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 improved quality of life

St. George’s Respiratory Questionnaire (SGRQ)

The SGRQ is a validated measure of health impairment for chronic respiratory diseases and is able to address the impact asthma has on a patient's quality of life. A clinically meaningful difference is defined as a reduction in score of 4 points or more.

The improvement in both treatment arms was clinically meaningful."toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"8

Based on the St. George's Respiratory Questionnaire (SGRQ), patients treated with NUCALA were more likely to respond compared with patients receiving placebo, 71% and 55%, respectively (odds ratio [OR] 2.1, 95% CI: 1.3, 3.2)

Statistical hierarchy was not met; endpoint is exploratory and results are descriptive only.

Improvement in SGRQ total score from baseline at Week 32 was –16 points for the group receiving NUCALA (NUCALA added to high-dose ICS and at least 1 other controller; n=194) vs –9 points for the placebo group (placebo added to high-dose ICS and at least 1 other controller; n=191)"toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"8

Asthma Control Questionnaire-5 (ACQ-5)

The ACQ-5 is a 5-item, patient-completed questionnaire that measures a subject’s asthma control. The responder rate is defined as a change in score of 0.5 or more."toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"8

  • The ACQ-5 responder rate for NUCALA was 57% compared with 45% for placebo with odds ratio of 1.8 (95% CI: 1.2, 2.8)

Statistical hierarchy was not met; endpoint is exploratory and results are descriptive only.

Study description: MENSA"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 hospitalizations 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