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Occurrence of acute renal failure on the same day as immune globulin product administrations during 2008 to 2014.
Transfusion. 2017 12; 57(12):2977-2986.T

Abstract

BACKGROUND

Acute renal failure (ARF) is a rare serious adverse event after immune globulin (IG) use. Our large claims-based study evaluated occurrence of same-day ARF after administration of different IGs and ascertained potential risk factors, during the 2008 to 2014 study period.

STUDY DESIGN AND METHODS

A retrospective cohort study was conducted using a large commercial administrative database. The cohort included individuals exposed to IG products as identified by procedure codes. ARF was ascertained using ICD-9-CM diagnoses. Unadjusted same-day ARF rates (per 1000 persons exposed) were estimated overall and by age, sex, and IG products. Regression analyses were conducted to control for confounding and assess potential risk factors.

RESULTS

Of 20,440 persons exposed, 163 (7.97 per 1000) had a recorded same-day ARF. The unadjusted nonzero same-day ARF rates (per 1000) ranged from 1.92 (95% confidence interval [CI], 0.05-10.69) for Hizentra to 16.97 (95% CI, 11.36-24.37) for Privigen and differed by sex. In multivariate analyses, compared to Gammagard Liquid, no significantly elevated ARF risks were identified with any IGs. A significantly lower odds ratio was identified with Gamunex, 0.53 (95% CI, 0.30-0.93). Age 45 and over, prior renal impairment, hypertension, and other factors were associated with increased risk of same-day ARF.

CONCLUSION

The study showed variation in the risk of IG-related ARF by age, sex, and IG products. The study results suggest the importance of recipient factors, such as older age and underlying health conditions. Variations in ARF occurrence may also be explained by product dosage, administration route and rate, and manufacturing processes, which warrant further evaluation.

Authors+Show Affiliations

HealthCore, Inc., Alexandria, Virginia.HealthCore, Inc., Alexandria, Virginia.Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.HealthCore, Inc., Alexandria, Virginia.Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

29027208

Citation

Ekezue, Bola F., et al. "Occurrence of Acute Renal Failure On the Same Day as Immune Globulin Product Administrations During 2008 to 2014." Transfusion, vol. 57, no. 12, 2017, pp. 2977-2986.
Ekezue BF, Sridhar G, Forshee RA, et al. Occurrence of acute renal failure on the same day as immune globulin product administrations during 2008 to 2014. Transfusion. 2017;57(12):2977-2986.
Ekezue, B. F., Sridhar, G., Forshee, R. A., Izurieta, H. S., Selvam, N., Mintz, P. D., Anderson, S. A., & Menis, M. D. (2017). Occurrence of acute renal failure on the same day as immune globulin product administrations during 2008 to 2014. Transfusion, 57(12), 2977-2986. https://doi.org/10.1111/trf.14330
Ekezue BF, et al. Occurrence of Acute Renal Failure On the Same Day as Immune Globulin Product Administrations During 2008 to 2014. Transfusion. 2017;57(12):2977-2986. PubMed PMID: 29027208.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Occurrence of acute renal failure on the same day as immune globulin product administrations during 2008 to 2014. AU - Ekezue,Bola F, AU - Sridhar,Gayathri, AU - Forshee,Richard A, AU - Izurieta,Hector S, AU - Selvam,Nandini, AU - Mintz,Paul D, AU - Anderson,Steven A, AU - Menis,Mikhail D, Y1 - 2017/10/12/ PY - 2016/12/05/received PY - 2017/07/21/revised PY - 2017/07/26/accepted PY - 2017/10/14/pubmed PY - 2018/1/3/medline PY - 2017/10/14/entrez SP - 2977 EP - 2986 JF - Transfusion JO - Transfusion VL - 57 IS - 12 N2 - BACKGROUND: Acute renal failure (ARF) is a rare serious adverse event after immune globulin (IG) use. Our large claims-based study evaluated occurrence of same-day ARF after administration of different IGs and ascertained potential risk factors, during the 2008 to 2014 study period. STUDY DESIGN AND METHODS: A retrospective cohort study was conducted using a large commercial administrative database. The cohort included individuals exposed to IG products as identified by procedure codes. ARF was ascertained using ICD-9-CM diagnoses. Unadjusted same-day ARF rates (per 1000 persons exposed) were estimated overall and by age, sex, and IG products. Regression analyses were conducted to control for confounding and assess potential risk factors. RESULTS: Of 20,440 persons exposed, 163 (7.97 per 1000) had a recorded same-day ARF. The unadjusted nonzero same-day ARF rates (per 1000) ranged from 1.92 (95% confidence interval [CI], 0.05-10.69) for Hizentra to 16.97 (95% CI, 11.36-24.37) for Privigen and differed by sex. In multivariate analyses, compared to Gammagard Liquid, no significantly elevated ARF risks were identified with any IGs. A significantly lower odds ratio was identified with Gamunex, 0.53 (95% CI, 0.30-0.93). Age 45 and over, prior renal impairment, hypertension, and other factors were associated with increased risk of same-day ARF. CONCLUSION: The study showed variation in the risk of IG-related ARF by age, sex, and IG products. The study results suggest the importance of recipient factors, such as older age and underlying health conditions. Variations in ARF occurrence may also be explained by product dosage, administration route and rate, and manufacturing processes, which warrant further evaluation. SN - 1537-2995 UR - https://www.unboundmedicine.com/medline/citation/29027208/Occurrence_of_acute_renal_failure_on_the_same_day_as_immune_globulin_product_administrations_during_2008_to_2014_ L2 - https://doi.org/10.1111/trf.14330 DB - PRIME DP - Unbound Medicine ER -