Off-label use of biologics in urticarial vasculitis: a European retrospective cohort study

Lucas Maisonobe¹, Anne-Sophie Korganow², Alvise Berti³, Alban Deroux⁴, Nicolas Dupin⁵, Selim Aractingi⁵, Giacomo Emmi⁶, Frederic Vandergheynst⁷, Marc Fabre⁸, Nicolas Kluger⁹, Marielle Roux⁸, Noémie Abisror¹⁰, Audrey Benyamine¹¹, Giulia Cassone¹², François Chasset^{13

14}, Maria Cinta Cid¹⁵, Marie-Sylvie Doutre¹⁶, Aurélie Foucher¹⁷, Caroline Freguin¹⁸, Delphine Gobert¹⁰, Yannick Gombeir¹⁹, José Hernandez-Rodriguez¹⁵, Noémie Legouellec²⁰, Anne-Lise Pinault²¹, Dimitri Titeca-Beauport²², Marie Jachiet²³, Benjamin Terrier¹

Affiliations

¹ Department of Internal Medicine, CHU Cochin, AP-HP, Paris Cité University, Paris, France.
² Department of Internal Medicine, CHRU Strasbourg, Strasbourg University, Strasbourg, France.
³ Rheumatology Unit, Santa Chiara Hospital APSS Trento, and Center for Medical Sciences (CISMed), Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Trento, Italy.
⁴ Department of Internal Medicine, CHU Grenoble, Grenoble, France.
⁵ Dermatology Department, CHU Cochin, AP-HP, Paris Cité University, Paris, France.
⁶ Department of Experimental and Clinical Medicine, Internal Interdisciplinary Medicine Unit, University of Florence Italy, Careggi University Hospital, Florence, Italy.
⁷ Department of Internal Medicine, Hôpital Erasme, Bruxelles, Belgium.
⁸ Department of Internal Medicine, Hôpital Pierre Oudot, Bourgoin-Jallieu, France.
⁹ Dermatology Department, Hôpital Universitaire d'Helsinki, Finland.
¹⁰ Department of Internal Medicine, CHU Saint-Antoine, AP-HP, Paris, France.
¹¹ Department of Internal Medicine, AP-HM, Hôpitaux Nord, Marseille, France.
¹² Rheumatology Unit, Università degli Studi di Modena e Reggio Emilia, Modena, Italy.
¹³ Faculty of Medicine, Dermatology Department, CHU Tenon, AP-HP, Sorbonne University, Paris, France.
¹⁴ Cente d'immunologie et des maladies infectieuses, INSERM U1135, Paris, France.
¹⁵ Autoimmune Diseases Department, Hospital Clinic Barcelona, Barcelona, Spain.
¹⁶ Dermatology Department, CHU Saint-André, Bordeaux, France.
¹⁷ Department of Internal Medicine, CHU Saint-Pierre, Saint-Pierre de la Réunion, France.
¹⁸ Nephrology Department, CH Saint-Brieux, Saint-Brieuc, France.
¹⁹ Department of Internal Medicine, EpiCURA, Bruxelles, Belgium.
²⁰ Department of Internal Medicine, Hôpital de Valenciennes, Valenciennes, France.
²¹ Dermatology Department, Hôpital d'Epinal, Epinal, France.
²² Nephrology Department, CHU Amiens, Amiens, France.
²³ Dermatology Department, Saint-Louis Hospital, AP-HP, Paris, France.

PMID: 39847537
DOI: 10.1093/rheumatology/keaf039

Multicenter Study

Off-label use of biologics in urticarial vasculitis: a European retrospective cohort study

Lucas Maisonobe et al. Rheumatology (Oxford). 2025.

. 2025 Jul 1;64(7):4309-4315.

doi: 10.1093/rheumatology/keaf039.

