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

DR. Cornblath, PA. van Doorn, HP. Hartung, ISJ. Merkies, HD. Katzberg, D. Hinterberger, E. Clodi, ProCID Investigators

. 2023 ; 46 (9) : 835-845. [pub] 20230628

Jazyk angličtina Země Nový Zéland

Typ dokumentu randomizované kontrolované studie, časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc23016387
E-zdroje Online Plný text

NLK ProQuest Central od 2008-06-01 do Před 1 rokem
Nursing & Allied Health Database (ProQuest) od 2008-06-01 do Před 1 rokem
Health & Medicine (ProQuest) od 2008-06-01 do Před 1 rokem

Odkazy

PubMed 37378806
DOI 10.1007/s40264-023-01326-z
Knihovny.cz E-zdroje

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.

Citace poskytuje Crossref.org

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