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Nucala: A targeted anti IL-5 therapy for adults and children ≥ 6 years with severe refractory eosinophilic asthma.1

  • Anbudsresultat

    Nucala er førstevalg ved bruk av biologiske legemidler mot alvorlig T2-høy astma2

    Nucala (mepolizumab) er førstevalg blant legemidler til behandling av alvorlig T2- høy astma som følge av en anbudskonkurranse utført av Sykehusinnkjøp på vegne av de Regionale Helseforetakene.

    Det betyr at Nucala fremdeles skal velges ved behandling av pasienter med alvorlig T2-høy astma.

    Nucala er tilgjengelig i tre forskjellige formuleringer; ferdigfylt pen, ferdigfylt sprøyte og pulver til rekonstituering, og man kan fritt velge mellom disse.

    Instruksen fra de regionale helseforetakene er at man skal følge rangeringen i anbudet. Nucala skal derfor velges framfor andre behandlingsalternativer. Dersom pasienten av medisinske grunner ikke kan bruke førstevalget, skal dette begrunnes i pasientens journal og neste preparat kan forsøkes. Anbudsperioden gjelder fra 1. april 2020.

    Rangering av produkter ved alvorlig T2-høy astma

    Alvorlig T2-høy astma 

    Behandlingsindikasjon vurderes etter adekvat utredning på sykehus/senter med nødvendig kompetanse i utredning og behandling av alvorlig astma, eller i samråd med slikt senter.

    Praktisk veileder for alvorlig astma hos voksne fra Norsk forening for lungemedisin (NFL) omtaler diagnostikk av alvorlig astma i kapittel 3 og 4. Veilederens kapittel 6 anbefaler at pasienter med alvorlig astma klassifiseres med molekylær fenotype; T2-høy eller T2-lav.

    Bruk av legemidlene i rangeringen betinger følgende kriterier (alle pkt. 1-4 innfridd):2

    1. Eosinofili (a eller b)
      a) Minst én måling der antall eosinofile celler i blod ≥ 300 celler per mikroliter.
      b) Minst én måling der antall eosinofile celler i blod er ≥ 150 celler per mikroliter under vedvarende systemisk kortikosteroidbehandling.
    2. Grunnbehandling og vedlikeholdsbehandling skal følge de norske behandlingsretningslinjene.
    3. Medikamentene skal forskrives av spesialist i lungesykdommer.
    4. Evaluering av effekt av behandlingen og vurdering av om behandlingen skal fortsette eller avbrytes skal foretas halvårlig.

  • Efficacy and safety

    Efficacy and Safety

    View a quick overview of the core efficacy and safety data for Nucala (mepolizumab) in adults with severe refractory eosinophilic asthma, with access to detailed summaries of the key MENSA and SIRIUS studies.

    Top 10 efficacy and safety facts

    1. Nucala is a targeted anti-IL-5 add-on therapy for adults, adolescents and children ≥ 6 years with severe refractory eosinophilic asthma1

    Nucala is a humanised monoclonal antibody that inhibits the bioactivity of interleukin (IL)-51

    • Nucala blocks the binding of IL-5 to the alpha chain of the IL-5 receptor complex on the eosinophil cell surface.1,3
    • This inhibits IL-5 signalling and reduces the growth, differentiation, recruitment, activation and survival of eosinophils.3,4

     

    2. Nucala significantly reduced exacerbations by 53% (MENSA primary endpoint) 5

    Nucala added to high dose ICS and an additional maintenance treatment(s) reduced clinically significant exacerbations vs. placebo added to high dose ICS and an additional maintenance treatment(s) by 53% (95% CI 36-65%, p<0.001) 5

    • Clinically significant exacerbations of asthma were defined as the worsening of asthma that required use of systemic corticosteroids or required hospitalisation and/or emergency department visits. 5

    Discover more about the MENSA study outcomes

    3. Nucala significantly reduced exacerbations resulting in hospitalisation and/or emergency department (ED) visits by 61% (MENSA secondary endpoint) 5

    Nucala added to high dose ICS and an additional maintenance treatment(s) also significantly reduced exacerbations resulting in hospitalisations and/or emergency department (ED) visits vs. placebo added to high dose ICS and an additional maintenance treatment(s) by 61% (Nucala: 0.08/year, placebo: 0.2/year; 95% CI 17-82%; p=0.02) 5

    Discover more about the MENSA study outcomes

    4. Nucala improved quality of life (SGRQ, MENSA secondary endpoint) 4

    Nucala added to high dose ICS and an additional maintenance treatment(s) improved* health-related quality of life (measured using St. George’s Respiratory Questionnaire [SGRQ]) vs. placebo added to high dose ICS and an additional maintenance treatment(s) by 7.0 units (95% CI -10.2 to -3.8, p<0.001). 5

    • The SGRQ is a validated, disease-specific health status assessment for use in asthma and COPD and a difference of ≥4.0 units is considered clinically meaningful. 6

    Statistical significance cannot be inferred due to the hierarchical ‘gate-keeping’ approach used. The p-values provided are unadjusted for multiple comparisons 5

    Discover more about the MENSA study outcomes

    5. Nucala improved lung function (MENSA secondary endpoint).

    Nucala added to high dose ICS and an additional maintenance treatment(s) improved lung function (as measured by pre-bronchodilator FEV1) vs. placebo added to high dose ICS and an additional maintenance treatment(s) by 98mL (95% CI 11-184mL; p=0.03). 5