Authors

Affiliations

¹ Department of Internal Medicine, CHU Cochin, AP-HP, Paris Cité University, Paris, France.
² Department of Internal Medicine, CHRU Strasbourg, Strasbourg University, Strasbourg, France.
³ Rheumatology Unit, Santa Chiara Hospital APSS Trento, and Center for Medical Sciences (CISMed), Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Trento, Italy.
⁴ Department of Internal Medicine, CHU Grenoble, Grenoble, France.
⁵ Dermatology Department, CHU Cochin, AP-HP, Paris Cité University, Paris, France.
⁶ Department of Experimental and Clinical Medicine, Internal Interdisciplinary Medicine Unit, University of Florence Italy, Careggi University Hospital, Florence, Italy.
⁷ Department of Internal Medicine, Hôpital Erasme, Bruxelles, Belgium.
⁸ Department of Internal Medicine, Hôpital Pierre Oudot, Bourgoin-Jallieu, France.
⁹ Dermatology Department, Hôpital Universitaire d'Helsinki, Finland.
¹⁰ Department of Internal Medicine, CHU Saint-Antoine, AP-HP, Paris, France.
¹¹ Department of Internal Medicine, AP-HM, Hôpitaux Nord, Marseille, France.
¹² Rheumatology Unit, Università degli Studi di Modena e Reggio Emilia, Modena, Italy.
¹³ Faculty of Medicine, Dermatology Department, CHU Tenon, AP-HP, Sorbonne University, Paris, France.
¹⁴ Cente d'immunologie et des maladies infectieuses, INSERM U1135, Paris, France.
¹⁵ Autoimmune Diseases Department, Hospital Clinic Barcelona, Barcelona, Spain.
¹⁶ Dermatology Department, CHU Saint-André, Bordeaux, France.
¹⁷ Department of Internal Medicine, CHU Saint-Pierre, Saint-Pierre de la Réunion, France.
¹⁸ Nephrology Department, CH Saint-Brieux, Saint-Brieuc, France.
¹⁹ Department of Internal Medicine, EpiCURA, Bruxelles, Belgium.
²⁰ Department of Internal Medicine, Hôpital de Valenciennes, Valenciennes, France.
²¹ Dermatology Department, Hôpital d'Epinal, Epinal, France.
²² Nephrology Department, CHU Amiens, Amiens, France.
²³ Dermatology Department, Saint-Louis Hospital, AP-HP, Paris, France.

PMID: 39847537
DOI: 10.1093/rheumatology/keaf039

Abstract

Objectives: Urticarial vasculitis (UV) is characterized by atypical urticarial lesions and leukocytoclastic vasculitis, sometimes with extracutaneous manifestations. First-line treatment is based on colchicine, hydroxychloroquine, dapsone or low-dose glucocorticoids. In refractory forms, the use of biologics has been anecdotally described as potentially effective. We aimed to describe the efficacy and safety of biologics in patients with UV.

Methods: We conducted a retrospective European multicentre study including patients with hypocomplementemic or normocomplementemic UV who received at least one biologic, including anti-CD20, anti-IgE and/or IL1-targeted therapy, from 2008 to 2021. We analysed clinical and biological characteristics as well as efficacy and safety of the biologics.

Results: Forty-one patients receiving 52 therapeutic sequences were analysed, including rituximab in 23, IL1-targeted therapy in 16 and anti-IgE in 13 cases. UV was hypocomplementemic in 24 (59%) cases. Biologics were used in median in fifth line of treatment, in combination with glucocorticoids in 75%. After a median follow-up of 25 (IQR 12-43) months, the cutaneous response was complete in 40%, partial in 37% and inadequate in 23%. Glucocorticoid discontinuation was achieved in 34% of patients. Serious adverse events, mainly infectious, were observed in 7 (17%) patients.

Conclusion: Biologics are an effective and rather well-tolerated treatment option for UV that are refractory to conventional therapies.

Keywords: anakinra; biologics; omalizumab; rituximab; urticarial vasculitis.

© The Author(s) 2025. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

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Off-label use of biologics in urticarial vasculitis: a European retrospective cohort study

Affiliations

Off-label use of biologics in urticarial vasculitis: a European retrospective cohort study

Authors

Affiliations

Abstract

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Medical