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Many patients with primary immunodeficiency (PID) require immunoglobulin G (IgG) replacement therapy, delivered as intravenous IgG (IVIG) or subcutaneous IgG (SCIG). We aim to identify trends in efficacy and safety that would not be evident in individual studies of small patient numbers. Seven open-label, Phase 3, prospective, multicenter studies of the efficacy and safety of Hizentra® (a SCIG), conducted in Japan, Europe, and the US were summarized. Overall, 125 unique patients received 15,013 weekly infusions during a total observation period of 250.9 patient-years. Mean weekly doses of Hizentra® were 83.22-221.3 mg/kg body weight; infusion rates per patient (total body rate) were 25.2-49.3 mL/h across studies. The rates of infections and serious bacterial infections were 3.10 and 0.03 events per patient/year, respectively. Annualized rates of days hospitalized due to infection, out of work/school, and prophylactic antibiotic use were 0.95, 5.14, and 36.78 per patient, respectively. For the equivalent monthly dose, weekly Hizentra® SCIG administration resulted in expectedly-increased serum IgG trough levels in patients switching from IVIG, and maintained levels in patients switching from previous SCIG. Adverse events (AEs) totaled 5039 (events/infusion 0.094-0.773), almost all of which were mild/moderate. Three thousand one hundred ninety-seven were considered treatment-related, the most common of which were injection site reactions (2919 events; 0.001-0.592 AEs per infusion). Systemic AEs were very uncommon. The results from these seven studies indicate that Hizentra® therapy was both efficacious and well tolerated during long-term treatment. This is particularly important in patients with PID, who may require lifelong IgG replacement therapy.

Background and Objectives: The incidence of definite stent thrombosis (ST) after use of drug-eluting stents (DES), as defined by the Academic Research Consortium, is known to be lower in Japan than in western countries. However, a statistical difference in the incidence of early definite ST (EDST) associated with the unrestricted use of DES has not yet been documented. Therefore, the incidence of EDST in our Japanese institute after unrestricted use of DES was retrospectively compared with those reported in western mega-studies., Methods and Results: During the 40 months from August 2004 to November 2007 (before approval of clopidogrel in Japan), DES were implanted in 3605 lesions in 1885 patients in our institute; lesion- and patient-associated percentages of DES use were 95.2% and 94.7%, respectively. Mean stent length per lesion was 33.2 mm, emergent procedures and ST-elevation myocardial infarctions made up 33.7% and 16.4% of the procedures, respectively, intravascular ultrasonography was used 96.0% of the time, a distal protection device for acute coronary syndrome was used 68.7% of the time, and the mean maximum inflation pressure was 19.5 atm. EDST was observed in five lesions (0.139%) in four patients (0.212%). The incidence of patient-associated EDST at our center was significantly lower than in four western mega-studies (0.736%, 66 of 8970 patients; 0.634%, 149 of 23,500; 0.595%, 52 of 8402; 0.997%, 20 of 2006) (p<0.05, <0.01, <0.05, <0.01, respectively, using a chi(2)-test)., Conclusion: Due to differences in procedural approaches in Japan, the incidence of EDST after unrestricted use of DES was significantly lower than in western countries.