Nucala is the only anti-IL-5 with up to 4.8 years of clinical trial safety data*†¹ in severe eosinophilic asthma

Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.²

The maximum exposure duration of mepolizumab in the phase 3 and open label extension studies was 4.8 years. A patient withdrawal range of 4 weeks to 4.8 years was observed in MENSA, SIRIUS, COSMOS and COSMEX.

The long-term safety and immunogenicity profile of Nucala was similar to that observed in placebo-controlled asthma trials ³ ⁴

Number of Nucala prescriptions in the UK

COSMEX: Most frequent on-treatment AEs and SEAs (N=339)

On-treatment AEs, n(%)  
Nasopharyngitis
143 (42)
Asthma 77 (23)
Bronchitis 64 (19)
Upper RTI 64 (19)
Sinusitis 62 (18)
Headache 57 (17)
Influenza 44 (13)
Back pain 42 (12)
On-treatment SAEs, n(%)  
Asthma
34 (10)
Pneumonia 6 (2)
Nasal polyps 4 (1)
Respiratory tract infection (RTI)
3 (0.9)
Foot fracture 3 (0.9)
Lower RTI 3 (0.9)
Osteonecrosis 2 (0.6)
Diverticulitis 2 (0.6)
Fracture 2 (0.6)
Gastroesophageal reflux disease 2 (0.6)
Hyponatraemia 2 (0.6)
Influenza
2 (0.6)

AEs occurring in ≥10% of the population, SEAs occurring in > 1 subject

Explore efficacy data

Footnotes

*Nucala is generally well tolerated. In clinical trials, Nucala had a similar incidence of adverse events vs. placebo with the exception of injection site reactions (8% vs. 3%), which occurred mainly within the first 3 injections.²

†The long-term safety and immunogenicity profile of Nucala was similar to that observed in placebo-controlled asthma trials.¹

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. These limitations are important when interpreting results: lack of comparator arm, differences in patient populations and data collection vs. randomised controlled trials.⁷

The recommended dose of Nucala is 100 mg SC once every 4 weeks in adults and adolescents 12 years and older, available in a pre-filled pen, pre-filled syringe or lyophilised powder. The licensed dose of Nucala in children aged 6–11 years is 40 mg SC regardless of weight and available in lyophilised powder. The pre-filled formulations are not indicated in 6-11 year olds.²

AE, Adverse event; SAE, Serious adverse event; SC, subcutaneous.

References
  1. Khurana S et al. Clin Ther 2019; 41:2041–2056
  2. Nucala SmPC, 2020
  3. Ortega HG et al. N Engl J Med 2014; 371:1198–1207
  4. Khatri S, et al. J Allergy Clin Immunol 2019; 143:1742-1751.e7
  5. GlaxoSmithKline data on file. REF-88009
  6. GlaxoSmithKline data on file. REF-74585
  7. Leather DA et al. Adv Ther 2020; 1–21

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441

© 2020 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.

PM-GB-MPL-WCNT-200031 | November 2020