A multicenter drug use surveillance of intravenous immunoglobulin utilization in US academic health centers.
BACKGROUND
The role of intravenous immunoglobulin (IVIG) in treating a variety of diseases is controversial and under active investigation for at least two reasons: first, a severe shortage of IVIG products exists in the US; second, numerous off-label (not specified in the Food and Drug Administration [FDA]-approved label) uses for IVIG have been, and continue to be, described in the literature. However, most off-label uses are not supported by evidence from properly designed clinical trials.


OBJECTIVE
To assess inpatient use of IVIG in a sample of US academic health centers and to compare it with published evidence-based model guidelines for IVIG use.


METHODS
Data on the use of IVIG and subsequent clinical outcomes in 251 patients were collected prospectively from 12 institutions. Recommendations from consensus guidelines were used to categorize patients who received IVIG into one of four groups: labeled uses; off-label, recommended; off-label, recommended as alternative; and off-label, not recommended. Outcomes were scored according to guideline criteria.


RESULTS
One hundred seven patients (43%) received IVIG for indications contained in the FDA-approved product label, 130 patients (52%) received IVIG for off-label indications, and 14 (5%) received undefined treatment. Among all patients administered IVIG, 31 (12%) were treated for off-label recommended reasons; 64 (26%) received off-label recommended as alternative therapy; and 35 (14%) received off-label not recommended therapy, as defined by model guidelines. Outcomes were not significantly different between the groups.


CONCLUSIONS
Our findings suggest that IVIG continues to be used to treat a wide variety of conditions not specified in the product label. Furthermore, a substantial proportion of the reported off-label uses are not recommended according to evidence-based guidelines.
Chen
C
C
Clinical Practice Advancement Center, University HealthSystem Consortium, Oak Brook, IL, USA.
Danekas
L H
LH
Ratko
T A
TA
Vlasses
P H
PH
Matuszewski
K A
KA
D000046:Academic Medical Centers; D000293:Adolescent; D000328:Adult; D000368:Aged; D003625:Data Collection; D004363:Drug Utilization; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D016896:Treatment Outcome; D014481:United States
D016756:Immunoglobulins, Intravenous