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Nucala on the market for more than 10 years.1
In a long-term study, the safety profile after up to 9,972* years of treatment with Nucala was consistent with the previously established safety profile, and no new safety signals were observed.2** From randomized, controlled clinical studies in patients with severe eosinophilic asthma.1-6
Outcomes with Nucala for Severe Asthma patients with or without comorbid CRSwNP:
Severe Asthma with comorbid CRSwNP:
Severe Asthma without comorbid CRSwNP
MENSA: the primary endpoint, annualised frequency of clinically significant exacerbations, was met (53% reduction in exacerbations vs. placebo (Nucala n=194, placebo n=191 (95% CI, 36-65)).3†
COSMEX8 (OLE)
Sustained reduction in exacerbation rate with prolonged mepolizumab treatment throughout multiple studies (MENSA, COSMOS, and COSMEX).8||
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.°8
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<0.001.8
MENSA AND MUSCA
MENSA: The primary endpoint, the annualised frequency of clinically significant exacerbations, was met (p<0.001).3
MUSCA: The primary endpoint, mean change in SGRQ total score from baseline, was met (p<0.0001).7
Post-hoc analysis of the MUSCA study (n = 551) and a meta-analysis of MUSCA and MENSA (n = 576): The primary endpoint, to determine the change in HRQoL in Nucala-treated patients with SEA either with or without nasal polyps, was met.9
Nucala reduces exacerbations especially in patients with comorbid nasal polyps vs. placebo*9
Exacerbation rate ratio Nucala vs. placebo: 0.20 (95% CI: 0.11, 0.35)9
MUSCA: Nucala improves nasal polyps symptoms for severe asthma** patients with comorbid nasal polyps8
‡Based on meta-analysis of 936 patients in MENSA and MUSCA, to determine change in HRQoL in Nucala-treated patients with SEA either with or without nasal polyps. MENSA and MUSCA were Phase 3 placebo-controlled, randomised, double-blind, parallel group, multicentre studies. Primary endpoint in MENSA, annualised frequency of clinically significant exacerbations (defined as worsening of asthma that required systemic corticosteroids for 3 or more days, or hospitalisation/emergency department visit), was met (p<0.001). Primary endpoint in MUSCA, mean change from baseline in SGRQ scores at week 24, was met (p<0.001). 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.
◇ For patients with Type 2 inflammation with an eosinophilic phenotype, in line with the Nucala label.1,2
Nucala is a once monthly biologic with a fixed-dose treatment for your patients with Severe Asthma*
* For patients with Type 2 inflammation with an eosinophilic phenotype, in line with the Nucala label.1,2
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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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 chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
In adults, it is also indicated as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils as a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA).
It is also indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA), and as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome (HES) without an identifiable non-haematological secondary cause.
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SELECTED SAFETY INFORMATION
Warnings/Precautions: Should not be used to treat acute asthma or COPD exacerbations. Patients should be advised to seek medical attention if asthma or COPD remains uncontrolled or worsens after initiation of treatment. Abrupt discontinuation of corticosteroids after starting treatment is not recommended.
Allergic reactions: Acute and delayed systemic reactions, including hypersensitivity reactions, have been reported. Patients should be advised to seek immediate medical attention if allergic reactions occur. Appropriate treatment should be initiated in case of hypersensitivity reactions.
Parasitic infections: Pre-existing helminth infections should be treated prior to initiation of treatment. If patients become infected during Nucala treatment and do not respond to anti-helminth treatment, temporary discontinuation of Nucala should be considered.
COPD patients with low blood eosinophil count: Data do not support use in COPD patients with a blood eosinophil count <150 cells/µL and no evidence of eosinophil counts ≥300 cells/µL within the past 12 months.
Organ-threatening or life-threatening manifestations of EGPA and HES: Have not been studied.
Adverse reactions: In clinical studies in patients with severe refractory eosinophilic asthma and EGPA, the most commonly reported adverse reactions during treatment were headache, injection site reactions, and back pain.
In patients with COPD: headache, back pain, and arthralgia.
In patients with CRSwNP: headache and back pain.
In patients with HES: headache, urinary tract infection, injection site reactions, and pyrexia.
