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Pick section Severe Eosinophilic Asthma (SEA)

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Severe Eosinophilic Asthma (SEA)

NUCALA IN SEA WITH COMORBID CRSwNP

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CLINICAL STUDY IN SEA WITH COMORBID NASAL POLYPS

REAL WORLD IN SEA WITH COMORBID NASAL POLYPS

SEA WITH COMORBID NASAL POLYPS

CLINICAL STUDY IN SEA COMORBID WITH NASAL POLYPS

NUCALA REDUCES EXACERBATIONS (MENSA/MUSCA POST-HOC META-ANALYSIS)1,2,3

Exacerbation in SEA with comorbid nasal polyps

NUCALA IMPROVES NASAL POLYPS SYMPTOMS AND DELIVERS ASTHMA CONTROL (MUSCA POST-HOC ANALYSIS)2

Nucala on symptom improvement in SEA with comorbid nasal polyps

*Based on meta-analysis of 936 patients in MENSA and MUSCA, to determine change in HRQoL in Nucala-treated patients with SEA either with or without nasal polyps.2 MENSA and MUSCA were Phase 3 placebo-controlled, randomised, double-blind, parallel group, multicentre studies.1,3 Primary endpoint in MENSA, annualised frequency of clinically significant exacerbations (defined as worsening of asthma that required systemic glucocorticoids for 3 or more days, or hospitalisation/emergency department visit), was met (p <0.001).3 Primary endpoint in MUSCA, mean change from baseline in SGRQ scores at Week 24, was met (p <0.0001).1 166/936 patients (18%) had nasal polyps at screening. Mean exacerbation rates were 3.1±2.1 for patients with nasal polyps and 3.2±2.3 for patients without.2

Cl, confidence interval; HRQoL, health-related quality of life; LS, least squares; MCID, minimal clinically important difference; RR, rate ratio; SC, subcutaneous; SEA, severe eosinophilic asthma; SGRQ, St. George's Respiratory Questionnaire; SNOT-22, sino-nasal outcome test 22-items.

REAL-WORLD IN SEA COMORBID WITH NASAL POLYPS

REALITI-A POST HOC ANALYSIS4**: NUCALA PROVIDES OCS REDUCTION FOR SEA PATIENTS WITH COMORBID NASAL POLYPS4

REALITI-A: OCS dose in SEA with comorbid nasal polyps

**REALITI-A is an international, prospective, single-arm, obeservational cohort study. Primary endpoint: rate of clinically significant exacerbations defined as exacerbations requiring OCS and/or hopspitalisation/ED visit was met, p>0.001 (n=368).4

SELECTED SAFETY INFORMATION

Warnings/Precautions: Should not be used to treat acute asthma exacerbations. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after starting treatment. Abrupt discontinuation of corticosteroids after initiation of mepolizumab treatment is not recommended.

Allergic reactions: Acute and delayed systemic reactions, including hypersensitivity reactions, have occurred following administration of mepolizumab. Patients should be instructed to seek medical attention immediately if allergic reactions occur. In the event of a hypersensitivity reaction, appropriate treatment as clinically indicated should be initiated.

Parasitic infections: Pre-existing helminth infections should be treated before starting therapy. If patients become infected whilst receiving treatment with mepolizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.

Adverse reactions: In clinical studies in patients with severe refractory eosinophilic asthma, headache, injection site reactions and back pain were the most commonly reported adverse reactions during treatment.

References

  1. 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;5:390-400.
  2. Howarth P, Chupp G, Nelsen LM, et al. Severe eosinophilic asthma with nasal polyposis: A phenotype for improved sinonasal and asthma outcomes with mepolizumab therapy.J Allergy Clin lmmunol. 2020;145(6):1713-1715.
  3. 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
  4. Harrison T, Canonica GW, Chupp G et al. Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis. Eur Respir J. 2020 Oct 15;56(4):2000151.

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PM-NO-MPL-WCNT-230024 - September 2023