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Nucala

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Pick section Severe Eosinophilic Asthma (SEA)

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Severe Eosinophilic Asthma (SEA)

REDUCTION IN EXACERBATIONS IN SEA

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CONTROLLED CLINICAL TRIAL DATA

REAL-WORLD EVIDENCE

CONTROLLED CLINICAL TRIAL DATA

MENSA clinical study shows significant reduction in exacerbations after 32 weeks with Nucala vs. placebo1*

The primary endpoint, annualised frequency of clinically significant exacerbations, was met:

Percentage of reduction in exacerbation

*MENSA is a 32-week multicentre, randomised, double-blind, double-dummy, Phase 3, placebo-controlled trial, with an 8-week follow-up safety phase. Primary endpoint: annualised frequency of clinically significant exacerbations, defined as worsening of asthma requiring systemic glucocorticoids for ≥3 days or hospitalisation/ED visit, Nucala: 0.83 (n=194), placebo: 1.74 (n=191; p < 0.001).1

ED, emergency department; SOC, standard of care; SEA, severe eosinophilic asthma.

REAL-WORLD EVIDENCE

REALITI-A: International real-life study shows significant reduction in exacerbations at 1 year with Nucala vs. baseline2*

NA

*Clinically significant exacerbations were defined as those requiring emergency department visit, hospitalisation and /or use/increased dose of OCS.1

CI, confidence interval; ED, emergency department; RR, rate ratio.

Belgian real-life study shows significant reduction in exacerbations after 6 months with Nucala vs. baseline3^

Belgian real-life study : in exacerbation

^Belgian real-world evidence study to confirm the results from the randomised controlled trials in real-life in a population of 116 severe eosinophilic asthmatics treated with mepolizumab and who were followed up at the asthma clinic every month for at least 18 months.3

French real-life ATU study shows reduction in exacerbations after 2 years with Nucala vs. baseline4*

French real-life study : in exacerbation

*French ATU is a retrospective observational study with 146 severe eosinophilic asthma patients. The main limitation of this study was the retrospective nature of the data collection and analysis.4

Spanish real-life REDES study shows significant reduction in exacerbations after 1 year with Nucala vs. baseline5*

Spanish real-life study : in exacerbation

*REDES is a phase 4, multicentric, observational cohort study with 318 SEA patients treated with Nucala across 24 Asthma Units in Spain. Primary endpoint: annual rate of clinically significant exacerbations defined as exacerbations requiring systemic corticosteroids for ≥3 days (or doubling the dose in patients on maintenance OCS) or hospitalisation/ED visit. Mean: 4.5/year at baseline; 1.0/year at 1 year.5

ED, emergency department; OCS, oral corticosteroids; SEA, severe eosinophilic asthma.

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. 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. Harrison T et al. Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis. Eur Respir J. 2020 Oct 15;56(4):2000151.
  3. Schleich F. et al. Real-world experience with mepolizumab: Does it deliver what it has promised?, Clin Exp Allergy 2020:50; 687-695.
  4. Taillé C, Chanez P, Devouassoux G et al. Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme. Eur Respir J 2020; 55: 1902345.
  5. Domingo-Ribas C et al. REAL WORLD Effectiveness and Safety of Mepolizumab in a Multicentric Spanish Cohort of Asthma Patients Stratified by Eosinophiles: The REDES Study. Drug. 2021;81(15):1763-1774.

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PM-NO-MPL-WCNT-230028 - August 2023