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Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Authors: Merkies I. S. J.; van Schaik I. N.; Leger J. -M.; Bril V.; van Geloven N.; Hartung H. -P.; Lewis R. A.; +161 Authors

Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Abstract

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.].

Countries
Belgium, Australia, Italy, Netherlands, Italy, Belgium, Italy, Italy, Poland, Australia, Germany, Germany
Keywords

2800 Neuroscience, Male, efficacy, 150, Medizin, Clinical sciences, CIDP; efficacy; IVIG; PATH; PRIMA; Neuroscience (all); Neurology (clinical), INFLAMMATORY DEMYELINATING POLYNEUROPATHY, intravenous immunoglobulin, Outcome Assessment, Health Care, Medicine and Health Sciences, PATH, Prospective Studies, prima, Aged, 80 and over, ddc:610, path, Immunoglobulins, Intravenous, inflammatory demyelinating polyneuropathy, Middle Aged, OPEN-LABEL, PREVALENCE, Europe, POLYRADICULONEUROPATHY, Female, Life Sciences & Biomedicine, CIDP; efficacy; IVIG; PATH; PRIMA, polyradiculoneuropathy, Adult, Efficacy, prevalence, Clinical Neurology, 610, PRIMA, CIDP, open-label, MAINTENANCE TREATMENT, Young Adult, Double-Blind Method, ivig, PRIMA Trial Investigators and the PATH Study Group, INTRAVENOUS IMMUNOGLOBULIN, Humans, Immunologic Factors, CIDP; efficacy; IVIG; PATH; PRIMA; Adult; Aged; Aged, 80 and over; Double-Blind Method; Europe; Female; Humans; Immunoglobulins, Intravenous; Immunologic Factors; Male; Middle Aged; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Prospective Studies; Young Adult; Outcome Assessment, Health Care, Aged, IVIG, Science & Technology, Neurology & Neurosurgery, maintenance treatment, Neurosciences, 3202 Clinical sciences, Research Reports, PHASE-III, phase-iii, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, cidp; efficacy; ivig; path; prima, 3209 Neurosciences, Neurosciences & Neurology, 2728 Clinical Neurology, cidp, 1109 Neurosciences

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selected citations
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This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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