Pneumologie 2019; 73(S 01)
DOI: 10.1055/s-0039-1677972
Freie Vorträge (FV DGP 2) – Sektion Pädiatrische Pneumologie
Freie Vorträge der Sektion Pädiatrische Pneumologie
Georg Thieme Verlag KG Stuttgart · New York

Mepolizumab for severe eosinophilic asthma: a comparison of efficacy in children, adolescents, and adults

A Gupta
1   Department of Paediatric Respiratory Medicine, Kingʼs College Hospital & Kingʼs College London
,
J Steinfeld
1   Department of Paediatric Respiratory Medicine, Kingʼs College Hospital & Kingʼs College London
,
RG Price
2   Clinical Statistics, Gsk, Stevenage, Hertfordshire, UK
,
J Azmi
3   Respiratory Therapeutic Area, Gsk, Stockley Park, Uxbridge, UK
,
E Bradford
4   Respiratory Therapeutic Area, Gsk, Research Triangle Park, Nc, USA
,
S Yancey
4   Respiratory Therapeutic Area, Gsk, Research Triangle Park, Nc, USA
› Author Affiliations
Further Information

Publication History

Publication Date:
19 February 2019 (online)

 

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

Children

Adults/Adolescents

200 363

MEA112997

MEA115588

200 862

MEA115575

1  A range of Kaplan Meier estimates provided where > 1 mepolizumab dose studied

Placebo

Not available

39.2%

38.2%

27.9%

44.2%

Mepolizumab1

27.8%

14.9% −22.7%

19.9% −25.0%

12.2%

30.0%

Abstract previously presented at ERS 2018 (#PA5447).