GlaxoSmithKline has unveiled new safety and efficacy data for its asthma biologic Nucala, showing that the drug’s risk/benefit profile was maintained over an extended 52-week period.
Nucala (mepolizumab) was approved in the both the US and European Union late last year as an add-on therapy in adult patients with severe refractory eosinophilic asthma, in which over-production of eosinophils causes inflammation in the lungs that can affect the airways, limiting breathing and increasing the frequency of asthma attacks.
Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival, and Nucala is the first and only approved biologic therapy that targets IL-5 and stops it from binding to its receptor, thereby interrupting the inflammation pathway.
The new data, presented at the American Academy of Allergy, Asthma & Immunology annual meeting, also show that exacerbation risk reduction, asthma control improvement and oral corticosteroid dose reduction seen in earlier trials was also demonstrated in the long-term study.
In patients continuing on Nucala therapy from the MENSA trial, exacerbation rates per year remained consistent with the pivotal studies: the rate was 0.91 exacerbations per year at the end of MENSA and 0.92 per year at the end of the combined 84-week period.
For patients previously treated with placebo, their risk of an exacerbation was nearly halved when they switched to mepolizumab, decreasing over time from 1.94 per year to 1.04 per year, which was consistent with previous data.
On the safety side, findings were similar to those from earlier studies, with the most frequently reported adverse events during the treatment period nasal congestion (30%), upper respiratory tract infection (16%), asthma (worsening/exacerbation) (14%), and headache (14%).
NEJM publishes long-term safety study
Meanwhile, the drugs giant also reported that its long-term study backing the safety of asthma combination therapy Advair Diskus has been published by the New England Journal of Medicine.
Advair Diskus is a combination of the LABA, salmeterol, and inhaled corticosteroid (ICS), fluticasone propionate (FP).
GSK - and other drugmakers with LABA-based products - had been asked by the US Food and Drug Administration to carry out a post-marketing study comparing the treatment’s safety against that of FP monotherapy, to ensure that adding a LABA doesn’t increase the risk of serious asthma-related adverse events.
The study showed that Advair had a safety profile comparable to FP, including no asthma-related deaths in either arm.