000506, NCT01691521, NCT02281318, NCT01691508) of mepolizumab 75 mg to 750 mg while children (40 mg SC if < 40 kg, 100 mg SC if ≥ 40 kg) were assessed in one open-label, uncontrolled study (NCT02377427). Comparisons after 12 weeks of treatment were considered post-hoc.
Results Subjects had similar mean exacerbation rates in the year prior to study: 4.0 in children and 2.8 – 3.6 in adolescents/adults. All subjects reported at least 2 exacerbations in the prior year. The incidence of exacerbations after 12 weeks of mepolizumab treatment was consistent between children and adolescents/adults (Table). The ACQ-5 responder rate (minimal clinically important reduction ≥ 0.5 points) at 12 weeks was 55% in children, 33 – 63% in adolescents, and 52 – 56% in adults.
Conclusions Mepolizumab in children with severe eosinophilic asthma results in similar efficacy (exacerbations and ACQ-5) when compared to adolescents/adults after 12 weeks.
Funding GSK
Tab. 1 Exacerbation Incidence After 12 Weeks of Treatment
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Children
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Adults/Adolescents
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|
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200 363
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MEA112997
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MEA115588
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200 862
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MEA115575
|
|
1 A range of Kaplan Meier estimates provided where > 1 mepolizumab dose studied
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Placebo
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Not available
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39.2%
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38.2%
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27.9%
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44.2%
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Mepolizumab1
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27.8%
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14.9% −22.7%
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19.9% −25.0%
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12.2%
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30.0%
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Abstract previously presented at ERS 2018 (#PA5447).
