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 significantly reduced exacerbations (MENSA study)

Exacerbations of asthma were defined as the worsening of asthma that required use of oral/systemic corticosteroids and/or hospitalization and/or emergency department (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."toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"8

Patients were randomized to receive either NUCALA added to SOC (n=194) or placebo added to SOC (n=191). At Week 32 the rate of exacerbations for the NUCALA group was 0.83 vs 1.74 for the placebo group.

Secondary endpoint

NUCALA added to SOC resulted in fewer exacerbations requiring hospitalization and/or ED visits compared with placebo added to high-dose ICS and at least 1 other controller.

The rate of exacerbations requiring hospitalization and/or emergency room visits was 0.08/year for the group receiving NUCALA vs 0.20/year for the placebo group (P=0.015)."toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"8

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

A 32-week study that evaluated the efficacy and safety of NUCALA compared with placebo.

Primary endpoint: Frequency of exacerbations.

Secondary endpoint: 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