Expanding treatment options in chronic spontaneous urticaria - the emerging role of dupilumab - author letter and clinical review

Sep 29, 2026

Expansion of dupilumab approval for chronic spontaneous urticaria (CSU) marks a new option for patients aged 12 years and older with inadequate response to standard H1 antihistamines. CSU affects about 0.5–1% of the population and causes recurrent pruritic wheals and impaired quality of life, with persistent symptoms despite optimized therapy. The article outlines mechanisms involving mast-cell degranulation and type 2 inflammation, summarizes evidence from phase 3 results, and discusses safety and guideline update needs.

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Expanding treatment options in chronic spontaneous urticaria

FDA approval and CSU background

Treatment mechanisms and prior antihistamine strategy

Role of omalizumab and emerging evidence for dupilumab

Safety profile and implications for clinical guidelines

References

# Expanding treatment options in chronicspontaneous urticaria: the emerging role ofdupilumab Hanna Fathima Haseena, MBBSa , Sakshi Kumari, MBBSa , Mohammed Hammad Jaber Amin, MBBSb ,* Dear Editor, The U.S. Food and Drug Administration has recentlyexpanded the approval of dupilumab (Dupixent) to include thetreatment of chronic spontaneous urticaria (CSU) in patientsaged 12 years and older who have an inadequate response tostandard H1 antihistamines, marking a significant milestone inthe treatment of refractory CSU. [1] CSU affects 0.5–1% of the population, predominantly amongindividuals aged 20–40, and is characterized by recurrent pruriticwheals and angioedema that significantly impair quality of life. [2,3]In many patients, symptoms persist despite optimized antihista -mine therapy. The underlying mechanism involves mast celldegranulation and histamine release, driven by both autoimmune(IgG-mediated) and autoallergic (IgE-mediated) pathways. [2]Treatment aims at complete symptom control, including pruritus,wheals, and swelling. This article is compliant with the TITANGuidelines 2025 – governing declaration and use of artificialintelligence [4] As inverse agonists, H1 antihistamines bind to theH1 receptor’sinactive state and stabilize it. According to a meta-analysis on H1antihistamine up-dosing for CSU, 63.8% of patients who wereuncontrolled on a standard dose responded to a fourfold increase.However, a large proportion remained unresponsive, highlightingthe need for further clinical interventions. In 2014, omalizumab, an injectable IgG anti-IgE antibody,received approval for the treatment of antihistamine-refractory aDepartment of Medicine, Shimoga Institute of Medical Sciences, Shimoga, Indiaand bDepartment of Medicine, Faculty of Medicine, AlzaiemAlazhari University,Khartoum Sudan Sponsorships or competing interests that maybe relevant to content are disclosedatthe end of this article. *Corresponding author. Address: Department of Medicine, Faculty of Medicine,AlzaiemAlazhari University, Khartoum 11111, Sudan. Tel.: +249119303629.E-mail: mohammesjaber123@gmail.com (M. H. Jaber Amin). Copyright © 2025 The Author(s). Published by Wolters Kluwer Health, Inc. This is anopen access article distributed under the terms of the Creative CommonsAttribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where itispermissible to download and share the work provided itis properly cited. The workcannot be changed in any way or used commercially without permission from thejournal. Annals of Medicine & Surgery (2026) 88:1025 Received 5 November 2025; Accepted 8 November 2025Published online 24 November 2025http://dx.doi.org/10.1097/MS9.0000000000004368 CSU inpatients aged 12 years and older. [5] In contrast, dupilumabinhibits IL-4Rα, blocking IL-4 and IL-13 signaling – key pathwaysin type 2 inflammation. [6] Recent phase 3 trial results demonstrate that dupilumab sig -nificantly reduces itching and hive severity in patients withoutprior omalizumab exposure who remain symptomatic despiteH1 antihistamines, leading to clinically and statistically signifi -cant improvements in urticaria disease activity.[2] Additionally,slight improvements inurticaria activity scores were observed inpatients who were intolerant of or incomplete responders toomalizumab, with marginal statistical significance.[2] Among omalizumab-intolerant or partial responders, dupi -lumab yielded modest improvements in urticaria activityscores, although the statistical significance was limited.These results suggest a potential benefit warranting furtherinvestigation.[2] Importantly, dupilumab was generally well tolerated, witha safety profile consistent with its use in other type 2 inflamma -tory diseases. Given these findings, we urge that clinical guide -lines be updated to incorporatedupilumab as a treatment optionfor patients with CSU unresponsive to H1-antihistamines andomalizumab. Raising clinician awareness and facilitatingbroad

FAQs

Who is dupilumab approved for in chronic spontaneous urticaria in the article?

For patients aged 12 years and older with inadequate response to standard H1 antihistamines, particularly for refractory CSU.

What mechanism is described for CSU symptoms and treatment goals?

CSU is linked to mast-cell degranulation and histamine release driven by autoimmune (IgG-mediated) and autoallergic (IgE-mediated) pathways, aiming for complete symptom control including pruritus, wheals, and swelling.

How does dupilumab perform compared with omalizumab in the summarized evidence?

Phase 3 results show clinically and statistically significant improvements for patients without prior omalizumab exposure, and modest improvements for those intolerant of or partial responders to omalizumab, with limited statistical significance in some subgroups.

What safety and guideline recommendations are emphasized?

Dupilumab is generally well tolerated with a safety profile consistent with other type 2 inflammatory diseases, and the article urges updating clinical guidelines to include dupilumab for H1-antihistamine and omalizumab-unresponsive CSU patients.

Sep 29, 2026

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