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IV immune globulin temporarily increases thromboembolic risks in CLL, multiple myeloma
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IV immune globulin use may temporarily increase the risk for thromboembolic events in patients with hypogammaglobulinemia secondary to chronic lymphocytic leukemia or multiple myeloma, according to the results of a retrospective cohort study.
However, the risk elevation appeared to be transient, according to the researchers.
IV immune globulin (IVIg) is sometimes administered to patients with hypogammaglobulinemia secondary to CLL or multiple myeloma to reduce the risk for infection. Since 2013, IVIg boxes have carried a warning about the risk for thromboembolic events, reported in 0.5% to 15% of patients, according to study background.
Erik Ammann, MS, a PhD candidate in epidemiology at University of Iowa’s School of Public Health, and colleagues sought to evaluate the risk for thromboembolic events associated with IVIg use, as well as their persistence.
Researchers used the SEER–Medicare Linked Database to identify older patients with CLL or multiple myeloma. The study included data from 2,724 new IVIg users (median age, 75 years; range 66-99), along with a propensity-matched comparison group of 8,035 non-users.
The occurrence of serious arterial thromboembolic events — defined as hospitalization for acute myocardial infarction or ischemic stroke — served as the primary endpoint.
IVIg users had higher rates of hospitalization (64%), pneumonia (50%), chronic bronchitis (18%), antineoplastic chemotherapy receipt (59%) and comorbid conditions compared with non-users.
The researchers found that IVIg users experienced an increased risk for thromboembolic events on the day of an IVIg infusion, as well as the day afterward (HR = 3.4; 95% CI, 1.25-9.25).
This risk declined during the rest of the 30-day treatment cycle.
Patients receiving IVIg had a 1-year absolute risk increase attributable to the drug of approximately 0.7% (95% CI, –0.2-2) for arterial thromboembolic events over the baseline risk of 1.8%. The nonsignificant risk increase for venous thromboembolic events was 0.3% (95% CI, –0.4-1.5), compared with a baseline risk of 1.1%
The researchers acknowledged the risks for potential confounding and bias inherent in the use of records data as a study limitation.
“Further research is needed to establish the generalizability of these results to patients receiving higher doses of IVIg for other indications,” Ammann and colleagues wrote. “Results from this study will allow patients and clinicians to better assess the likely risk–benefit ratio for IVIg therapy for a variety of indications.” – by Cameron Kelsall
Disclosure: Ammann and four other study researchers reports prior salary support related to a study conducted under Task Order 6 of the Mini-Sentinel project, which received funding from the FDA through the Department of Health and Human Services. The other researchers report no relevant financial disclosures.
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