Efficacy

Clinical response observed within 7 days1,2*
Results from a pivotal trial
*Ready-to-use OCTAGAM 10% was investigated in a prospective phase 3 study of 116 adult patients with ITP (platelet count ≤20 x 109/L). Sixty-six patients had chronic ITP and 49 were newly diagnosed. Patients received OCTAGAM 10% 1 g/kg/day on 2 consecutive days, and the infusion rate was adjusted according to tolerability to a maximum of 12 mg/kg/min. The primary efficacy variable was the attainment of a clinical response, defined as an increase in platelet count to ≥50 x 109/L within 6 days of dosing. Secondary efficacy variables included the time to achieve a clinical response, the maximum platelet level achieved, assessment of bleeding, and the duration of platelet response.1,2
  • 82% of patients (54 of 66 with chronic ITP) reached the clinical endpoint within 7 days of the first infusion, with a rise in platelet count to at least 50 x 109/L1,2
    • Median time to reach platelet response was 2 days after the first infusion
  • 78% of patients (35 of 45 with bleeding at baseline) had no bleeding on day 71
    • Decreased severity in bleeding by day 7 was seen in 84% of patients (34 of 45)
Duration of clinical response1,2
  • Mean duration of clinical response was 20.9 days
  • At day 63, mean platelet count in 54 responders was 88 x 109/L
 
REFERENCES
  1. OCTAGAM 10% [prescribing information]. Hoboken, NJ: Octapharma USA Inc; May 2018.
  2. Robak T, Mainau C, Pyringer B, et al. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam® 10%) in patients with immune thrombocytopenia. Hematology. 2010;15(5):351-359.
  3. Data on file, Octapharma USA Inc.