Expert opinion: Defining response to omalizumab in patients with chronic spontaneous urticaria

Marta Ferrer, Isabelle Boccon-Gibod, Margarida Gonçalo, Hüseyin Serhat İnalöz, André Knulst, Hilde Lapeere, Anchala Parthasaradhi, Georg Stingl, Anna Tagka, Fernando Valenzuela, Jensen Yeung, Simon Francis Thomsen*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review


Omalizumab (a recombinant, humanized anti-immunoglobulin-E antibody) has been shown in three pivotal Phase III trials (ASTERIA I, II and GLACIAL) and real-world studies to be effective and well-tolerated for the treatment of chronic spontaneous urticaria (CSU), and is the only licensed third-line treatment for CSU. However, the definition of response to omalizumab treatment often differs between clinical trials, real-world studies, and daily practice of individual physicians globally. As such, a consensus definition of “complete”, “partial” and “nonresponse” to omalizumab is required in order to harmonize treatment management and compare data. Here, it is proposed that a disease measurement tool, for example, the 7-Day Urticaria Activity Score (UAS7) or Urticaria Control Test (UCT) is required for defining response. The addition of quality of life measurements is helpful to gain insight into a patient’s disease burden and its changes during treatment. A potential omalizumab treatment approach based on speed and pattern of response at 1-3 and 3-6 months is suggested. In cases where there is no response during the first 1-3 months, physicians should consider reassessing the original CSU diagnosis. Moreover, in patients showing partial response at 12 weeks, treatment with omalizumab should be continued in order to maximize the possibility of achieving symptom control. If patients have a UAS7>6 and/or UCT<12, then continued treatment is advised, dependent on physician judgement and patient expectations. In treatment responders, omalizumab treatment can be resumed at a later stage after discontinuation with the same degree of symptom control.

Original languageEnglish
Pages (from-to)455-463
Number of pages9
JournalEuropean Journal of Dermatology
Issue number5
Publication statusPublished - 1 Sept 2017


  • Chronic spontaneous urticaria
  • Complete response
  • H-antihistamines
  • Omalizumab
  • Partial response


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