1,594
Views
37
CrossRef citations to date
0
Altmetric
Drug Evaluation

Omalizumab for treating chronic spontaneous urticaria: an expert review on efficacy and safety

Pages 375-385 | Received 12 Oct 2016, Accepted 19 Jan 2017, Published online: 09 Feb 2017

References

  • Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA(2)LEN task force report. Allergy. 2011;66(3):317–330.
  • Gaig P, Olona M, Munoz Lejarazu D, et al. Epidemiology of urticaria in Spain. J Investig Allergol Clin Immunol. 2004;14(3):214–220.
  • Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA(2) LEN/EDF/WAO guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy. 2014;69(7):868–887.
  • Curto-Barredo L, Ribs Archilla L, Roura Vives G, et al. Observational retrospective cohort study of 549 patients with chronic spontaneous urticaria. ePoster presented at the 25th European Academy of Dermatology and Venereology Congress https://www.eadv.org/; 2016. Presentation number p2322. Available from: https://user-cc0betr.cld.bz/Final-Programme-Vienna/2
  • Zuberbier T, Asero R, Bindslev-Jensen C, et al. EAACI/GA(2)LEN/EDF/WAO guideline: management of urticaria. Allergy. 2009;64(10):1427–1443.
  • Zuberbier T, Aberer W, Asero R, et al. Methods report on the development of the 2013 revision and update of the EAACI/GA2 LEN/EDF/WAO guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2014;69(7):e1–29.
  • Guillen-Aguinaga S, Jauregui Presa I, Aguinaga-Ontoso E, et al. Up-dosing non-sedating antihistamines in patients with chronic spontaneous urticaria: a systematic review and meta-analysis. Br J Dermatol. 2016;175(6):1153–1165.
  • Richards RN. Side effects of short-term oral corticosteroids. J Cutan Med Surg. 2008;12(2):77–81.
  • Irving PM, Gearry RB, Sparrow MP, et al. Review article: appropriate use of corticosteroids in Crohn’s disease. Aliment Pharmacol Ther. 2007;26(3):313–329.
  • Schulman ES. Development of a monoclonal anti-immunoglobulin E antibody (omalizumab) for the treatment of allergic respiratory disorders. Am J Respir Crit Care Med. 2001;164(8 Pt 2):S6–11.
  • Xolair. Prescribing information. 2015; Available at: http://www.gene.com/download/pdf/xolair_prescribing.pdf. [Last accessed September 2016]
  • EMEA. Xolair SmPC 2016; Available at: http://ec.europa.eu/transparency/regdoc/rep/3/2014/EN/3-2014-1463-EN-F1-1-ANNEX-1.PDF. [Last accessed September 2016]
  • Spector SL, Tan RA. Effect of omalizumab on patients with chronic urticaria. Ann Allergy, Asthma Immunol. 2007;99(2):190–193.
  • Godse KV. Omalizumab in severe chronic urticaria. Indian J Dermatol Venereol Leprol. 2008;74(2):157–158.
  • Spector SL, Tan RA. Therapeutic alternatives for chronic urticaria: additional reports on omalizumab. Ann Allergy Asthma Immunol. 2008;101(6):647.
  • Romano C, Sellitto A, De Fanis U, et al. Maintenance of remission with low-dose omalizumab in long-lasting, refractory chronic urticaria. Ann Allergy Asthma Immunol. 2010;104(1):95–97.
  • Kaplan AP, Joseph K, Maykut RJ, et al. Treatment of chronic autoimmune urticaria with omalizumab. J Allergy Clin Immunol. 2008;122(3):569–573..
  • Ferrer M, Gamboa P, Sanz ML, et al. Omalizumab is effective in nonautoimmune urticaria. J Allergy Clin Immunol. 2011;127(5):1300–1302.
  • Gober LM, Sterba PM, Eckman JA, et al. Effect of Anti-IgE (Omalizumab) in chronic idiopathic urticaria (CIU) patients. J Allergy Clin Immunol. 2008;121(2):S147–S147..
  • Saini S, Rosen KE, Hsieh HJ, 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..
  • Maurer M, Altrichter S, Bieber T, et al. Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase. J Allergy Clin Immunol. 2011;128(1):202–209e5..
