TY - JOUR
T1 - Efficacy and safety of IVIG in CIDP
T2 - Combined data of the PRIMA and PATH studies
AU - on Behalf of the PRIMA Trial Investigators and the PATH Study Group
AU - Merkies, Ingemar S.J.
AU - van Schaik, Ivo N.
AU - Léger, Jean Marc
AU - Bril, Vera
AU - van Geloven, Nan
AU - Hartung, Hans Peter
AU - Lewis, Richard A.
AU - Sobue, Gen
AU - Lawo, John Philip
AU - Durn, Billie L.
AU - Cornblath, David R.
AU - De Bleecker, Jan L.
AU - Sommer, Claudia
AU - Robberecht, Wim
AU - Saarela, Mika
AU - Kamienowski, Jerzy
AU - Stelmasiak, Zbigniew
AU - Tackenberg, Björn
AU - Mielke, Orell
AU - Sabet, A.
AU - George, K.
AU - Roberts, L.
AU - Carne, R.
AU - Blum, S.
AU - Henderson, R.
AU - Van Damme, P.
AU - Demeestere, J.
AU - Larue, S.
AU - D'Amour, C.
AU - Kunc, P.
AU - Valis, M.
AU - Sussova, J.
AU - Kalous, T.
AU - Talab, R.
AU - Bednar, M.
AU - Toomsoo, T.
AU - Rubanovits, I.
AU - Gross-Paju, K.
AU - Sorro, U.
AU - Saarela, M.
AU - Auranen, M.
AU - Pouget, J.
AU - Attarian, S.
AU - Masson, G. Le
AU - Wielanek-Bachelet, A.
AU - Desnuelle, C.
AU - Delmont, E.
AU - Clavelou, P.
AU - Aufauvre, D.
AU - Drory, V.
N1 - Publisher Copyright:
© 2019 The Authors. Journal of the Peripheral Nervous System published by Wiley Periodicals, Inc. on behalf of Peripheral Nerve Society.
PY - 2019/3
Y1 - 2019/3
N2 - 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.].
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.].
KW - CIDP
KW - IVIG
KW - PATH
KW - PRIMA
KW - efficacy
UR - http://www.scopus.com/inward/record.url?scp=85061703237&partnerID=8YFLogxK
U2 - 10.1111/jns.12302
DO - 10.1111/jns.12302
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C2 - 30672091
AN - SCOPUS:85061703237
SN - 1085-9489
VL - 24
SP - 48
EP - 55
JO - Journal of the Peripheral Nervous System
JF - Journal of the Peripheral Nervous System
IS - 1
ER -