P 46. Assessment of individualized treatment decisions for intravenous immunoglobulin therapy in patients with chronic immune-mediated neuropathies: observational study design and progress

Abstract

Introduction. Chronic immune-mediated neuropathies such as chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN) are associated with immune mediated peripheral nerve damage and neurological deficits. Randomized, controlled clinical trials have demonstrated the effectiveness of human intravenous immunoglobulin (IVIG) for these conditions. IVIG is considered a treatment of choice for both disorders. German and EFNS/PNS guidelines recommend individualization of IVIG therapy during treatment for CIDP and MMN. However, there is a lack of documentation of individualized dosing in real-world practice. Objective. This study is designed to determine the patterns of use of 10% IVIG in real-world clinical practice and identify the factors driving treatment decisions for patients with CIDP or MMN. Methods. The study is non-interventional, longitudinal, multicenter design. Primary data collected will be physicians“ practice patterns, demographics, treatment regimens and tolerability of 10% IVIG. Adult patients (n=150) diagnosed with CIDP or MMN and with current or prospective therapy with 10% IVIG will be eligible for the study. Approximately 40 sites in Germany will participate in the study. The planned recruitment period for the study is 18 months starting in first half of 2021. Results. According to the study protocol, patient demographics, medical and disease history and concomitant medication are to be assessed at baseline. Data will be collected at the baseline visit and at each infusion visit (approximately every 3 weeks as scheduled for routine care) for up to 18 months . In addition, the study will include an initial , cross-sectional, quantitative survey for participating physicians on their current practice patterns for CIDP and MMN. The survey will include assessment of initial therapy choices, IVIG dosing, outcome measures, dosing reductions and treatment schemes for relapses. The criteria used for decisions about initiation, continuation and individualization of IVIG treatment (dosing, intervals, co-medication) will be recorded at each visit. Physicians are also requested to provide the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score at baseline and other study visits, if these scores are routinely determined. The physician-assessed Clinical Global Impression of Improvement (CGI-I) is to be performed at all visits. The potential impact of the COVID-19 pandemic on an individual subject“s treatment algorithm will also be captured in the electronic data capture system . To assess safety, serious adverse events and adverse drug reactions will be evaluated at each visit. Conclusions. Results from this clinical trial will allow identification of the factors driving treatment decisions by physicians utilizing 10% IVIG to treat patients with CIDP or MMN as part of their clinical routine and allow assessment of the influence of patient-reported outcomes and objective clinical measures.