A V Marzano1,2, G Genovese1,2, G Casazza3, M T Fierro4, P Dapavo4, N Crimi5, S Ferrucci1, P Pepe6, S Liberati6, P D Pigatto7, A Offidani8, E Martina8, G Girolomoni9, M Rovaris9, C Foti10, L Stingeni11, A Cristaudo12, G W Canonica13, E Nettis14, R Asero15. 1. UOC Dermatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. 2. Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Università degli Studi di Milano, Milan, Italy. 3. Dipartimento di Scienze Biomediche e Cliniche "L. Sacco", Università degli Studi di Milano, Milan, Italy. 4. Department of Medical Sciences, Section of Dermatology, University of Turin, Turin, Italy. 5. Department of Clinical and Experimental Medicine-Respiratory Medicine & Allergy, University of Catania, Catania, Italy. 6. Dermatology Unit, Surgical, Medical and Dental Department of Morphological Sciences Related to Transplant, Oncology and Regenerative Medicine, University of Modena and Reggio Emilia, Modena, Italy. 7. Clinical Dermatology, Department of Biomedical, Surgical and Dental Sciences, IRCCS Galeazzi Orthopaedic Institute, University of Milan, Milan, Italy. 8. Dermatology Unit, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Ancona, Italy. 9. Department of Medicine, Section of Dermatology, University of Verona, Verona, Italy. 10. Department of Biomedical Science and Human Oncology, Section of Dermatology, University of Bari, Bari, Italy. 11. Section of Clinical, Allergological and Venereological Dermatology, Department of Medicine, University of Perugia, Perugia, Italy. 12. Service of Occupational and Environmental Allergic Dermatology, San Gallicano Dermatology Institute for Research and Care, Rome, Italy. 13. Department of Internal Medicine, Respiratory Disease Clinic, IRCCS Humanitas Clinical and Research Center, Humanitas University, Milan, Italy. 14. Department of Emergency and Organ Transplantation, School of Allergology and Clinical Immunology, University of Bari Aldo Moro, Bari, Italy. 15. Ambulatorio di Allergologia, Clinica San Carlo, Paderno Dugnano, Milan, Italy.
Abstract
BACKGROUND: Chronic spontaneous urticaria (CSU) is defined as spontaneous occurrence of wheals and/or angioedema for ≥6 weeks. Omalizumab is a monoclonal anti-IgE antibody effective in refractory CSU, but its mechanism of action and markers predictive of response remain not completely defined. OBJECTIVES: To correlate baseline levels of two proposed biomarkers, total IgE (bIgE) and d-dimer (bd-dimer), and clinical parameters to omalizumab response and to relapses after drug withdrawal. METHODS: In this retrospective Italian multicentre study, clinical data were collected in 470 CSU patients, and bIgE and bd-dimer were measured in 340 and 342 patients, respectively. Disease activity was determined by Urticaria Activity Score 7 (UAS7) at week 1 and 12 after omalizumab starting. Relapses were evaluated during a 2- and 3-month interval after a first and a second course of treatment, respectively. RESULTS: bIgE correlated to a good response to omalizumab since levels were significantly higher in responders than non-responders (P = 0.0002). Conversely, bd-dimer did not correlate to response. There was no correlation between both bIgE and d-dimer and either first or second relapse. Disease duration was significantly longer in patients who experienced either first or second relapse (P < 0.0001 and P = 0.0105, respectively), while baseline UAS7 correlated only to first relapse (P = 0.0023). CONCLUSIONS: Our study confirms bIgE as a reliable biomarker predicting response to omalizumab in CSU, while it does not support the usefulness of bd-dimer unlike previous findings. CSU duration before omalizumab and baseline UAS7 may be clinical markers of relapse risk.
