• About
  • Masthead
  • License Content
  • Advertise
  • Submit Press Release
  • RSS/Email List
  • 2MM Podcast
  • Write for us
  • Contact Us
2 Minute Medicine
No Result
View All Result

No products in the cart.

SUBSCRIBE
  • Specialties
    • All Specialties, All Recent Reports
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Pharma
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • AI Roundup
  • Pharma
  • The Scan+
  • Classics™+
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Podcasts
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • Account
    • Subscribe
    • Sign-in
    • My account
2 Minute Medicine
  • Specialties
    • All Specialties, All Recent Reports
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Pharma
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • AI Roundup
  • Pharma
  • The Scan+
  • Classics™+
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Podcasts
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • Account
    • Subscribe
    • Sign-in
    • My account
SUBSCRIBE
2 Minute Medicine
Subscribe
Home All Specialties Chronic Disease

Benralizumab not shown to ameliorate COPD exacerbation rates when compared to placebo

byShani ChibberandDayton McMillan
May 25, 2019
in Chronic Disease, Pulmonology
Reading Time: 3 mins read
0
Share on FacebookShare on Twitter

1. Two complementary phase 3 clinical trials randomized patients with moderate-to-severe COPD to receive either benralizumab or a placebo and found that the trial agent did not lead to a significant reduction in chronic obstructive pulmonary disease (COPD) exacerbation rates.

2. Safety outcomes were comparable between groups.

Evidence Rating Level: 1 (Excellent)  

Study Rundown: COPD leads to progressive limitation to airflow into the lungs leading to worsening respiratory function. COPD is often also associated with eosinophilic inflammation which ultimately affects patients’ responsiveness to glucocorticoid medication. Benralizumab, an interlukin-5 receptor alpha-directed cytolytic monoclonal antibody, has been evaluated as an agent that leads to substantial eosinophil depletion which could ameliorate respiratory symptoms. In this analysis, complementary phase 3 studies GALATHEA (Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease with Exacerbation History) and TERRANOVA (Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease with Exacerbation History) were conducted to assess the efficacy and safety of benralizumab versus placebo among patients with moderate to severe COPD.  There was not a significant difference in COPD exacerbation rates among patients on benralizumab versus placebo. They also did not note any difference in serious adverse events between groups.

This study underscores that eosinophil depletion may not have an effect in ameliorating COPD exacerbations. It is notable that it included merging of results from two separate but related trials and limited by the depth of subgroup analysis reported.

Click to read the study in NEJM

RELATED REPORTS

Verona’s Ohtuvayre shows promise in the treatment and management of Chronic Obstructive Pulmonary Disease

#VisualAbstract: Tezepelumab Does Not Reduce Exacerbations in Adults with Chronic Obstructive Pulmonary Disease

#VisualAbstract: High-Intensity Noninvasive Positive Pressure Ventilation Reduces Need for Endotracheal Intubation in COPD

Relevant Reading: Efficacy and safety of benralizumab for eosinophilic asthma: A systematic review and meta-analysis of randomized controlled trials

In-Depth [randomized controlled trial]: GALATHEA (n=1120) and TERRANOVA (n=1545) were both phase 3, double-blind, parallel-group randomized control trials. Eligible patients were randomized in a 1:1:1 ratio (GALATHEA) or 1:1:1:1 ratio (TERRANOVA) to either receive benralizumab or placebo via subcutaneous injection every four weeks. Doses of benralizumab were administered at either 30mg for asthma treatment or 100mg for the GALATHEA trial and at either 10mg, 30mg or 100 mg in the TERRANOVA trial. The primary endpoint of both trials were the treatment effects of benralizumab versus placebo, determined by the rate of COPD exacerbations after 56 weeks of treatment. Secondary endpoints included changes in FEV1, changes in the St. George’s Respiratory Questionnaire (SGRQ) score, and occurrence of any adverse events. The annual COPD exacerbation rate in GALATHEA was noted to be 1.19 per year among patients receiving 30mg benralizumab (95% confidence interval [CI], 1.04 to 1.36) and 1.03 among patients randomized to receive 100mg benralizumab  (95% CI, 0.90 to 1.19) versus 1.24 in the placebo group (95% CI, 1.08 to 1.42). The annual COPD exacerbation ratio in TERRANOVA was noted to be 0.99 in the 10-mg benralizumab group (95% CI, 0.87 to 1.13), 1.21 in the 30mg benralizumab group (95%CI, 1.08 to 1.37), 1.09 in the 100mg benralizumab group (95%CI, 0.96 to 1.23) and 1.17 in the placebo group (95% CI, 1.04 to 1.32).  In the GALATHEA trial, the mean change from baseline in FEV1 was 7mL in the 30mg benralizumab group (95% CI, -35 to 48) and 21 ml in the 100mg benralizumab group (95% CI, -12 to 62). Changes in SGRQ scores were noted to be -1.011 in the 30mg benralizumab group (95% CI, -2.887 to 0.865) and -2.136 in the 100mg benralizumab group (95% CI, -4.020 to -0.251). In the TERRANOVA group the mean change from baseline in FEV1 was 15mL in the 10mg benralizumab group (95% CI, -29 to 59), -7mL in the 30mg benralizumab group (95% CI, -51 to 37) and 20mL in the 100mg benralizumab group (95% CI, -24 to 64). Differences in SGRQ scores were -1.011 (95% CI, -3.192 to 1.171) in the 10mg group, -1.388 in the 30mg group (95% CI, -3.562 to 0.786) and -0.602 in the 100mg group (95% CI, -2.763 to 1.560). In terms of safety events, both trials led to eosinophil depletion among patients who took benralizumab, however adverse events occurred at a similar rate in both trial and placebo groups.

