Objective: This study aims to assess how baseline Systemic Immune-Inflammation Index (SIRI) and Aggregate Index of Systemic Inflammation (AISI) values relate to six-month clinical outcomes of Omalizumab treatment in patients with chronic spontaneous urticaria (CSU). Additionally, whether these systemic inflammatory markers could serve as predictors for relapse risk following discontinuation of therapy has been evaluated. Materials and Methods: In this single-center study, a total of 312 CSU patients who were on Omalizumab treatment have been retrospectively analyzed. The overall response to the therapy is evaluated at the end of a 6-month follow-up period, while 217 patients who gave up Omalizumab treatment after the successful control period have also been evaluated afterwards for any relapse situations over a 12-month period. A favorable response is detected as achieving a Urticaria Control Test (UCT) score ≥12. The predictive accuracy of inflammatory indices and potential relapse-related variables have also been examined in the study. Result: It is seen that the baseline SIRI (Median 1.47 vs. 1.06; p<0.001) and AISI (Median 452.98 vs. 306.06; p<0.001) values of the non-responder group (n=38) are statistically significantly higher than those of the responder group (n=274). Both AISI (AUC=0.744) and SIRI (AUC=0.727) have demonstrated a strong performance in predicting non-response. In the relapse analysis subgroup (n=217), patients who relapsed (n=122) have had significantly higher baseline SIRI (p=0.012) and AISI (p=0.024) values compared to those who remained in remission (n=95). Conclusion: It is concluded that baseline SIRI and AISI values are valuable, practical, and cost-effective biomarkers for predicting an inadequate response to Omalizumab treatment and the risk of post-treatment relapse in patients with CSU. They have the potential to serve as helpful tools for clinicians to guide the treatment decisions and optimize the management of patients.
Keywords: Biomarkers, Omalizumab, Recurrence, Treatment Outcome, Urticaria
Cite this Article As :
Gerek ME, Colkesen F, Sagun F, Kolak S, Onalan T, Akkus FA, Sadi Aykan F, Kahraman S, Arslan S. Elevated Baseline Systemic Inflammation Indices Predict
Poor Response and Higher Relapse Risk in Chronic Spontaneous Urticaria Patients on Omalizumab. Selcuk Med J 2026;42(2): 135-143
1. Maurer M, Abuzakouk M, Bérard F, et al. The burden of chronic spontaneous urticaria is substantial: Real-world evidence from ASSURE-CSU. Allergy. 2017;72(12):2005-16. doi:10.1111/all.13209
2. Curto-Barredo L, Silvestre JF, Giménez-Arnau AM. Update on the treatment of chronic urticaria. Actas Dermosifiliogr. 2014;105(5):469-82. doi:10.1016/j.ad.2012.12.019
3. Folci M, Heffler E, Canonica GW, et al. Cutting edge: biomarkers for chronic spontaneous urticaria. J Immunol Res. 2018;2018:5615109. doi:10.1155/2018/5615109
4. Beck LA, Bernstein JA, Maurer M. A review of international recommendations for the diagnosis and management of chronic urticaria. Acta Derm Venereol. 2017;97(2):149-58. doi:10.2340/00015555-2496
5. Liu X, Li J, Sun L, et al. The association between neutrophil-to-lymphocyte ratio and disease activity in rheumatoid arthritis. Inflammopharmacology. 2023;31(5):2237-44. doi:10.1007/s10787-023-01273-2
6. Mercan R, Bitik B, Tufan A, et al. The association between neutrophil/lymphocyte ratio and disease activity in rheumatoid arthritis and ankylosing spondylitis. J Clin Lab Anal. 2016;30(5):597-601. doi:10.1002/jcla.21908
7. Kucharczyk A, Marczyk K, Kucharczyk B, et al. Predicting relapse in chronic spontaneous urticaria: A retrospective cohort study evaluating omalizumab withdrawal regimens. Allergy. 2024;79(9):2554-7. doi:10.1111/all.16194
8. Foti C, Romita P, Ambrogio F, et al. Analysis of clinical factors as possible predictors of response to omalizumab and relapse after treatment discontinuation in chronic spontaneous urticaria. Dermatol Ther. 2022;35(2):e15248. doi:10.1111/dth.15248
