Evidence map›Paper›PMID 30095981›Full record

Trial reportAmerican journal of respiratory and critical care medicine2019

Activin Type II Receptor Blockade for Treatment of Muscle Depletion in Chronic Obstructive Pulmonary Disease. A Randomized Trial.

Michael I Polkey, Jens Praestgaard, Amy Berwick, Frits M E Franssen, Dave Singh, Michael C Steiner, Richard Casaburi, Hanns-Christian Tillmann, Estelle Lach-Trifilieff, Ronenn Roubenoff and 1 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of respiratory and critical care medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01669174 (A Randomized, Double Blind, Placebo Controlled, Multi-centre Study to Asses the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of BYM338 in Chronic Obstructive Pulmonary Disease Patients With Cachexia), which is not on this map. Cited by 69 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 2 pooled it
8.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01669174 phase2completednot on this map

A Randomized, Double Blind, Placebo Controlled, Multi-centre Study to Asses the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of BYM338 in Chronic Obstructive Pulmonary Disease Patients With Cachexia

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2014Enrolled67ConditionsChronic Obstructive Pulmonary Disease (COPD) With CachexiaArmsPlacebo, BYM338
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 2 syntheses or guidelines pooled it, 97 citations in OpenAlex.

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9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 4 countries.

Michael I Polkey1 National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield National Health Service Foundation Trust and Imperial College London, London, United Kingdom.
Jens Praestgaard2 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Amy Berwick3 Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.
Frits M E Franssen4 Department of Research and Education, CIRO, Center of Expertise for Chronic Organ Failure, Horn, the Netherlands.
Dave Singh5 Centre for Respiratory Medicine and Allergy, University of Manchester and the Medicines Evaluation Unit, University Hospital of South Manchester National Health Service Foundation Trust, Manchester, United Kingdom.
Michael C Steiner6 Centre for Exercise and Rehabilitation Science, National Institute for Health Research Leicester Biomedical Research Centre, Respiratory, Glenfield Hospital, Leicester, United Kingdom.
Richard Casaburi7 Rehabilitation Clinical Trials Center, Los Angeles Biomedical Research Institute, Harbor-University of California Los Angeles Medical Center, Torrance, California; and.
Hanns-Christian Tillmann8 Novartis Institutes for BioMedical Research, Basel, Switzerland.
Estelle Lach-Trifilieff8 Novartis Institutes for BioMedical Research, Basel, Switzerland.
Ronenn Roubenoff8 Novartis Institutes for BioMedical Research, Basel, Switzerland.
Daniel S Rooks3 Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.
Novartis (Switzerland) · CHBoston Biomedical Research Institute · USNational Health Service · GBCiro · NLGlenfield Hospital · GBNovartis (United States) · USThe Lundquist Institute · US

Funding

Medical Research Council G0501985Medical Research Council G1001362
6 · The paper itself

Abstract

rationaleBimagrumab is a fully human monoclonal antibody that blocks the activin type II receptors, preventing the activity of myostatin and other negative skeletal muscle regulators.

objectivesTo assess the effects of bimagrumab on skeletal muscle mass and function in patients with chronic obstructive pulmonary disease (COPD) and reduced skeletal muscle mass.

methodsSixty-seven patients with COPD (mean FEV MEASUREMENTS AND MAIN

resultsWe assessed changes in thigh muscle volume (cubic centimeters) as the primary endpoint along with 6-minute-walk distance (meters), safety, and tolerability. Fifty-five (82.1%) patients completed the study. Thigh muscle volume increased by Week 4 and remained increased at Week 24 in bimagrumab-treated patients, whereas no changes were observed with placebo (Week 4: +5.9% [SD, 3.4%] vs. 0.0% [3.3%], P < 0.001; Week 8: +7.0% [3.7%] vs. -0.7% [2.8%], P < 0.001; Week 16: +7.8% [5.1%] vs. -0.9% [4.5%], P < 0.001; Week 24: +5.0% [4.9%] vs. -1.3% [4.3%], P < 0.001). Over 24 weeks, 6-minute-walk distance did not increase significantly in either group. Adverse events in the bimagrumab group included muscle-related symptoms, diarrhea, and acne, most of which were mild in severity.

conclusionsBlocking the action of negative muscle regulators through the activin type II receptors with bimagrumab treatment safely increased skeletal muscle mass but did not improve functional capacity in patients with COPD and low muscle mass. Clinical trial registered with www.clinicaltrials.gov (NCT01669174).

Indexed as

Activin ReceptorsAdultAgedAged, 80 and overAntibodies, BlockingAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBody CompositionDouble-Blind MethodFemaleHumansMaleMiddle AgedMuscle, SkeletalMuscular AtrophyPulmonary Disease, Chronic ObstructiveActivin ReceptorsAntibodies, BlockingAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedbimagrumab6-minute-walk distancebimagrumablean body massthigh muscle volume

Identifiers

PMID30095981
PMCPMC6363975
OpenAlexW2886434005

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.