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P.045 Safety profile overview of Efgartigimod Clinical Trials in participants with diverse Diverse IgG-Mediated Autoimmune Diseases

Published online by Cambridge University Press:  05 June 2023

V Bril
Affiliation:
(Toronto)*
A Behin
Affiliation:
(Paris)
K Gwathmey
Affiliation:
(Richmond)
CM Broome
Affiliation:
(Washington)
M Goebeler
Affiliation:
(Würzburg)
H Murai
Affiliation:
(Tokyo)
Z Bata-Csörgo
Affiliation:
(Szeged)
A Newland
Affiliation:
(London)
P Ulrichts
Affiliation:
(Ghent)
R Kerstens
Affiliation:
(Ghent)
JT Guptill
Affiliation:
(Ghent)
S Agha
Affiliation:
(Ghent)
M Jiang
Affiliation:
(Ghent)
JF Howard Jr
Affiliation:
(Chapel Hill)
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Abstract

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Background: Efgartigimod is a human IgG1 antibody Fc-fragment that reduces IgG autoantibody levels through FcRn blockade. This study reports safety of efgartigimod across IgG-mediated disorders. Methods: The safety of intravenous efgartigimod was evaluated in 204 efgartigimod-treated subjects with generalized myasthenia gravis (phase 3 ADAPT and 3-year open-label extension ADAPT+ trials), primary immune thrombocytopenia (phase 3 ADVANCE trial), or pemphigus (open-label phase 2 trial). These studies examined different efgartigimod doses (10–25 mg/kg), including cyclical dosing in generalized myasthenia gravis and continuous weekly dosing in primary immune thrombocytopenia and pemphigus. Results: Across all indications and doses studied, efgartigimod demonstrated a consistent safety profile, with treatment-emergent adverse event (TEAE) rates comparable to placebo (ADAPT, 77.4% efgartigimod/84.3% placebo; ADVANCE, 93.0% efgartigimod/95.6% placebo; and 85% in the pemphigus study). Most TEAEs were mild to moderate in severity. Discontinuation rates due to adverse events were consistently low (ADAPT, 3.6% efgartigimod/3.6% placebo; ADVANCE, 3.5% efgartigimod/2.2% placebo; and 3% of pemphigus study participants). In ADAPT+, no increases in TEAEs or infections occurred with additional efgartigimod dosing (19 cycles). Conclusions: Efgartigimod was well tolerated across indications and doses studied. Most TEAEs, including infections, were mild or moderate in severity and did not increase in frequency with recurrent dosing.

Type
Abstracts
Copyright
© The Author(s), 2023. Published by Cambridge University Press on behalf of Canadian Neurological Sciences Federation