Updates on the Treatment and Management of Urticaria in 2025

Authors

  • Karla Robles-Velasco, MD LEADER Research Inc., Hamilton, Ontario, Canada
  • Veronica Ferris Pasquini, MD LEADER Research Inc., Hamilton, Ontario, Canada
  • Patryck Pontes, MD LEADER Research Inc., Hamilton, Ontario, Canada
  • Hermenio Lima, MD LEADER Research Inc., Hamilton, Ontario, Canada, Associate Clinical Professor, Division of Dermatology, Department of Medicine, McMaster University, Faculty of Health Sciences, Hamilton, Ontario, Canada.

DOI:

https://doi.org/10.58931/cait.2025.5282

Abstract

Chronic spontaneous urticaria (CSU) is increasingly recognized as a complex immune-mediated disorder, driven by interactions among T cells, mast cells, and inflammatory mediators. This paper summarizes the latest advances in urticaria treatment and management, incorporating new targeted therapies and evidence-based clinical guidelines.

Author Biographies

Karla Robles-Velasco, MD, LEADER Research Inc., Hamilton, Ontario, Canada

Dr. Karla Robles-Velasco is an International Medical Graduate with a residency in Clinical Allergy and Immunology. She completed her medical studies at Universidad Espíritu Santo in Samborondón, Ecuador. Since 2022, Dr. Robles‑Velasco has been an active member of the UCARE Network, contributing extensively to the field of chronic urticaria research. She has authored over 40 scientific publications in leading journals. Dr. Robles-Velasco came to Canada in 2024 and has since been part of LEADER Research, where she participates in international projects focusing on observational studies, artificial intelligence, large language models, and sleep disturbances.

Veronica Ferris Pasquini, MD, LEADER Research Inc., Hamilton, Ontario, Canada

Dr. Veronica Ferris Pasquini is a Family Medicine Resident at McMaster University, Niagara campus. She earned her MD from the Universidad del Valle de México in Querétaro, Mexico, and holds a Bachelor of Arts in Spanish from the University of Toronto. Before starting residency, Dr. Ferris Pasquini worked clinically and supported research in dermatology and clinical immunology at Dr. Lima’s Clinic and LEADER Research in Hamilton, Ontario. Her experience across Mexican, American, and Canadian healthcare systems has shaped her commitment to patient-centered and culturally sensitive care.

Patryck Pontes, MD, LEADER Research Inc., Hamilton, Ontario, Canada

Dr. Patryck Pontes is a physician trained at the Universidade Católica de Pernambuco, Brazil, with experience in emergency, critical care, and public health. During the COVID-19 pandemic, he worked in public hospitals and intensive care units, providing compassionate, patient-centered care in challenging clinical settings. Since relocating to Canada in 2023, Dr. Pontes has collaborated with multiple specialists and currently works in a dermatology clinic focused on individualized and holistic patient care. He also serves as a blind evaluator at LEADER Research in Hamilton, Ontario, contributing to international projects and clinical trials involving new dermatologic therapies. His academic interests include clinical dermatology, patient-centered communication, and the integration of research and technology to enhance medical care.

Hermenio Lima, MD, LEADER Research Inc., Hamilton, Ontario, Canada, Associate Clinical Professor, Division of Dermatology, Department of Medicine, McMaster University, Faculty of Health Sciences, Hamilton, Ontario, Canada.

Dr. Hermenio Lima is a Clinical Immunologist and a Dermatologist. He earned his MD from the Federal University of Ceará, Brazil, and completed his PhD in Immunology at Harvard University. He was a professor at multiple academic institutions in Brazil until he returned to Harvard for a fellowship in Clinical Trials. He came to Canada in 2010 and is now an Associate Clinical Professor of Dermatology and Clinical Immunology at McMaster University in Hamilton, Ontario. Dr. Lima founded LEADER Research, a clinical research center specializing in inflammatory skin diseases, and directs Dr. Lima’s Clinic, providing advanced dermatological care and clinical trials, in 2021. He has authored over 100 scientific publications and has been Principal Investigator of over 60 clinical trials focused on atopic dermatitis, psoriasis, urticaria, hidradenitis suppurativa, alopecia areata, and vitiligo.

