RT Journal Article
T1 Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies.
A1 Merkies, Ingemar S J
A1 van Schaik, Ivo N
A1 Léger, Jean-Marc
A1 Bril, Vera
A1 van Geloven, Nan
A1 Hartung, Hans-Peter
A1 Lewis, Richard A
A1 Sobue, Gen
A1 Lawo, John-Philip
A1 Durn, Billie L
A1 Cornblath, David R
A1 De Bleecker, Jan L
A1 Sommer, Claudia
A1 Robberecht, Wim
A1 Saarela, Mika
A1 Kamienowski, Jerzy
A1 Stelmasiak, Zbigniew
A1 Tackenberg, Björn
A1 Mielke, Orell
A1 PRIMA Trial Investigators and the PATH Study Group, 
K1 CIDP
K1 IVIG
K1 PATH
K1 PRIMA
K1 efficacy
AB Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naïve or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was -1.0 (interquartile range -2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].
YR 2019
FD 2019-02-15
LK http://hdl.handle.net/10668/13449
UL http://hdl.handle.net/10668/13449
LA en
DS RISalud
RD Apr 18, 2025