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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
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
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
- Khurana S et al. Clin Ther 2019; 41:2041–2056
- Nucala SmPC, 2020
- Ortega HG et al. N Engl J Med 2014; 371:1198–1207
- Khatri S, et al. J Allergy Clin Immunol 2019; 143:1742-1751.e7
- GlaxoSmithKline data on file. REF-88009
- GlaxoSmithKline data on file. REF-74585
- 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
