Complementary use of passive surveillance and Mini‐Sentinel to better characterize hemolysis after immune globulin

Winiecki, Scott K.; Baer, Bethany; Chege, Wambui; Jankosky, Christopher; Mintz, Paul D.; Baker, Meghan A; Woodworth, Tiffany; Nguyen, Michael

doi:10.1111/trf.13116

Cited by 18 publications

(40 citation statements)

References 21 publications

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“…Our study also suggests history of hemolysis to be consistently the biggest predictor of IG‐related same‐day HRs, which needs further confirmation. As supported by the literature, our study furthermore suggests the importance of IG product dosage, especially in persons with underlying risk factors for hemolysis. Future population‐based clinical investigations are needed to ascertain the effects of product dosages, rates and routes of administration, specific product indications, and different IG product manufacturing processes.…”

Section: Discussionmentioning

confidence: 99%

Occurrence of hemolytic reactions on the same day as immune globulin product administrations during 2008 to 2014

Sridhar¹,

Ekezue²,

Izurieta

et al. 2017

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BACKGROUND Hemolytic reactions (HRs) are rare serious adverse events after immune globulin (IG) use. Our large claims‐based study evaluated occurrence of same‐day hemolysis after administration of different IG products and potential risk factors, during the 2008 to 2014 study period. STUDY DESIGN AND METHODS We conducted a retrospective cohort study using a large commercial administrative database. The study included individuals exposed to IG products as identified by procedure codes. HRs were ascertained using ICD‐9‐CM diagnosis codes. Unadjusted same‐day hemolysis rates (per 1000 persons) were estimated overall, by age, sex, and IG products. Multivariable regression analyses were used to evaluate potential risk factors. RESULTS Of 20,440 persons exposed, 211 (10.3 per 1000) had same‐day HRs. The median numbers of doses for IG users with versus without same‐day hemolysis were one and six, respectively. The unadjusted product‐specific HR rates ranged from 1.92 for subcutaneous product Hizentra to 17.99 for intravenous Octagam. The multivariable regression analyses showed significantly increased same‐day HR risk in males and in IG users with histories of hemolysis, pneumonia, and hereditary hemolytic anemias. Compared to Gammagard Liquid, significantly elevated overall hemolysis risk was identified with Octagam (odds ratio, 2.36; 95% confidence interval, 1.04‐5.35), using Firth's method to account for small sample size bias. CONCLUSION The study showed variation in the same‐day IG‐related hemolysis by age, sex, and IG products administered. The results suggest importance of underlying health conditions, especially prior hemolysis, and first IG product dose. Differences in HR occurrence may also be explained by product manufacturing processes, indications, routes, and rates of administration, which warrant further investigation.

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Section: Discussionmentioning

confidence: 99%

Occurrence of hemolytic reactions on the same day as immune globulin product administrations during 2008 to 2014

Sridhar¹,

Ekezue²,

Izurieta

et al. 2017

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“…In the case series of Berg and coworkers, approximately two‐thirds of patients were diagnosed with hemolysis between 0 and 72 hours after the last dose of IVIG, and the remainder of cases were identified 72 hours to 14 days later . In the series reported by Winieki and coworkers, 55% of cases were diagnosed within 48 hours of the last infusion and 75% within the first 96 hours. In the absence of prospectively collected data, it is not certain when hemolysis might first have been detected.…”

Section: Clinical and Epidemiologic Findings (The Patients)mentioning

confidence: 99%

Safeguarding immune globulin recipients against hemolysis: what do we know and where do we go?

Scott

Epstein

2015

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“…In 2012, the US Food and Drug Administration (FDA) published a safety communication mentioning FDA's heightened awareness of IG‐associated hemolysis, particularly in patients with non‐O blood groups, those who have underlying associated inflammatory conditions, and those receiving high cumulative doses of IGs over the course of several days . Hemolysis is a rarely reported complication of IG treatment, and a case definition of IG‐associated hemolysis has not been uniformly adopted . Several recent publications reported the occurrence of IG‐associated hemolysis in limited patient populations and proposed hypotheses on the etiology of this event .…”

mentioning

confidence: 99%

Hemolytic events associated with intravenous immune globulin therapy: a qualitative analysis of 263 cases reported to four manufacturers between 2003 and 2012

Berg

Shebl

Kimber³

et al. 2015

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Data examined confirm that IVIG-associated hemolysis predominantly occurs following infusion of high IVIG doses, and can affect patients at every age of both genders. While presence of hemagglutinins appears to play a major role in pathogenesis of hemolytic disorders, high hemagglutinin titers of IVIG products themselves seem to be of less relevance, indicating that the pathomechanism of IVIG-associated hemolysis may be related to the presence, but not the absolute amount, of hemagglutinins. Patients with hemolysis had additional hemolytic risks such as multiple comorbidities and medication use. IG-treated patients with multiple risks should be closely monitored for hemolysis.

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Complementary use of passive surveillance and Mini‐Sentinel to better characterize hemolysis after immune globulin

Cited by 18 publications

References 21 publications

Occurrence of hemolytic reactions on the same day as immune globulin product administrations during 2008 to 2014

Occurrence of hemolytic reactions on the same day as immune globulin product administrations during 2008 to 2014

Safeguarding immune globulin recipients against hemolysis: what do we know and where do we go?

Hemolytic events associated with intravenous immune globulin therapy: a qualitative analysis of 263 cases reported to four manufacturers between 2003 and 2012

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