Omalizumab chronic spontaneous urticaria: Efficacy, safety, predictors of treatment outcome, and time to response

Italian OCUReL Study Group

Research output: Contribution to journalArticle

Abstract

Background: Omalizumab is a recombinant anti-immunoglobulin E (IgE) antibody used in the treatment of patients with chronic spontaneous urticaria (CSU). Objective: This multicentric study assessed the safety and efficacy of omalizumab in patients (n=322) with CSU refractory to second-generation antihistamines, also investigating predictors of poor treatment outcome and time lag to response to anti-IgE therapy by serum auto-reactivity. Methods: This retrospective observational study comprised a 4-week pretreatment period, a 24-week treatment period with omalizumab (300 mg/month), and a 16-week follow-up period. Primary efficacy endpoints were mean and median change in 7-day urticaria activity score (UAS7), weekly itch severity score (ISS), and hive score from baseline to 4-, 12-, and 24-week values. Secondary endpoints included the proportion of patients (defined “responders”) with well-controlled urticaria (UAS7 ≤ 6) and complete treatment response (UAS7=0). Safety in terms of side effects was also assessed. Results: Omalizumab significantly and consistently reduced the mean UAS7, ISS, and hive score from baseline to weeks 4, 12, and 24, with a clear decreasing trend over time. At the end of the treatment period (week 24), 84.2% of patients had a UAS7 score of 6 or less and 66.7% had a UAS7 of 0. Higher pretreatment IgE levels were less likely to be associated with poor treatment response (ie, UAS7 > 6). Patients with a positive autologus serum skin test (ASST) were significantly more likely to be “slow responders” to omalizumab treatment (ie, response beyond 8 days since omalizumab administration) than ASST-negative patients (P <.001). No treatment-related adverse events were recorded. Conclusion: Monitoring baseline characteristics of patients before introduction of omalizumab therapy may help to predict treatment outcome in CSU patients.

Original languageEnglish
Pages (from-to)474-478
Number of pages5
JournalAnnals of Allergy, Asthma and Immunology
Volume121
Issue number4
DOIs
Publication statusPublished - Oct 1 2018

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Urticaria
Safety
Immunoglobulin E
Therapeutics
Skin Tests
Non-Sedating Histamine H1 Antagonists
Serum
Passive Immunization
Omalizumab
Observational Studies
Retrospective Studies
Antibodies

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pulmonary and Respiratory Medicine

Cite this

Omalizumab chronic spontaneous urticaria : Efficacy, safety, predictors of treatment outcome, and time to response. / Italian OCUReL Study Group.

In: Annals of Allergy, Asthma and Immunology, Vol. 121, No. 4, 01.10.2018, p. 474-478.

Research output: Contribution to journalArticle

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title = "Omalizumab chronic spontaneous urticaria: Efficacy, safety, predictors of treatment outcome, and time to response",
abstract = "Background: Omalizumab is a recombinant anti-immunoglobulin E (IgE) antibody used in the treatment of patients with chronic spontaneous urticaria (CSU). Objective: This multicentric study assessed the safety and efficacy of omalizumab in patients (n=322) with CSU refractory to second-generation antihistamines, also investigating predictors of poor treatment outcome and time lag to response to anti-IgE therapy by serum auto-reactivity. Methods: This retrospective observational study comprised a 4-week pretreatment period, a 24-week treatment period with omalizumab (300 mg/month), and a 16-week follow-up period. Primary efficacy endpoints were mean and median change in 7-day urticaria activity score (UAS7), weekly itch severity score (ISS), and hive score from baseline to 4-, 12-, and 24-week values. Secondary endpoints included the proportion of patients (defined “responders”) with well-controlled urticaria (UAS7 ≤ 6) and complete treatment response (UAS7=0). Safety in terms of side effects was also assessed. Results: Omalizumab significantly and consistently reduced the mean UAS7, ISS, and hive score from baseline to weeks 4, 12, and 24, with a clear decreasing trend over time. At the end of the treatment period (week 24), 84.2{\%} of patients had a UAS7 score of 6 or less and 66.7{\%} had a UAS7 of 0. Higher pretreatment IgE levels were less likely to be associated with poor treatment response (ie, UAS7 > 6). Patients with a positive autologus serum skin test (ASST) were significantly more likely to be “slow responders” to omalizumab treatment (ie, response beyond 8 days since omalizumab administration) than ASST-negative patients (P <.001). No treatment-related adverse events were recorded. Conclusion: Monitoring baseline characteristics of patients before introduction of omalizumab therapy may help to predict treatment outcome in CSU patients.",
author = "{Italian OCUReL Study Group} and Eustachio Nettis and Luca Cegolon and {Di Leo}, Elisabetta and {Lodi Rizzini}, Fabio and Aikaterini Detoraki and Canonica, {Giorgio Walter}",
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T2 - Efficacy, safety, predictors of treatment outcome, and time to response

AU - Italian OCUReL Study Group

AU - Nettis, Eustachio

AU - Cegolon, Luca

AU - Di Leo, Elisabetta

AU - Lodi Rizzini, Fabio

AU - Detoraki, Aikaterini

AU - Canonica, Giorgio Walter

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