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Treatment of Bullous Pemphigoid with Avdoralimab: Multicenter, Randomized, Open-Labeled Phase 2 Study
Thierry Passeron1,2, Eric Fontas3, Thierry Boye4
1Department of Dermatology, Centre Hospitalier Universitaire de Nice, University Côte D'Azur, Nice, France.
JID Innovations : Skin Science From Molecules to Population Health
|September 23, 2024
Summary
This study investigated avdoralimab for bullous pemphigoid, finding no significant benefit over topical steroids alone. Further research is needed to explore avdoralimab
Area of Science:
- Immunodermatology
- Complement system research
- Clinical trial methodology
Background:
- Bullous pemphigoid (BP) pathogenesis involves the C5a-C5a receptor 1 (C5aR1) axis.
- Avdoralimab is a monoclonal antibody targeting C5aR1.
Purpose of the Study:
- To evaluate the efficacy and safety of avdoralimab in treating bullous pemphigoid.
- To assess if avdoralimab provides added benefit to topical corticosteroids in BP management.
Main Methods:
- Phase 2, open-label, randomized multicenter study.
- Patients with BP randomized to topical steroids alone or with avdoralimab.
- Primary endpoint: proportion of patients in complete clinical remission at 3 months without relapse.
Main Results:
- Fifteen patients enrolled (7 topical steroids, 8 avdoralimab + steroids).
- Disease control at week 4 in 2 patients per group.
- Complete remission at 12 weeks: 1 patient in avdoralimab group, none in control group.
- No treatment-related adverse events reported.
Conclusions:
- This pilot study did not demonstrate additional efficacy of avdoralimab combined with topical steroids for bullous pemphigoid.
- The C5aR1 axis may not be a primary driver for treatment response in all BP patients.
- Further investigation into avdoralimab's role in BP is warranted.
