GlaxoSmithKline has presented data showing that its biologic Nucala improved asthma control in patients with severe disease not adequately managed with Novartis’ Xolair.
The OSMO trial met its primary endpoint of asthma control with clinically significant improvements, as evidenced by the Asthma Control Questionnaire (ACQ-5), as well as a stream of key secondary targets, in patients switching to the drug.
According to the data, presented at the American Academy of Allergy, Asthma & Immunology and World Allergy Organisation Joint Congress in Orlando, the rate of exacerbations requiring oral steroids was reduced by 64 percent after patients were switched to Nucala (mepolizumab) compared to the 12 months before starting treatment with the drug, while exacerbations requiring an emergency department visit or hospitalisation dropped 69 percent.
There was also an improvement in lung function of 159 mL vs baseline and a reduction in blood eosinophils of around 80 percent by Week 4 (vs baseline), which was sustained until Week 32.
Also, in a pooled, post-hoc meta-analysis of data from the MENSA and MUSCA studies presented at the Congress, Nucala showed improvements in lung function of patients with severe eosinophilic asthma compared with placebo. Early improvements were recorded in week one and sustained at the end of the observational period.
The results “provide evidence that supports the use of mepolizumab in those eligible patients who are not well controlled by omalizumab,” noted Jonathan Sweeting, SVP and head, Global Respiratory Franchise at GSK.
“In addition, the meta-analysis…which showed Nucala provides an early improvement, sustained over time in lung function compared with placebo, is further evidence supporting the effectiveness of this treatment in patients with severe eosinophilic asthma.”
Nucala was first approved in the EU back in December 2015, as 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.