Treatment of Chronic Spontaneous Urticaria: a Focused Update in Omalizumab
- 23 Downloads
Purpose of review
Chronic spontaneous urticaria (CSU) is a common disease in the general population that causes significant effects on quality of life and a financial burden on the health care system. Guidelines are essential to assure patients are being managed appropriately, although given the rigor to develop these reviews they are not as up to date as cutting-edge scientific evidence. This review details the most recent phase II, III, and IV clinical trials that have been published since the development of the US practice parameters.
Phase II, III, and IV clinical trials, ASTERIA I, POLARIS, X-ACT, MoA, and CTEND-CIU, demonstrate safety, long-term efficacy, and improvement in patient’s quality of life by decreasing disease-burdened days and severity of disease in comparison with placebo, as well as transcriptional level changes in gene expression with omalizumab use. Data is emerging regarding efficacy in inducible urticarias, predictors of response, and optimal methods for discontinuation of omalizumab.
Optimal treatment of CSU should be based on recent practice parameters and guidelines. Recent evidence supports the use of omalizumab in antihistamine refractory urticaria patients, but the mechanism for its effect, identification of biomarkers to predict response to therapy, optimal duration, and adjustments in dosing all require additional investigation.
KeywordsOmalizumab Urticaria Treatment Adverse effect Angioedema
Compliance with Ethical Standards
Conflict of Interest
Whitney A. Blackwell declares that she has no conflict of interest.
David A. Khan declares that he has no conflict of interest.
Human and Nnimal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
References and Recommended Reading
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
- 6.Lee SJ, Ha EK, Jee HM, Lee KS, Lee SW, Kim MA, et al. Prevalence and risk factors of urticaria with a focus on chronic urticaria in children. Allergy, Asthma Immunol Res. 2017;9(3):212–9.Google Scholar
- 8.•• Zuberbier T, Aberer W, Asero R, Abdul Latiff AH, Baker D, Ballmer-Weber B, et al. The EAACI/GA(2)LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2018;73(7):1393–414 The most recent international guidelines for definition, classification, diagnosis, and treatment of urticaria.PubMedGoogle Scholar
- 9.• Wood RA, Khan DA, Lang DM, Fasano MB, Peden DB, Busse PJ, et al. American Academy of allergy, asthma and immunology response to the EAACI/GA(2) LEN/EDF/WAO guideline for the definition, classification, diagnosis, and management of Urticaria 2017 revision. Allergy. 2019;74(2):411–3 This is reviews the AAAAI’s response to the changes made to the international guidelines.PubMedGoogle Scholar
- 10.Lutfeali S, Khan DA. Review and perspectives of the recent international guidelines on treatment of chronic urticaria. Curr Treat Options Allergy. 2018;5(4):392–404.Google Scholar
- 12.Weller K, Groffik A, Church MK, Hawro T, Krause K, Metz M, et al. Development and validation of the Urticaria Control Test: a patient-reported outcome instrument for assessing urticaria control. J Allergy Clin Immunol. 2014;133(5):1365–72 72 e1-6.Google Scholar
- 18.Staevska M, Gugutkova M, Lazarova C, Kralimarkova T, Dimitrov V, Zuberbier T, et al. Night-time sedating H1 -antihistamine increases daytime somnolence but not treatment efficacy in chronic spontaneous urticaria: a randomized controlled trial. Br J Dermatol. 2014;171(1):148–54.PubMedPubMedCentralGoogle Scholar
- 23.Morgan M, Khan DA. Therapeutic alternatives for chronic urticaria: an evidence-based review, part 2. Ann Allergy Asthma Immunol. 2008;100(6):517–26 quiz 26-8, 44.Google Scholar
- 24.Morgan M, Khan DA. Therapeutic alternatives for chronic urticaria: an evidence-based review, part 1. Ann Allergy Asthma Immunol. 2008;100(5):403–11 quiz 12-4, 68.Google Scholar
- 32.Xolair. Prescribing information. 2015 [Available from: http://www.gene.com/download/pdf/xolair_prescribing.pdf. Accessed 1 May 2019.
- 35.Saini S, Rosen KE, Hsieh HJ, Wong DA, Conner E, Kaplan A, et al. A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. J Allergy Clin Immunol. 2011;128(3):567–73 e1.Google Scholar
- 36.Gober L, Sterba P, Eckman J. Effect of anti-IgE (Omalizumab) in chronic idiopathic urticaria (CIU) patients. J Allergy Clin Immunol. 2008;121(2):S147.Google Scholar
- 39.Saini SS, Bindslev-Jensen C, Maurer M, Grob JJ, Bulbul 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.PubMedGoogle Scholar
- 41.Casale TB, Murphy TR, Holden M, Rajput Y, Yoo B, Bernstein JA. Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: results from a randomized study (XTEND-CIU). J Allergy Clin Immunol Pract. 2019.Google Scholar
- 43.• Metz M, Torene R, Kaiser S, Beste MT, Staubach P, Bauer A, et al. Omalizumab normalizes the gene expression signature of lesional skin in patients with chronic spontaneous urticaria: a randomized, double-blind, placebo-controlled study. Allergy. 2019;74(1):141–51 The first study to demonstrate changes in skin gene expression with omalizumab.PubMedGoogle Scholar
- 60.Yang C, Cho Y, Chu C. Efficacy of omalizumab treatment for patients with chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) in Taiwan. Dermatol Sin. 2017;35:182–6.Google Scholar
- 62.Ghazanfar MN, Thomsen S. Transient hair loss in patient with chronic spontaneous urticaria treated with omalizumab. Eur Ann Allergy Clin Immunol. 2017;49(6):284–5.Google Scholar