Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study.
Journal
Drug safety
ISSN: 1179-1942
Titre abrégé: Drug Saf
Pays: New Zealand
ID NLM: 9002928
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
accepted:
05
06
2023
medline:
23
8
2023
pubmed:
28
6
2023
entrez:
28
6
2023
Statut:
ppublish
Résumé
The ProCID study evaluated the efficacy and safety of three doses of a 10% liquid intravenous immunoglobulin (IVIg) preparation (panzyga 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. 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. 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. EudraCT 2015-005443-14, NCT02638207.
Sections du résumé
BACKGROUND AND AIMS
The ProCID study evaluated the efficacy and safety of three doses of a 10% liquid intravenous immunoglobulin (IVIg) preparation (panzyga
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.
Identifiants
pubmed: 37378806
doi: 10.1007/s40264-023-01326-z
pii: 10.1007/s40264-023-01326-z
pmc: PMC10442284
doi:
Substances chimiques
Immunoglobulins, Intravenous
0
Banques de données
ClinicalTrials.gov
['NCT02638207']
EudraCT
['2015-005443-14']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
835-845Investigateurs
S Kastrev
(S)
V Rizova
(V)
I Milanov
(I)
R Massie
(R)
R Taleb
(R)
M Bednar
(M)
P Ridzon
(P)
J Schmidt
(J)
J Zschüntzsch
(J)
R Csilla
(R)
L Vécsei
(L)
K Rejdak
(K)
M Koszewicz
(M)
S Budrewicz
(S)
A Docu-Axelerad
(A)
A Dulamea
(A)
M Marian
(M)
A Kadar
(A)
L Zecheru-Lapusneanu
(L)
V Mikhailov
(V)
D Zakharov
(D)
N Suponeva
(N)
M Piradov
(M)
N Smolko
(N)
D Smolko
(D)
Informations de copyright
© 2023. The Author(s).
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