Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study.

ABSTRACT:

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 pa

SUBMITTER: Cornblath DR 

PROVIDER: S-EPMC10442284 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature