William Busse of the University of Wisconsin-Madison presented the study results at this year’s annual congress of the American Academy of Allergy, Asthma & Immunology (AAAI).
How the researchers proceeded
The international study included 86 youth aged 12 to 17 years. All participants suffered from severe asthma. Around half (n=46) received a subcutaneous injection of benralizumab every four (n=14) or eight (n=32) weeks in addition to their standard therapy. The other participants were injected with a placebo.
Results of the study
After two years, results showed that:
- Benralizumab was well tolerated – no serious side effects occurred
- When administered every eight weeks, it reduced the number of asthma attacks to less than half, compared with the group receiving the placebo.
“The efficacy and tolerability also had a positive effect on the quality of life of the young patients”, added Busse.
It should be noted that one in five participants terminated the treatment prematurely – five of them in the placebo groups and 12 receiving benralizumab.
Why is this study important?
Once a drug has been approved, it must be reviewed regularly for safety and efficacy even if it has been used for a long time. The BORA study is the first long-term study of benralizumab, which was approved throughout Europe at the beginning of 2018. BORA investigated the effect not only in adolescents, but also in adults.
However, the AAAI presentation focused only on the results in children and adolescents.
Until now, benralizumab (Fasenra®) has only been approved in adults with severe eosinophilic asthma as an adjunct to standard therapy.
The positive results are not (yet) sufficient to prove that the substance is safe for use in children and adolescents. This is because the study was too small. “The results are promising, but we must not lose sight of the fact that there were only a few patients in the individual groups. We need studies with more participants”, said Busse.
Busse W et al. Three-Year Safety and Efficacy of Benralizumab for Adolescent Patients with Severe, Uncontrolled Asthma: Results of the BORA Extension Study. J Allergy Clin Immunol. 2020;145(2), Suppl AB174, Feb 01.
Müller C. Neuer Asthma-Antikörper Benralizumab erhält Zulassung (New asthma antibody benralizumab is approved). Deutsche Apotheker Zeitung (DAZ.online), press release dated 17 January 2018. (In German)
Federal Joint Committee (GBA). Medicinal Products Directive/Annex XII: Benralizumab – Grounds for the Decision. GBA, 2 August 2018. (In German)