Journal Article

046 Efficacy and safety of intravenous immunoglobulin (IVIG) IGPRO10 in chronic inflammatory demyelinating polyneuropathy (CIDP)

Bril, Vera, Merkies, Ingemar SJ, Hartung, Hans Peter, Cornblath, David R, Robberecht, Wim, Leger, Jean-Marc, Bleecker, Jan LDe, Gloven, Nan van, Stelmasiak, Zbigniew, Sabet, Arman, Kamienowski, Jerzy, Schaik, Ivo N van, Lewis, Richard A, Sommer, Claudia, Durn, Billie L, Tackenberg, Bjorn, Mielke, Orell, Sobue, Gen, Lawo, John-Philip, Saarela, Mika

2018

Overview

IntroductionWe analysed the efficacy and safety of IVIG IgPro10 (CSL Behring) in two CIDP studies: PRIMA and PATH.MethodsPRIMA was a prospective, open-label, single-arm study in 28 CIDP patients (n=13 IVIG-pretreated; n=15 untreated) investigating efficacy and safety of IgPro10 for induction (2 g/kg) and maintenance therapy (1 g/kg every 3 weeks for 21 weeks). This regimen was also used for 207 IVIG-pretreated patients during the 10–13 week pre-randomization phase of the PATH study (before randomization to subcutaneous immunoglobulin maintenance therapy or placebo). Both studies investigated a 1-point decrease in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score as a response parameter, and evaluated changes in mean grip strength and Medical Research Council (MRC) score. Treatment-emergent adverse events (AEs) were assessed.ResultsResponse rate was 76.9% (95% confidence interval [CI] 49.7–91.8) in PRIMA (IVIG-pretreated patients) at week 21% and 72.9% (95%CI 66.5–78.5) in PATH at week 13; median time to first INCAT response was 3.0 and 3.7 weeks, respectively. Median (Q1;Q3) improvements in outcome measures (baseline to last observation) for PRIMA pre-treated patients and PATH, respectively, were: INCAT, −2.0 (-3.0;−1.0) and −1.0 (-2.0;0.0) points; grip strength, 5.0 (-9.0;22.0) and 9.4 (1.3;18.8) kPa; and MRC score, 5.0 (3.0;10.0) and 3.0 (0.0;6.0) points. In the PRIMA safety population (n=28), 108 AEs occurred in 22 (78.6%) patients (0.417/infusion); 284 AEs in 100 (48.3%) patients (0.175/infusion) were reported in the PATH safety population (n=207). Headache was the most frequent AE. Causally related serious AEs in PRIMA and PATH occurred in 2 and 7 patients, respectively.ConclusionSimilar efficacy results of IgPro10 in CIDP were observed in PRIMA and the PATH pre-randomization period. IgPro10 is well tolerated, with clinically meaningful improvement in disability in CIDP patients.Study SupportCSL Behring

• Publisher: BMJ Publishing Group LTD
• Subject: Immunoglobulins