Benralizumab for adolescent patients with severe, eosinophilic asthma: Safety and efficacy after 3 years of treatment
| Autor: | Gary T. Ferguson, William W. Busse, Eugene R. Bleecker, J. Mark FitzGerald, Richard F. Olsson, Laura Brooks, Peter Barker, Bora study investigators, Mitchell Goldman, Ubaldo J. Martin |
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| Rok vydání: | 2021 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Immunology Eosinophilic asthma Antibodies Monoclonal Humanized Placebo 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Primary outcome Double-Blind Method Forced Expiratory Volume Internal medicine medicine Humans Immunology and Allergy Anti-Asthmatic Agents 030212 general & internal medicine Pulmonary Eosinophilia Adverse effect Asthma Asthma exacerbations business.industry Benralizumab medicine.disease Discontinuation Eosinophils 030228 respiratory system chemistry Disease Progression Drug Therapy Combination Female business |
| Zdroj: | Journal of Allergy and Clinical Immunology. 148:266-271.e2 |
| ISSN: | 0091-6749 |
| Popis: | Background Adults and adolescents with severe asthma who completed the 48-week SIROCCO and 56-week CALIMA phase III benralizumab trials entered the safety extension study BORA (NCT02258542). The continued safety and efficacy of benralizumab in the first year of BORA (year 2 of treatment) have been reported. Objective We sought to report outcomes for adolescents during years 2 and 3 of treatment in BORA. Methods Patients on benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (Q8W) in SIROCCO/CALIMA continued their regimens in BORA (Q4W/Q4W and Q8W/Q8W, respectively), whereas placebo patients were rerandomized 1:1 to benralizumab (placebo/Q4W and placebo/Q8W, respectively) for 108 weeks. The primary outcome was safety; secondary outcomes included reduction in annual asthma exacerbation rate and change from baseline in prebronchodilator FEV1. Results Adolescents (N = 86) were treated with benralizumab Q8W (n = 61) or Q4W (n = 25); 69 completed treatment (Q8W: n = 51; Q4W: n = 18). For Q4W and Q8W regimens, rates of treatment-emergent adverse events were 68% (17 of 25) and 74% (45 of 61), respectively, rates of treatment-emergent adverse events (TEAEs) were 68% (17/25) and 74% (45/61), TEAEs leading to discontinuation were 4% (1/25) and 0%, serious AEs were 8% (2/25) and 7% (4/61), and no deaths occurred. In efficacy analyses, 69% (42 of 61) Q8W patients were exacerbation-free (placebo/Q8W: 62% [18 of 29], Q8W/Q8W: 75% [24 of 32]). Mean ± SD change in FEV1 at week 108 versus BORA baseline was 0.327 ± 0.452 L (placebo/Q8W) and 0.323 ± 0.558 L (Q8W/Q8W). Conclusions Safety and efficacy profiles in this 2-year extension study (up to 3 years of benralizumab treatment in adolescents) were consistent with previous findings. |
| Databáze: | OpenAIRE |
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