Editor’s note: Article corrected 6/7 to include accurate data from the BORA and related clinical trials and link to study abstract.
Patients with severe eosinophilic asthma, who participated in three different Phase 3 trials of benralizumab (Fasenra) and then enrolled in a long-term trial of the drug’s efficacy and safety, continued to experience fewer exacerbations and improved pulmonary function and quality of life, according to research presented at ATS 2019.
The analysis provides long-term efficacy and safety data for Fasenra from the one-year Phase III SIROCCO and CALIMA exacerbation trials, the one-year Phase III BORA extension trial and the 28-week Phase III ZONDA OCS-sparing trial.
The integrated analysis includes 1,161 Fasenra patients, of whom 1,030 are in the SIROCCO/CALIMA/BORA full analysis set and 131 are in the ZONDA/BORA analysis set.
In the integrated analysis of ZONDA and BORA, 75% of patients had at least a 50% reduction in their OCS dosages from baseline after 84 weeks of Fasenra treatment every eight weeks, and 39% of patients had at least a 90% reduction. OCS dosage was reduced by 67% by the end of the integrated study period, which was similar to reductions seen in the ZONDA trial of 75% from baseline compared with 25% for placebo. Fasenra is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
Colin Reisner, Senior Vice President and Head of Late RIA, R&D BioPharmaceuticals, said: “These new data strengthen Fasenra’s clinical profile and are an important confirmation of its long-term efficacy and safety profile in severe eosinophilic asthma, which is a debilitating, chronic disease.”
J. Mark FitzGerald, MD, Director of the Centre for Heart and Lung Health at the Vancouver Coastal Health Research Institute, and lead investigator, said: “Long-term efficacy and safety data as shown in this Fasenra integrated analysis are important to physicians treating severe asthma. The results can also give confidence to physicians that their ability to reduce patients’ oral corticosteroid use can be maintained long term, a key treatment goal given the potential for significant adverse effects.”
The integrated analysis demonstrated that the improvements in exacerbation rate, lung function, asthma control and health-related quality of life observed in the SIROCCO/CALIMA trials during the initial one-year treatment period were maintained in continuously treated patients over the two-year integrated treatment period.
The safety profile in the integrated analysis was similar to that observed in the SIROCCO, CALIMA, ZONDA and BORA trials, with no increase in the frequencies of overall or serious adverse events. The three most common adverse events reported for those SIROCCO or CALIMA patients who received Fasenra and entered BORA were viral upper respiratory infection, upper respiratory tract infection and bronchitis.
Fasenra is AstraZeneca’s first respiratory biologic and is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and several other countries.