[Intravenous immunoglobulin (Endobulin) clinical tolerance: prospective therapeutic follow-up of 142 adults and children]. / Tolérance clinique d'une préparation thérapeutique d'immunoglobulines humaines polyvalentes à usage intraveineux (Endobuline): suivi prospectif d'une population de 142 adultes et enfants.

ABSTRACT

PURPOSE: Prospective report of Endobulin clinical tolerance experience for 19 months over a large number of patients. METHOD: Collect diagnosis, age, gender, weight, dose regimen, infusion duration, and clinical tolerance of Endobulin. Treatment with this product was the only inclusion criteria in this follow-up. RESULTS: A hundred and forty-two patients, 85 children and 57 adults, mean age 23 (1-85 years) received 70 substitutive treatments for primary immunodeficiency, 36 substitutive treatments for secondary immunodeficiency and 36 immunomodulatory treatments. A thousand six hundred and sixty Endobulin infusions that led to 14, 061.5 g, from 52 different batches. Tolerance was judged as good for 135 patients even though side effects occurred in 2 of them. Thus, 133 out of 142 patients, that is 93.7% did not present any side effect and their tolerance to Endobulin infusions was defined as good. Tolerance was bad for 7 patients because of side effects occurrence. For a mean number of 11.7 infusions per patient (1-31), the 9 side effects observed led to a rate of 0.54% of collected infusions and 6.3% of patients included. CONCLUSION: This therapeutic follow-up of 142 patients confirms Endobulin clinical tolerance judged as good in 93.7% of patients (133/142) with a very low rate of side effects of 0.54% of infusions (9 side effects for 1660 infusions) for a mean number of 11.7 infusions per patient for an average of 10.9 months follow-up.