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P.033 Long-term efficacy of Efgartigimod PH20 SC in patients with chronic inflammatory demyelinating polyneuropathy: interim results from the ADHERE+ study

Published online by Cambridge University Press:  10 July 2025

JA Allen
Affiliation:
(Minneapolis)
J Lin
Affiliation:
(Shanghai)
M Stettner
Affiliation:
(Essen)
J Guptill
Affiliation:
(Durham)
K Gwathmey
Affiliation:
(Richmond)
G Istas
Affiliation:
(Ghent)
A De Roeck
Affiliation:
(Ghent)
S Kuwabara
Affiliation:
(Chiba)
G Lauria
Affiliation:
(Milan)
L Querol
Affiliation:
(Barcelona)
N Suresh
Affiliation:
(Tampa)
C Karam
Affiliation:
(Philadelphia)
T Skripuletz
Affiliation:
(Hanover)
S Rinaldi
Affiliation:
(Oxford)
A Echaniz-Laguna
Affiliation:
(Le Kremlin-Bicetre)
B Van Hoorick
Affiliation:
(Ghent)
R Yamasaki
Affiliation:
(Fukuoka)
H Katzberg
Affiliation:
(Rotterdam)
PA Van Doorn
Affiliation:
(Rotterdam)
RA Lewis
Affiliation:
(Los Angeles)
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Abstract

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Background: Efgartigimod, a human immunoglobulin (Ig)G1 antibody Fc fragment, blocks the neonatal Fc receptor, reducing IgGs involved in chronic inflammatory demyelinating polyneuropathy (CIDP). The multi-stage, double-blinded, placebo-controlled ADHERE (NCT04281472) and open-label extension ADHERE+ (NCT04280718) trials (interim analysis cutoff: February 16, 2024) assessed efgartigimod PH20 SC in participants with CIDP. Methods: Participants with active CIDP received open-label, weekly efgartigimod PH20 SC 1000 mg during ≤12-week run-in (stage-A). Responders were randomized (1:1) to efgartigimod or placebo for ≤48 weeks (stage-B). Participants with clinical deterioration in stage-B or who completed ADHERE entered ADHERE+. Week 36 changes from run-in baseline (CFB) in adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT), Inflammatory Rasch-built Overall Disability Scale (I-RODS), and grip strength scores were evaluated. Results: Of 322 stage-A participants, 221 were randomized and treated in stage-B, and 99% entered ADHERE+. Mean CFB (SE) in aINCAT, I-RODS, and grip strength scores were -1.2 (0.15) and 8.8 (1.46) and 17.5 (2.02), respectively, at ADHERE+ Week 36 (N=150). Half the participants with clinical deterioration during ADHERE stage-B restabilized on efgartigimod from ADHERE+ Week 4. Conclusions: Interim results from ADHERE+ indicate long-term effectiveness of efgartigimod PH20 SC in clinical outcomes in participants with CIDP.

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Abstracts
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of Canadian Neurological Sciences Federation