Journal ArticleDOI
Opportunistic infections and biologic therapies in immune-mediated inflammatory diseases: consensus recommendations for infection reporting during clinical trials and postmarketing surveillance
Kevin L. Winthrop,Shannon A. Novosad,John W. Baddley,L. Calabrese,Tom Chiller,Philip M. Polgreen,F Bartalesi,Marc Lipman,Xavier Mariette,Olivier Lortholary,Michael E. Weinblatt,Michael S. Saag,Josef S Smolen +12 more
TLDR
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.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.read more
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The emerging safety profile of JAK inhibitors in rheumatic disease
TL;DR: Although nomalignancy signals have been identified to date, long-term follow-up and further research are needed to understand the risk of malignancy associated with these compounds, and vaccination is important to mitigate the risks of these emerging therapies.
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Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials
Stanley Cohen,Yoshiya Tanaka,Xavier Mariette,Jeffrey R. Curtis,Eun Bong Lee,Peter Nash,Kevin L. Winthrop,Christina Charles-Schoeman,Krishan Thirunavukkarasu,Ryan DeMasi,Jamie Geier,Kenneth Kwok,Lisy Wang,R. Riese,Juergen Wollenhaupt +14 more
TL;DR: An integrated safety summary of tofacitinib from two phase I, nine phase II, six phase III and two long-term extension studies in adult patients with active RA is reported, finding AEs were generally stable over time and no new safety signals were observed compared with previous tofacItinib reports.
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Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment
Josef S Smolen,Mark C. Genovese,Tsutomu Takeuchi,David L. Hyslop,William L. Macias,Terence Rooney,L. Chen,C. Dickson,Jennifer Riddle Camp,Tracy Cardillo,T. Ishii,Kevin L. Winthrop +11 more
TL;DR: In this integrated analysis of patients with moderate to severe active RA with exposure up to 5.5 years, baricitinib has an acceptable safety profile in the context of demonstrated efficacy.
Journal ArticleDOI
Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma.
Sumita Khatri,Wendy C. Moore,Peter G. Gibson,Richard Leigh,Arnaud Bourdin,Jorge Maspero,Manuel Barros,Roland Buhl,Peter H. Howarth,Frank C. Albers,Eric S. Bradford,Martyn J. Gilson,Robert G. Price,Steven W. Yancey,Hector Ortega +14 more
TL;DR: The long‐term safety and efficacy of mepolizumab in patients with severe eosinophilic asthma are supported, and the immunogenicity profile was consistent with previous studies.
Journal ArticleDOI
A systematic review and meta-analysis of infection risk with small molecule JAK inhibitors in rheumatoid arthritis
Katie Bechman,Sujith Subesinghe,Sam Norton,Fabiola Atzeni,Massimo Galli,Andrew P. Cope,Kevin L. Winthrop,James Galloway +7 more
TL;DR: The absolute SI rates were low, however across the JAK inhibitors, the incidence of HZ is higher than expected for the population (3.23 per 100 patient-years).
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