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LONG TERM DATA WITH NUCALA
Sustained and consistent reduction in exacerbation rate with prolonged Nucala treatment throughout multiple studies (MENSA, COSMOS, and COSMEX)1-3*
0.98/year at Weeks > 136-188 vs 5.02/year pre-treatment**
*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 multicentre, 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 eosinophilic 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.1
**Pre-treatment refers to the 12 months prior to enrolment in MENSA.1
AE, adverse event; SC, subcutaneous.
COSMEX clinical study shows sustained reduction in OCS with Nucala in long term data.1
Nucala (n=20): 11.3mg/day (Baseline) vs. 1.3mg/day (Week 128) Data are summarized in terms of prednisone equivalent dose.
*OCS, oral corticosteroids; SC: subcutaneous
*OCS use throughout the SIRIUS (24 weeks), COSMOS (52 weeks), and COSMEX (up to 172 weeks) studies in patients with ≥128 weeks of continuous enrollment. In total, 38 patients with ≥128 weeks of continuous reporting across SIRIUS, COSMOS, and COSMEX with ≤12 weeks between the last dose in COSMOS and first dose in COSMEX are summarized (SIRIUS, placebo, n = 18; mepolizumab, n = 20).2 Patients included from SIRIUS were required to have a reduction in OCS dose by ≥50% compared with the patient's optimised OCS dose at randomisation in SIRIUS, during SIRIUS for those randomised to mepolizumab, and during the first 6 months of COSMOS for those randomised to placebo.2
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
- Khurana Set al. Long-term safety and clinical benefit of mepolizumab in patients with the most severe eosinophilic asthma; the COSMEX study.Clin Ther 2019; 41 :2041-2056.
- Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-1207.
- Lugogo N, Domingo C, Chanez P, et al. Long-term Efficacy and Safety of Mepolizumab in Patients With Severe Eosinophilic Asthma: A Multi-center, Open-label, Phase IIIb Study. Clin Ther. 2016;38(9):2058-2070.
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PM-NO-MPL-WCNT-230025 - September 2023
