#1 IVIg used in US hospitals since 20101
Annual rate of serious bacterial infections* in the extension study was 0.0214
97% of adverse reactions were non-serious in the pivotal trial†, and 96% were non-serious in the extension trial‡14
In the clinical studies, the most common adverse reactions, observed in >5% of study subjects, were headache, fatigue, nausea, chills, vomiting, back pain, pain, elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, pharyngolaryngeal pain, urticaria, and dizziness.
Overall response rates to Privigen were 61% and 73% in PRIMA and PATH,* respectively†
Almost all who responded† to Privigen did so after 1–2 maintenance treatments at Weeks 4 and 7*
In both studies,* 97% of adverse reactions were mild or moderate in intensity with 2 and 8 subjects experiencing serious adverse reactions in PRIMA and PATH, respectively‡
PATH, one of two clinical trials,* was the largest ever CIDP study, evaluating 207 patients
In the clinical studies, the most common reactions, observed in >5% of subjects, were headache, asthenia, hypertension, nausea, pain in extremity, hemolysis, influenza-like illness, leukopenia, and rash.
80.7% had a 150% platelet count increase within 7 days*12
Mean platelet count rose above 50 x 109/L in 1 day*12
Duration of response was at least 8.8 days in 75% of patients*12
* Study was performed on 57 subjects with chronic ITP. Each subject had a platelet count of ≤20 x 109/L. Dose was 1 g/kg on 2 consecutive days. Primary endpoint was elevation of platelet count to at least 50 x 109/L within 7 days of infusion.