Efficacy and safety of a new intravenous immunoglobulin (Panzyga® ) in chronic immune thrombocytopenia

O Arbach, A B Taumberger, S Wietek, L Cervinek, A Salama, O Arbach, A B Taumberger, S Wietek, L Cervinek, A Salama

Abstract

Objectives: To assess the efficacy and safety of intravenous immunoglobulin (IVIG) 10% (Panzyga® ), a novel human normal IVIG 10%, in patients with chronic immune thrombocytopenia (ITP).

Background: First-line treatment options in ITP include IVIGs.

Methods: In this prospective, open-label, non-controlled, multicentre, phase III study, patients received a daily dose of IVIG 10% (1 g kg-1 body weight) for two consecutive days. The primary end point was clinical response rate; secondary end points included alternate response definitions, time to response, response duration, platelet counts, regression of bleeding and safety.

Results: Forty patients were enrolled (57·5% male, mean age 36·7 years); the full analysis set comprised 36 patients. A clinical response was seen for 29 of 36 patients (80·6%). Median time to response and response duration was 2 days and 14 days, respectively. IVIG 10% was well tolerated at a maximum infusion rate of 8 mg (kg min)-1 in all but one patient; adverse events were mainly mild to moderate in severity, and the most frequent was headache (42·5%).

Conclusion: IVIG 10% is well tolerated even at a high infusion speed and induces a rapid platelet count increase, thus decreasing the bleeding rate and the severity of bleeding events.

Trial registry: ClinicalTrials.gov record: NCT01349790.

Keywords: ITP; IVIG; Panzyga®; immune thrombocytopenia; intravenous immunoglobulin; platelet count; safety.

Conflict of interest statement

A. B. T. is an employee (Senior Global Clinical Project Manager) of Octapharma (Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria). Dr S. W. was an employee (Head of Global Medical and Scientific Affairs) of Octapharma (Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria) when the study was conducted. Currently, Dr S. W. is working as a Freelancer Medical Affairs and Clinical Study Management for Octapharma (Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria). Dr A. S., Dr O. A. and Dr L. C. declare no conflict of interest.

© 2019 The Authors. Transfusion Medicine published by John Wiley & Sons Ltd on behalf of British Blood Transfusion Society.

Figures

Figure 1
Figure 1
Platelet count over time in the full analysis set (N = 36). ET, early termination.
Figure 2
Figure 2
Change in mean platelet count versus all haemorrhages over time in the full analysis set (N = 36). Solid line = platelet count; thick dotted line = haemorrhage count; thin dotted line = complete response threshold (CR = platelet count ≥50 × 109 L−1 within 8 days post‐treatment). BL, baseline; CR, clinical response; EOT, end of treatment.

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Source: PubMed

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