Assess the impact of the immunoaffinity chromatography (IAC) step on spontaneous reporting rates of hemolysis with Privigen (IgPro10) versus baseline (no risk minimization measure [RMM]) and versus the RMM of anti-A donor screening.

Reporting rates of spontaneous cases of hemolysis across the 3 periods until end of 2017 were compared. The Standard MedDRA Query (SMQ) Hemolytic Disorders – Broad was used. The hemolysis reporting rate (cases/1000 kg sold) was calculated.

Anti-A donor screening showed a decrease in worldwide reporting rates from 4.05 (at baseline) to 2.00 cases/1000 kg IgPro10 (51% reduction). A substantial decrease with IAC to 0.70 cases/1000 kg IgPro10 (83% reduction) was observed. In 2017 (higher proportion of IAC lots in market than 2016), a further reduction to 0.32 cases/1000 kg (92% reduction) with IAC was observed.  High dose indications (Guillain Barré Syndrome, Immune Thrombocytopenia and Kawasaki Disease) were most frequently reported, as were patients with blood groups A and AB. Reduction of hemolysis rates were greatest in patients presenting these risk factors. Research limitations include possible confounders; overlap of non-IAC lots in the assessment period, changes in IVIG prescribing practices, variability in spontaneous reporting behaviours and/or lack of information.

Hemolysis reporting rates with IVIG therapy have been substantially reduced by IAC in the IgPro10 production process; and more effectively than anti-A donor screening.