Immune tolerance induction has been accepted as the only clinically proven treatment allowing antigen-specific tolerance to factor VIII. However, some of its issues, such as patient selection, timing, factor VIII dosing, use of immunosuppressive or immunomodulatory procedures, still remain the subject of debate.
Historically, immunoglobulins were employed as a part of immunosuppression in the Malmo protocol used in the 1980´s -1990´s. This protocol is not in common use more.
There were anecdotal reports on the solo use of immunoglobulins during ITI aimed to increase the chance of success. However, so far no evidence based outcome advantage relative to standard ITI has been proved and a use of ivIgG is not supported as a part of the first ITI attempt by any recent and/or current guidelines/reports on the ITI (Di Michelle. J Thromb Haemost 2011; 9 (Suppl. 1): 216–225,M. Makris et al. Haemophilia (2012), 18 (Suppl. 4), 48–53; Collins et al, BJH 2013; 160, 153–170). In a survey within 21 centres from 14 European countries performing a total of 233 ITI, no centre would consider the use of any immunosuppressive agent in patients below the age of 6 years (Astermark et al, Haemophilia 2006; 12, 363– 371).
In a view of a high success rate of 80% of high dose ITI using vWF/FVIII concentrates (Auerswald et al. Haematologica 2003; 88, Suppl. 9, 21–25) determining the role of IVIG is difficult. An addition of immunoglobulis to ITI might be probably considered in patients with inadequate response to ITI/failed first-line therapy.
A different situation is in hemophilia B with inhibitors. In patients with a history of allergic reactions the IvIgG pulses, however, again along with other immunosuppressive drugs may enable to perform successful ITI even with high doses of factor IX.
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