Tolerability and safety of the intravenous immunoglobulin octagam 10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials.

Objectives: To provide detailed data on the tolerability and safety of octagam 10%, a ready-to-use intravenous immunoglobulin, in a subgroup of patients with immune thrombocytopenia (ITP) involved in an integrated analysis of post-authorisation safety surveillance (PASS) studies.

Methods: A subgroup analysis was conducted using data collected from two non-interventional studies that included patients with ITP treated with octagam 10%. Patients were observed and monitored for possible adverse drug reactions (ADRs) during or after administration of octagam 10%, with a particular focus on thromboembolic events (TEEs). ADRs were analysed at the case and event level.

Results: In this analysis of 112 patients receiving octagam 10% (mean dose 0.4 g/kg/infusion), there were five cases with at least one adverse drug reaction (ADR) associated with 626 infusions of octagam 10% (case incidence of 0.8% per infusion). ADRs were of mild or moderate severity. There were a total of 10 events, most commonly back pain (n = 3) and headache (n = 2). Nausea, dizziness and a sensation of heaviness were also reported. The remaining two events involved drug exposure during pregnancy. There were no TEEs or other serious ADRs.

Discussion: In this subgroup analysis of patients who received octagam 10% (manufactured using an amended process) in two PASS studies, the overall ADR rate was low, with ADRs occurring in only 0.8% of all infusions. No TEEs or other serious ADRs were reported.

Conclusions: Routine clinical use of octagam 10% was safe and well tolerated, with no unexpected safety issues, in patients with ITP. The two studies from which data were taken are registered with the International Standard Randomised Controlled Trial Number Registry, numbers ISRCTN58800347 and ISRCTN02245668.