Test your expertise in CIDP pathophysiology, humoral IgG-mediated immune mechanisms, and FcRn-targeted therapeutics. Explore the ADHERE Phase 3 trial, patient selection, response assessment, and self-administration.
5 questions
What is the pathophysiologic rationale for using an IgG-reducing FcRn antagonist in CIDP?
Correct Answer: C
CIDP is an immune-mediated neuropathy in which humoral IgG mechanisms are thought to contribute in at least a subset of patients. FcRn blockade accelerates IgG catabolism and lowers circulating IgG. Antibodies to CNTN1, NF155, Caspr1, and related nodal/paranodal proteins are now generally classified under autoimmune nodopathies rather than conventional CIDP and should not be presented as routine CIDP biomarkers.
https://onlinelibrary.wiley.com/doi/10.1111/ene.14959
ADHERE Phase 3 trial: What study design was used to demonstrate FcRn antagonist efficacy in CIDP?
Correct Answer: D
ADHERE used a randomized withdrawal design — patients stabilized on efgartigimod SC were randomized to continue active treatment or switch to placebo. Significantly fewer active-arm patients experienced CIDP relapse or worsening (measured by adjusted INCAT disability score).
https://reports.argenx.com/2024/argenx-group/our-products-and-product-candidates/efgartigimod-indications.html
What was the historical significance of FcRn antagonist approval in CIDP (FDA, June 2024)?
Correct Answer: A
Efgartigimod SC received FDA approval for CIDP in June 2024, becoming the first and only FcRn blocker approved for this indication — representing a novel mechanistic class that targets pathogenic IgG catabolism, distinct from IVIg, SCIg, and corticosteroids.
https://www.neurologylive.com/view/fda-approves-pre-filled-syringe-administration-fcrn-modulator-efgartigimod
What practical advantage does SC FcRn antagonist administration offer CIDP patients vs IVIg?
Correct Answer: B
Unlike IVIg (requiring 2 to 5-hour infusion center visits), SC efgartigimod can be self-injected at home in 20 to 30 seconds following training. The 2026 prefilled syringe approval further simplifies administration, significantly reducing treatment burden for this chronic, relapsing condition.
Which outcome measure is the standard endpoint for detecting CIDP relapse or improvement in clinical trials?
The adjusted INCAT disability scale assesses upper and lower limb functional impairment on a 0–10 scale, with at least 1-point worsening defining clinically meaningful relapse. It was the primary endpoint in ADHERE and other pivotal CIDP trials.
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