Adverse events should be reported to GlaxoSmithKline on 22 70 20 00. Read the prescribing information before prescribing Nucala.
Reseptgruppe C.
Finansiering: H-resept: R03D X09_1 Mepolizumab.
Der det er utarbeidet nasjonale handlingsprogrammer/nasjonal faglig retningslinje og/eller anbefalinger fra RHF/LIS spesialistgruppe skal rekvirering gjøres i tråd med disse. Vilkår: 216 Refusjon ytes kun etter resept fra sykehuslege eller avtalespesialist.
Maksimalpriser: 100 mg 1 stk ferdigfylt penn/sprøyte 13587,10 kr. 40 mg 1 stk ferdigfylt sprøyte 5537,80kr.
Avtalepris inngår i Sykehusinnkjøp anbud Alvorlig ukontrollert T2-høy astma fra 01.09.2026. Anbudet inneholder rabatterte priser.
Nucala (mepolizumab) er besluttet innført av Beslutningsforum til behandling av alvorlig eosinofil astma, kronisk rhinosinusitt med nasal polypose (CRSwNP) og hypereosinofilt syndrom (HES). Det er besluttet at Nucala ikke skal benyttes til granulomatose med polyangiitt (EGPA). Nucala er per i dag ikke finansiert for pasienter med kols.
*Langtidsstudien2 med Nucala var en åpen, multisenter, fase 3b langtids- og sikkerhetsstudie, med opptil ca. 10 års oppfølging (over 1500 pasient-år). Langtidsbruk av Nucala ble undersøkt hos 514 pasienter med alvorlig eosinofil astma, som tidligere hadde deltatt i en klinisk studie med Nucala (bl.a. MENSA4 SIRIUS3, COLUMBA5, COSMOS6). Alle pasienter fikk subkutan behandling med Nucala hver 4. uke (100 mg til voksne og 40 mg til barn [6–11 år med vekt <40 kg]) som tillegg til standardbehandling i opptil 10 år. Den totale eksponeringstiden for hver pasient var 0,08 til 9,97 år (median 2,03 år), med en gjennomsnittlig eksponering på 2,92 år (standardavvik: 2,45). Eksponeringstiden i langtidsstudien alene var 0,08 til 6,44 år (median 1,30 år), med en gjennomsnittlig eksponering på 1,79 år (standardavvik: 1,55) år.2
**Bivirkninger i kliniske studier:2 Svært vanlige bivirkninger er hodepine. Vanlige bivirkninger er infeksjon i nedre luftveier, urinveisinfeksjon, faryngitt, overfølsomhetsreaksjoner/anafylaksi, tett nese, smerter i øvre del av abdomen, eksem, ryggsmerter, artralgi, lokale og systemiske injeksjonsrelaterte reaksjoner og feber (pyreksi).
†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
§ 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.
References
- Nucala preparatomtale (Avsnitt 9, dato for første markedsføringstillatelse: 02. desember 2015).
- Pavord I, et al. Long-term safety of mepolizumab for up to ∼10 years in patients with severe asthma: open-label extension study. Ann Med. 2024 Dec;56(1):2417184.
- Ortega HG, Liu MC, Pavord ID, et al. Nucala treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-1207.
- Bel EH, Wenzel SE, Thompson PJ, et al. Oral glucocorticoid-sparing effect of Nucala in eosinophilic, asthma. N Engl J Med. 2014;371(13):1189-1197.
- Khatri S, Moore W, Gibson PG, et al. Assessment of the long-term safety of Nucala and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019;143(5):1742 1751e7.
- Lugogo N, Domingo C, Chanez P, et al. Long-term efficacy and safety of Nucala in patients with severe eosinophilic asthma: a multi-center, open-label, phase IIIb study. Clin Ther. 2016;38(9):2058–2070 e1.
- Chupp GL, Bradford ES, Albers FC, et al. Efficacy of Nucala add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double blind, placebocontrolled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017;5(5):390-400.
- Khurana S et al. Clin Ther. 2019;41(10):2041-2055.e5.
- Howart P et al. Severe eosinophilic asthma with nasal polyposis: A phenotype for improved sinonasal and asthma outcomes with mepolizumab therapy. J Allergy Clin Immunol. 2020 Jun;145(6):1713-1715.
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