Omalizumab chronic spontaneous urticaria

Efficacy, safety, predictors of treatment outcome, and time to response

Italian OCUReL Study Group, Eustachio Nettis, Luca Cegolon, Elisabetta Di Leo, Fabio Lodi Rizzini, Aikaterini Detoraki, Giorgio Walter Canonica

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

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Omalizumab chronic spontaneous urticaria : Efficacy, safety, predictors of treatment outcome, and time to response. / Group, Italian OCUReL Study; Nettis, Eustachio; Cegolon, Luca; Di Leo, Elisabetta; Lodi Rizzini, Fabio; Detoraki, Aikaterini; Canonica, Giorgio Walter.

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

Research output: Contribution to journalArticle

Group, Italian OCUReL Study ; Nettis, Eustachio ; Cegolon, Luca ; Di Leo, Elisabetta ; Lodi Rizzini, Fabio ; Detoraki, Aikaterini ; Canonica, Giorgio Walter. / Omalizumab chronic spontaneous urticaria : Efficacy, safety, predictors of treatment outcome, and time to response. In: Annals of Allergy, Asthma and Immunology. 2018 ; Vol. 121, No. 4. pp. 474-478.
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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",
author = "Group, {Italian OCUReL Study} 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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T1 - Omalizumab chronic spontaneous urticaria

T2 - Efficacy, safety, predictors of treatment outcome, and time to response

AU - Group, Italian OCUReL Study

AU - Nettis, Eustachio

AU - Cegolon, Luca

AU - Di Leo, Elisabetta

AU - Lodi Rizzini, Fabio

AU - Detoraki, Aikaterini

AU - Canonica, Giorgio Walter

PY - 2018/10/1

Y1 - 2018/10/1

N2 - 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

AB - 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

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DO - 10.1016/j.anai.2018.06.014

M3 - Article

VL - 121

SP - 474

EP - 478

JO - Annals of Allergy, Asthma and Immunology

JF - Annals of Allergy, Asthma and Immunology

SN - 1081-1206

IS - 4

ER -