Nucala improves CRSwNP symptoms and delivers asthma control* in patients with SEA and comorbid CRSwNP1,2
*measured by change from baseline in ACQ-5 score
Post-hoc analysis of modified intention-to-treat (mITT) population (aged 12 +) in MUSCA.1 MUSCA primary endpoint, change in SGRQ total score from baseline at week 24, was met.3 LS mean change (SE) from baseline in SNOT-22 score of NP patients at week 24 (n=78) Nucala: -13.7 (2.6) n=44, (greater than MCID of -8.9 points); (n=34) placebo: -1.9 (3.0). Treatment difference of −11.8 (95% CI, −19.8 to −3.9).1,5
REALITI-A post hoc analysis at 2-years.2 REALITI-A primary endpoint, rate of clinically significant exacerbations 12-months post-exposure, was met.4 ACQ-5 LS mean score at 24 months with CRSwNP at enrollment, Nucala: 0.98 (n=84) vs. Baseline: 2.72 (n=307). Statistical significance not calculated.2
The image above is a fictional patient for illustrative purposes.
Nucala (mepolizumab) Indication
Nucala (mepolizumab) is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. Nucala is also indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.6
Nucala is not reimbursed for CRSwNP in the UK.
Did you know 40% of patients with severe asthma suffer from co-morbid CRSwNP?7
For patients with severe asthma and co-morbid CRSwNP, disease burden is higher than those without co-morbidities.8
Find out more about the burden of disease
Both Severe Eosinophilic Asthma and CRSwNP are characterised by type 2 inflammation9,10
Nucala blocks IL-5, a dominant cytokine linked to T2 inflammation11,12
Dosing & Administration
The recommended dose of Nucala for Severe Eosinophilic Asthma in adults and adolescents aged 12 years and older is 100mg subcutaneously once every 4 weeks. The licenced dose of Nucala in children aged 6 to 11 years old is 40mg subcutaneously once every 4 weeks. In adults for severe CRSwNP the recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.6
Pre-filled pen (indicated for patients aged 12 years and above for severe eosinophilic asthma. Indicated for adult patients with severe CRSwNP.)6
Pre-filled syringe (indicated for severe eosinophilic asthma: available in 40mg for children patients aged 6-11 years old, and 100mg for patients aged 12 years and above. Also indicated for adult severe CRSwNP: available in 100mg for adult patients)6
Nucala is for subcutaneous injection only and should be administered by a healthcare professional. Nucala may be self-administered by the patient or administered by a caregiver if their healthcare professional determines that it is appropriate, and the patient or caregiver are trained in injection techniques.6
Abbreviations
ACQ, asthma control questionnaire; CI, confidence interval; CRSwNP, chronic rhinosinusitis with nasal polyps; IL-5, interleukin-5; LS (mean), least squares (mean); MCID, minimal clinically important difference; NP, nasal polyps; SE, standard error; SEA, severe eosinophilic asthma; SNOT, sino-nasal outcome test.
References
- Howarth P, et al. J Allergy Clin Immunol. 2020;145:1713-15.
- Lee et al. AAAAI 2023; poster 48
- Chupp GL; Lancet Respir Med. 2017; 5;390-400
- Harrison T, et al. Eur Respir J. 2020;56:2000151
- GSK Data on File REF-215426
- Nucala Summary of Product Characteristics.
- Canonica G; Respiratory Medicine. 2020;166;1-5
- Bakakos P, et al. J Allergy Clin Immunol Glob. 2024;4(1):100343
- Israel, E and Reddel, H. NEJM. 2017;377;965-976
- Laidlaw T, et al. JACI; 2021; 9(3):1133-1141
- GSK Data on File REF-215426
- Bel EH; N Engl J Med. 2014;371;1189-1197
- Pelaia C; Front Physiol. 2019;10;1-11
- Gevaert P; Int Forum Allergy Rhinol. 2022;12;1413-1423
- Trivedi SG; Cellular and Molecular Life Sciences. 2007;64;1269-1289
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 GSK on 0800 221 441 or UKSafety@gsk.com.
April 2025 | PM-GB-MPL-WCNT-240015 (V1.0)