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REDUCTION IN OCS WITH NUCALA
SIRIUS study: shows reduction in OCS dose with Nucala1
More patients with Nucala (n=69) than placebo (n=66) had a reduction of 90 to 100% in OCS dose (23% vs. 11%) and a reduction of 75 to less than 90% (17% vs. 8%) in the SIRIUS trial at 20 to 24 weeks (primary endpoint).1
The primary endpoint, percentage reduction in daily OCS dose during week 20-24 compared to baseline was met (p=0.008).1*
Median % OCS reduction was a secondary endpoint.1
CI, confidence interval; OCS, oral corticosteroid; SoC, standard of care.
*SIRIUS was a 24-week multicentre, randomised, placebo-controlled, double-blind, parallel-group study. The primary efficacy outcome was the percentage reduction in daily OCS 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).1
REDUCTION IN MEDIAN MAINTENANCE OCS DOSE AT 1 YEAR
vs. baseline2
Secondary endpoint: The median (IQR) daily maintenance OCS dose fell from 10.0 (5.0–15.0) mg/day during pre-treatment to 5.0 (0.9–10.0) mg/day by week 21–24 and remained at the same level until week 53–56 (5.0 (0.0–7.5) mg/day
Results are descriptive.
REAL-WORLD MEPOLIZUMAB INITIATION LEADS TO A REDUCTION IN DAILY MAINTENANCE OCS DOSE.2
The median percent reduction from baseline in maintenance OCS dose was 52% (95% CI 50.0–75.0%) (weeks 53–56).2**
IQR, interquartile range; OCS, oral corticosteroid.
*REALITI-A is a 1-year international, prospective, single-arm, observational study exploring the real-world impact of Nucala on clinical outcomes in patients with severe asthma. Data were collected as part of routine asthma healthcare visits. Patients were newly prescribed mepolizumab. Initiation of mepolizumab was at the physician's discretion.2 Real world studies are designed to evaluate associations among variables and not to definitely establish causality. Limitations important when interpreting results: no comparator arm, differences in patient populations and data collection vs. randomised controlled trials.2
**The median daily maintenance OCS dose fell from 10.0 (5.0-15.0) mg/day during pre-treatment to 5.0 (0.9-10.0) mg/day by week 21-24 and remained at the same level until week 53-56 (5.0 (0.0-7.5) mg/day.2
REALITI-A 1-YEAR
Discontinued mOCS 1-year post Nucala treatment2
Patients with severe asthma. Nucala patients discontinuing mOCS: n=43/125 at Weeks 53-562
Real Life study Belgium:
Real-world evidence study shows reduction in OCS dose with Nucala3^
^Belgian real-world evidence study to confirm the results from the randomised controlled trials in real-life in a population of 116 severe eosinophilic asthmatics treated with mepolizumab and who were followed up at the asthma clinic every month for at least 18 months.3
FRANCE ATU: Real-world evidence study shows reduced need for OCS with Nucala4*
Reduce and even eliminate OCS use4
ATU, Temporary Authorisation for Use; Cl, confidence interval; OCS, oral corticosteroid.
*In the 24-week Phase Ill study, SIRIUS, the primary endpoint, percentage reduction in daily OCS dose, was met. SIRIUS secondary endpoint: 50% Nucala (n=69) (95% Cl: 20.0-75.0) vs. 0% placebo (n=66) (95% Cl: -20.0-33.3) (p=0.007). The secondary outcome of total cessation in OCS use was not significant (N (%); Nucala 10/69 ( 14%) vs. 5/66 (8%) placebo p=0.41), However, the protocol did not allow for patients on higher doses (25mg/day or more) to be weaned completely.1 France ATU is a retrospective observational study with 146 severe eosinophilic asthma patients. The main limitation of this study was the retrospective nature of the data collection and analysis.4
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
- Bel EH et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. 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.
- Schleich F et al, Real-world experience with mepolizumab: Does it deliver what it has promised?, Clin Exp Allergy 2020;00: 1-9. https:/doi.org/10.1111/cea.13601
- Taillé C, Chanez P, Devouassoux G et al. Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme. Eur Respir J 2020; 55: 1902345.
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PM-NO-MPL-WCNT-230027 - December 2023
