06 May FASENRA® – Benralizumab for Adolescent Patients with Severe, Uncontrolled Asthma
MedicalResearch.com Interview with:
Ubaldo Martin MD
VP Clinical Respiratory
RIA Late Stage Development
MedicalResearch.com: What is the background for this study?
Response: BORA was an extension study evaluating the long-term safety and specific aspects of efficacy in patients who had previously been in the benralizumab pivotal studies. After the patients completed the pivotal studies (Calima, Sirocco and Zonda), they were eligible to join BORA which followed adults for an additional year and adolescent for an additional 2 years. All patients receive one of two dosages of benralizumab. The abstract reports the outcomes of adolescents in the BORA study who were followed for approximately 3 years in total.
MedicalResearch.com: What are the main findings?
Response: The observed safety profile was consistent with previous studies in terms of adverse events and severe adverse event and there were no deaths in this population. In terms of efficacy 69% of adolescents remained exacerbation free at the end of the 108 week (approximately 2 year) follow up period.
MedicalResearch.com: What should readers take away from your report?
Response: The safety profile of benralizumab in adolescents, a population that is deemed vulnerable, is commensurate to what has been observed in previous trials and similar to the safety profile seen in adults. The effects of benralizumab on efficacy appear to persist over the approximately 2 year follow up period following the initial one year pivotal studies.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Future research will be focused on younger patients, particularly on children between 6 and 12 years of age.
Three-Year Safety and Efficacy of Benralizumab for Adolescent Patients with Severe, Uncontrolled Asthma: Results of the BORA Extension Study
Busse, William et al.
Journal of Allergy and Clinical Immunology, Volume 145, Issue 2, AB174
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Last Updated on May 6, 2020 by Marie Benz MD FAAD