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Efficacy and Safety

View a quick overview of the core efficacy and safety data for Nucala (mepolizumab) in adults with severe refractory eosinophilic asthma, with access to detailed summaries of the key MENSA and SIRIUS studies.

Top 10 efficacy and safety facts

1. Nucala is a targeted anti-IL-5 add-on therapy for adults, adolescents and children ≥ 6 years with severe refractory eosinophilic asthma 1

Nucala is a humanised monoclonal antibody that inhibits the bioactivity of interleukin (IL)-5 1

  • Nucala blocks the binding of IL-5 to the alpha chain of the IL-5 receptor complex on the eosinophil cell surface. 12
  • This inhibits IL-5 signalling and reduces the growth, differentiation, recruitment, activation and survival of eosinophils. 23

Discover how Nucala works. Watch the mode of action video

2. Nucala significantly reduced exacerbations by 53% (MENSA primary endpoint) 4

Nucala added to high dose ICS and an additional maintenance treatment(s) reduced clinically significant exacerbations vs. placebo added to high dose ICS and an additional maintenance treatment(s) by 53% (95% CI 36-65%, p<0.001) 4

  • Clinically significant exacerbations of asthma were defined as the worsening of asthma that required use of systemic corticosteroids or required hospitalisation and/or emergency department visits. 4

Discover more about the MENSA study outcomes

3. Nucala significantly reduced exacerbations resulting in hospitalisation and/or emergency department (ED) visits by 61% (MENSA secondary endpoint) 4

Nucala added to high dose ICS and an additional maintenance treatment(s) also significantly reduced exacerbations resulting in hospitalisations and/or emergency department (ED) visits vs. placebo added to high dose ICS and an additional maintenance treatment(s) by 61% (Nucala: 0.08/year, placebo: 0.2/year; 95% CI 17-82%; p=0.02) 4

Discover more about the MENSA study outcomes

4. Nucala improved quality of life (SGRQ, MENSA secondary endpoint) 4

Nucala added to high dose ICS and an additional maintenance treatment(s) improved* health-related quality of life (measured using St. George’s Respiratory Questionnaire [SGRQ]) vs. placebo added to high dose ICS and an additional maintenance treatment(s) by 7.0 units (95% CI -10.2 to -3.8, p<0.001). 4

  • The SGRQ is a validated, disease-specific health status assessment for use in asthma and COPD and a difference of ≥4.0 units is considered clinically meaningful. 5

Statistical significance cannot be inferred due to the hierarchical ‘gate-keeping’ approach used. The p-values provided are unadjusted for multiple comparisons 4

Discover more about the MENSA study outcomes

5. Nucala improved lung function (MENSA secondary endpoint).

Nucala added to high dose ICS and an additional maintenance treatment(s) improved lung function (as measured by pre-bronchodilator FEV1) vs. placebo added to high dose ICS and an additional maintenance treatment(s) by 98mL (95% CI 11-184mL; p=0.03). 4

Statistical significance cannot be inferred due to the hierarchical ‘gate-keeping’ approach used. The p-values provided are unadjusted for multiple comparisons. 4

Discover more about the MENSA study outcomes

6. Nucala reduced daily OCS dose while maintaining symptom control (SIRIUS primary endpoint)

The odds of achieving a reduction in OCS dose while maintaining symptom control were 2.39 times higher in patients receiving Nucala vs. placebo, when both were added to high dose ICS and an additional maintenance treatment(s) (95% CI 1.25-4.65; p=0.008) 6

Discover more about the SIRIUS study outcomes

7. Safety profile of Nucala

A total of 915 patients with severe refractory eosinophilic asthma have received either a subcutaneous (SC) or an intravenous (IV) dose of Nucala during clinical studies of 24 to 52 weeks duration. Nucala is licensed for SC use only. 1

The most commonly reported adverse reactions during treatment were headache, injection site reactions and back pain. 1

8. Nucala had a similar safety profile compared with placebo when added to high dose ICS and an additional maintenance treatment(s), except for injection site reactions which were more common in the Nucala group (8% (21/263) for Nucala, 3% (8/257) for placebo) 1

In both MENSA5 and SIRIUS7 studies, the incidences of adverse events and serious adverse events with Nucala were found to be similar to placebo when both were added to high dose ICS and an additional maintenance treatment(s), with the exception of injection site reactions. 1

10. Injection site reactions with Nucala treatment mainly occurred at the start of treatment

In clinical studies, injection site reactions were more frequent in patients treated with Nucala (8% [21/263]) as compared to placebo (3%) [8/257]). 1 5 6

  • Injection site reactions occurred mainly at the start of treatment and within the first three injections, with fewer reports on subsequent injections. 1

11. Special warnings and precautions for use 

  • Nucala should not be used to treat acute asthma exacerbations.
  • Asthma-related adverse events or exacerbations may occur during treatment. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
  • Abrupt discontinuation of corticosteroids after initiation of Nucala is not recommended. Reduction in corticosteroid doses, if required, should be gradual and performed under the supervision of a physician.
  • Hypersensitivity and administration-related reactions: Acute and delayed systemic reactions, including hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, rash, bronchospasm, hypotension), have occurred following administration of Nucala. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., typically within several days). These reactions may occur for the first time after a long duration of treatment.
  • Parasitic infections: Patients with pre-existing helminth infections should be treated before starting therapy. If patients become infected whilst receiving treatment with Nucala and do not respond to anti-helminth treatment, temporary discontinuation of Nucala should be considered.

Find out how to identify patients who may benefit from Nucala

Watch the Nucala reconstitution video

References:

  1.  Nucala SmPC.
  2. Garcia G, Taillé C, Laveneziana P et al. Anti-interleukin-5 therapy in severe asthma. Eur Respir Rev 2013; 22(129):251-257.
  3. Kouro T and Takatsy K. IL-5- and eosinophil-mediated inflammation: from discovery to therapy. Int Immunol 2009; 21(12):1303-1309.
  4. Ortega H, Liu MC, Pavord ID et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371:1198-1207.
  5. Jones PW. St. George's Respiratory Questionnaire: MCID. COPD 2005; 2(1):75-79.
  6. Bel E, Wenzel SE, Thompson PJ et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014; 371(13):1189-1197.

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