    Statistical significance cannot be inferred due to the hierarchical ‘gate-keeping’ approach used. The p-values provided are unadjusted for multiple comparisons. 5

    Discover more about the MENSA study outcomes

    6. Nucala reduced daily OCS dose while maintaining symptom control (SIRIUS primary endpoint)

    The odds of achieving a reduction in OCS dose while maintaining symptom control were 2.39 times higher in patients receiving Nucala vs. placebo, when both were added to high dose ICS and an additional maintenance treatment(s) (95% CI 1.25-4.65; p=0.008) 7

    Discover more about the SIRIUS study outcomes

    7. Safety profile of Nucala

    A total of 896 adults and 19 adolescent subjects with severe refractory eosinophilic asthma received either a subcutaneous or an intravenous dose of Nucala during three placebo-controlled clinical studies of 24 to 52 weeks duration. Nucala is licensed for SC use only. 1

    The most commonly reported adverse reactions during treatment were headache, injection site reactions and back pain. The safety profile of mepolizumab in severe refractory eosinophilic asthma patients (n=998) treated for a median of 2.8 years (range 4 weeks to 4.5 years) in open-label extension studies was similar to that observed in the placebo-controlled studies. 1

    8. Nucala had a similar safety profile compared with placebo when added to high dose ICS and an additional maintenance treatment(s), except for injection site reactions which were more common in the Nucala group (8% (21/263) for Nucala, 3% (8/257) for placebo) 1

    In both MENSA5 and SIRIUS7 studies, the incidences of adverse events and serious adverse events with Nucala were found to be similar to placebo when both were added to high dose ICS and an additional maintenance treatment(s), with the exception of injection site reactions. 1,5,7

    9. Injection site reactions with Nucala treatment mainly occurred at the start of treatment

    In clinical studies, injection site reactions were more frequent in patients treated with Nucala (8% [21/263]) as compared to placebo (3%) [8/257]). 1,5,7

    • Injection site reactions occurred mainly at the start of treatment and within the first three injections, with fewer reports on subsequent injections. 1

    10. Special warnings and precautions for use 

    • Nucala should not be used to treat acute asthma exacerbations.
    • Asthma-related adverse events or exacerbations may occur during treatment. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
    • Abrupt discontinuation of corticosteroids after initiation of Nucala is not recommended. Reduction in corticosteroid doses, if required, should be gradual and performed under the supervision of a physician.
    • Hypersensitivity and administration-related reactions: Acute and delayed systemic reactions, including hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, rash, bronchospasm, hypotension), have occurred following administration of Nucala. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., typically within several days). These reactions may occur for the first time after a long duration of treatment.
    • Parasitic infections: Patients with pre-existing helminth infections should be treated before starting therapy. If patients become infected whilst receiving treatment with Nucala and do not respond to anti-helminth treatment, temporary discontinuation of Nucala should be considered.

    Find out more about the MENSA and SIRIUS study outcomes.

  • Sikkerhetsinformasjon

    Nucala bivirkningsprofil

    SVÆRT VANLIG BIVIRKNING (≥1/10) Hodepine
    VANLIGE BIVIRKNINGER
    (≥1/100 til <1/10)    		 Smerter i øvre del av magen, reaksjoner relatert til administrering (systemisk ikke-allergisk), feber, lokale reaksjoner på injeksjonsstedet (som smerte, erytem, hevelse, kløe og en brennende følelse), eksem, overfølsomhetsreaksjon, faryngitt, nedre luftveisinfeksjon, urinveisinfeksjon, nesetetthet, ryggsmerter

    Full liste over bivirkninger finnes i preparatomtalen. Les preparatomtalen før forskrivning av Nucala

    Nucala skal ikke benyttes som anfallsmedisin. Astmarelaterte bivirkninger eller eksaserbasjoner kan forekomme. Instruer pasienter om å kontakte lege dersom deres astma fortsetter å være ukontrollert eller forverres etter behandlingsstart. Abrupt seponering av orale kortikosteroider etter oppstart med Nucala anbefales ikke. Reduksjon av OCS bør skje gradvis og i samråd med lege. Allergiske reaksjoner kan oppstå under og etter injeksjon. Informer pasienten om å søke legehjelp umiddelbart dersom dette skulle oppstå. Les preparatomtalen før forskrivning av Nucala.

References

  1. Nucala preparatomtale
  2. Sykehusinnkjøp LIS-2016 Biologiske legemidler mot alvorlig T2-høy astma, perioden 01.04.2020-31.03.2022 (sist sett 27.10.2021)
  3. Garcia G, Taillé C, Laveneziana P et al. Anti-interleukin-5 therapy in severe asthma. Eur Respir Rev 2013; 22(129):251-257.
  4. Kouro T and Takatsy K. IL-5- and eosinophil-mediated inflammation: from discovery to therapy. Int Immunol 2009; 21(12):1303-1309.
  5. Ortega H, Liu MC, Pavord ID et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371:1198-1207.
  6. Jones PW. St. George's Respiratory Questionnaire: MCID. COPD 2005; 2(1):75-79.
  7. Bel E, Wenzel SE, Thompson PJ et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014; 371(13):1189-1197.

Nucala is a trademark of the GSK group of companies