![Table Efficacy Clinical Trials](/documents/4265257/4266204/table-efficacy-clinical-trials.png/93bcd08d-0a70-468c-b615-6dcf50cb325b?t=1516033518323)
![Table Regression Hemorrhage/Bleedings](/documents/4265257/4266204/table-regression-hemorrhage-bleedings.png/2b45184e-83b7-4030-9adf-baeb19936596?t=1521795953112)
- Flebogamma® DIF had a response rate of ≥70%1,2
- Flebogamma® DIF was effective in raising the platelet count with most patients responding in less than 3 days1,2
- In trial B, 100% of pediatric patients* (n=12) responded to Flebogamma® DIF 10% and improved hemorrhagic episodes during the clinical follow-up period2
*>2 years old
Proven tolerability in autoimmune disease1,2
In the ITP trial of Flebogamma® DIF 5% all potentially related AEs were graded as mild to moderate in intensity1
![Chart severity AEs](/documents/4265257/4266214/chart-severity-aes_MobileExpanded.png/dbe24716-dfe7-48c8-b2a6-19d3ded6b037?t=1516871981923)
![Chart severity AEs](/documents/4265257/4266204/chart-severity-aes.png/3ad47481-b640-4af1-a58a-ae9608aa5fe9?t=1516033517961)
In the ITP trial of Flebogamma® DIF 10%2 over 85% of AEs were mild to moderate in intensity
- Only 5 adult patients experienced serious AEs, which resolved without sequelae (n=64)2
- Zero serious AEs in pediatric patients in trial B (n=12)2
- The nature and severity of trial A and trial B AEs are consistent with what is expected for IVIG therapies for patients with chronic ITP2
![Chart Flebogamma DIF 10% treatment 1 AE Trial A](/documents/4265257/4266204/chart-flebogamma-dif-10_-treatment-1-AE-trial-a.png/13d4baa4-4797-40af-933a-04531b10c8b3?t=1516033517841)
Subjects treated with Flebogamma® DIF 10% with at least 1 AE occurring between the start of IVIG infusion visit and the last follow-up visit (n=16 in Trial A; n=53 in Trial B)
The most common AEs in trial A were petechiae, ecchymosis, headache and pyrexia2
The most common AEs in trial B were headache, nausea, pyrexia and chills. Nausea, vomiting and hypotension were much more frequent in children than in adult subjects2
Six serious AEs were reported in 2 adults from Trial A and 3 adults from Trial B: leukopenia and decreased hemoglobin in 1 subject (probably drug-related); soft tissue inflammation (not drug-related); severe headache in 2 subjects and thrombosis (possibly drug-related)2
References:
- Julia A, Kovaleva L, Loria S, et al. Clinical efficacy and safety of Flebogamma DIF, a new high-purity human intravenous immunoglobulin, in adult patients with chronic idiopathic thrombocytopenic purpura. Transfus Med. 2009;19(5):260-268.
- Kovaleva L, Apte S, Damodar S, el al. Safety and efficacy of a 10% intravenous immunoglobulin preparation in patients with immune thrombocytopenic purpura: results of two international, multicenter studies. Immunotherapy. 2016;8(12):1371-1381.