Nearly 70% of patients showed improvement after treatment with efgartigimod plus rHuPH20 in phase 2 of the largest randomized controlled trial for CIDP to date.
, according to the results of a phase 2 multinational trial, which were reported at the 2024 annual meeting of the American Academy of Neurology.
The primary endpoint of stage A was the percentage of patients with evidence of clinical improvement . Patients who participated in the run-in were allowed to resume their prior treatment for stage A and the subsequent blinded stage B. Stage A was event driven so that it was closed once 88 events were reached.
There were 322 patients in stage A. Of these, 211 enrolled in stage B. They were randomized in a 1:1 ratio to 1000 mg of E-PH20 or placebo administered weekly by subcutaneous injection. Of those eligible for stage B, 40% had not participated in the run-in.For stage B, the primary endpoint was time from baseline to a clinically meaningful limitation of activity. This was evaluated with the adjusted inflammatory neuropathy cause and treatment disability score.
On functional aINCAT scores, 80.9% achieved at least a 1-point improvement. The improvement was at least 2 points in 42.7%, at least 3 points in 28.2%, and at least 4 points in 11.8%.
Chronic Inflammatory Demyelinating Polyneuropathy CIDP Demyelination Demyelinating Igg Immunoglobulin G Corticosteroid Iga Immunoglobulin A Intravenous Immunoglobulin Disability Adverse Effects Side Effects Autoimmune Disease Intravenous IV - Intravenous Intravenous Route Minnesota Neuropathy Plasmapheresis Steroids Headache
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