Benralizumab safe, effective in severe asthma for up to 5 years
Click Here to Manage Email Alerts
Treatment with benralizumab in adults with severe, uncontrolled asthma was well tolerated for up to 5 years, with a long-term safety profile consistent with previous phase 3 trials.
The data come from an integrated analysis including data from the MELTEMI phase 3, open-label extension trial, which was presented at the American Thoracic Society International Conference.
The MELTEMI trial assessed safety and tolerability of subcutaneous benralizumab (Fasenra, AstraZeneca) in patients with severe, uncontrolled asthma on an inhaled corticosteroid and long-acting beta agonist therapy with or without chronic oral corticosteroids and/or other asthma controllers. Patients had completed one of three phase 3, placebo-controlled predecessor trials (SIROCCO, CALIMA, ZONDA) and were then enrolled in the double-blind BORA safety extension trial, with further transition into the MELTEMI open-label extension trial, according to a press release issued by AstraZeneca.
At ATS 2021, Arnaud Bourdin, MD, PhD, professor of respiratory medicine in the department of pulmonology at the University of Montpellier, France, presented data from the integrated analysis, which included patients who had received benralizumab for up to 5 years from the beginning of the treatment period in the predecessor studies.
The analysis included 446 patients (mean age, 51.5 years; 64% women). Of those, 86% completed the on-treatment period and 16% were on treatment for at least 5 years, according to the release.
The primary endpoint in MELTEMI was safety and tolerability.
During the period of the BORA and MELTEMI extension trials, adverse events and serious adverse events did not increase from rates comparable to placebo observed in the phase 3 trials, according to the release. Nasopharyngitis (11.9%), asthma (7.4%), headache (5%) and bronchitis (4.3%) were the most commonly reported adverse events during the open-label period for patients receiving benralizumab every 8 weeks. No new safety signals were identified, Bourdin said during the presentation. No deaths occurred, and rates of serious infections, hypersensitivity and malignancy were low, according to the release.
Rate of annual asthma exacerbations was a secondary endpoint in MELTEMI.
In patients who were taking high-dose ICS with blood eosinophils 300 cells/µL assigned benralizumab every 8 weeks, the annualized asthma exacerbation rate decreased from 3.1 exacerbations per year before treatment to 0.5 per year in the predecessor studies, with a further reduction to 0.2 by year 4 of the open-label trial. In the same group, 59% of patients experienced no exacerbations during the 4 years of the open-label period (BORA and MELTEMI) and at least 75% of patients each year experienced no exacerbations. In the fifth year of the trial, 87% of patients experienced no exacerbations, according to the release.
“Clinicians treating severe eosinophilic asthma want to ensure the therapy they prescribe will continue to help patients control their illness in the long term, with a consistent safety profile,” Bourdin said in the release. “Based on the new MELTEMI data, physicians and their patients should feel confident that Fasenra provides a treatment option that can do exactly that — reduce exacerbations, with a known safety profile.”
Benralizumab is approved as an add-on maintenance therapy for patients with severe eosinophilic asthma in the U.S., European Union, Japan and other countries, as well as approved for self-administration in the U.S. and EU.