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

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.

• Authors: 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
• Journal: Journal of the European Academy of Dermatology and Venereology : JEADV (J Eur Acad Dermatol Venereol) Vol. 33 Issue 5 Pg. 918-924 (May 2019) ISSN: 1468-3083 [Electronic] England
• PMID: 30451325 (Publication Type: Journal Article, Multicenter Study)
• Copyright: © 2018 European Academy of Dermatology and Venereology.

Chemical References

• Anti-Allergic Agents
• Biomarkers
• Fibrin Fibrinogen Degradation Products
• fibrin fragment D
• Omalizumab
• Immunoglobulin E

Topics

• Adult
• Anti-Allergic Agents (therapeutic use)
• Biomarkers (blood)
• Chronic Disease
• Female
• Fibrin Fibrinogen Degradation Products (metabolism)
• Humans
• Immunoglobulin E (blood)
• Italy
• Male
• Middle Aged
• Omalizumab (therapeutic use)
• Recurrence
• Retrospective Studies
• Treatment Outcome
• Urticaria (blood, drug therapy, physiopathology)