Du är nu på väg att lämna en GSK-hemsida

Denna länk leder till en hemsida som inte tillhör GSK. GSK tar inget ansvar för innehållet på tredje parts hemsidor.

Fortsätt

Tillbaka

Nucala

Product menu

Pick section Severe Eosinophilic Asthma (SEA)

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Severe Eosinophilic Asthma (SEA)

IMPROVE QUALITY OF LIFE

On this page:

CONTROLLED CLINICAL TRIAL DATA

REAL-WORLD EVIDENCE

CONTROLLED CLINICAL TRIAL DATA

MUSCA clinical study shows significant improvement in quality of life after 24 weeks with Nucala vs. placebo1*

The primary endpoint, mean change in SGRQ total score from baseline, was met.1

MUSCA: quality of life
Hand holding medical icon symbol

*MUSCA is a 24-week Phase 3b, randomised, placebo-controlled, double-blind, parallel-group, multicentre study. Primary endpoint: significant improvements at week 24 from baseline in SGRQ total score: least squares mean [SE] change from baseline.1 Participants were patients ≥ 12 years old with SEA and a history of ≥ 2 exacerbations requiring treatment in the previous 12 months before screening despite regular use of high-dose ICS plus other controller medicines.1
Mean SGRQ total scores (and SD) at baseline were 47.4 (18.1) for treatment group (n=274) and 46.3 (18.9) for placebo group (n=277).1

Cl, confidence interval; ICS, inhaled corticosteroid; MCID, minimal clinically important difference; OR, odds ratio; SD, standard deviation; SE, standard error; SEA, severe eosinophilic asthma; SGRQ, St. George's Respiratory Questionnaire.

Patients icon

OSMO clinical study shows improvement in quality of life after 32 weeks with Nucala vs. baseline4*

OSMO quality of life
Hand holding medical icon symbol
Patients icon

WHAT THIS MEANS FOR YOUR PATIENTS:4

  • Reduced impact of SEA has on their lives

*OSMO was a multicentre, open-label, single-arm 32-week study in patients with ≥ 2 asthma exacerbations in the year prior to enrolment, despite receiving high-dose ICS and other controller(s), plus omalizumab (≥4 months). Study objective: To assess if patients eligible for both biologics but not optimally controlled with omalizumab experience improved asthma control when switched directly to mepolizumab. Primary endpoint: LS mean change (SE) in ACQ-5 total score: -1.45 (0.107); from 3.20 (0.076) at baseline to 1.75 (0.096) at Week 32.4
ACQ-5, asthma control questionnaire; ICS, inhaled corticosteroid; LS, least squares; MCID, minimal clinically important difference; SEA, severe eosinophilic asthma; SE, standard error; SGRQ, St. George's Respiratory Questionnaire.

REAL WORLD EVIDENCE

REDES: Spanish real-life study shows 37% of patients achieving three-component on-treatment clinical remission after 52 weeks with Nucala vs. baseline5,6*

Clinical remission

Clinical remission was defined as:

  • OCS-free
  • Exacerbation-free
  • ACT score of at least 20.
REDES: Clinical remission

*Post-hoc analysis of REDES data. REDES is a phase 4, multicentric, observational cohort study of SEA patients treated with Nucala across 24 Asthma Units in Spain. Primary endpoint: annual rate of clinically significant exacerbations defined as exacerbations requiring systemic corticosteroids for ≥3 days (or doubling the dose in patients on maintenance OCS) or hospitalisation/ED visit. Mean: 4.5/year at baseline; 1.0/year at 1 year.5,6

†Patients who were exacerbation-free, OCS-free and had an ACT score of ≥20. Excludes patients with missing ACT score or percent predicted post-bronchodilator FEV1 at Week 52.5

ACT, asthma control test; ED, emergency department; FEV1, forced expiratory volume in 1 second; OCS, oral corticosteroids; SEA, severe eosinophilic asthma.

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.

Adverse reactions: In clinical studies in patients with severe refractory eosinophilic asthma, headache, injection site reactions and back pain were the most commonly reported adverse reactions during treatment.

References

  1. Chupp GL, Bradford ES, Albers FC, et al. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017;5:390-400.
  2. Nucala SmPC
  3. Nelsen LM, Kimel M, Murray LT, et al. Qualitative evaluation of the St. George's Respiratory Questionnaire in patients with severe asthma. Respir Med. 2017;126:32-38.
  4. Chapman KR, Albers FC, Chipps B, et al. The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma. Allergy. 2019;74:1716-1726.
  5. Domingo Ribas C, Carrillo Dfaz T, Blanco Aparicio M, et al. REAL WORLD Effectiveness and Safety of Mepolizumab in a Multicentric Spanish Cohort of Asthma Patients Stratified by Eosinophils: The REDES Study. Drugs. 2021;81(15):1763-1774.
  6. Pavord I, Gardiner F, Heaney LG, et al. Remission outcomes in severe eosinophilic asthma with mepolizumab therapy: Analysis of the REDES study. Front Immunol. 2023 Apr 12;14:1150162. doi: 10.3389/fimmu.2023.1150162. PMID: 37122713; PMCID: PMC10131245.

©2023 GSK group of companies or its licensor
Trade marks are owned by or licensed to the GSK group of companies

PM-NO-MPL-WCNT-230026 - September 2023