Anitbodies, Monoclonal

This monoclonal antibody that blacks the inflammatory response to both neutrophils and eosinophils appears to improve health-related quality of life and reduce moderate to severe exacerbations in people with COPD. However, it may not be available yet and is probably going to be very expensive when it is available.

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Rationale
The efficacy and safety of astegolimab, an anti-ST2 monoclonal antibody, was evaluated in participants with chronic obstructive pulmonary disease (COPD) and frequent exacerbations in the pivotal ALIENTO and ARNASA trials.

Objectives
To report the prespecified pooled analysis of ALIENTO and ARNASA.

Methods
ALIENTO and ARNASA were randomized, double-blind, placebo-controlled trials with similar designs and included participants with COPD, a history of frequent exacerbations, and current/former smoking status, irrespective of blood eosinophil count and chronic bronchitis. Participants were randomized 1:1:1 to astegolimab 476 mg every 2 weeks (Q2W), astegolimab every 4 weeks (Q4W), or placebo for 52 weeks, plus optimized maintenance therapy. The primary endpoint was annualized rate of moderate/severe exacerbations. Secondary endpoints included annualized rate of severe exacerbations. A hierarchical statistical plan was followed with hypothesis testing of secondary efficacy endpoints gated on the primary efficacy endpoint success.

Measurements and Main Results
A total of 2682 participants were included in the pooled intent-to-treat population. Astegolimab significantly reduced the annualized rate of moderate/severe exacerbations by 15% in the Q2W arm (adjusted rate ratio, 0.85 [95% CI, 0.76-0.96]; P = .0077) and by 12% in the Q4W arm (rate ratio, 0.88 [95% CI, 0.78-0.99]; P = .0265). A nominally significant reduction in the annualized rate of severe COPD exacerbations (rate ratio, 0.68 [95% CI, 0.52-0.87]; P = .0028) was observed for astegolimab Q2W vs placebo. Astegolimab was well tolerated.

Conclusions
Astegolimab every 2 weeks reduced the annualized rate of moderate/severe exacerbations in a clinically heterogeneous population of participants with COPD and frequent exacerbations.

Clinical trial registration
ClinicalTrials.gov: NCT05037929; NCT05595642

Author/s:

Jadwiga A Wedzicha, Alvar Agustí, Christopher E. Brightling, Peter Calverley, James D. Chalmers, Neil J. Greening, MeiLan K. Han, Divya Mohan, Julie Ng, Papi, Alberto, Nicolas Roche, Rebecca Saenz, Katerina Samara, Ruth Tal-Singer, Claus F. Vogelmeier, Xiaoying Yang, Bartolome R. Celli

Ulcerative Colitis in Adults: A Review

Rowan Hutchins — Tue, 03 Oct 2023 05:00:00 +0000

Date Added:

October 3, 2023

Journal/Publication:

JAMA

Publisher:

AMA

Publication Date:

September 12, 2023

Issue:

Volume:

330

Pages:

951-965

URL:

Ulcerative Colitis in Adults: A Review

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2023.15389

Keywords

ulcerative colitis

Mesalamine

quality of life

PMID (1):

37698559

MeSH

Antibodies

Anitbodies, Monoclonal

Colitis

Ulcerative* / complications

Ulcerative* / diagnosis

Colorectal Neoplasms* / diagnosis

Colorectal Neoplasms* / epidemiology

A review of ulcerative colitis in adults. James W. Mold, MD, MPH

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Importance: Ulcerative colitis (UC) is a chronic inflammatory condition of the colon, with a prevalence exceeding 400 per 100 000 in North America. Individuals with UC have a lower life expectancy and are at increased risk for colectomy and colorectal cancer.

Author/s:

Gros, Beatriz, Kaplan, Gilaad

SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates

Devin Evans — Fri, 13 Nov 2020 06:00:00 +0000

Date Added:

November 13, 2020

Journal/Publication:

Lancet

Publication Date:

October 13, 2020

Issue:

10262

Volume:

396

Pages:

1595-1606

URL:

SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/S0140-6736(20)32137-1

Keywords

PMID (1):

33065034

MeSH

Anitbodies, Monoclonal

A review of what is currently known about the immune response to COVID-19 and its implications for therapy and vaccines. James W. Mold, MD, MPH

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Understanding immune responses to severe acute respiratory syndrome coronavirus 2 is crucial to understanding disease pathogenesis and the usefulness of bridge therapies, such as hyperimmune globulin and convalescent human plasma, and to developing vaccines, antivirals, and monoclonal antibodies. A mere 11 months ago, the canvas we call COVID-19 was blank. Scientists around the world have worked collaboratively to fill in this blank canvas. In this Review, we discuss what is currently known about human humoral and cellular immune responses to severe acute respiratory syndrome coronavirus 2 and relate this knowledge to the COVID-19 vaccines currently in phase 3 clinical trials.

Author/s:

Gregory A., Ovsyannikova , Inna G., Kennedy, Richard B.