Proven tolerability in ITP
Multiple studies have shown the safety and tolerability of octagam® in ITP.1-4
Immune Thrombocytopenia (ITP)
)
Established efficacy in ITP
ITP is an autoimmune disease characterised by a low platelet count, which leads to an increased risk of bleeding.1
octagam®5% can effectively increase platelet count, arrest spontaneous bleeding, and prevent bleeding prior to surgery in patients with ITP*.2
Treatment response was observed in 82% of patients (18/22)*.2 For the remaining four patients, platelet count remained below 50 x 109/L, although arrest of bleeding was still observed.2
*Twenty-three infusions were given to arrest bleeding, and eight treatments were given to prevent surgical bleeding. In patients with bleeding, response was defined as arrest of bleeding, and an increase in platelet count to ≥50 x 109/L.2
Platelet count following octagam® treatment2
Response was usually rapid, appearing 24–48 hours after octagam® therapy and lasting 7–21 days.2
For seven patients, octagam® prevented excessive bleeding during splenectomy, and in another patient during laryngectomy. For all seven splenectomised patients, the platelet count remained above 200 x 109/L.2
The efficacy of octagam®10% for increasing platelet count in patients (n=115) with ITP has been proven in a phase III prospective trial.1
Most patients (80%; 92/115), with either newly diagnosed or chronic ITP, responded to treatment with octagam®10%**.1
Clinical response (increased platelet count**)1
Bleeding completely resolved in 75% (64/85) of patients with ITP who had bleeding at baseline.1
** Clinical response was defined as an increase in platelet count to ≥50 x 109/L within 6 days of dosing (primary efficacy endpoint).1
Safety and tolerability from a 10-year prospective observational study of octagam®5% in ITP3
In a 10-year prospective observational study, 3.5% of ITP patients experienced AEs. The most common AEs were non-serious, such as headache.3
Number of patients with ITP | 521 |
Number of infusions | 4,609 |
Percentage of patients with ADRs | 3.5% |
Percentage of infusions with ADRs | 0.43% |
Prospective phase III study with octagam®10%—no unexpected safety issues1
In this study of 115 patients with ITP treated with octagam®10%, all AEs were mild or moderate, and only one patient experienced a serious AE (moderate headache). No prophylactic medication was administered to prevent AEs.1
Most common related adverse events (AEs) | Patients with AEs, n (%) |
|---|---|
Headache | 29 (25.0) |
Pyrexia | 17 (14.7) |
Heart rate increased | 13 (11.2) |
Hypertension | 5 (4.3) |
Heart rate decrease | 4 (3.4) |
Chills | 4 (3.4) |
Nausea | 4 (3.4) |
Vomiting | 4 (3.4) |
Blood pressure increased | 3 (2.6) |
Leukopenia | 3 (2.6) |
Tolerability and safety of octagam®10% was also assessed by collecting data from two non-interventional studies that included patients with ITP.4
In this analysis of 112 patients receiving a total of 626 octagam®10% infusions, the incidence of AEs was 0.8% per infusion.4
ADRs were mild or moderate, most commonly being back pain and headache. No serious AEs were reported.4
References
Robak T, et al. Hematology 2010;15:351–9.
Brenner B. Clin Exp Rheumatol. 1996;14(Suppl. 15):S115–119.
Debes A, et al. Pharmacoepidemiol Drug Saf. 2007;16(9):1038-1047.
Wietek S, et al. Hematology 2018;23:242–7.
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IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).
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