Switching to Nucala reduces asthma exacerbations, ED visits
Patients with severe eosinophilic asthma not optimally controlled with Xolair who switched directly to Nucala showed clinically meaningful reductions in exacerbations and necessary ED visits, according to findings presented at the American Academy of Allergy Asthma and Immunology/World Allergy Organization (AAAAI/WAO) Joint Congress.
“Not all people with severe asthma are the same,” Frank Albers, MD, PhD, from GlaxoSmithKline, told Healio Internal Medicine. “They have different clinical symptoms, biomarkers and phenotypes.”
Albers and colleagues conducted a multicenter, open-label, single arm study known as OSMO to investigate whether patients with severe eosinophilic asthma not controlled with Xolair (omalizumab, Genentech) who switch to Nucala (mepolizumab, GlaxoSmithKline) would benefit in terms of exacerbation and safety outcomes.
The researchers enrolled 145 patients with uncontrolled severe eosinophilic asthma who experienced at least two asthma exacerbations within the past year despite treatment with omalizumab. Participants were switched directly to mepolizumab and were followed for 32 weeks. They received 100 mg of subcutaneous mepolizumab every 4 weeks for 7 months.
Results demonstrated that switching to mepolizumab reduced clinically significant exacerbations by 64% and exacerbations requiring ED visits by 69%. Treatment with mepolizumab also lowered blood eosinophil counts by 76% from baseline to the end of the study.
Additionally, quality of life and lung function were improved when patients switched to mepolizumab.
During the length of the treatment period, Asthma Control Questionnaire-5 scores improved by –1.45 points, with 77% having the minimal clinically important difference of 0.5 or more points fewer. The mean St. George’s Respiratory Questionnaire total score improved by –19 points with 79% of patients having the minimal clinically important difference of four or more fewer points than at baseline. In addition, at week 32, patients’ mean prebronchodilator FEV1 score went up 159 mL, and patients’ mean postbronchodilator FEV1 second score went up 120 mL.
Adverse events were experienced by 86% of participants and 11% were serious. Anti-drug antibodies were observed in 8% of participants postbaseline. Neutralizing antibodies were not detected. New safety issues were not reported.
“With a treatment like Nucala and other biologics, we are now able to treat their asthma in a more personalized way,” Albers said. “For example, sometimes, those phenotypes overlap in one patient, and clinicians ask if they can switch from one biologic treatment to another. In this often difficult to treat population, the OSMO study showed that patients with an overlapping phenotype and uncontrolled asthma despite treatment with Xolair improved their asthma control when switched directly to Nucala.” – by Alaina Tedesco and Janel Miller
Galkin D, et al. “Efficacy and safety of mepolizumab in uncontrolled patients with severe eosinophilic asthma following a switch from omalizumab (OSMO study): Exacerbation and safety outcomes.” Presented at: American Academy of Allergy Asthma & Immunology / World Allergy Organization Joint Congress. March 2-5, 2018; Orlando.
Disclosure: Albers reports working for GlaxoSmithKline.