Ten patients, who had been treated according to the Malmo model for immune
tolerance induction (ITI), were analysed regarding treatment with clotting
factors and chemotherapy during the time period between inhibitor detection
and ITI. Of the patients who were successfully rendered tolerant (n = 6) a
ll but one had received treatment with FVIII, either alone (n = 1), or comb
ined with cyclophosphamide (n = 4). Of the patients who did not become tole
rant, three of four had received treatment with FVIII during the inhibitor
period but only one with FVIII and chemotherapy. The total amount of treatm
ent received was in general much lower in the group that did not become tol
erant. In individual cases, it appeared very clear that the inhibitor level
and anamnestic response was substantially reduced prior to the ITI using t
he Malmo treatment model. We conclude that treatment of acute bleeds during
the inhibitor period may be of importance for ITI and that the different r
esponse rates published for different immune tolerance regimens most likely
do not reflect the true response rate for the respective regimen.