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Predictors of response to omalizumab and relapse in chronic spontaneous urticaria: a study of 470 patients
Author(s) -
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.,
Caica G.W.,
Nettis E.,
Asero R.
Publication year - 2019
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.15350
Subject(s) - omalizumab , medicine , angioedema , biomarker , gastroenterology , d dimer , refractory (planetary science) , immunoglobulin e , antibody , immunology , biochemistry , chemistry , physics , astrobiology
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 (b d ‐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 b d ‐dimer were measured in 340 and 342 patients, respectively. Disease activity was determined by Urticaria Activity Score 7 ( UAS 7) 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, b d ‐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 UAS 7 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 b d ‐dimer unlike previous findings. CSU duration before omalizumab and baseline UAS 7 may be clinical markers of relapse risk.