Real Life Use of Omalizumab in Chronic Urticaria

Chronic Urticaria Clinical Trial

— XO-DS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04584190
• Other study ID #: RECHMPL19_0327
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: October 2020
• Source: University Hospital, Montpellier
• Contact: Julie Litovsky, resident
• Phone: 606934527
• Email: julie.litovsky[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Urticaria
• Urticaria

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (9)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Centre Hospitalier Universitaire de Saint Etienne, Lille University Hospital, Lyon Civil Hospitals - Lyon Sud Hospital Center, Nantes University Hospital, Tenon Hospital, Paris, University Hospital, Bordeaux, University Hospital, Grenoble, University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	predictive factors of duration between initiation and first discontinuation of omalizumab	predictive factors of duration between initiation and first discontinuation of omalizumab	1 day
Secondary	efficacy of omalizumab and relapse at discontinuation	efficacy of omalizumab and relapse at discontinuation	1 day
Secondary	discontinuation cause	discontinuation cause	1 day
Secondary	rechallenge with omalizumab and efficacy	rechallenge with omalizumab and efficacy	1 day
Secondary	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
Secondary	mid and long-term tolerance of omalizumab.	mid and long-term tolerance of omalizumab.	1 day