References

Peck G, Hashim MJ, Shaughnessy C, Muddasani S, Elsayed NA, Fleischer AB. Global epidemiology of urticaria: increasing burden among children, females and low-income regions. Acta Derm Venereol. 2021;101(4):adv00433. doi:10.2340/00015555-3796

Kolkhir P, Giménez-Arnau AM, Kulthanan K, Peter J, Metz M, Maurer M. Urticaria. Nat Rev Dis Primer. 2022;8(1):1–22. doi:10.1038/s41572-022-00389-z

Kolkhir P, Bieber K, Hawro T, Kridin K, Ludwig MA, Olbrich H, et al. Mortality in adult patients with chronic spontaneous urticaria: a real-world cohort study. J Allergy Clin Immunol. 2025;155(4):1290-1298. doi:10.1016/j.jaci.2024.11.036

Muñoz M, Kocatürk E, Maurer M, Kolkhir P. Emerging therapeutics in chronic urticaria. Immunol Allergy Clin North Am. 2024;44(3):517–528. doi:10.1016/j.iac.2024.03.008

Metz M, Giménez-Arnau A, Hide M, Lebwohl M, Mosnaim G, Saini S, et al. Remibrutinib in chronic spontaneous urticaria. N Engl J Med. 2025;392(10):984–994. doi:10.1056/NEJMoa2408792

Maurer M, Casale TB, Saini SS, Ben-Shoshan M, Giménez-Arnau AM, Bernstein JA, et al. Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): two randomized, double-blind, placebo-controlled, phase 3 trials. J Allergy Clin Immunol. 2024;154(1):184–194. doi:10.1016/j.jaci.2024.01.028

Kolkhir P, Elieh-Ali-Komi D, Metz M, Siebenhaar F, Maurer M. Understanding human mast cells: lesson from therapies for allergic and non-allergic diseases. Nat Rev Immunol. 2022;22(5):294–308. doi:10.1038/s41577-021-00622-y

Giménez-Arnau AM, DeMontojoye L, Asero R, Cugno M, Kulthanan K, Yanase Y, et al. The pathogenesis of chronic spontaneous urticaria: the role of infiltrating cells. [published correction appears in J Allergy Clin Immunol Pract. 2021 Sep;9(9):3533. doi: 10.1016/j.jaip.2021.07.001.] [published correction appears in J Allergy Clin Immunol Pract. 2021 Dec;9(12):4509-4511. doi: 10.1016/j.jaip.2021.10.010.]. J Allergy Clin Immunol Pract. 2021;9(6):2195-2208. doi:10.1016/j.jaip.2021.03.033

Mubariki R, Samara R, Gimenez-Arnua AM, Maurer M, Bejar J, Toubi E, et al. CD4+CCR5+ T cells and CCL3+ mast cells are increased in the skin of patients with chronic spontaneous urticaria. Front Immunol. 2024;15:1327040. doi:10.3389/fimmu.2024.1327040

Tedeschi A, Kolkhir P, Asero R, Pogorelov D, Olisova O, Kochergin N, et al. Chronic urticaria and coagulation: pathophysiological and clinical aspects. Allergy. 2014;69(6):683–691. doi:10.1111/all.12389

Kolkhir P, Muñoz M, Asero R, Ferrer M, Kocatürk E, Metz M, et al. Autoimmune chronic spontaneous urticaria. J Allergy Clin Immunol. 2022 Jun;149(6):1819–1831. doi:10.1016/j.jaci.2022.04.010

Shtessel M, Limjunyawong N, Oliver ET, Chichester K, Gao L, Dong X, et al. MRGPRX2 activation causes increased skin reactivity in patients with chronic spontaneous urticaria. J Invest Dermatol. 2021;141(3):678-681.e2. doi:10.1016/j.jid.2020.06.030

Guillén‐Aguinaga S, Jáuregui Presa I, Aguinaga‐Ontoso E, Guillén‐Grima F, Ferrer M. Updosing nonsedating antihistamines in patients with chronic spontaneous urticaria: a systematic review and meta‐analysis. Br J Dermatol. 2016;175(6):1153–1165. doi:10.1111/bjd.14768

Ayse Ornek S, Orcen C, Church MK, Kocaturk E. An evaluation of remission rates with first and second line treatments and indicators of antihistamine refractoriness in chronic urticaria. Int Immunopharmacol. 2022;112:109198. doi:10.1016/j.intimp.2022.109198

Xiang YK, Fok JS, Podder I, Yücel MB, Özkoca D, Thomsen SF, et al. An update on the use of antihistamines in managing chronic urticaria. Expert Opin Pharmacother. 2024 Mar;25(5):551–569. doi:10.1080/14656566.2024.2345731

Saini SS, Bindslev-Jensen C, Maurer M, Grob JJ, Bülbül Baskan E, Bradley MS, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on h1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015;135(1):67–75. doi:10.1038/jid.2014.306

Casale TB, Gimenez-Arnau AM, Bernstein JA, Holden M, Zuberbier T, Maurer M. Omalizumab for patients with chronic spontaneous urticaria: a narrative review of current status. Dermatol Ther. 2023;13(11):2573–2588. doi:10.1007/s13555-023-01040-9

Press Release: Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria [Internet]. Sanofi; 2025 Apr 18 [cited 2025 May 6]. Available from: https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-18-15-15-00-3064131

Maurer M, Ensina LF, Gimenez-Arnau AM, Sussman G, Hide M, Saini S, et al. Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials. Lancet. 2024;403(10422):147–159. doi:10.1016/S0140-6736(23)01684-7

Wu L, Hu F, Guo R, Ding L, Liu H, Zhu R, et al. An interim analysis of Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for CSU. J Allergy Clin Immunol. 2025;155(2):AB224.

