title: Intravenous immune globulin and thromboembolic adverse events in patients with hematologic malignancy.
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.
authors.affiliation: Department of Epidemiology and.
authors.forename: Eric M
authors.identifier: http://orcid.org/0000-0001-5882-5388
authors.initials: EM
authors.lastname: Ammann
authors.affiliation: Department of Biostatistics, College of Public Health, University of Iowa, Iowa City, IA;
authors.forename: Michael P
authors.initials: MP
authors.lastname: Jones
authors.affiliation: Division of Hematology, Oncology and Blood & Marrow Transplantation, Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA;
authors.forename: Brian K
authors.initials: BK
authors.lastname: Link
authors.affiliation: Department of Epidemiology and.
authors.forename: Ryan M
authors.initials: RM
authors.lastname: Carnahan
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation & Research, US Food and Drug Administration, Silver Spring, MD;
authors.forename: Scott K
authors.identifier: http://orcid.org/0000-0003-4912-4621
authors.initials: SK
authors.lastname: Winiecki
authors.affiliation: Department of Epidemiology and.
authors.forename: James C
authors.initials: JC
authors.lastname: Torner
authors.affiliation: Population Research Core, Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics, Iowa City, IA; and.
authors.forename: Bradley D
authors.initials: BD
authors.lastname: McDowell
authors.affiliation: Division of Research, Kaiser Permanente Northern California, Oakland, CA.
authors.forename: Bruce H
authors.initials: BH
authors.lastname: Fireman
authors.affiliation: Department of Epidemiology and Population Research Core, Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics, Iowa City, IA; and.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Chrischilles
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D005260:Female; D005500:Follow-Up Studies; D019337:Hematologic Neoplasms / Q000453:epidemiology / Q000628:therapy*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000627:therapeutic use*; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods; D008297:Male; D012189:Retrospective Studies; D018426:SEER Program; D013923:Thromboembolism / Q000139:chemically induced* / Q000453:epidemiology; D014481:United States / Q000453:epidemiology
chemical_list: D016756:Immunoglobulins, Intravenous