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CLINICAL EFFICACY

  • Powerful protection from exacerbations

    MENSA (Trial 2)1

    Lasting exacerbation rate observed for 4 years

    Post hoc analysis: COLUMBA (4.5-year open-label study)2

    Results are descriptive.

    Results should be interpreted with additional care as results in the latter stages of the trial are based on fewer patients (due to attrition) compared with the first 2 to 3 years.

    Trend of greater reduction in exacerbations with increasing blood eosinophil level

    Post hoc analysis: MENSA (Trial 2)3

    Results are descriptive.

    The post hoc analysis assessed the relationship between baseline blood eosinophil counts and efficacy outcomes after treatment.

    Graph only includes data from patients who received NUCALA or placebo and had blood eosinophil counts ≥150 cells/μL.3,4

  • Powerful reduction in OCS dose

    SIRIUS (Trial 3)5

    Patients treated with NUCALA achieved greater reductions in daily OCS dose, while maintaining asthma control vs placebo (P=0.008)5

    Sensitivity analysis: Daily OCS dose reduction5

    Performed as a sensitivity analysis to the primary endpoint; results are descriptive.

    Lasting reduced OCS dose observed for an additional 52 weeks

    Post hoc analysis: COSMOS (open-label extension study)6

    Durability of OCS Dose Reduction*

    Results are descriptive.

    Graph only includes patients who completed COSMOS.6

    1. *Durability of response was defined as OCS dose reduction when combined with SIRIUS (Trial 3) data.6

    Adapted with permission from Elsevier HS Journal, Inc. ©2016

    93% of patients from SIRIUS (Trial 3) enrolled in COSMOS6

  • Improved lung function

    MUSCA: Pre-bronchodilator FEV13,7

    Week 4 results are descriptive.

    Secondary endpoint: Mean change from baseline in pre-bronchodilator FEV1 at week 24.7

    FEV1=forced expiratory volume in 1 second.

    Numerical improvements in lung function were observed (mean change from baseline in FEV1 with NUCALA vs placebo) at end of treatment (difference [95% CI] in the following 3 controlled trials: MENSA: 98 mL [11, 184]*; SIRIUS: 114 mL [-42, 271]; DREAM 75 mg IV: 61 mL [-39, 161]).

    Improvements were not consistent. Results are descriptive.

    *Statistical hierarchy was not met.

REFERENCES:

  1. Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371:1198-1207.
  2. Khatri S, Moore W, Gibson PG, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019;143(5):1742-1751.
  3. Data on file, GSK.
  4. Ortega HG, Yancey SW, Mayer B, et al. Severe eosinophilic asthma treated with mepolizumab stratified by baseline eosinophil thresholds: a secondary analysis of the DREAM and MENSA studies. Lancet Respir Med. 2016;4(7):549-556.
  5. Bel EH, Wenzel SE, Thompson PJ, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371:1189-1197.
  6. Lugogo N, Domingo C, Chanez P, et al. Long-term efficacy and safety of mepolizumab in patients with severe eosinophilic asthma: a multi-center, open-label, phase IIIb study. Clin Ther. 2016;38(9):2058-2070.e1.
  7. Chupp GL, Bradford ES, Albers FC, et al. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017;5(5):390-400.
  8. Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J. 2002;19(3):398-404.
  9. Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicenter, double-blind, placebo-controlled trial. Lancet. 2012;380:651-659.