Evidence map›Paper›PMID 28793896›Full record

Trial reportRespiratory research2017

A randomised, placebo-controlled trial of anti-interleukin-1 receptor 1 monoclonal antibody MEDI8968 in chronic obstructive pulmonary disease.

Peter M A Calverley, Sanjay Sethi, Michelle Dawson, Christine K Ward, Donna K Finch, Mark Penney, Paul Newbold, René van der Merwe

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01448850 (A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 49 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT01448850 phase2completednot on this map

A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorMedImmune LLCRan2011 to 2014Enrolled464ConditionsChronic Obstructive Pulmonary DiseaseArmsMEDI8968 600 mg IV, 300 mg SC, Placebo
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  15. Multi-Criteria Decision Analysis of Biologics in Chronic Obstructive Pulmonary Disease.International journal of chronic obstructive pulmonary disease · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Peter M A CalverleySchool of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK. pmacal@liverpool.ac.uk.
Sanjay SethiDivision of Pulmonary, Critical Care and Sleep Medicine, University of Buffalo, State University of New York, Buffalo, NY, USA.
Michelle DawsonMedImmune, Cambridge, UK.
Christine K WardMedImmmune, Gaithersburg, MD, USA.
Donna K FinchMedImmune, Cambridge, UK.
Mark PenneyMedImmune, Cambridge, UK.
Paul NewboldMedImmmune, Gaithersburg, MD, USA.
René van der MerweMedImmune, Cambridge, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInterleukin-1 receptor 1 (IL-1R1) inhibition is a potential strategy for treating patients with chronic obstructive pulmonary disease (COPD). MEDI8968, a fully human monoclonal antibody, binds selectively to IL-1R1, inhibiting activation by IL-1α and IL-1β. We studied the efficacy and safety/tolerability of MEDI8968 in adults with symptomatic, moderate-to-very severe COPD.

methodsThis was a phase II, randomised, double-blind, placebo-controlled, multicentre, parallel-group study. Subjects aged 45-75 years and receiving standard maintenance therapy with ≥2 exacerbations in the past year were randomised 1:1 to receive placebo or MEDI8968 300 mg (600 mg intravenous loading dose) subcutaneously every 4 weeks, for 52 weeks. The primary endpoint was the moderate/severe acute exacerbations of COPD (AECOPD) rate (week 56 post-randomisation). Secondary endpoints were severe AECOPD rate and St George's Respiratory Questionnaire-COPD (SGRQ-C) score (week 56 post-randomisation).

resultsOf subjects randomised to placebo (n = 164) and MEDI8968 (n = 160), 79.3% and 75.0%, respectively, completed the study. There were neither statistically significant differences between treatment groups in moderate/severe AECOPD rate ([90% confidence interval]: 0.78 [0.63, 0.96], placebo; 0.71 [0.57, 0.90], MEDI8968), nor in severe AECOPD rate or SGRQ-C scores. Post-hoc analysis of subject subgroups (by baseline neutrophil count or tertiles of circulating neutrophil counts) did not alter the study outcome. The incidence of treatment-emergent adverse events (TEAEs) with placebo and MEDI8968 treatment was similar. The most common TEAE was worsening of COPD.

conclusionsIn this phase II study, MEDI8968 did not produce statistically significant improvements in AECOPD rate, lung function or quality of life.

trial registrationClinicalTrials.gov, NCT01448850 , date of registration: 06 October 2011.

Indexed as

AgedAntibodies, MonoclonalDouble-Blind MethodFemaleHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveReceptors, Interleukin-1Antibodies, MonoclonalReceptors, Interleukin-1COPDC-reactive proteinFibrinogenInterleukin-1 receptor 1MEDI8968NeutrophilsPharmacology

Identifiers

PMID28793896
PMCPMC5551010

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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.