autoimmune-2-pics [M06]

Table Efficacy Clinical Trials Table Regression Hemorrhage/Bleedings
  • 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 Chart severity AEs

Flebogamma® DIF 5% treatment-related AEs (n=21) classified according to the degree of severity

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

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

autoimmune-references

References:

  1. 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.
  2. 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.