Improvement in patients with comorbidity
Nucala reduces exacerbations in patients with co-morbid nasal polyps and asthma.1,2
In nasal polyps patients with comorbid asthma
SYNAPSE1,5

Post hoc analysis: rate ratio: 0.33, 95% CI:0.12, 0.951*
In patients with severe eosinophilic asthma with comorbid nasal polyps:
MENSA3/MUSCA4 - post hoc meta-analysis

Rate ratio: 0.20, 95% CI: 0.11, 0.35. N=1662
49% reduction in clinically significant asthma exacerbations in patients without nasal polyps (rate ratio: 0.51, 95% CI: 0.41, 0.64). N=7702
SELECTED SAFETY INFORMATION
Warnings/Precautions: Should not be used to treat acute asthma exacerbations. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after starting treatment. Abrupt discontinuation of corticosteroids after initiation of mepolizumab treatment is not recommended.
Allergic reactions: Acute and delayed systemic reactions, including hypersensitivity reactions, have occurred following administration of mepolizumab. Patients should be instructed to seek medical attention immediately if allergic reactions occur. In the event of a hypersensitivity reaction, appropriate treatment as clinically indicated should be initiated.
Parasitic infections: Pre-existing helminth infections should be treated before starting therapy. If patients become infected whilst receiving treatment with mepolizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
Organ-threatening or life-threatening manifestations of EGPA and HES: Has not been studied
Adverse reactions: In clinical studies in patients with severe refractory eosinophilic asthma and EGPA, headache, injection site reactions and back pain were the most commonly reported adverse reactions during treatment. In patients with CRSwNP: Headache and back pain. In patients with HES: Headache, urinary tract infection, injection site reactions and pyrexia.
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SYNAPSE is a 52-week, randomised, double-blind, parallel group Phase III study assessing the clinical efficacy and safety of Nucala 100mg SC as an add-on to maintenance treatment in adults with severe bilateral nasal polyps, compared to placebo.5 Other objective: change from baseline in ACQ-5 score at Week 52. Asthma control was improved by 50% from baseline with Nucala (n=138) vs. 19% in placebo (n=144) by Week 52 of treatment in patients with asthma and comorbid nasal polyps Mean ACQ-5 score decrease of -1.18 from mean baseline score of 2.38 in treatment group vs. -0.40 from 2.15 in placebo.1 MCID ≥0.5;6 scores out of 6, >1.5 indicates poor symptom control.7
*Post hoc analysis: exacerbations per year for participants with asthma, Nucala: 0.05 (95% CI: 0.02, 0.12), placebo: 0.15 (95% CI: 0.08, 0.26).1
†Based on meta-analysis of MENSA and MUSCA, of 936 patients to determine change in HRQoL in Nucala-treated patients with SEA either with or without nasal polyps.2 MENSA and MUSCA were Phase III placebo-controlled, randomised, double-blind, parallel group, multicentre studies.3,4 Primary endpoint in MENSA, annualised frequency of clinically significant exacerbations (defined as worsening of asthma that required systemic glucocorticoids for 3 or more days, or hospitalisation/emergency department visit), was met (p<0.001).3 Primary endpoint in MUSCA, mean change from baseline in SGRQ scores at Week 24, was met (p<0.0001).4 166/936 patients (18%) had nasal polyps at screening. Mean exacerbation rates were 3.1±2.1 for patients with nasal polyps and 3.2±2.3 for patients without.2
ACO, asthma control questionnaire; CI, confidence interval; HRQoL, health-related quality of life; MICD, minimal clinically important difference; NERD, non-steroidal anti-inflammatory drug-exacerbated respiratory disease; SEA, severe eosinophilic asthma; SGRQ, St. George’s respiratory questionnaire.
REFERENCES
- Han JK et al. Lancet Respir Med. 2021;9:1141-1153 (supplementary)
- Howarth P et al. J Allergy Clin Immunol 2020;145(6):1713-1715
- Ortega HG et al. N Engl J Med. 2014;371(13):1198-1207
- Chupp G et al. Lancet Respir Med. 2017;5:390-400
- Han JK et al. Lancet Respir Med. 2021;9:1141-1153
- Juniper EF et al. Respir Med. 2005;99(5):553-558
- Juniper EF et al. Respir Med. 2006;100:616-621
PM-NO-MPL-WCNT-230004 June 2023