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.].

• Authors: Ingemar S J Merkies, Ivo N van Schaik, Jean-Marc Léger, Vera Bril, Nan van Geloven, Hans-Peter Hartung, Richard A Lewis, Gen Sobue, John-Philip Lawo, Billie L Durn, David R Cornblath, Jan L De Bleecker, Claudia Sommer, Wim Robberecht, Mika Saarela, Jerzy Kamienowski, Zbigniew Stelmasiak, Björn Tackenberg, Orell Mielke, PRIMA Trial Investigators and the PATH Study Group
• Journal: Journal of the peripheral nervous system : JPNS (J Peripher Nerv Syst) Vol. 24 Issue 1 Pg. 48-55 (03 2019) ISSN: 1529-8027 [Electronic] United States
• PMID: 30672091 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2019 The Authors. Journal of the Peripheral Nervous System published by Wiley Periodicals, Inc. on behalf of Peripheral Nerve Society.

Chemical References

• Immunoglobulins, Intravenous
• Immunologic Factors

Topics

• Adult
• Aged
• Aged, 80 and over
• Double-Blind Method
• Europe
• Female
• Humans
• Immunoglobulins, Intravenous (administration & dosage, pharmacology)
• Immunologic Factors (administration & dosage, pharmacology)
• Male
• Middle Aged
• Outcome Assessment, Health Care
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (drug therapy)
• Prospective Studies
• Young Adult