Pneumologie 2018; 72(S 01): S17
DOI: 10.1055/s-0037-1619161
Sektion 7 – Klinische Pneumologie
Posterbegehung – Titel: Asthma I
Georg Thieme Verlag KG Stuttgart · New York

Efficacy of mepolizumab in patients with severe eosinophilic asthma who had previously received omalizumab treatment

E Bardford
1   Glaxosmithkline GmbH & Co KG; Research Triangle Park, NC, USA
,
L Nelsen
1   Glaxosmithkline GmbH & Co KG; Research Triangle Park, NC, USA
,
D Bratton
1   Glaxosmithkline GmbH & Co KG; Research Triangle Park, NC, USA
,
F Albers
1   Glaxosmithkline GmbH & Co KG; Research Triangle Park, NC, USA
,
C Taille
2   Hôpital Bichat, Hôpitaux de Paris
,
A Magnan
3   L'institut du Thorax,Université de Nantes, Chu de Nantes
› Author Affiliations
Further Information

Publication History

Publication Date:
21 February 2018 (online)

Also available at
 

Purpose:

Mepolizumab (MEPO) has been shown to improve health-related quality of life (HRQoL) and exacerbation rate in clinical studies of patients with severe eosinophilic asthma (SEA). A substantial proportion of these patients were atopic and had previously received omalizumab (OMA). Therefore, understanding the efficacy of MEPO in this subset of patients is of clinical interest.

Methods:

MUSCA was a Phase IIIb, placebo-controlled, randomised, double-blind study. Patients with SEA and a history of ≥2 exacerbations in the previous year, despite regular high-dose inhaled corticosteroids plus other controller(s), received MEPO 100 mg s.c. or placebo on top of standard of care, every 4 weeks for 24 weeks. Efficacy endpoints included change from baseline in SGRQ, ACQ-5, FEV1 and exacerbation rate at Week 24. A post hoc subgroup analysis was performed to determine the efficacy of MEPO on these endpoints in patients with/without prior OMA use.

Results:

Of the 551 patients in MUSCA, 16% (MEPO n = 40; placebo n = 46) had prior OMA use. In patients with/without prior OMA use, the geometric mean baseline blood eosinophil count was 350/320 cells/µL; mean (SD) baseline SGRQ and ACQ-5 scores were 52.7 (16.6)/45.8 (18.6) and 2.54 (1.01)/2.14 (1.14), respectively. Mean change from baseline in SGRQat Week 24 was greater with MEPO vs. placebo, both in patients with prior OMA use (difference: -13.1 [95% confidence interval [CI]:-19.8,-6.5] and without (difference: -6.6 [95% CI:-9.7,-3.5]). A similar pattern was seen with SGRQ domain scores. ACQ-5 scores also improved from baseline with MEPO vs. placebo in patients who had/had not previously received OMA, with respective treatment differences of -0.91 (95% CI:-1.40,-0.43) and -0.31 (95% CI:-0.50,-0.11). FEV1 improvement and exacerbation rate reduction were similar between patients with/without prior OMA use.

Conclusion:

In patients with SEA, MEPO efficacy on HR-QoL, asthma control, lung function and exacerbation rates was shown regardless of prior OMA treatment, showing consistent and meaningful clinical benefits in this patient population.

Funding:

GSK (200862/NCT02281318).

Abstract previously presented at EAACI 2017 (#0660), Allergy, 2017;72 (Suppl 103):413.