Safety and efficacy of a 10% intravenous immunoglobulin preparation in patients with immune thrombocytopenic purpura: results of two international, multicenter studies

Immunotherapy. 2016 Dec;8(12):1371-1381. doi: 10.2217/imt-2016-0088. Epub 2016 Nov 7.

Abstract

Aim: To assess safety and efficacy of a 10% intravenous immunoglobulin in patients with primary immune thrombocytopenic purpura (ITP).

Patients & methods: ITP patients in two multicenter studies (Trials A/B) were treated with 2 g/kg Flebogamma® 10% DIF (over 2-5 days) and were followed up to 1-3 months.

Results: 18 patients in Trial A and 58 in Trial B were enrolled (12 children in Trial B). The response rate (platelet count ≥50 × 109/l) was 72.2% (Trial A) and 76.1/100% (adults/children; Trial B). Most patients improved bleedings (83.3% Trial A; 88.9% Trial B). Potential treatment-related adverse events were reported by 38.9% (Trial A) and 30.4/83.3% (adults/children; Trial B) of patients. All serious adverse events (five patients) resolved without sequelae.

Conclusion: Flebogamma 10% DIF was effective and safe in patients with primary ITP.

Keywords: Flebogamma® 10% DIF; hemorrhage; immune thrombocytopenic purpura; intravenous immunoglobulin.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Female
  • Follow-Up Studies
  • Humans
  • Immunoglobulins, Intravenous / therapeutic use*
  • Immunosuppressive Agents / therapeutic use*
  • Immunotherapy / methods*
  • International Cooperation
  • Male
  • Middle Aged
  • Prospective Studies
  • Purpura, Thrombocytopenic, Idiopathic / immunology
  • Purpura, Thrombocytopenic, Idiopathic / mortality
  • Purpura, Thrombocytopenic, Idiopathic / therapy*
  • Survival Analysis
  • Treatment Outcome
  • Young Adult

Substances

  • Immunoglobulins, Intravenous
  • Immunosuppressive Agents