Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jul 1;53(4):7-13.
doi: 10.15586/aei.v53i4.1343. eCollection 2025.

Biomarkers of response to omalizumab in patients with chronic spontaneous urticaria

Özge Öztürk Aktaş  1   2 , Dilek Öksüzer Çimşir  3 , Esra Nur Bülbül  3 , Neyran Şerbetçi  3 , Türkan Zeynep Fendoğlu  3 , Esra İnan  3 , Begüm Görgülü Akın  3 , Şengül Beyaz  3 , Zeynep Çelebi Sözener  4 , Şadan Soyyiğit  1   3
Affiliations

Biomarkers of response to omalizumab in patients with chronic spontaneous urticaria

Özge Öztürk Aktaş et al. Allergol Immunopathol (Madr). .

Abstract

Background and objectives: Managing chronic spontaneous urticaria (CSU) resistant to anti-histamines remains challenging, and predictors of omalizumab efficacy are not fully understood. This study evaluated omalizumab's effectiveness, response patterns, and predictors in CSU patients.

Materials and methods: A retrospective analysis was conducted on 72 patients receiving omalizumab for at least six months. Factors influencing response to anti-IgE therapy were examined.

Results: Among the 72 patients with chronic spontaneous urticaria (CSU), 86.1% responded to omalizumab: 58.3% had a good response (UAS-7 <6), 27.8% showed a partial response, and 13.9% were non-responders. Baseline total IgE levels were significantly higher in responders compared to non-responders (good: 291.4 kUA/L vs. 60.2 kUA/L, p = 0.003; partial: 148 kUA/L vs. 60.2 kUA/L, p = 0.049). ROC analysis identified a total IgE cut-off of 64 kUA/L for predicting omalizumab response (AUC: 0.67, p = 0.019; sensitivity: 82%, specificity: 48%). Non-responders had significantly higher erythrocyte sedimentation rates (20.0 mm/h vs. 8.25 mm/h, p = 0.018). Patients with recurrence post-treatment had elevated thyroid-stimulating hormone (TSH) and C-reactive protein (CRP) levels (p = 0.006, p = 0.007). Among responders, 29% had an early response and 71% a late response. Early responders had significantly lower anti-thyroglobulin (anti-TG) and antinuclear antibody (ANA) positivity (p = 0.036, p = 0.035). Systemic inflammatory indices (SII, SIRI) did not predict response.

Conclusions: Baseline total IgE may predict omalizumab response, while ANA and anti-TG positivity correlate with delayed response. Elevated TSH and CRP levels may indicate a higher recurrence risk after treatment discontinuation.

Keywords: chronic spontaneous urticaria; immunoglobulin E; omalizumab; urticaria activity score.

PubMed Disclaimer

Conflict of interest statement

The authors declarre no conflict of interest.

References

    1. Zuberbier T, Aberer W, Asero R, Abdul Latiff AH, Baker D, Ballmer-Weber B, et al. The EAACI/GA2LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2018;73(7):1393–414. 10.1111/all.13397 - DOI
    1. Fricke J, Ávila G, Keller T, Weller K, Lau S, Maurer M, et al. Prevalence of chronic urticaria in children and adults across the globe: Systematic review with meta-analysis. Allergy. 2020;75(2):423–32. 10.1111/all.14037 - DOI
    1. Ferrer M, Kinét JP, Kaplan AP. Comparative studies of functional and binding assays for IgG anti-Fc(epsilon)RIalpha (alpha-subunit) in chronic urticaria. J Allergy Clin Immunol. 1998;101(5):672–6. 10.1016/s0091-6749(98)70176-9 - DOI
    1. Hide M, Francis DM, Grattan CE, Hakimi J, Kochan JP, Greaves MW. Autoantibodies against the high-affinity IgE receptor as a cause of histamine release in chronic urticaria. N Engl J Med. 1993;328(22):1599–604. 10.1056/NEJM199306033282204 - DOI
    1. Asero R, Tedeschi A, Riboldi P, Griffini S, Bonanni E, Cugno M. Severe chronic urticaria is associated with elevated plasma levels of D-dimer. Allergy. 2008;63(2):176–80. 10.1111/j.1398-9995.2007.01514.x - DOI

LinkOut - more resources