Jemincare. A multicenter, randomized, double-blind, parallel-group, active-controlled phase ii clinical study to evaluate the efficacy, safety and tolerability of JYB1904 injection in adult patients with chronic spontaneous urticaria inadequately controlled by H1 antihistamines [Internet]. clinicaltrials.gov; 2024 Nov 29 [cited 2025 Mar 6]. Report No.: NCT06509334. Available from: https://clinicaltrials.gov/study/NCT06509334

Sluzevich J, Mayo Clinic. Mepolizumab for the treatment of chronic spontaneous urticaria: an open-label, single-arm, exploratory study [Internet]. clinicaltrials.gov; 2025 Feb 27 [cited 2025 Mar 6]. Report No.: NCT03494881. Available from: https://clinicaltrials.gov/study/NCT03494881

McLaren J, Chon Y, Gorski KS, Bernstein JA, Corren J, Hayama K, et al. Tezepelumab for the treatment of chronic spontaneous urticaria: results of the phase 2b INCEPTION study. J Allergy Clin Immunol. 2025;155(6):1945-1956. doi:10.1016/j.jaci.2025.01.045

Genentech Inc. A Study to assess the efficacy, safety, and tolerability of kpl-716 in reducing pruritus in chronic pruritic diseases. [Internet]. clinicaltrials.gov; 2019 May 29 [cited 2025 Mar 6]. Report No.: NCT03858634. Available from: https://clinicaltrials.gov/study/NCT03858634

Ye YM, Cho YS, Lee SY, Park JW, Choi JH, Kim SH, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of YH35324, a novel long-acting high-affinity IgETrap-Fc fusion protein, in patients with chronic spontaneous urticaria refractory to H1 antihistamines. J Allergy Clin Immunol. 2025;155(2):AB212.

Metz M, Kolkhir P, Altrichter S, Siebenhaar F, Levi-Schaffer F, Youngblood BA, et al. Mast cell silencing: a novel therapeutic approach for urticaria and other mast cell-mediated diseases. Allergy. 2024;79(1):37–51. doi:10.1111/all.15850

Evommune, Inc. An open label study evaluating the safety, tolerability, and efficacy of EVO756 in adults with chronic inducible urticaria [Internet]. clinicaltrials.gov; 2024 Aug 14 [cited 2025 Mar 5]. Report No.: NCT06603220. Available from: https://clinicaltrials.gov/study/NCT06603220

Escient Pharmaceuticals, Inc. Phase 1b, open-label study to evaluate the safety, tolerability, and pharmacodynamics of EP262 in subjects with chronic inducible urticaria (CALM-CIndU) [Internet]. clinicaltrials.gov; 2024 Dec 9 [cited 2025 Mar 6]. Report No.: NCT06050928. Available from: https://clinicaltrials.gov/study/NCT06050928

Escient Pharmaceuticals, Inc. Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the effects of EP262 in subjects with chronic spontaneous urticaria (CALM-CSU) [Internet]. clinicaltrials.gov; 2025 Jan 16 [cited 2025 Mar 6]. Report No.: NCT06077773. Available from: https://clinicaltrials.gov/study/NCT06077773

Maurer M, Kobielusz-Gembala I, Mitha E, Leflein J, Gotua M, Kwiek B, et al. Barzolvolimab significantly decreases chronic spontaneous urticaria disease activity and is well tolerated: top line results from a phase 2 trial. J Allergy Clin Immunol. 2024;153(2):AB366.

Casale T, Tucker E, Yuan J, Adelman D, Ku D, Marcantonio A, et al. Initial results from BEACON, a phase 1b/2a dose escalation study of the anti-c-Kit briquilimab antibody in adults with chronic spontaneous urticaria (CSU). J Allergy Clin Immunol. 2025;155(2):AB435.

touchDERMATOLOGY BEACON study: Initial findings indicate briquilimab provides rapid and effective relief in chronic spontaneous urticaria. [Internet]. touchDERMATOLOGY; 2025 Mar 3 [cited 2025 Mar 10]. Available from: https://touchderma.com/insight/beacon-study-initial-findings-indicate-briquilimab-provides-rapid-and-effective-relief-in-chronic-spontaneous-urticaria/

Hide M, Fukunaga A, Yagami A. Bruton’s tyrosine kinase inhibitor TAS5315 showed long-lasting hive-free condition in patients with chronic spontaneous urticaria. Ann Allergy Asthma Immunol. 2024;133(6):S7.