  • Maurer M, Rosen K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013;368(10):924–935..
  • Kaplan A, Ledford D, Ashby M, et al. Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. J Allergy Clin Immunol. 2013;132(1):101–109..
  • Saini SS, Bindslev-Jensen C, Maurer M, 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..
  • Staubach P, Metz M, Chapman-Rothe N, et al. Effect of omalizumab on angioedema in H1 -antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial. Allergy. 2016;71(8):1135–1144.
  • Goh CL, Tan KT. Chronic autoimmune urticaria: where we stand?. Indian J Dermatol. 2009;54(3):269–274.
  • Presta LG, Lahr SJ, Shields RL, et al. Humanization of an Antibody-Directed against Ige. Journal of Immunology. 1993;151(5):2623–2632.
  • Holgate S, Buhl R, Bousquet J, et al. The use of omalizumab in the treatment of severe allergic asthma: a clinical experience update. Respir Med. 2009;103(8):1098–1113.
  • Kaplan AP, Gimenez-Arnau AM, Saini SS. Mechanisms of action that contribute to efficacy of omalizumab in chronic spontaneous urticaria. Allergy. 2016. 15 November 2016. DOI:10.1111/all.13083
  • Hochhaus G, Brookman L, Fox H, et al. Pharmacodynamics of omalizumab: implications for optimised dosing strategies and clinical efficacy in the treatment of allergic asthma. Curr Med Res Opin. 2003;19(6):491–498.
  • Zhao ZT, Ji CM, Yu WJ, et al. Omalizumab for the treatment of chronic spontaneous urticaria: a meta-analysis of randomized clinical trials. J Allergy Clin Immunol. 2016;137(6):1742–1750e4.
  • Casale TB, Bernstein JA, Maurer M, et al. Similar efficacy with omalizumab in chronic idiopathic/spontaneous urticaria despite different background therapy. J Allergy Clin Immunol Pract. 2015;3(5):743–50e1..
  • Kaplan A, Ferrer M, Bernstein JA, et al. Timing and duration of omalizumab response in patients with chronic idiopathic/spontaneous urticaria. J Allergy Clin Immunol. 2016;137(2):474–481.
  • Ferrer M, Giménez-Arnau A, Saldana D, et al. Identification of parameters that could predict time to return of symptoms after stopping omalizumab treatment: exploratory analysis of phase III data from patients with chronic idiopathic/spontaneous urticaria. Allergy 2016;71(S102):185. Available from: http://onlinelibrary.wiley.com/doi/10.1111/all.12972/pdf
  • Labrador-Horrillo M, Valero A, Velasco M, et al. Efficacy of omalizumab in chronic spontaneous urticaria refractory to conventional therapy: analysis of 110 patients in real-life practice. Expert Opin Biol Ther. 2013;13(9):1225–1228.
  • Metz M, Ohanyan T, Church MK, et al. Retreatment with omalizumab results in rapid remission in chronic spontaneous and inducible urticaria. JAMA Dermatol. 2014;150(3):288–290.
  • Har D, Patel S, Khan DA. Outcomes of using omalizumab for more than 1 year in refractory chronic urticaria. Ann Allergy Asthma Immunol. 2015;115(2):126–129.
  • Gonul M, Ozenergun Bittaci A, Ergin C. Omalizumab-induced triphasic anaphylaxis in a patient with chronic spontaneous urticaria. J Eur Acad Dermatol Venereol. 2016 Nov;30(11):e135-e136.
  • Ertas R, Ozyurt K, Yildiz S, et al. Adverse reaction to omalizumab in patients with chronic urticaria: flare up or ineffectiveness?. Iran J Allergy Asthma Immunol. 2016;15(1):82–86.
  • Lai T, Wang S, Xu Z, et al. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis. Sci Rep. 2015;5:8191.
  • Abraham I, Alhossan A, Lee CS, et al. ‘Real-life’ effectiveness studies of omalizumab in adult patients with severe allergic asthma: systematic review. Allergy. 2016;71(5):593–610.
  • O’Donnell BF, Lawlor F, Simpson J, et al. The impact of chronic urticaria on the quality of life. Br J Dermatol. 1997;136(2):197–201.
