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Misinterpretation of time-to-first event curves can lead to inappropriate treatment

Benjamin Hartley, Gerard J. Criner, Mark T. Dransfield, David M.G. Halpin, MeiLan K. Han, C. Elaine Jones, Sally Kilbride, Peter Lange, David A. Lipson, David A. Lomas, Neil Martin, Fernando J. Martinez, Dave Singh, Robert A. Wise, Sally Lettis
European Respiratory Journal 2019 54: 1900634; DOI: 10.1183/13993003.00634-2019
Benjamin Hartley
Statistics and Programming, Veramed Ltd, Twickenham, UK
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Gerard J. Criner
Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA
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Mark T. Dransfield
Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA
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David M.G. Halpin
Dept of Respiratory Medicine, Royal Devon and Exeter Hospital, Exeter, UK
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MeiLan K. Han
University of Michigan, Pulmonary and Critical Care, Ann Arbor, MI, USA
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C. Elaine Jones
GlaxoSmithKline, Research Triangle Park, NC, USA
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Sally Kilbride
GlaxoSmithKline, Stockley Park West, Uxbridge, UK
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Peter Lange
Dept of Public Health, Section of Epidemiology, University of Copenhagen, Copenhagen, DenmarkMedical Dept, Herlev and Gentofte Hospital, Herlev, Denmark
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David A. Lipson
GlaxoSmithKline, Collegeville, PA, USAPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
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  • ORCID record for David A. Lipson
David A. Lomas
UCL Respiratory, University College London, London, UK
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Neil Martin
GlaxoSmithKline, Brentford, UKUniversity of Leicester, Leicester, UK
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Fernando J. Martinez
New York-Presbyterian Weill Cornell Medical Center, New York, NY, USA
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Dave Singh
University of Manchester, Manchester, UK
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Robert A. Wise
Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
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Sally Lettis
GlaxoSmithKline, Stockley Park West, Uxbridge, UK
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  • For correspondence: sally.x.lettis@gsk.com
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Extract

Great care should be taken when assessing the consistency of treatment effect over time based on a survival curve plot, and even more so when a treatment affects a repeating event end-point, such as exacerbations, rather than an event that can occur only once, like death.

Abstract

Evaluation of treatment effect durability over time cannot be based on analyses that examine the first of many events. Here, it is explained how misinterpretation of survival curves led to wrong conclusions in a recent ERJ editorial. http://bit.ly/2K3amgQ

Footnotes

  • Conflict of interest: B. Hartley reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; B. Hartley is a contingent worker on assignment at GlaxoSmithKline, and holds shares in GlaxoSmithKline, outside the submitted work.

  • Conflict of interest: G.J. Criner reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; personal fees from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, CSA Medical, Eolo, GlaxoSmithKline, HGE Technologies, Novartis, Nuvaira, Olympus, Pulmonx, Verona and NGM Bio, outside the submitted work.

  • Conflict of interest: M.T. Dransfield reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; grants from Department of Defense and NIH, has received personal fees for consultancy from and undertaken clinical trials for Boehringer Ingelheim, AstraZeneca, PneumRx/BTG, Boston Scientific and GlaxoSmithKline, undertaken clinical trials for Novartis, Yungjin and Pulmonx, personal fees for consultancy from Genentech and Quark Pharmaceuticals, outside the submitted work.

  • Conflict of interest: D.M.G. Halpin reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; personal fees from AstraZeneca, Chiesi, GlaxoSmithKline and Pfizer, personal fees and non-financial support from Boehringer Ingelheim and Novartis, outside the submitted work.

  • Conflict of interest: M.K. Han reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; personal fees from AstraZeneca and Boehringer Ingelheim, grant support from Novartis and Sunovion, outside the submitted work.

  • Conflict of interest: C.E. Jones reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; C.E. Jones is an employee of and holds shares/options in GlaxoSmithKline, outside the submitted work.

  • Conflict of interest: S. Kilbride reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; S. Kilbride is an employee of and holds shares/options in GlaxoSmithKline, outside the submitted work.

  • Conflict of interest: P. Lange reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim and Chiesi, outside the submitted work.

  • Conflict of interest: D.A. Lipson reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; D.A. Lipson is an employee of and holds shares/options in GlaxoSmithKline, outside the submitted work.

  • Conflict of interest: D.A. Lomas reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; grants, personal fees for consultancy and honoraria from GlaxoSmithKline, personal fees for consultancy from Grifols, outside the submitted work.

  • Conflict of interest: N. Martin reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; N. Martin is an employee of and holds shares/options in GlaxoSmithKline, outside the submitted work.

