Clinical trial NCT04584190: Real Life Use of Omalizumab in Chronic Urticaria
Official title: Drug Survival of Omalizumab in Chronic Urticaria : a Retrospective Multicentric Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Urticaria
Keywords: Chronic urticaria treated with OMALIZUMAB
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Lyon Civil Hospitals - Lyon Sud Hospital Center
name: Tenon Hospital, Paris
name: Nantes University Hospital
name: University Hospital, Grenoble
name: University Hospital, Rouen
name: Lille University Hospital
name: University Hospital, Bordeaux
name: Centre Hospitalier Universitaire de Saint Etienne
First posted: 2020-10-12
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French referal hospital centers of chronic urticaria managment

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: duration between initiation and first discontinuation of OMALIZUMAB
timeFrame: 1 day
Secondary outcomes:
measure: predictive factors of duration between initiation and first discontinuation of omalizumab
timeFrame: 1 day
measure: efficacy of omalizumab and relapse at discontinuation
timeFrame: 1 day
measure: discontinuation cause
timeFrame: 1 day
measure: rechallenge with omalizumab and efficacy
timeFrame: 1 day
measure: persistance of antihistamine intake at 1year, 2 years and 3 years
timeFrame: at 1year, 2years and 3years
measure: mid and long-term tolerance of omalizumab.
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Aurélie Du Thanh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: