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CLINICAL EFFICACY

NUCALA: Proven protection from exacerbations

MENSA (32 weeks)1

SOC=standard of care.

NUCALA: Proven protection from exacerbations requiring
hospitalizations/ED visits

 

ED=emergency department.

Trend of greater reduction in exacerbations with
increasing blood eosinophil level


Post hoc analysis: MENSA2

The post hoc analysis assessed the relationship between baseline blood eosinophil counts and efficacy outcomes after treatment.
Graph includes data only from patients who received NUCALA or placebo and had blood eosinophil counts ≥150 cells/µL.
2,6

NUCALA: Exacerbation rate in severe eosinophilic asthma
patients by presence of nasal polyps

MENSA/MUSCA post hoc meta-analysis:
Subgroup Analysis2

Results are descriptive.

Mean baseline blood eosinophil levels: current nasal polyps, 440 cells/µL; no nasal polyps, 290 cells/µL; total patient population, 330 cells/µL.2
 

*Nasal polyps reported by patient and assessed by investigator at baseline.
 

MENSA/MUSCA post hoc study design: Post hoc meta-analysis that evaluated annual rate of exacerbations in select subgroups of patients with severe eosinophilic asthma.

NUCALA: Exacerbation rate in severe eosinophilic
asthma patients by atopic status

MENSA/MUSCA post hoc meta-analysis:
Subgroup Analysis9

Results are descriptive.

Of the total population (N=936), 907 patients had analyzable data.9

* Positive atopic status defined as a RAST score ≥3 (ie, High or Very High allergic response) on at least 1 of 5 allergens: house dust mite, dog dander, cat dander, Alternaria, and cockroach.9

RAST=radioallergosorbent test.

NUCALA: Proven reduction in OCS dose

 

SIRIUS8

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

Sensitivity analysis*: Daily OCS dose reduction

*Sensitivity analysis to the primary endpoint.

REFERENCES:

  1. Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-1207.
  2. Data on file, GSK.
  3. Juniper JF, Svensson K, Mörk AC, Stahl E. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med. 2005;99(5):553-558.
  4. Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George’s Respiratory Questionnaire. Am Rev Respir Dis. 1992:145(6):1321-1327.
  5. Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J. 2002;19(3):398-404.
  6. 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.
  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. Bel EH, Wenzel SE, Thompson PJ, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189-1197.
  9. Humbert M, Albers FC, Bratton DJ, et al. Effect of mepolizumab in severe eosinophilic asthma according to omalizumab eligibility. Resp Med. 2019;154:69-75. https://doi.org/10.1016/j.rmed.2019.06.004.