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

Department of Neurology, Maastricht University Medical Center, Maastricht, the Netherlands, and Department of Neurology, St Elizabeth Hospital, Curacao. Department of Neurology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands. National Referral Center for Rare Neuromuscular Diseases, Hopital Pitie-Salpetriere and University Paris VI, France. Department of Medicine (Neurology), University Health Network, University of Toronto, Toronto, Canada. Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, the Netherlands. Department of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Medical Faculty, Heinrich Heine University, Dusseldorf, Germany. Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan. CSL Behring, Pennsylvania, USA. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. AZ St-Lucas, Gent, Belgium. Department of Neurology, Universitatsklinikum Wurzburg, Wurzburg, Germany. UZ Leuven, Leuven, Belgium. Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland. Dolnoslaski Szpital Specjalistyczny, Poland. Samodzielny Publiczny Szpital Kliniczny, Lublin, Poland. Department of Neurology, Philipps University, Marburg, Germany.

Journal of the peripheral nervous system : JPNS. 2019
INTRODUCTION Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). METHODS To investigate the efficacy and safety of the IVIG IgPro10 (Privigen(R)) for treatment of CIDP, results from PRIMA, a prospective, open-label, single-arm study of IVIG in Ig-naive or IVIG-pretreated subjects (NCT01184846, n=28) and PATH, a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG-pretreated 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. RESULTS 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 71.9%, 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 (IQR -2.0; 0.0) points 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 adverse drug reactions (ADRs) were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. CONCLUSIONS 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. This article is protected by copyright. All rights reserved.
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