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
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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
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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