BACKGROUND: Chronic spontaneous urticaria (CSU) is defined as spontaneous occurrence of wheals and/or angioedema for ≥6 weeks. Omalizumab is a monoclonal anti-IgE antibody effective in refractory CSU, but its mechanism of action and markers predictive of response remain not completely defined. OBJECTIVES: To correlate baseline levels of two proposed biomarkers, total IgE (bIgE) and d-dimer (bd-dimer), and clinical parameters to omalizumab response and to relapses after drug withdrawal. METHODS: In this retrospective Italian multicentre study, clinical data were collected in 470 CSU patients, and bIgE and bd-dimer were measured in 340 and 342 patients, respectively. Disease activity was determined by Urticaria Activity Score 7 (UAS7) at week 1 and 12 after omalizumab starting. Relapses were evaluated during a 2- and 3-month interval after a first and a second course of treatment, respectively. RESULTS: bIgE correlated to a good response to omalizumab since levels were significantly higher in responders than non-responders (P = 0.0002). Conversely, bd-dimer did not correlate to response. There was no correlation between both bIgE and d-dimer and either first or second relapse. Disease duration was significantly longer in patients who experienced either first or second relapse (P < 0.0001 and P = 0.0105, respectively), while baseline UAS7 correlated only to first relapse (P = 0.0023). CONCLUSIONS: Our study confirms bIgE as a reliable biomarker predicting response to omalizumab in CSU, while it does not support the usefulness of bd-dimer unlike previous findings. CSU duration before omalizumab and baseline UAS7 may be clinical markers of relapse risk.
Authors: Pavel Kolkhir; Ana M Giménez-Arnau; Kanokvalai Kulthanan; Jonny Peter; Martin Metz; Marcus Maurer Journal: Nat Rev Dis Primers Date: 2022-09-15 Impact factor: 65.038
Authors: Eustachio Nettis; Luisa Brussino; Vincenzo Patella; Laura Bonzano; Aikaterini Detoraki; Elisabetta Di Leo; Maria Maddalena Sirufo; Cristiano Caruso; Fabio Lodi Rizzini; Mariaelisabetta Conte; Mona-Rita Yacoub; Massimo Triggiani; Erminia Ridolo; Luigi Macchia; Giovanni Rolla; Raffaele Brancaccio; Amato De Paulis; Giuseppe Spadaro; Danilo Di Bona; Angela Maria D'Uggento; Lia Ginaldi; Francesco Gaeta; Eleonora Nucera; Kliljeda Jaubashi; Danilo Villalta; Lorenzo Dagna; Domenico Ciotta; Francesco Pucciarini; Diego Bagnasco; Giorgio Celi; Fulvia Chieco Bianchi; Lorenzo Cosmi; Maria Teresa Costantino; Maria Angiola Crivellaro; Simona D'Alò; Pietro Del Biondo; Stefano Del Giacco; Mario Di Gioacchino; Linda Di Pietro; Elisabetta Favero; Sebastiano Gangemi; Gabriella Guarnieri; Enrico Heffler; Maria Stefania Leto Barone; Carla Lombardo; Francesca Losa; Andrea Matucci; Paola Lucia Minciullo; Paola Parronchi; Giovanni Passalacqua; Stefano Pucci; Oliviero Rossi; Lorenzo Salvati; Michele Schiappoli; Gianenrico Senna; Andrea Vianello; Alessandra Vultaggio; Yang Baoran; Cristoforo Incorvaia; Giorgio Walter Canonica Journal: Clin Mol Allergy Date: 2022-05-19
Authors: Marcus Maurer; Kilian Eyerich; Stefanie Eyerich; Marta Ferrer; Jan Gutermuth; Karin Hartmann; Thilo Jakob; Alexander Kapp; Pavel Kolkhir; Désirée Larenas-Linnemann; Hae-Sim Park; Gunnar Pejler; Mario Sánchez-Borges; Knut Schäkel; Dagmar Simon; Hans-Uwe Simon; Karsten Weller; Torsten Zuberbier; Martin Metz Journal: Int Arch Allergy Immunol Date: 2020-03-30 Impact factor: 2.749