RT Journal Article
SR Electronic
T1 Opportunistic infections and biologic therapies in immune-mediated inflammatory diseases: consensus recommendations for infection reporting during clinical trials and postmarketing surveillance
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 2107
OP 2116
DO 10.1136/annrheumdis-2015-207841
VO 74
IS 12
A1 K L Winthrop
A1 S A Novosad
A1 J W Baddley
A1 L Calabrese
A1 T Chiller
A1 P Polgreen
A1 F Bartalesi
A1 M Lipman
A1 X Mariette
A1 O Lortholary
A1 M E Weinblatt
A1 M Saag
A1 J Smolen
YR 2015
UL http://ard.bmj.com/content/74/12/2107.abstract
AB 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.