MULTICENTER CROSSOVER COMPARISON OF THE SAFETY AND EFFICACY OF INTRAGLOBIN-F WITH GAMIMUNE-N, SANDOGLOBULIN, AND GAMMAGARD IN PATIENTS WITHPRIMARY IMMUNODEFICIENCY DISEASES

The safety and clinical efficacy of a liquid, beta-propiolactone-stabi lized intravenous gamma-globulin, Intraglobin-F, was evaluated in a mu lticenter, double-blind study comparing Intraglobin-F to Gamimune-N, S andoglobulin, or Gammagard. beta-Propiolactone stabilizes the IgG mole cule to decrease aggregate formation and is a potent virucidal agent t hat reduces the risk of viral transmission by intravenous gamma-globul in (IVIG) preparations. Twenty-seven patients with primary immunodefic iency diseases were enrolled at three centers. Each patient received 6 months of therapy with either Intraglobin-F or the IVIG preparation t hat they had received during the preceding 3 months, then crossed over to the other preparation. Twenty-three patients completed the study. One patient withdrew because of an adverse event, generalized urticari a. A second patient withdrew because of fatigue and perceived decrease d efficacy. Adverse reactions were comparable and occurred in 8.7% of the infusions of Intraglobin-F and 6% of the infusions with Sandoglobu lin. None were severe or life-threatening. There was no discernible di fference in efficacy between any of the products. The number of days w hen patients noted symptoms in their diaries was similar for Intraglob in-F and the comparison preparations, 4158 vs 4143. Similarly, there w ere no differences in the number of physician visits (33 vs 22), days missed from work or school (405 vs 404), days with fever (41 vs 47), o r days of prophylactic antibiotics (675 vs 642). There was an increase in the number of days when antibiotics were given therapeutically (57 8 vs 451); most of the difference was attributable to one patient. The re also was a difference in the number of days of hospitalization (21 vs 0), but 19 of the days were accounted for by two patients. When the patients were asked to score their feeling of well-being on a scale o f 1 to 5, with 1 being entirely well, the mean score for the patients on Intraglobin-F was 1.86 (range, 1.0 to 3.0), compared to 1.85 (range , 1.0 to 3.2) for patients while on the comparison preparations. Troug h IgG levels were slightly lower during the period when patients were treated with Intraglobin-F compared to the other products. There were no abnormalities in blood chemistries or hematologic parameters. Thus, Intraglobin-F is comparable to three of the marketed IVIG preparation s in efficacy and safety, as well as patient acceptability, and offers the additional benefit of an extra virucidal step to reduce further t he risk of transmitting viral infections.