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Proven and tested in 4 eosinophilic diseases
INCLUDING SEA.1
Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.1
Nucala provides durable disease control for your patients with SEA in clinical practice
Advance patient outcomes with Nucala
DURABLE EXACERBATION REDUCTION
MENSA: the primary endpoint, annualised frequency of clinically significant exacerbations, was met (53% reduction in exacerbations vs. placebo; p<0.001)2*
DURABLE OCS REDUCTION
SIRIUS: The primary endpoint, % reduction in daily OCS dose during Week 20-24 compared to baseline, was met OR: 2.39 (1.25–4.56) (p<0.008).5‡
COSMEX3† (OLE)
Sustained reduction in exacerbation rate with prolonged mepolizumab treatment throughout multiple studies (MENSA, COSMOS, and COSMEX).3
0.98/year at Weeks > 136-188 vs. 5.02/year pre-treatment; n=339
REALITI-A§ (RWE)
Relative reduction in the rate of clinically significant exacerbations per year.°4
At 1-year: Nucala reduced the rate of clinically significant exacerbations per year from 4.63 (12 months pre-exposure, n=366) to 1.43 (12 months post-exposure; n=367); RR: 0.31 (95% CI 0.27–0.35); p<0.001.4
SIRIUS secondary endpoint:
Reduction in median daily OCS dose
vs. placebo.5
50% Nucala (n=69) (95% CI:20.0-75.0) vs. 0% placebo (n=66) (95% CI: -20.0-33.3) (p=0.007).
REALITI-A (RWE):
REALITY-A secondary endpoint: change and percentage reduction in median daily maintenance OCS dose from pre-treatment to 12 months
vs. baseline.4
At 1-year: Nucala achieved a 52% relative reduction of median maintenance OCS dose post Nucala treatment initiation (baseline: 10.0 (5.0-15.0) mg/day to 5.0 (0.9-10.0) mg/day 95% CI 50.0–75.0%) by week 21-24 and remained at the same level until week 53-56 (5.0 (0.0-7.5) mg/day)).4,6
REALITY-A secondary endpoint: change and percentage reduction in median daily maintenance OCS dose from pre-treatment to 12 months
vs. baseline.4
At 1-year: Nucala achieved a 52% relative reduction of median maintenance OCS dose post Nucala treatment initiation (baseline: 10.0 (5.0-15.0) mg/day to 5.0 (0.9-10.0) mg/day 95% CI 50.0–75.0%) by week 21-24 and remained at the same level until week 53-56 (5.0 (0.0-7.5) mg/day)).4,6
REALITY-A secondary endpoint: change and percentage reduction in median daily maintenance OCS dose from pre-treatment to 12 months
vs. baseline.4
At 1-year: Nucala achieved a 52% relative reduction of median maintenance OCS dose post Nucala treatment initiation (baseline: 10.0 (5.0-15.0) mg/day to 5.0 (0.9-10.0) mg/day 95% CI 50.0–75.0%) by week 21-24 and remained at the same level until week 53-56 (5.0 (0.0-7.5) mg/day)).4,6
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.
Nucala is a once monthly biologic with a fixed-dose treatment for your patients with SEA
The recommended dose of mepolizumab is 100 mg administered SC once every 4 weeks in adults and adolescents 12 years and older. The licensed dose of Nucala in children aged 6-11 years is 40mg SC once every 4 weeks regardless of weight.1
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*MENSA is a 32-week multicenter, randomised, double-blind, double dummy, Phase 3, placebo-controlled trial, with an 8 week follow-up safety phase. Primary endpoint: annualised frequency of clinically significant exacerbations, defined as worsening of asthma requiring systemic glucocorticoids for ≥3 days or hospitalisation/ED visit, Nucala: 0.83 (n=194), placebo: 1.74 (n=191, p<0.001).2
†Patients with ≥188 weeks continued reporting across MENSA, COSMOS and COSMEX with ≤12 weeks between the last dose in COSMOS and the first dose in COSMEX. COSMEX was a multi-centre, open-label, long-term, Phase 3b, single-arm extension study assessing the safety and efficacy of Nucala 100 mg SC in 339 patients with severe asthma with an eosiniphilic phenotype. COSMEX enrolled a subset of patients from COSMOS with a history of life=threatening or seriously debilitating asthma. Median duration of Nucala treatment in COSMEX was 2.2 years (range 8 weeks-3.3 years); maximum exposure to Nucala was up to 4.8 years (includes participation in MENSA [32 weeks] or SIRIUS [24 weeks] and COSMOS [52 weeks] prior to inclusion in COSMEX [ up to 172 weeks]). The primary endpoints were AE frequency and exacerbation rate/year.3
‡SIRIUS is a 24-week multicentre, randomised, placebo-controlled, parallel-group study. The primary efficacy outcome was the percentage reduction in daily OCS dose during weeks 20-24, compared with the dose determined during the optimisation phase (odds ratio: 2.39 [95% CI: 1.25, 4.56]; p=0.008).5
§ REALITI-A is a 1-year international, prospective, single-arm, observational cohort study. Primary endpoint: rate of clinically significant exacerbations defined as exacerbations requiring OCS and/or hospitalisation/ED visit was met, p<0.001 (n=368).4,6
° Clinically significant exacerbations were defined as those requiring emergency department visit, hospitalisation and /or use/increased dose of OCS.
Abbreviations:
AE, adverse event; CI, confidence interval; ED, emergency department; IQR, interquartile range; OCS, oral corticosteroids; OLE, open label extension; RR, rate ratio; RWE, real world evidence; SC, subcutaneous; SEA, severe eosinophilic asthma.
References
- Nucala preparatomtale
- Ortega HG et al. N Engl J Med. 2014;371(13):1198-1207.
- Khurana S et al. Clin Ther. 2019;41(10):2041-2056.e5.
- Harrison T et al. Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis. Eur Respir J. 2020 Oct 15;56(4):2000151.
- Bel EH et al. N Engl J Med. 2014;371:1189-1197.
- Harrison T et al. Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis. Eur Respir J. 2020 Oct 15;56(4):2000151 (supplementary material).
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Trade marks are owned by or licensed to the GSK group of companies.
PM-NO-MPL-WCNT-230007 June 2023