  • Sussman G, Hebert J, Gulliver W, et al. Insights and advances in chronic urticaria: a Canadian perspective. Allergy Asthma Clin Immunol. 2015;11(1):7.
  • O’Donnell BF. Urticaria: impact on quality of life and economic cost. Immunol Allergy Clin North Am. 2014;34(1):89–104.
  • Gimenez-Arnau AM, Spector S, Antonova E, et al. Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies. Clin Transl Allergy. 2016;6:32.
  • Balp M, Chambenoit O, Chiva-Razavi S, et al. Work productivity and activity impairment among chronic spontaneous/idiopathic urticaria patients: results From the first international burden of illness study (Assure-Csu). Value Health. 2015;18(7):A427.
  • Tian H, Chambenoit O, Chiva-Razavi S, et al. Healthcare resource utilisation among chronic spontaneous/idiopathic urticaria patients- findings from the first international burden of illness study (Assure-Csu). Value Health. 2015;18(7):A424.
  • Balp MM, Vietri J, Tian H, et al. The impact of chronic urticaria from the patient’s perspective: a survey in five european countries. Patient. 2015;8(6):551–558.
  • Vietri J, Turner SJ, Tian H, et al. Effect of chronic urticaria on US patients: analysis of the national health and wellness survey. Ann Allergy Asthma Immunol. 2015;115(4):306–311.
  • Baiardini I, Pasquali M, Braido F, et al. A new tool to evaluate the impact of chronic urticaria on quality of life: chronic urticaria quality of life questionnaire (CU-QoL). Allergy. 2005;60(8):1073–1078.
  • Mlynek A, Magerl M, Hanna M, et al. The German version of the chronic urticaria quality-of-life questionnaire: factor analysis, validation, and initial clinical findings. Allergy. 2009;64(6):927–936.
  • Weller K, Groffik A, Magerl M, et al. Development and construct validation of the angioedema quality of life questionnaire. Allergy. 2012;67(10):1289–1298.
  • Stull DE, McBride D, Houghton K, et al. Correlation between changes in urticaria symptoms and sleep experience in patients with chronic spontaneous/idiopathic urticaria (CSU/CIU): a post-hoc analysis from 2 randomized, double-blind, placebo-controlled phase 3 trials of omalizumab. J Am Acad Dermatol. 2015;72(5):Ab43–Ab43.
  • Weller K, Groffik A, Church MK, 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, 1372 e1-6.
  • Savic S, Marsland A, McKay D, et al. Retrospective case note review of chronic spontaneous urticaria outcomes and adverse effects in patients treated with omalizumab or ciclosporin in UK secondary care. Allergy Asthma Clin Immunol. 2015;11(1):21.
  • Gimenez-Arnau A, Velasco M, Armario Hita JC, et al. Omalizumab: what benefits should we expect?. Eur J Dermatol. 2016;26(4):340–344.
  • Target My Hives. [Last accessed January 10, 2017]. Available at: http://myhives.com/.
  • Urticaria Day. [Last accessed January 10, 2017]. Available from: http://urticariaday.org/.
  • Chronic Urticaria Registry. [Last accessed January 10, 2017]. Available at: http://www.urticaria-registry.com/.
  • Deza G, Bertolín-Colilla M, Pujol RM, et al. Down-regulation of basophil FcεRI expression in CSU during omalizumab therapy. GA2LEN Global Urticaria Forum abstract book. [Last accessed January 10, 2017]. Available from: http://www.globalurticariaforum.org/.
  • Kocaturk E, Kuteyla Can P, Etikan Akbas P Management of chronic inducible urticaria according to guidelines; do same treatment algorithms work? GA2LEN Global Urticaria Forum abstract book. [Last accessed January 10, 2017]. Available from: http://www.globalurticariaforum.org/.
  • Barron C, Saperia C, Kobric D, et al. Chronic spontaneous urticaria; centre of excellence. GA2LEN Global Urticaria Forum abstract book. [Last accessed January 10, 2017]. Available from: http://www.globalurticariaforum.org/.
  • Maurer M, Schütz A, Weller K, et al. Omalizumab in cold urticaria: results of a randomized placebo-controlled trial. GA2LEN Global Urticaria Forum abstract book. [Last accessed January 10, 2017]. Available from: http://www.globalurticariaforum.org/.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.