BACKGROUND AND AIMS: The ProCID study evaluated the efficacy and safety of three doses of a 10% liquid intravenous immunoglobulin (IVIg) preparation (panzyga®) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). This report describes the safety findings. METHODS: Patients were randomised to receive a 2.0 g/kg induction dose followed by maintenance doses of either 0.5, 1.0 or 2.0 g/kg IVIg every 3 weeks over 24 weeks. RESULTS: All 142 enrolled patients were included in the safety analyses. In total, 286 treatment-emergent adverse events (TEAEs) were reported in 89 patients, of which 173 (60.5%) were considered treatment-related. Most TEAEs were of mild severity. Eleven serious TEAEs were reported in 6 patients. Two serious TEAEs in one patient (headache and vomiting) were considered related to treatment, which resolved without study discontinuation. No treatment-related thrombotic events, haemolytic transfusion reactions or deaths occurred. One patient discontinued the study due to a TEAE (allergic dermatitis) probably related to IVIg. Headache was the only dose-dependent TEAE, with incidences ranging from 2.9 to 23.7%, the incidence of all other TEAEs was similar across treatment groups. Most TEAEs were associated with the induction dose infusion, and the rate of TEAEs decreased thereafter. The median (IQR) daily IVIg dose was 78 (64-90) g, and 94.4% of patients tolerated the maximal infusion rate of 0.12 ml/kg/min without pre-medication. INTERPRETATION: Infusions of 10% IVIg at doses up to 2.0 g/kg with high infusion rates were safe and well tolerated in patients with CIDP. CLINICAL TRIAL NUMBERS: EudraCT 2015-005443-14, NCT02638207.

Brain and Mind Center University of Sydney Sydney NSW 2050 Australia

Curaçao Medical Center Willemstad Curaçao

Department of Neurology Erasmus University Medical Center 3015 CE Rotterdam The Netherlands

Department of Neurology Johns Hopkins University Baltimore MD 21287 USA

Department of Neurology Maastricht University Medical Center 6229 HX Maastricht The Netherlands

Department of Neurology Medical Faculty Heinrich Heine University 40225 Düsseldorf Germany

Department of Neurology Medical University of Vienna 1090 Vienna Austria

Department of Neurology Palacky University 771 47 Olomouc Czech Republic

Department of Neurology University of Toronto Toronto M5G 2C4 Canada

Octapharma PPG 1100 Vienna Austria

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ClinicalTrials.gov
NCT02638207

EudraCT
2015-005443-14