Abstract Details

Patients were randomized to either low (0.5g/kg), standard (1.0g/kg) or high (2.0g/kg) maintenance dosing every 3 weeks (total duration: 24 weeks). Dosing was done by actual bodyweight with no upper limit per day. Patients had to stop or reduce their previous CIDP treatment (87% received corticosteroids) and needed to show deterioration prior to enrollment.

Overall 142 patients were enrolled. The mean IVIg amount/day was 76.5g (range 10.6g to 128g). Starting with the first infusion, the infusion rate could be increased stepwise to a maximum of 12mg/kg/min. Infusions were given over 2 consecutive days (= 1 infusion-cycle; patients receiving low or standard dosing, were infused with saline solution on the second day to keep blinding). In 971/982 infusion cycles (98.8%), the maximum infusion speed was reached at least once. In only 8 of 142 patients the highest possible infusion rate was not reached or infusion had to be interrupted and rate reduced due to adverse reaction (AR) occurring at the maximum infusion rate. 11 patients (7.75%) received premedication. Most common adverse reactions were headache, pyrexia, and dermatitis, with headache being the only AR showing a dose dependent effect with an incidence of 2.9%, 14.5% and 23.7% in the 0.5, 1.0 and 2.0g/kg group, respectively. The most serious adverse reaction related to IVIG was vomiting and headache (1 patient). In one patient, allergic dermatitis (related to study drug) led to study discontinuation.

The ProCID study showed that Panyzga® infusions were well tolerated at high doses and high infusion rates and rarely needed premedication, even in IVIg naïve CIDP patients.