Brennan VM, Salome-Bentley NJ, Chapel HM. Clin Exp Immunol. 2003;133:247–251
Purpose of the Study.
To determine the incidence of adverse reactions among a large group of patients receiving intravenous immunoglobulin (IVIG) replacement therapy in an institutional setting or at home, with or without supervision by a health care professional.
The patients were 92 children (<18 years of age) and 367 adults (total: 459 patients). All had been diagnosed as having a primary antibody deficiency, and all had been receiving IVIG replacement therapy for ≥6 months before entry into the study. The majority of patients (290 total, 72 children) received IVIG therapy at home; 160 patients (19 children) received IVIG therapy as outpatients in a hospital, and 9 patients (1 child) received IVIG therapy in a primary care provider’s office.
IVIG therapy was administered according to the manufacturer’s guidelines. Prophylaxis (with nonsteroidal antiinflammatory drugs and/or antihistamines) to prevent adverse reactions varied among centers supervising IVIG therapy and was not uniform across the study population. Data were collected prospectively for 2 years (13 508 infusions). For infusions administered in institutional settings, data were recorded by health care professionals. Patients receiving IVIG therapy at home were self-infusing and recorded their own symptom data; these records were reviewed by investigators before assignment of a classification. All adverse reactions were classified as mild, moderate, or severe with uniform criteria for all centers.
A total of 111 adverse reactions were documented (overall rate: 0.8%). Of these, 91 (82%) were mild and 20 (18%) were moderate. One patient accounted for 19 of the mild reactions. No severe adverse reactions were recorded. There was no significant variation in the rate of adverse reactions according to age or the setting in which IVIG therapy was administered. For 45 reactions (41%), there was an associated predisposing factor (infection, delay after previous infusion, or administration error [too rapid]); 47 reactions (42%) occurred despite prophylaxis, although the effect of prophylaxis on the overall reaction rate was not mentioned. Three of the 12 centers had relatively higher rates of adverse reactions; the reasons for this, if known, were not stated.
There was a low overall rate of adverse reactions to IVIG infusion and a very low rate (<0.007%) of severe adverse reactions to IVIG administration. The importance of recognizing and avoiding predisposing factors for adverse reactions was emphasized.
Home IVIG infusion is clearly safe. More detailed analyses of the effects of prophylaxis on reaction rates and of the differences among centers would have been helpful.