Predictors of response to omalizumab and relapse in chronic spontaneous urticaria: a study of 470 patients

A. V. Marzano, G. Genovese, G. Casazza, M. T. Fierro, P. Dapavo, N. Crimi, S. Ferrucci, P. Pepe, S. Liberati, P. D. Pigatto, A. Offidani, E. Martina, G. Girolomoni, M. Rovaris, C. Foti, L. Stingeni, A. Cristaudo, G. W. Canonica, E. Nettis, R. Asero

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)918-924
JournalJournal of the European Academy of Dermatology and Venereology
Volume33
Issue number5
DOIs
Publication statusPublished - 2019

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Urticaria
Biomarkers
Recurrence
Immunoglobulin E
Angioedema
Omalizumab
Multicenter Studies
Monoclonal Antibodies
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases

Cite this

Predictors of response to omalizumab and relapse in chronic spontaneous urticaria : a study of 470 patients. / Marzano, A. V.; Genovese, G.; Casazza, G.; Fierro, M. T.; Dapavo, P.; Crimi, N.; Ferrucci, S.; Pepe, P.; Liberati, S.; Pigatto, P. D.; Offidani, A.; Martina, E.; Girolomoni, G.; Rovaris, M.; Foti, C.; Stingeni, L.; Cristaudo, A.; Canonica, G. W.; Nettis, E.; Asero, R.

In: Journal of the European Academy of Dermatology and Venereology, Vol. 33, No. 5, 2019, p. 918-924.

Research output: Contribution to journalArticle

Marzano, AV, Genovese, G, Casazza, G, Fierro, MT, Dapavo, P, Crimi, N, Ferrucci, S, Pepe, P, Liberati, S, Pigatto, PD, Offidani, A, Martina, E, Girolomoni, G, Rovaris, M, Foti, C, Stingeni, L, Cristaudo, A, Canonica, GW, Nettis, E & Asero, R 2019, 'Predictors of response to omalizumab and relapse in chronic spontaneous urticaria: a study of 470 patients', Journal of the European Academy of Dermatology and Venereology, vol. 33, no. 5, pp. 918-924. https://doi.org/10.1111/jdv.15350
Marzano, A. V. ; Genovese, G. ; Casazza, G. ; Fierro, M. T. ; Dapavo, P. ; Crimi, N. ; Ferrucci, S. ; Pepe, P. ; Liberati, S. ; Pigatto, P. D. ; Offidani, A. ; Martina, E. ; Girolomoni, G. ; Rovaris, M. ; Foti, C. ; Stingeni, L. ; Cristaudo, A. ; Canonica, G. W. ; Nettis, E. ; Asero, R. / Predictors of response to omalizumab and relapse in chronic spontaneous urticaria : a study of 470 patients. In: Journal of the European Academy of Dermatology and Venereology. 2019 ; Vol. 33, No. 5. pp. 918-924.
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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.",
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T1 - Predictors of response to omalizumab and relapse in chronic spontaneous urticaria

T2 - a study of 470 patients

AU - Marzano, A. V.

AU - Genovese, G.

AU - Casazza, G.

AU - Fierro, M. T.

AU - Dapavo, P.

AU - Crimi, N.

AU - Ferrucci, S.

AU - Pepe, P.

AU - Liberati, S.

AU - Pigatto, P. D.

AU - Offidani, A.

AU - Martina, E.

AU - Girolomoni, G.

AU - Rovaris, M.

AU - Foti, C.

AU - Stingeni, L.

AU - Cristaudo, A.

AU - Canonica, G. W.

AU - Nettis, E.

AU - Asero, R.

PY - 2019

Y1 - 2019

N2 - 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.

AB - 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.

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