CONTRAINDICATIONS
NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

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NUCALA lowered the risk of time to first exacerbation (MENSA study)

  • By Week 32, the probability of having an exacerbation was lower with NUCALA added to high-dose inhaled corticosteroid (ICS) and at least 1 other controller, with or without oral corticosteroids (OCS) vs placebo added to high-dose ICS and at least 1 other controller (32.8% vs 56.4%, respectively, Hazard ratio = 0.44, 95% CI: 0.32, 0.60)"toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"8
 
Results are descriptive only; statistical significance cannot be inferred.

 

Time to first exacerbation"toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"8

* SOC=standard of care (regular treatment with high-dose inhaled corticosteroid and at least 1 other controller with or without oral corticosteroids).

 

Study Description: MENSA (Trial 2)"toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"8 (Trial 2)

Design: 32-week study comparing treatment with NUCALA or placebo in 576 patients with severe asthma with an eosinophilic phenotype (identified by blood eosinophil counts ≥150 cells/μL at initiation of treatment [within 6 weeks of dosing] or ≥300 cells/μL in the past 12 months).

Primary endpoint: Frequency of exacerbations.

Secondary endpoint: Included frequency of exacerbations requiring hospitalization and/or ED visits.

Exacerbation definition: Exacerbations of asthma were defined as the worsening of asthma that required use of oral/systemic corticosteroids and/or hospitalization and/or ED visits; for patients requiring maintenance oral/systemic corticosteroids, exacerbations were defined as at least double the existing maintenance dose for at least 3 days.

View full MENSA study design >

   818427R0 April 2017