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P.043 Long-term safety, tolerability, and efficacy of efgartigimod in patients with Generalized Myasthenia Gravis: concluding analyses from ADAPT+

Published online by Cambridge University Press:  05 June 2023

A Genge
Affiliation:
(Montreal)*
M Pasnoor
Affiliation:
(Kansas City)
V Bril
Affiliation:
(Toronto)
C Karam
Affiliation:
(Philadelphia)
S Peric
Affiliation:
(Belgrade)
JL De Bleecker
Affiliation:
(Ghent)
H Murai
Affiliation:
(Tokyo)
A Meisel
Affiliation:
(Berlin)
S Beydoun
Affiliation:
(Los Angeles)
T Vu
Affiliation:
(Tampa)
P Ulrichts
Affiliation:
(Ghent)
B Van Hoorick
Affiliation:
(Ghent)
C T’joen
Affiliation:
(Ghent)
K Utsugisawa
Affiliation:
(Hanamaki)
J Verschuuren
Affiliation:
(Leiden)
R Mantegazza
Affiliation:
(Milan)
JF Howard Jr
Affiliation:
(Chapel Hill) ADAPT Investigator Study Group ()
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Abstract

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Background: Efgartigimod is a human IgG1 antibody Fc-fragment that reduces total and pathogenic IgG autoantibody levels through FcRn blockade. ADAPT was a phase 3 trial evaluating efgartigimod in patients with generalized myasthenia gravis (gMG). Patients who completed ADAPT could enroll in ADAPT+ (open-label extension). Methods: Efgartigimod (10 mg/kg intravenous) was administered in cycles of 4 weekly infusions, with subsequent cycles initiated based on clinical evaluation. ADAPT+ evaluated long-term safety and tolerability of efgartigimod in patients with gMG. Efficacy was assessed utilizing MG-ADL and QMG scores. Results: Of 167 patients from ADAPT, 151 (90%) entered ADAPT+, and 145 received ≥1 cycle as of January 2022. Over 217.55 patient-years of follow-up (mean duration per patient, 548 days), incidence of adverse events did not increase with subsequent cycles. AChR-Ab+ patients with ≥1 year of follow-up across ADAPT/ADAPT+ (n=95) received a median (range) 5.0 (0.4–7.6) cycles per year. All AChR-Ab+ patients (n=111) demonstrated consistent improvements (mean change [SE], week 3 of cycle 1) in MG-ADL (-5.0 [0.33]; up to 14 cycles) and QMG (-4.7 [0.41]; up to 7 cycles) scores during each cycle. Conclusions: These ADAPT+ analyses suggest long-term efgartigimod treatment is well tolerated and efficacious. Additional final data cut analyses will be presented at CNSF 2023.

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