Real Life Use of Omalizumab in Chronic Urticaria (XO-DS)

Drug Survival of Omalizumab in Chronic Urticaria : a Retrospective Multicentric Study

Chronic urticaria affects up to 1% of the population. Chronic urticaria refractory to updosing antihistamines can benefit from OMALIZUMAB, which is an anti-IgE IgG1 monoclonal antibody administrated every 4 weeks subcutaneously which represents a cost of nearly 800€/month excluding nurse fees. Efficacy and good tolerance have already been demonstrated in real-life large cohorts of patients. A 6 months treatment duration is proposed before evaluating the efficacy and discontinuating the treatment in the absence of adequate response. Mean duration of chronic urticaria is 3 to 5 years with high standard deviations. Therefore, optimal duration of treatment with OMALIZUMAB is unknown and discontinuation modalities differ between physicians.

The aim of this study is to evaluate the mean duration between initiation and first discontinuation of OMALIZUMAB in patients treated for chronic urticaria and explore the different factors influencing this duration and its outcome.

Study Overview

• Status: Unknown
• Conditions: Chronic Urticaria

Detailed Description

Chronic urticaria affects up to 1% of the population. Rarely, chronic urticaria may be refractory to updosing four-fold antihistamine drugs and then can be improved with subcutaneous OMALIZUMAB. OMALIZUMAB is available for chronic urticaria since 2015. It is an IgG1 monoclonal antibody targeting IgE and administrated every 4 weeks which represent a cost of nearly 800€/month excluding nurse fees. Efficacy and good tolerance have already been demonstrated in real-life large cohorts of patients. A 6 months treatment duration is proposed before evaluating the efficacy and discontinuating the treatment in the absence of adequate response. Mean duration of chronic urticaria is 3 to 5 yearss with high standard deviations. Therefore, optimal duration of treatment with OMALIZUMAB is unknown and discontinuation modalities differ between physicians.

The aim of this study is to evaluate the mean duration between initiation and first discontinuation of OMALIZUMAB in patients treated for chronic urticaria and explore the different factors influencing this duration and its outcome.

To accomplish this, the investigators will conduct a restrospective analyse of all patients treated with OMALIZUMAB for chronic urticaria from 2010 to 2020 in the major French hospital reference centers for chronic urticaria management : Paris, Lyon, Grenoble, Lille, Bordeaux, Nantes, Rouen, Saint-Etienne, Montpellier.

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Julie Litovsky, resident; Phone Number: 33 606934527; Email: julie.litovsky@gmail.com
• Study Contact Backup: Name: Aurélie Du Thanh, MD, PhD; Phone Number: 33 61148890; Email: a-du_thanh@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • UH Montpellier
    • Contact: Aurélie Du-Thanh, MD, PhD; Phone Number: 33 467336906; Email: a-du_thanh@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

French referal hospital centers of chronic urticaria managment

Description

Inclusion criteria:

• chronic spontaneous or inducible urticaria
• treated with omalizumab
• at least once between January the 1st 2010 and july 2020.

Exclusion criteria:

• unknown intiation and discontinuation date of omalizumab
• omalizumab initiated for asthma
• other diagnosis (vascularitis, aquagenic pruritus)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration between initiation and first discontinuation of OMALIZUMAB	assessed at the time of inclusion Description: duration between initiation and first discontinuation of OMALIZUMAB	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
predictive factors of duration between initiation and first discontinuation of omalizumab	predictive factors of duration between initiation and first discontinuation of omalizumab	1 day
efficacy of omalizumab and relapse at discontinuation	efficacy of omalizumab and relapse at discontinuation	1 day
discontinuation cause	discontinuation cause	1 day
rechallenge with omalizumab and efficacy	rechallenge with omalizumab and efficacy	1 day
persistance of antihistamine intake at 1year, 2 years and 3 years	persistance of antihistamine intake at 1year, 2 years and 3 years	at 1year, 2years and 3years
mid and long-term tolerance of omalizumab.	mid and long-term tolerance of omalizumab.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: University Hospital, Rouen; Centre Hospitalier Universitaire de Saint Etienne; University Hospital, Bordeaux; University Hospital, Grenoble; Nantes University Hospital; Tenon Hospital, Paris; Lyon Civil Hospitals - Lyon Sud Hospital Center; Lille University Hospital
• Investigators: Principal Investigator: Aurélie Du Thanh, MD, PhD, University Hospitals of Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ANTICIPATED): November 30, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (ACTUAL): October 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Chronic urticaria treated with OMALIZUMAB
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Chronic Urticaria
• Other Study ID Numbers: RECHMPL19_0327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No