Richard M Nowak1, Joseph M Parker2, Robert A Silverman3, Brian H Rowe4, Howard Smithline5, Faiz Khan6, Jon P Fiening7, Keunpyo Kim8, Nestor A Molfino9. 1. Clinical Trial Center, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, USA. Electronic address: rnowak1@hfhs.org. 2. Clinical Development, MedImmune, One MedImmune Way, Gaithersburg, MD, USA. Electronic address: parkerj@medimmune.com. 3. Department of Emergency Medicine, North Shore-Long Island Jewish Medical Center, 270-05 76th Ave New Hyde Park, NY, USA. Electronic address: aresilv@aol.com. 4. Department of Emergency Medicine and School of Public Health, University of Alberta, 1G1.42 Walter Mackenzie Centre, Edmonton, Alberta, Canada. Electronic address: brian.rowe@ualberta.ca. 5. Department of Emergency Medicine, Baystate Emergency Medicine, 759 Chestnut St, Springfield, MA, USA. Electronic address: howard.smithline@bhs.org. 6. Department of Emergency Medicine, Nassau University Medical Center, 2201 Hempstead Turnpike, Box 14, East Meadow, NY, USA. Electronic address: faizkhan3@aol.com. 7. Clinical Operations, MedImmune, One MedImmune Way, Gaithersburg, MD, USA. Electronic address: fieningj@medimmune.com. 8. Clinical Biostatistics, MedImmune, One MedImmune Way, Gaithersburg, MD, USA. Electronic address: kimk@medimmune.com. 9. Clinical Research, MedImmune, One MedImmune Way, Gaithersburg, MD, USA. Electronic address: nmolfino@kalobios.com.
Abstract
BACKGROUND:Patients with frequent asthma exacerbations resulting in emergency department (ED) visits are at increased risk for future exacerbations. We examined the ability of 1 dose of benralizumab, an investigational antiinterleukin 5 receptor α monoclonal antibody, to reduce recurrence after acute asthma exacerbations. METHODS: In this randomized, double-blind, placebo-controlled study, eligible subjects presented to the ED with an asthma exacerbation, had partial response to treatment, and greater than or equal to 1 additional exacerbation within the previous year. Subjects received 1 intravenous infusion of placebo (n = 38) or benralizumab (0.3 mg/kg, n = 36 or 1.0 mg/kg, n = 36) added to outpatient management. The primary outcome was the proportion of subjects with greater than or equal to 1 exacerbation at 12 weeks in placebo vs the combined benralizumab groups. Other outcomes included the time-weighted rate of exacerbations at week 12, adverse events, blood eosinophil counts, asthma symptom changes, and health care resource utilization. RESULTS: The proportion of subjects with greater than or equal to 1 asthma exacerbation at 12 weeks was not different between placebo and the combined benralizumab groups (38.9% vs 33.3%; P = .67). However, compared with placebo, benralizumab reduced asthma exacerbation rates by 49% (3.59 vs 1.82; P = .01) and exacerbations resulting in hospitalization by 60% (1.62 vs 0.65; P = .02) in the combined groups. Benralizumab reduced blood eosinophil counts but did not affect other outcomes, while demonstrating an acceptable safety profile. CONCLUSIONS: When added to usual care, 1 dose of benralizumab reduced the rate and severity of exacerbations experienced over 12 weeks by subjects who presented to the ED with acute asthma.
RCT Entities:
BACKGROUND:Patients with frequent asthma exacerbations resulting in emergency department (ED) visits are at increased risk for future exacerbations. We examined the ability of 1 dose of benralizumab, an investigational antiinterleukin 5 receptor α monoclonal antibody, to reduce recurrence after acute asthma exacerbations. METHODS: In this randomized, double-blind, placebo-controlled study, eligible subjects presented to the ED with an asthma exacerbation, had partial response to treatment, and greater than or equal to 1 additional exacerbation within the previous year. Subjects received 1 intravenous infusion of placebo (n = 38) or benralizumab (0.3 mg/kg, n = 36 or 1.0 mg/kg, n = 36) added to outpatient management. The primary outcome was the proportion of subjects with greater than or equal to 1 exacerbation at 12 weeks in placebo vs the combined benralizumab groups. Other outcomes included the time-weighted rate of exacerbations at week 12, adverse events, blood eosinophil counts, asthma symptom changes, and health care resource utilization. RESULTS: The proportion of subjects with greater than or equal to 1 asthma exacerbation at 12 weeks was not different between placebo and the combined benralizumab groups (38.9% vs 33.3%; P = .67). However, compared with placebo, benralizumab reduced asthma exacerbation rates by 49% (3.59 vs 1.82; P = .01) and exacerbations resulting in hospitalization by 60% (1.62 vs 0.65; P = .02) in the combined groups. Benralizumab reduced blood eosinophil counts but did not affect other outcomes, while demonstrating an acceptable safety profile. CONCLUSIONS: When added to usual care, 1 dose of benralizumab reduced the rate and severity of exacerbations experienced over 12 weeks by subjects who presented to the ED with acute asthma.
Authors: Sanjay Ramakrishnan; James R Camp; Bavithra Vijayakumar; Frances M Hardinge; Matilda L Downs; Richard E K Russell; Ian D Pavord; Mona Bafadhel Journal: Am J Respir Crit Care Med Date: 2020-06-01 Impact factor: 21.405
Authors: Diego Bagnasco; Matteo Ferrando; Marco Caminati; Alice Bragantini; Francesca Puggioni; Gilda Varricchi; Giovanni Passalacqua; Giorgio Walter Canonica Journal: Drug Saf Date: 2017-07 Impact factor: 5.606