Taiho Pharmaceutical Co., Ltd. A phase 2a, randomized, double-blind, study of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines [Internet]. clinicaltrials.gov; 2024 Aug 7 [cited 2025 Mar 6]. Report No.: NCT05335499. Available from: https://clinicaltrials.gov/study/NCT05335499

Chen M, Du S, Cheng Y, Zhu X, Wang Y, Shu S, et al. Safety, pharmacokinetics and pharmacodynamics of HWH486 capsules in healthy adults: a randomized, double-blind, placebo-controlled, phase I dose-escalation study. Int Immunopharmacol. 2024;126:111285. doi:10.1016/j.intimp.2023.111285

Sanofi. Rilzabrutinib for the treatment of chronic spontaneous urticaria in patients who remain symptomatic despite the use of H1 antihistamine (RILECSU) [Internet]. clinicaltrials.gov; 2024 Jul 19 [cited 2025 Mar 6]. Report No.: NCT05107115. Available from: https://clinicaltrials.gov/study/NCT05107115

Maurer M, Gimenez-Arnau A, Ferrucci S, Mikol V, Sun I, Mannent L, et al. Efficacy and safety of rilzabrutinib in patients with chronic spontaneous urticaria: 12-week results from the RILECSU phase 2 dose-ranging study. J Allergy Clin Immunol. 2024;153(2):AB373.

Talia J, Sarbjit S, Lee CH, Sun I, Mikol V, Mannet L, et al. Rilzabrutinib improves chronic spontaneous urticaria in patients with and without allergic comorbidities: a subgroup analysis from the RILECSU study. J Allergy Clin Immunol. 2025;155(2):AB227.

Dickson MC, Walker A, Grattan C, Perry H, Williams N, Ratia N, et al. Effects of a topical treatment with spleen tyrosine kinase inhibitor in healthy subjects and patients with cold urticaria or chronic spontaneous urticaria: results of a phase 1a/b randomised double-blind placebo-controlled study. Br J Clin Pharmacol. 2021;87(12):4797–4808. doi:10.1111/bcp.14923

Incyte Corporation. Study evaluating the efficacy and safety of povorcitinib in adults with chronic spontaneous urticaria [Internet]. clinicaltrials.gov; 2025 Apr 3 [cited 2025 Mar 6]. Report No.: NCT05936567. Available from: https://clinicaltrials.gov/study/NCT05936567

Lu Q, Yang B, Liu L, Li L, Liu W, Yao X, et al. Efficacy and safety of TLL-018 in moderate to severe chronic spontaneous urticaria patients with inadequate response to H1 antihistamine: results from a phase Ⅰb study. J Allergy Clin Immunol. 2024;153(2):AB372.

Hangzhou Highlightll Pharmaceutical Co., Ltd. A Study of efficacy and safety of TLL-018 in CSU Participants [Internet]. clinicaltrials.gov; 2024 Dec 17 [cited 2025 Mar 6]. Report No.: NCT06396026. Available from: https://clinicaltrials.gov/study/NCT06396026

InflaRx GmbH. Evaluate safety and pharmacokinetics of inf904 in subjects with moderate to severe chronic spontaneous urticaria or hidradenitis suppurativa [Internet]. clinicaltrials.gov; 2025 May 1 [cited 2025 Mar 6]. Report No.: NCT06555328. Available from: https://clinicaltrials.gov/study/NCT06555328

Carvallo A, Sánchez-Fernández S, Morales-Palacios MP. Fenebrutinib and BTK inhibition: unveiling a new target for the treatment of chronic spontaneous urticaria. Allergy. 2023;78(2):603–605. doi:10.1111/all.15592

Maurer M, Altrichter S, Metz M, Zuberbier T, Church M k., Bergmann KC. Benefit from reslizumab treatment in a patient with chronic spontaneous urticaria and cold urticaria. J Eur Acad Dermatol Venereol. 2018;32(3):e112–e113. doi:10.1111/jdv.14594

Downloads

Published

2025-11-04

How to Cite

1.
Robles-Velasco K, Pasquini VF, Pontes P, Lima H. Updates on the Treatment and Management of Urticaria in 2025. Can Allergy Immunol Today [Internet]. 2025 Nov. 4 [cited 2025 Nov. 7];5(2):5–16. Available from: https://canadianallergyandimmunologytoday.com/article/view/5-2-Robles-Velasco_et_al

Issue

Section

Articles