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Frequently Asked Questions

Find out answers to frequently asked questions concerning severe refractory eosinophilic asthma and add-on treatment with Nucala.

About severe eosinophilic asthma

What is severe eosinophilic asthma?

Severe asthma is a heterogeneous disease comprised of different phenotypes with specific clinical and pathophysiological features. 12

Severe eosinophilic asthma is an identifiable severe asthma phenotype, characterised by eosinophilic inflammation 13

  • In this condition, eosinophil levels are a useful biomarker for asthma symptoms and severity 45
  • Increased numbers of blood eosinophils can be associated with severe asthma exacerbations 367

What are eosinophils?

Eosinophils are white blood cells and are activated by lymphocytes of the adaptive immune response. 7They also play a role in maintaining long-term inflammation and exacerbation risk, under the control of interleukin(IL)-5. 689

Eosinophilic airway inflammation 4

What is the role of IL-5?

IL-5 is the major cytokine responsible for the growth, differentiation, recruitment, activation and survival of eosinophils. 11

What is the difference between severe eosinophilic and severe allergic asthma?

These asthma phenotypes are distinct:

Severe eosinophilic asthma is a phenotype of severe asthma characterised by sputum and blood eosinophils, frequent exacerbations and high nitric oxide (measured using FeNO) 1-31213

Severe allergic asthma is defined as asthma with the inherited predisposition to generate immunoglobulin E (IgE) against common environmental allergens 1114

 

Learn more about severe eosinophilic asthma

About Nucala

What is Nucala?

Nucala is a targeted anti-IL-5 add-on therapy for adults, adolescents and children ≥ 6 years with severe refractory eosinophilic asthma 7

How do I identify appropriate patients for Nucala?

The Nucala clinical development programme evaluated efficacy in a targeted group of patients with severe refractory eosinophilic asthma most likely to benefit from treatment using 3 criteria:

Current therapy – high doses of inhaled corticosteroids (ICS, e.g. fluticasone propionate ≥1000 μg or budesonide ≥1600 μg per day 1) and an additional maintenance treatment(s)

Exacerbation history – two or more exacerbations in the prior 12 months and/or dependency on systemic corticosteroids

Blood eosinophil level – ≥150 cells/μL (≥0.15 x 109 cells/L) at initiation of treatment or ≥300 cells/μL (≥0.3 x 109 cells/L) in the prior 12 months (determined through a routine blood test)

How does Nucala work?

Nucala blocks the binding of IL-5 to the alpha chain of the IL-5 receptor complex on the eosinophil cell surface. This inhibits IL-5 signalling and reduces the growth, differentiation, recruitment, activation and survival of eosinophils 7111215

What are the potential benefits of treatment with Nucala?

In clinical trials, Nucala added to high dose ICS and an additional maintenance treatment(s) demonstrated improvements in certain clinical endpoints vs. placebo added to high dose ICS and an additional maintenance treatment(s):

  • reduced clinically significant exacerbations* by 53% (MENSA primary endpoint, Nucala: 0.83/year, placebo: 1.74/year, 95% CI 36-65%; p<0.001) 15
  • improved quality of life (SGRQ) by 7.0 units (MENSA secondary endpoint, Nucala: -16.0 units, placebo: -9.0 units; 95% CI -10.2 to -3.8; p<0.001)† 15
  • improved lung function (pre-bronchodilator FEV1) by 98mL (MENSA secondary endpoint, Nucala: 183mL, placebo: 86mL, 95% CI 11-184mL; p=0.03)† 15
  • reduced daily OCS dose, while maintaining asthma control (SIRIUS primary endpoint likelihood of reduction 2.39 times greater with Nucala than with placebo, 95% CI 1.25-4.56; p=0.008) 17

In placebo-controlled clinical trials with Nucala (added to high dose ICS and additional maintenance treatment[s]), the rate of adverse events was similar across treatment arms, with the exception of injection site reactions (8% [21/263] for Nucala, 3% [8/257] for placebo) 71617

*Clinically significant exacerbations of asthma were defined as the worsening of asthma that required use of systemic corticosteroids for at least three days or required hospitalisation and/or ED visits 16

†This secondary study endpoint is clinically meaningful, however, statistical significance cannot be inferred due to the hierarchical ‘gatekeeping’ approach used.

Learn more about the MENSA and SIRIUS study outcomes

Safety

What is the 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. 7

In placebo-controlled clinical trials with Nucala (added to high dose ICS and additional maintenance treatment[s]), the rate of adverse events was similar across treatment arms, with the exception of injection site reactions (8% [21/263] for Nucala, 3% [8/257] for placebo) 7

The most commonly reported adverse reactions during treatment were headache, injection site reactions and back pain. Systemic reactions, including hypersensitivity, were reported at an incidence comparable to that of placebo. 7

The most common symptoms associated with subcutaneous injections included: pain, erythema, swelling, itching, and burning sensation. These occurred mainly at the start of treatment and within the first 3 injections with fewer reports on subsequent injecitons. 7

In phase III clinical trials, the incidences of adverse events (AEs) and serious adverse events (SAEs) with Nucala were found to be similar to placebo when both were added to high dose ICS and an additional maintenance treatment(s) 1617

Incidences of adverse events and serious adverse events 1617

Find out more about the Efficacy and Safety of Nucala

What were the most frequent adverse events?

