TOLERABILITY OF INTRAVENOUSLY ADMINISTERED IMMUNE GLOBULIN IN THE HOME SETTING

Author(s)

Mark A Tankersley, PhD, DPh, Director of Health OutcomesAccredo Health, Inc, Memphis, TN, USA

OBJECTIVES Patients with primary immune deficiencies and many neurological disorders are frequently treated with immune globulin, administered intravenously or subcutaneously. The aim of this study was to evaluate tolerability of intravenously administered immune globulin products in patients in the home setting. METHODS A retrospective, longitudinal cohort analysis of patients (18 years and older) provided intravenous immunoglobulin (IVIG) using data from the Accredo Therapeutics electronic medical record was conducted. Inclusion criterion was infusion of at least one dose of IVIG during the study period. Patients were followed from July 1, 2007 to June 28, 2008. Three components to estimate tolerability were evaluated. The first was aggregate adverse drug event rate. The second was infusion completion rate (ICR), calculated by dividing the number of successful infusions by the number of attempted infusions. The third measure was a managed therapy completion rate (MTCR-A) for patients that had an identified ADE and were still managed to completion of therapy. RESULTS The sample size for review was 33,065 doses of IVIG dispensed during the study period. The results based upon the three measures of tolerability were: 1) an ADE rate of 2.35% (95% CI: 1.79% - 2.93%) based on 778 reported adverse drug events; 2) an infusion completion rate (ICR) of 99.74% (95% CI: 99.65% - 99.82%); and 3) a managed through completion of therapy (MTCR-A) of 88.6% (95% CI: 80.8% - 92.35%). Gender, age, diagnoses and BMI were also evaluated for their effect upon tolerability of infusion. CONCLUSIONS Intravenous administration of immune globulin is an important alternative infusion option for patients. Patients can be well managed in the home on intravenously administered immunoglobulin. These findings contribute to previous research related to safety of administration of immunoglobulin in the home.

Conference/Value in Health Info

2009-05, ISPOR 2009, Orlando, FL, USA

Value in Health, Vol. 12, No. 3 (May 2009)

Code

PSY14

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Multiple Diseases, Neurological Disorders, Systemic Disorders/Conditions

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