According to investigators, recent trial results indicate no other biologic treatment has shown as rapid onset than benralizumab for patients with eosinophilic asthma.
One of the indications that an asthma treatment is working is how quickly the medication takes effect. A recent study analyzed the results of a trio of phase 3 trials evaluating the impact of benralizumab (Fasenra) and found that in addition to significantly lowering asthma exacerbations, the therapy had a rapid onset of action.
Geoffrey Chupp, MD
Eosinophilic asthma is notoriously difficult to treat. Patients experience severe inflammation in the lungs and airways and have high levels of eosinophils—a type of white blood cell—in their blood. It is not known how many asthma patients have eosinophilic asthma, but according to the American Partnership for Eosinophilic Disorders (APFED), it is estimated at 10%.
Fasenra, sold by AstraZeneca, is an interleukin 5 (IL-5) receptor alpha-directed cytolytic monoclonal antibody administered in the form of a single injection at first dose, second dose at 4 weeks, and third dose at 8 weeks. After the third, doses are given once every 8 weeks. As an add-on asthma treatment, it has been proven to nearly eliminate eosinophils in the both the blood and lungs in the SIROCCO, CALIMA, and ZONDA trials.
In addition to onset of action, investigators sought to assess Fasenra’s impact on Peak expiratory flow (PEF).
“Monitoring either symptoms or PEF is an important aspect of asthma management,” the study authors wrote. “Monitoring PEF may be most effective for patients with severe asthma [and] time to improvement in PEF is a key indicator of the onset of action after initiation of an asthma treatment.”
Patients aged 12-75 (SIROCCO and CALIMA) and 18-75 (ZONDA) years old were randomized to receive injections of 30 mg of Fasenra every 4 weeks, every 8 weeks, or placebo. Trial length was 28 weeks for ZONDA, 56 weeks for CALIMA, and 48 weeks for SIROCCO. Morning PEF was self-measured before taking asthma controller medication. Ambulatory lung function was measured as least 6 hours after the last dose of a rescue medication.
The Asthma Control Questionnaire 6 (ACQ-6) determined asthma symptoms during night-time awakening, morning awakening, activity limitation, shortness of breath and wheezing, and short-acting beta 2 antagonist use.
In all 3 trials, 30 mg of Fasenra caused a greater improvement in morning PEF within 24 hours of the first dose compared to placebo. From baseline to final week, PEF increased 16.46 L/min for SIROCCO, 15.27 L/min for CALIMA, and 28.52 L/min for ZOMNDA. Notably in the ZONDA trial, when oral corticosteroids were reduced significantly, lung function remained improved.
“This data is important because physicians and patients wants to know how quickly they will respond to or feel a difference when starting the drug,” said lead investigator Geoffrey Chupp, MD, Professor of Pulmonary Medicine and Director of Yale Center for Asthma and Airways Disease. “To date, no other biologic has shown this rapid response.”
The study, “Rapid Onset of Effect of Benralizumab on Morning Peak Expiratory Flow in Severe Uncontrolled Asthma," was published online in the Annals of Allergy, Asthma and Immunology.