Trial reportFrontiers in neurology2026
Immunoglobulin G dose-exposure-efficacy response in patients with chronic inflammatory demyelinating polyradiculoneuropathy.
Trial report in Frontiers in neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multifocal Motor Neuropathy
A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
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Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: Intravenous immunoglobulin (IVIG) 10% and hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% are both used as maintenance treatments for patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Owing to the rarity of the condition, data regarding the relationship between dose, exposure, and clinical outcomes are sparse for these therapies. This analysis aimed to characterize the relationships between dose, exposure, and clinical efficacy of IVIG 10% and fSCIG 10% in CIDP. Materials and methods: Data were pooled from two phase 3 studies in patients with CIDP (NCT02549170; ADVANCE-CIDP 1) and multifocal motor neuropathy (NCT00666263). A sequential population pharmacokinetic (PK)-pharmacodynamic (PD) model was developed to characterize the PK-PD relationship between the PK of serum total immunoglobulin G (IgG) and, as the PD endpoint, the probability of increased adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score (higher scores indicate greater disability). The model was then used to simulate changes in total serum IgG concentrations and the PD endpoint for patients with CIDP. Dosing scenarios simulated were 6 months of IVIG 10% or 3 months of IVIG 10% followed by 9 months of fSCIG 10% at dosages of 0.4, 0.8, and 1.0 g/kg every 2 weeks, 1.0 and 2.0 g/kg every 3 weeks, and 0.4, 0.8, 1.0, and 2.0 g/kg every 4 weeks. Results: Our results showed that higher doses and more frequent IVIG/fSCIG 10% administration were associated with a lower mean probability of increased adjusted INCAT score (i.e., lower probability of relapse), remaining < 50% in all simulations except the 0.4 g/kg every 4 weeks dosage. The probability of increased adjusted INCAT score tended to be higher toward the end of the dosing interval for patients treated less frequently. Discussion: Higher and more frequent dosing may result in more consistent treatment efficacy in patients with CIDP.
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