  • Conflict of interest: F.J. Martinez reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; personal fees and travel support for educational activities from American College of Chest Physicians, Inova Fairfax Health System, MD Magazine, Miller Communications, National Association for Continuing Education, PeerView Communications, Prime Communications, Puerto Rican Respiratory Society, Potomac, University of Alabama Birmingham, Physicians Education Resource, Canadian Respiratory Network and Dartmouth, personal fees for advisory board work, steering committee work and lectures, and travel support from AstraZeneca, personal fees for advisory board work, data monitoring committee work and lectures, and travel support from Boehringer Ingelheim and Genentech, non-financial support for advisory board work from ProterrixBio, personal fees for educational activities from Columbia University, Integritas, Methodist Hospital Brooklyn, New York University, UpToDate, WebMD/MedScape, Western Connecticut Health Network, PlatformIQ, Rockpointe, Rare Disease Healthcare Communications and France Foundation, personal fees for advisory board work and travel support from ConCert, Sunovion, Theravance and Teva, personal fees for advisory board work and non-financial support for travel, lecturing, steering committee work and data monitoring committee work from GlaxoSmithKline, personal fees for advisory board work and lectures, and travel support from Novartis, personal fees for advisory board work and non-financial support for steering committee work from Pearl Pharmaceuticals, personal fees for advisory board work and educational activites, and travel support from Chiesi, non-financial support for steering committee work from Afferent/Merck, Gilead, Nitto, Veracyte, Prometic, Bayer and ProMedior, personal fees for consultancy and steering committee work from Patara/Respivant, non-financial support for data monitoring committee and steering committee work from Biogen, non-financial support for lecturing and advisory board work from Zambon, personal fees for journal editorship from American Thoracic Society, grants from NIH, non-financial support for consultancy from Bridge Biotherapeutics, outside the submitted work.

  • Conflict of interest: D. Singh reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, Cipla, Genentech and Peptinnovate, grants and personal fees from AstraZeneca, Boehringer Ingleheim, Chiesi, Glenmark, Menarini, Mundipharma, Novartis, Pfizer, Pulmatrix, Therevance and Verona, outside the submitted work.

  • Conflict of interest: R.A. Wise reports grant support and medical writing support funded by GlaxoSmithKline, personal fees for data monitoring committee and advisory board work from GlaxoSmithKline, during the conduct of the study; grants and personal fees for data monitoring committee and consultancy work from AstraZeneca/Medimmune and GSK, grants and personal fees for data monitoring and steering committee work from Boehringer Ingelheim, personal fees for clinical end-point committee work from Contrafect, personal fees for data monitoring committee work from Pulmonx, Roche, Merck and AbbVie, personal fees for steering committee work from Spiration, personal fees for workshops and consultancy from Sunovion, grants from Pearl Therapeutics and Sanofi-Aventis, personal fees for consultancy from Circassia, Pneuma, Verona, Denali, Aradigm, Mylan/Theravance and Propelloer Health, personal fees for safety review committee work from Bonti, outside the submitted work.

  • Conflict of interest: S. Lettis reports grant support and medical writing support funded by GlaxoSmithKline, during the conduct of the study; S. Lettis is an employee of and holds shares/options in GlaxoSmithKline, outside the submitted work.

  • Support statement: Editorial support (in the form of assembling figures, collating author comments, grammatical editing and referencing) was provided by Chrystelle Rasamison, at Fishawack Indicia Ltd, UK, and was funded by GSK. This study was funded by GSK (study number CTT116855). The funders of the study had a role in the study design, data analysis, data interpretation, and writing of the report. Funding information for this article has been deposited with the Crossref Funder Registry.

  • Received March 29, 2019.
  • Accepted May 30, 2019.
  • Copyright ©ERS 2019
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Misinterpretation of time-to-first event curves can lead to inappropriate treatment
Benjamin Hartley, Gerard J. Criner, Mark T. Dransfield, David M.G. Halpin, MeiLan K. Han, C. Elaine Jones, Sally Kilbride, Peter Lange, David A. Lipson, David A. Lomas, Neil Martin, Fernando J. Martinez, Dave Singh, Robert A. Wise, Sally Lettis
European Respiratory Journal Sep 2019, 54 (3) 1900634; DOI: 10.1183/13993003.00634-2019

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Misinterpretation of time-to-first event curves can lead to inappropriate treatment
Benjamin Hartley, Gerard J. Criner, Mark T. Dransfield, David M.G. Halpin, MeiLan K. Han, C. Elaine Jones, Sally Kilbride, Peter Lange, David A. Lipson, David A. Lomas, Neil Martin, Fernando J. Martinez, Dave Singh, Robert A. Wise, Sally Lettis
European Respiratory Journal Sep 2019, 54 (3) 1900634; DOI: 10.1183/13993003.00634-2019
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