Nervenheilkunde 2025; 44(03): 150-151
DOI: 10.1055/s-0045-1802621
Abstracts
POSTER
Immunologische Prozesse (Myositis, Neuritis, Neuropathie, Myasthenia Gravis)

Efficacy and safety of efgartigimod PH20 subcutaneously (sc) in chronic inflammatory demyelinating polyneuropathy (CIDP): results from the ADHERE/ADHERE+ studies

O Hoffmann
1   Alexianer St. Josefs-Krankenhaus Potsdam-Sanssouci, Klinik für Neurologie, Potsdam, Deutschland
2   Universitätskrankenhaus der Medizinischen Hochschule Brandenburg Theodor Fontane, Neuruppin, Deutschland
,
P van Doorn
3   Erasmus MC, University Medical Center, Department of Neurology, Rotterdam, Niederlande
,
J Allen
4   University of Minnesota, Department of Neurology, Minneapolis, MN, Vereinigte Staaten
,
I Basta
5   University of Belgrade, Neurology Clinic, University Clinical Center of Serbia, Faculty of Medicine, Belgrad, Serbien
,
T Dysgaard
6   Universität Kopenhagen, Department of Neurology, Copenhagen, Dänemark
,
C Eggers
7   Kepler University Hospital, Johannes Kepler University, Department of Neurology, Linz, Österreich
9   Duke University, School of Medicine, Durham, Vereinigte Staaten
,
J Guptill
8   argenx, , Ghent, Belgien
,
K Gwathmey
10   Virginia Commonwealth University, Department of Neurology, Richmond, VA, Vereinigte Staaten
,
C Hewamadduma
11   University of Sheffield, Sheffield Institute for Translational Neuroscience (SITRAN), Sheffield, Vereinigtes Königreich
12   Sheffield Teaching Hospitals Foundation NHS Trust, Academic Neuromuscular Unit, Sheffield, Vereinigtes Königreich
,
E Hofman
8   argenx, , Ghent, Belgien
,
Y Hussain
13   Austin Neuromuscular Center, ustin, Vereinigte Staaten
,
S Kuwabara
14   Graduate School of Medicine, Chiba University, Department of Neurology, Chiba, Japan
,
G Le Masson
15   University Hospital of Bordeaux (CHU Bordeaux), ALS Center, Department of Neurology (Nerve-Muscle Unit), AOC National Reference Center for Neuromuscular Disorders, Bordeaux, Frankreich
,
F Leypoldt
16   Christian-Albrecht Universität zu Kiel, Fachbereich Neuroimmunologie, Institut für Klinische Chemie, Kiel, Deutschland
17   Universitätsklinikum Schleswig-Holstein, Kiel, Deutschland
,
J Lin
18   Huashan Hospital, Fudan University, Department of Neurology, Shanghai, China, Volksrepublik
,
M Lipowska
19   Medical University of Warsaw, Department of Neurology, Warschau, Polen
20   European Reference Network On Rare Neuromuscular Diseases (ERN EURO-NMD), Paris, Frankreich
,
M Lowe
8   argenx, , Ghent, Belgien
,
G Lauria
21   Fondazione IRCCS Istituto Neurologico Carlo Besta, Scientific Directorate, Mailand, Italien
,
G Pinter
22   Universität Mailand, Department of Medical Biotechnology and Translational Medicine, Mailand, Italien
,
L Querol
23   Hospital de La Santa Creu I Sant Pau, Universitat Autònoma de Barcelona, Department of Neurology, Neuromuscular Diseases Unit, Barcelona, Spanien
24   Centro Para La Investigación Biomédica en Red en Enfermedades Raras (CIBERER), Madrid, Spanien
,
M-A Simu
25   Victor Babes University of Medicine and Pharmacy, Department of Neurology, Tim, Rumänien
,
N Suresh
25   Victor Babes University of Medicine and Pharmacy, Department of Neurology, Tim, Rumänien
26   University of South Florida Morsani College of Medicine, Department of Neurology, Tampa, FL, Vereinigte Staaten
,
T Chang
27   The Fourth Military Medical University, Tangdu Hospital, Department of Neurology, Xi'an, China, Volksrepublik
,
A Tse
8   argenx, , Ghent, Belgien
,
P Ulrichts
8   argenx, , Ghent, Belgien
,
B van Hoorick
8   argenx, , Ghent, Belgien
,
R Yamasaki
28   Kyushu University, Kyushu University Hospital and Department of Neurology, Neurological Institute, Graduate School of Medical Sciences, Fukuoka, Japan
,
R Lewis
29   Cedars-Sinai Medical Center, Department of Neurology, Los Angeles, CA, Vereinigte Staaten
› Institutsangaben
 

Background: The efficacy and safety of efgartigimod PH20 sc 1000 mg in CIDP were investigated in the ADHERE study (NCT04281472) and the ongoing extension study ADHERE+ (NCT04280718).

Methodology: ADHERE enrolled adults with active CIDP. In Phase A, all received efgartigimod PH20 sc once weekly. Those who responded to treatment were randomized (1:1) to receive blinded efgartigimod PH20 sc or placebo once weekly in Phase B. Participants were then eligible to participate in the extension study ADHERE+ (efgartigimod PH20 sc once weekly). Primary endpoints were confirmed evidence of clinical improvement (Phase A), risk of recurrence (Phase B) and safety (ADHERE+).

Results: In Phase A, 214 of 322 participants (66.5%) had confirmed improvement. In Phase B, efgartigimod significantly reduced the risk of relapse compared with placebo (hazard ratio: 0.394 [95% CI, 0.253-0.614]; P=0.00004), regardless of whether prior CIDP therapy had been given. 99% of eligible participants chose to continue treatment with efgartigimod PH20 sc in ADHERE+. Efgartigimod was well tolerated and showed a consistent safety profile in ADHERE+.

Conclusion: The results of ADHERE/ADHERE+ demonstrate the efficacy of efgartigimod PH20 sc in reducing the risk of recurrence in CIDP without any unexpected safety signals.



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Artikel online veröffentlicht:
11. März 2025

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