Hyperimmune globulins and same-day thrombotic adverse events as recorded in a large healthcare database during 2008-2011.
Mikhail Menis,Gayathri Sridhar,Nandini Selvam,Mikhail V Ovanesov,Hozefa A. Divan,Yideng Liang,Dorothy E. Scott,Basil Golding,Richard A. Forshee,Robert Ball,Steven A. Anderson,Hector S. Izurieta +11 more
TLDR
Increase in the same‐day TE DC risk with GamaSTAN S/D IG >10 cc is identified for the first time and suggests potentially elevated TE risk with other HIGs.Abstract:
Thrombotic events (TEs) are rare serious complications following administration of hyperimmune globulin (HIG) products. Our retrospective claims-based study assessed occurrence of same-day TEs following administration of HIGs during 2008-2011 and examined potential risk factors using HealthCore's Integrated Research Database (HIRD(SM) ) and laboratory testing of products' procoagulant Factor XIa activity by U.S. Food and Drug Administration. Multivariable regression was used to estimate same-day TE risk for different products. Of 101,956 individuals exposed to 23 different HIG product groups, 86 (0.84 per 1,000 persons) had a TE diagnosis code (DC) recorded on the same day as HIG administration. Unadjusted same-day TE DC rates (per 1,000 persons) ranged from 0.4 to 148.9 for different products. GamaSTAN S/D IG >10 cc had statistically significantly higher same-day TE DC risk compared to Tetanus IG (OR = 57.57; 95% CI = 19.72-168.10). Increased TE risk was also observed with older age (≥45 years), prior thrombotic events, and hypercoagulable state(s). Laboratory investigation identified elevated Factor XIa activity for GamaSTAN S/D, HepaGam B, HyperHep B S/D, WinRho SDF, HyperRHO S/D full dose, and HyperTET S/D. Our study, for the first time, identified increase in the same-day TE DC risk with GamaSTAN S/D IG >10 cc and suggests potentially elevated TE risk with other HIGs.read more
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Iconographies supplémentaires de l'article : Practice parameter for the diagnosis and management of primary immunodeficiency
Francisco A. Bonilla,David A. Khan,Zuhair K. Ballas,Javier Chinen,Michael M. Frank,Joyce T. Hsu,Michael D. Keller,Lisa Kobrynski,Hirsh D. Komarow,Bruce Mazer,Robert P. Nelson,Jordan S. Orange,John M. Routes,William T. Shearer,Ricardo U. Sorensen,James W. Verbsky,David I. Bernstein,Joann Blessing-Moore,David Lang,Richard A. Nicklas,John Oppenheimer,Jay M Portnoy,Christopher Randolph,Diane E. Schuller,Sheldon L. Spector,S. Tilles,Dana V. Wallace,D.A. Khan +27 more
TL;DR: This document incorporated the efforts of many participants, and no single individual, including those who served on the Joint Task Force, is authorized to provide an official AAAAI or ACAAI interpretation of these practice parameters.
Journal ArticleDOI
Practice parameter for the diagnosis and management of primary immunodeficiency
Francisco A. Bonilla,D.A. Khan,Zuhair K. Ballas,Javier Chinen,Michael M. Frank,Joyce T. Hsu,Michael A. Keller,Lisa Kobrynski,Hirsh D. Komarow,Bruce Mazer,Robert P. Nelson,Jordan S. Orange,John M. Routes,William T. Shearer,Ricardo U. Sorensen,James W. Verbsky,David I. Bernstein,Joann Blessing-Moore,David M. Lang,Richard A. Nicklas,John Oppenheimer,Jay M. Portnoy,Christopher Randolph,Diane E. Schuller,Sheldon L. Spector,Stephen A. Tilles,Dana Wallace,David A. Khan +27 more
TL;DR: The American Academy of Allergy, Asthma & Immunology (AAAAI) and the American College of Allergies, asthma and immunology (ACAAI) have jointly accepted responsibility for establishing the "practice parameter for the diagnosis and management of primary immunodeficiency" as discussed by the authors.
Journal ArticleDOI
Treatment of COVID-19: old tricks for new challenges.
TL;DR: A feasibility intervention study of convalescent plasma for MERS-CoV infection treatment failed to identify sufficient high-titer plasma from patients with confirmed/suspected MERS, their close family members, or healthcare workers exposed to MERS.
Journal ArticleDOI
Treatment for emerging viruses: Convalescent plasma and COVID-19.
TL;DR: This report summarizes existing literature around convalescent plasma as a therapeutic option for COVID-19 and suggests that given the lack of information around the natural history of this disease, PRT should be considered to add a layer of safety to protect recipients of convalescence plasma.
Journal ArticleDOI
European consensus proposal for immunoglobulin therapies
TL;DR: Consensus recommendations for the optimal use of Ig in clinical practice, including priority rankings for the most urgent indications, are urgently needed.
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