Journal article
Intravenous immune globulin and thromboembolic adverse events in patients with hematologic malignancy
Blood, Vol.127(2), pp.200-207
01/14/2016
DOI: 10.1182/blood-2015-05-647552
PMCID: PMC4713161
PMID: 26443622
Abstract
In patients with hypogammaglobulinemia secondary to chronic lymphocytic leukemia (CLL) or multiple myeloma (MM), intravenous immune globulin (IVIg) may be administered to reduce the risk of infection. Since 2013, IVIg products have carried a boxed safety warning about the risk of thromboembolic events (TEEs), with TEEs reported in 0.5% to 15% of patients treated with IVIg. In this retrospective cohort study of older patients with CLL or MM identified from the Surveillance, Epidemiology, and End Results-Medicare Linked Database, we assessed rates of clinically serious TEEs in 2724 new users of IVIg and a propensity-matched comparison group of 8035 nonusers. For the primary end point, arterial TEE, we observed a transient increased risk of TEE during the day of an IVIg infusion and the day afterward (hazard ration = 3.40; 95% confidence interval [CI]: 1.25, 9.25); this risk declined over the remainder of the 30-day treatment cycle. When considered in terms of absolute risk averaged over a 1-year treatment period, the increase in risk attributable to IVIg was estimated to be 0.7% (95% CI: -0.2%, 2.0%) compared with a baseline risk of 1.8% for the arterial TEE end point. A statistically nonsignificant risk increase of 0.3% (95% CI: -0.4%, 1.5%) compared with a baseline risk of 1.1% was observed for the venous TEE end point. Further research is needed to establish the generalizability of these results to patients receiving higher doses of IVIg for other indications.
Details
- Title: Subtitle
- Intravenous immune globulin and thromboembolic adverse events in patients with hematologic malignancy
- Creators
- Eric M Ammann - Department of Epidemiology andMichael P Jones - Department of Biostatistics, College of Public Health, University of Iowa, Iowa City, IABrian K Link - Division of Hematology, Oncology and Blood & Marrow Transplantation, Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IARyan M Carnahan - Department of Epidemiology andScott K Winiecki - Office of Biostatistics and Epidemiology, Center for Biologics Evaluation & Research, US Food and Drug Administration, Silver Spring, MDJames C Torner - Department of Epidemiology andBradley D McDowell - Population Research Core, Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics, Iowa City, IA; andBruce H Fireman - Division of Research, Kaiser Permanente Northern California, Oakland, CAElizabeth A Chrischilles - Department of Epidemiology and Population Research Core, Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics, Iowa City, IA; and
- Resource Type
- Journal article
- Publication Details
- Blood, Vol.127(2), pp.200-207
- DOI
- 10.1182/blood-2015-05-647552
- PMID
- 26443622
- PMCID
- PMC4713161
- NLM abbreviation
- Blood
- ISSN
- 0006-4971
- eISSN
- 1528-0020
- Publisher
- United States
- Grant note
- HHSF22301006T / PHS HHS U58 DP003862 / NCCDPHP CDC HHS HHSN261201000035C / NCI NIH HHS HHSN261201000140C / NCI NIH HHS HHSF223200910006I / FDA HHS HHSN261201000034C / NCI NIH HHS HHSN2612010000CRC / PHS HHS U58DP003862-01 / NCCDPHP CDC HHS P30 CA086862 / NCI NIH HHS HHSN261201000035I / NCI NIH HHS
- Language
- English
- Date published
- 01/14/2016
- Academic Unit
- Statistics and Actuarial Science; Pharmacy; Epidemiology; Biostatistics; Surgery; Injury Prevention Research Center; Public Policy Center (Archive); Neurosurgery; Holden Comprehensive Cancer Center; Internal Medicine
- Record Identifier
- 9983985966002771
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