Treatment of Moderate to Severe Hidradenitis Suppurativa
Authors: Vinay Prasad
Journal: Annals of Internal Medicine (2013)

LettersJuly 2, 2013Treatment of Moderate to Severe Hidradenitis SuppurativaVinay Prasad, MDVinay Prasad, MDFrom National Cancer Institute and National Institutes of Health, Bethesda, Maryland.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-159-1-201307020-00015 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:The phase 2 randomized trial by Kimball and colleagues (1), which claims a benefit of adalimumab in hidradenitis suppurativa, raises numerous questions about its methodology history (2). First, although the authors state that the primary outcome was “prespecified,” the trial's history of changes on ClinicalTrials.gov notes substantial alterations on 7 May 2011, more than 2 years after the trial began (3). Specifically, the primary outcome was altered on that date from an undefined “Physician's Global Assessment” to “Percentage of Participants Achieving Clinical Response at Week 16.” Another primary outcome of “Adverse Events” at a time point of ...References1. Kimball AB, Kerdel F, Adams D, Mrowietz U, Gelfand JM, Gniadecki R, et al. Adalimumab for the treatment of moderate to severe hidradenitis suppurativa: a parallel randomized trial. Ann Intern Med. 2012;157:846-55 LinkGoogle Scholar2. Krumholz HM. Documenting the methods history: would it improve the interpretability of studies? [Editorial]. Circ Cardiovasc Qual Outcomes. 2012;5:418-9. [PMID: 22811497] CrossrefMedlineGoogle Scholar3. ClinicalTrials.gov. Changes to NCT00918255 on 2011_05_07. Accessed at http://clinicaltrials.gov/archive/NCT00918255/2011_05_07/changes on 23 December 2012. Google Scholar4. ClinicalTrials.gov. Changes to NCT00918255 on 2009_11_12. Accessed at http://clinicaltrials.gov/archive/NCT00918255/2009_11_12/changes on 23 December 2012. Google Scholar5. Ioannidis JP. The importance of potential studies that have not existed and registration of observational data sets. JAMA. 2012;308:575-6. [PMID: 22871867] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From National Cancer Institute and National Institutes of Health, Bethesda, Maryland.Disclaimer: The views and opinions of the author do not reflect those of the National Institutes of Health.Disclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoAdalimumab for the Treatment of Moderate to Severe Hidradenitis Suppurativa Alexa B. Kimball , Francisco Kerdel , David Adams , Ulrich Mrowietz , Joel M. Gelfand , Robert Gniadecki , Errol P. Prens , Joel Schlessinger , Christos C. Zouboulis , Hessel H. van der Zee , Marie Rosenfeld , Parvez Mulani , Yihua Gu , Susan Paulson , Martin Okun , and Gregor B.E. Jemec Treatment of Moderate to Severe Hidradenitis Suppurativa Alexa B. Kimball , Yihua Gu , and Martin Okun Trust but Verify: Trial Registration and Determining Fidelity to the Protocol Deborah A. Zarin and Tony Tse Metrics Cited byTrust but Verify: Trial Registration and Determining Fidelity to the ProtocolDeborah A. Zarin, MD and Tony Tse, PhD July 2, 2013Volume 159, Issue 1Page: 72KeywordsConflicts of interestFistulas ePublished: 2 July 2013 Issue Published: July 2, 2013 Copyright & PermissionsCopyright © 2013 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...