In clinical studies in subjects with severe refractory eosinophilic asthma, the most commonly reported adverse reactions during treatment were headache, injection site reactions and back pain. The safety profile was similar for Nucala and placebo except for injection site reactions, which were more frequent with Nucala (8% [21/263] for Nucala, 3% [8/257] for placebo). 71617

What about injection site reactions?

In clinical studies injection site reactions were more frequent in patients treated with Nucala (8% [21/263]) compared with placebo (3% [8/257]). Injection site reactions occurred mainly at the start of treatment and within the first 3 injections with fewer reports on subsequent injections. The most common symptoms associated with SC injections included: pain, erythema, swelling, itching and burning sensation. 71617

Discover the potential benefits of add-on treatment with Nucala

Dosing and administration

How is Nucala administered?

Nucala is administered as a single SC injection to the upper arm, thigh or abdomen, administered once every 4 weeks. For adults and adolescents ≥12 years, 100mg (1.0mL) is the administered dose. For children aged 6 to 11 years old, 40mg (0.4mL) is the administered dose. It must also be administered by a healthcare professional. 7

Find out more about how to administer Nucala

How is Nucala supplied?

Nucala is provided as a lyophilised, white powder in a single-use vial for SC injection only. 15Nucala is available in a pack containing one single use vial.

How is Nucala prepared?

Nucala should be reconstituted before administration. 7

Reconstitute the contents of the vial with 1.2mL of sterile water for injection, preferably using a 2 to 3mL syringe and a 21G needle. 7

Note: the reconstituted solution must not be shaken during the procedure as this may lead to product foaming or precipitation. Reconstitution is typically complete within 5 minutes after the sterile water has been added, but it may take additional time. 7

Watch the Reconstitution Video to find out how to prepare Nucala.

For complete reconstitution and dilution instructions, visit the Dosage and Administration section of this site, or see the full Prescribing Information.

Can a patient self‐administer Nucala?

No. Nucala should only be administered by a healthcare professional. 7

How should Nucala be stored?

The shelf-life of an unopened vial of Nucala is 4 years: 7

  • Store below 25°C
  • Do not freeze
  • Keep the vial in the outer carton in order to protect from light

References:

  1. Chung KF, Wenzel SE, Brozek JL et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014;43(2): 343-373.
  2. Campo P, Rodríguez F, Sánchez-García S et al. Phenotypes and endotypes of uncontrolled severe asthma: new treatments. J Investig Allergol Clin Immunol 2013; 23(2):76-88.
  3. Wenzel SE. Asthma: defining of the persistent adult phenotypes. Lancet 2006; 368(9537):804-813.
  4. Spahn J Covar R, Stempel DA. Asthma: Addressing consistency in results from basic science, clinical trials, and observational experience. J Allergy Clin Immunol 2002; 109 (5, Supplement): S490-S502.
  5. Pavord I, Bafadhel M. Exhaled nitric oxide and blood eosinophilia: independent markers of preventable risk. J Allergy Clin Imunol 2013; 132(4):828–829.
  6. Malinovschi A, Fonseca JA, Jacinto T et al. Exhaled nitric oxide levels and blood eosinophil counts independently associate with wheeze and asthma events in National Health and Nutrition Examination Survey subjects. J Allergy Clin Immunol 2013; 132(4):821–827.
  7.  Nucala SmPC.
  8. Janeway CA Jr, et al. Immunobiology: The Immune System in Health and Disease. 5th ed. New York: Garland Science; 2001.
  9. Patterson MF, Borish L, Kennedy JL. The past, present, and future of monoclonal antibodies to IL-5 and eosinophilic asthma: a review. J Asthma Allergy 2015; 8:125-34. doi: 10.2147/JAA.S74178. eCollection 2015.
  10. Heaney LLG, Brightling CE, Menzies-Gow A et al. Refractory asthma in the UK: cross-sectional findings from a UK multicentre registry. Thorax 2010; 65(9):787-794.
  11. Kouro T and Takatsu K. IL-5- and eosinophil-mediated inflammation: from discovery to therapy. Int Immunol 2009; 21(12):1303-1309.
  12. Garcia G, Taillé C, Laveneziana P et al. Anti-interleukin-5 therapy in severe asthma. Eur Respir Rev 2013; 22(129):251-257.
  13. Corren J. Asthma phenotypes and endotypes: an evolving paradigm for classification. Discov Med 2013; 15(83):243–249.
  14. Mukherjee AB and Zhang Z. Allergic asthma: influence of genetic and environmental factors. J Biol Chem 2011; 286(38):32883-32889.
  15. Ortega H, Chupp G, Bardin P et al. The role of mepolizumab in atopic and nonatopic severe asthma with persistent eosinophilia. Eur Respir J 2014; 44(1):239-241.
  16. Ortega H, Liu MC, Pavord ID et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371(13):1198-1207.
  17. 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.

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