9. Soegiharto R, Alizadeh Aghdam M, Sørensen JA, et al. Multinational drug survival study of omalizumab in patients with chronic urticaria and potential predictors for discontinuation. JAMA Dermatol. 2024;160(9):927-35. doi:10.1001/jamadermatol.2024.2056
10. Marzano AV, Genovese G, Casazza G, et al. Predictors of response to omalizumab and relapse in chronic spontaneous urticaria: a study of 470 patients. J Eur Acad Dermatol Venereol. 2019;33(5):918-24. doi:10.1111/jdv.15350
11. Zhang DG, Sørensen JA, Ghazanfar MN, et al. EXtending omalizumab treatment Intervals in patients with chronic spontaneous urticaria (EXOTIC): protocol of a multicentre, randomised, open-label, non-inferiority trial. BMJ Open. 2025;15(1):e084987. doi:10.1136/bmjopen-2024-084987
12. Kuna M, Štefanović M, Davidović L, et al. Chronic urticaria biomarkers IL-6, ESR and CRP in correlation with disease severity and patient quality of life—a pilot study. Biomedicines. 2023;11(8):2232. doi:10.3390/biomedicines11082232
13. Kasperska-Zajac A, Grzanka A, Damasiewicz-Bodzek A. IL-6 transsignaling in patients with chronic spontaneous urticaria. PLoS One. 2015;10(12):e0145751. doi:10.1371/journal.pone.0145751
14. Grzanka R, Damasiewicz-Bodzek A, Kasperska-Zajac A. Interplay between acute phase response and coagulation/fibrinolysis in chronic spontaneous urticaria. Allergy Asthma Clin Immunol. 2018;14:27. doi:10.1186/s13223-018-0255-8
15. Karabay EA, Çerman A, Altunay I. Serum c-reactive protein, neutrophil-lymphocyte ratio and uric acid levels in chronic spontaneous urticaria. Turkiye Klinikleri J Dermatol. 2016;26(3):125-31. doi:10.5336/DERMATO.2016-52709
16. Qiu X, Ran Q, Pan J, et al. Neutrophil/lymphocyte ratio as a biomarker of response to H1-antihistamine therapy in patients with chronic spontaneous urticaria. Indian J Dermatol. 2024;69(5):367-70. doi:10.4103/ijd.ijd_558_22
17. Coşansu NC. Evaluation of new inflammatory parameters in patients with chronic spontaneous urticaria: a new predictor of refractoriness to antihistamine treatment. Namik Kemal Med J. 2020;8(3):404-11. doi:10.37696/nkmj.731617
18. Bakay OSK, Kacar N, Gul B, et al. What can be learned from real-world data about chronic spontaneous urticaria? Allergy Asthma Proc. 2024;45(4):255-61. doi:10.2500/aap.2024.45.240041
19. Atik Ö, Tepetam FM, Özden Ş, et al. Eosinophilic cationic protein and D-Dimer are potential biomarkers to predict response to antihistamines but not to omalizumab in chronic spontaneous urticaria. Libyan J Med. 2024;19(1):2420483. doi:10.1080/19932820.2024.2420483
20. Miyatani Y, Kobayashi T. Evidence-based approach to the discontinuation of immunomodulators or biologics in inflammatory bowel disease. Digestion. 2022;104(1):66-73. doi:10.1159/000527776
21. Imbert A, Gavlovsky P-J, Judor J-P, et al. T cell immuno-phenotyping : a source of predictive biomarkers for autoimmune hepatitis relapse. Sci Rep. 2024;14(1):24448. doi:10.1038/s41598-024-75624-6
22. Asero R, Ferrer M, Kocaturk E, et al. Chronic spontaneous urticaria: The role and relevance of autoreactivity, autoimmunity, and autoallergy. J Allergy Clin Immunol Pract. 2023;11(8):2302-8. doi:10.1016/j.jaip.2023.02.022
23. Asero R, Tedeschi A. Chronic spontaneous urticaria: from the hunt for causes and pathogenesis to the identification of different endotypes. Eur Ann Allergy Clin Immunol. 2023;55(6):253-60. doi:10.23822/EurAnnACI.1764-1489.307
24. Sella JA, Ferriani MPL, Melo JML, et al. Type I and type IIb autoimmune chronic spontaneous urticaria: Using common clinical tools for endotyping patients with CSU. J Allergy Clin Immunol Glob. 2023;2(4):100159. doi:10.1016/j.jacig.2023.100159
25. Wong D, Waserman S, Sussman GL. Endotypes of chronic spontaneous urticaria and angioedema. J Allergy Clin Immunol. 2025;156(1):17-23. doi:10.1016/j.jaci.2025.04.004
Research Paper
View as PDF
Keywords
Biomarkers, Omalizumab, Recurrence, Treatment Outcome, Urticaria