Image: PD

©2019 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc

Tags: Benralizumabchronic obstructive pulmonary disease (COPD)GALATHEATERRANOVA
Previous Post

Quick Take: Breast cancer risk in transgender people receiving hormone treatment

Next Post

Quick Take: Fracture risk after Roux-en-Y gastric bypass adjustable gastric banding among Medicare beneficiaries

RelatedReports

2 Minute Medicine Rewind May 20, 2019
Pharma

Verona’s Ohtuvayre shows promise in the treatment and management of Chronic Obstructive Pulmonary Disease

January 20, 2025
#VisualAbstract: Tezepelumab Does Not Reduce Exacerbations in Adults with Chronic Obstructive Pulmonary Disease
StudyGraphics

#VisualAbstract: Tezepelumab Does Not Reduce Exacerbations in Adults with Chronic Obstructive Pulmonary Disease

December 23, 2024
#VisualAbstract: High-Intensity Noninvasive Positive Pressure Ventilation Reduces Need for Endotracheal Intubation in COPD
StudyGraphics

#VisualAbstract: High-Intensity Noninvasive Positive Pressure Ventilation Reduces Need for Endotracheal Intubation in COPD

October 2, 2024
Extensive lymphadenectomy may not increase patient survival with esophageal cancer
Chronic Disease

Benralizumab associated with histologic response in eosinophilic esophagitis

July 18, 2024
Next Post
Addressing non-obesity related barriers may improve bariatric surgery effectiveness

Quick Take: Fracture risk after Roux-en-Y gastric bypass adjustable gastric banding among Medicare beneficiaries

The SENSCIS trial: nintedanib slows declines in FVC in patients with interstitial lung disease caused by systemic sclerosis

The SENSCIS trial: nintedanib slows declines in FVC in patients with interstitial lung disease caused by systemic sclerosis

Prenatal antidepressant exposure may increase risk of poor motor development

Quick Take: Association between incidence exposure to benzodiazepines in early pregnancy and risk of spontaneous abortion

2 Minute Medicine® is an award winning, physician-run, expert medical media company. Our content is curated, written and edited by practicing health professionals who have clinical and scientific expertise in their field of reporting. Our editorial management team is comprised of highly-trained MD physicians. Join numerous brands, companies, and hospitals who trust our licensed content.

Recent Reports

  • Seventh cervical nerve neurotomy may augment speech therapy in patients with chronic aphasia post-stroke
  • Time-restricted eating does not confer changes in sleep, mood, or quality of life
  • Commonly cited medication triggers may not increase risk of microscopic colitis among older adults
License Content
Terms of Use | Disclaimer
Cookie Policy
Privacy Statement (EU)
Disclaimer

© 2021 2 Minute Medicine, Inc. - Physician-written medical news.

  • Specialties
    • All Specialties, All Recent Reports
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Pharma
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • AI Roundup
  • Pharma
  • The Scan
  • Classics™
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Podcasts
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • Account
    • Subscribe
    • Sign-in
    • My account
No Result
View All Result

© 2021 2 Minute Medicine, Inc. - Physician-written medical news.