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Safety profile of Nucala from Phase III clinical study1
| Nucala (n=206) |
Placebo (n=201) |
|
| Any on-treatment AE | 169 (82%) | 168 (84%) |
| AE related to study treatment | 30 (15%) | 19 (9%) |
| AEs leading to permanent discontinuation of study treatment | 4 (2%) | 4 (2%) |
| AEs leading to withdrawal from the study | 0 | 1 (1%) |
| Most frequent on-treatment AEs† | ||
| Nasopharyngitis | 52 (25%) | 46 (23%) |
| Headache | 37 (18%) | 44 (22%) |
| Sinusitis | 10 (5%) | 22 (11%) |
| Any on-treatment SAE | 12 (6%) | 13 (6%) |
| SAEs related to study treatment‡ | 0 | 1 (1%) |
| Fatal SAEs§ | 0 | 1 (1%) |
Nucala has been studied in over 3,000 patients in 26 clinical trials across multiple eosinophilic conditions.2*
Need more information?
SYNAPSE is a 52-week, randomised, double-blind, parallel group Phase III study assessing the clinical efficacy and safety of Nucala 100mg SC as an add-on to maintenance treatment in adults with severe bilateral nasal polyps, compared to placebo.1
*Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older; as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control; as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA); as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.3
†Reported in 5% or more patients in any treatment group.1
‡Transient ischaemic attack.1
§Due to myocardial infarction during the follow-up period.1
AE, adverse event; CRSwNP, chronic rhinosinusitis with nasal polyps; IL, interleukin; SAE, serious adverse event; SC, subcutaneous.
References
- Han JK et al. Lancet Respir Med. 2021; 9:1141-1153
- GlaxoSmithKline. GSK Nucala (mepolizumab) filings accepted by European Medicines Agency for three additional eosinophil-drives diseases [Press release}. 29 October 2020. Available at: https://www.gsk.com/en-gb/media/press-releases/gsk-nucala-mepolizumab-filings-accepted-by-european-medicines-agency-for-three-additional-eosinophil-driven-diseases/ (Accessed June 2023).
- Nucala preparatomtale
Nucala is a trademark of the GSK group of companies
PM-NO-MPL-WCNT-230006 June 2023
