Journal article
Opportunistic infections and biologic therapies in immune-mediated inflammatory diseases: consensus recommendations for infection reporting during clinical trials and postmarketing surveillance
Annals of the rheumatic diseases, Vol.74(12), pp.2107-2116
12/2015
DOI: 10.1136/annrheumdis-2015-207841
PMID: 26395500
Abstract
No consensus has previously been formed regarding the types and presentations of infectious pathogens to be considered as ‘opportunistic infections’ (OIs) within the setting of biologic therapy. We systematically reviewed published literature reporting OIs in the setting of biologic therapy for inflammatory diseases. The review sought to describe the OI definitions used within these studies and the types of OIs reported. These findings informed a consensus committee (infectious diseases and rheumatology specialists) in deliberations regarding the development of a candidate list of infections that should be considered as OIs in the setting of biologic therapy. We reviewed 368 clinical trials (randomised controlled/long-term extension), 195 observational studies and numerous case reports/series. Only 11 observational studies defined OIs within their methods; no consistent OI definition was identified across studies. Across all study formats, the most numerous OIs reported were granulomatous infections. The consensus group developed a working definition for OIs as ‘indicator’ infections, defined as specific pathogens or presentations of pathogens that ‘indicate’ the likelihood of an alteration in host immunity in the setting of biologic therapy. Using this framework, consensus was reached upon a list of OIs and case-definitions for their reporting during clinical trials and other studies. Prior studies of OIs in the setting of biologic therapy have used inconsistent definitions. The consensus committee reached agreement upon an OI definition, developed case definitions for reporting of each pathogen, and recommended these be used in future studies to facilitate comparison of infection risk between biologic therapies.
Details
- Title: Subtitle
- Opportunistic infections and biologic therapies in immune-mediated inflammatory diseases: consensus recommendations for infection reporting during clinical trials and postmarketing surveillance
- Creators
- K L Winthrop - Oregon Health & Science UniversityS A Novosad - Oregon Health & Science UniversityJ W Baddley - University of Alabama at BirminghamL Calabrese - Cleveland ClinicT Chiller - Centers for Disease Control and PreventionP Polgreen - University of IowaF Bartalesi - Azienda Ospedaliero-Universitaria CareggiM Lipman - Royal Free London NHS Foundation TrustX Mariette - Université Paris-SudO Lortholary - Hôpital Necker-Enfants MaladesM E Weinblatt - Brigham and Women's HospitalM Saag - University of Alabama at BirminghamJ Smolen - Medical University of Vienna
- Resource Type
- Journal article
- Publication Details
- Annals of the rheumatic diseases, Vol.74(12), pp.2107-2116
- DOI
- 10.1136/annrheumdis-2015-207841
- PMID
- 26395500
- NLM abbreviation
- Ann Rheum Dis
- ISSN
- 0003-4967
- eISSN
- 1468-2060
- Language
- English
- Date published
- 12/2015
- Academic Unit
- Infectious Diseases; Epidemiology; Injury Prevention Research Center; Internal Medicine
- Record Identifier
- 9984359772702771
Metrics
8 Record Views