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

Status

Unknown

Conditions

Chronic Urticaria

Study type

Observational

Funder types

Other

Identifiers

NCT04584190
RECHMPL19_0327

Details and patient eligibility

About

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.

Full 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.

Enrollment

700 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

There are currently no registered sites for this trial.

Central trial contact

Julie Litovsky, resident; Aurélie Du Thanh, MD, PhD

Timeline

Last updated: Oct 12, 2020

Start date

Jul 01, 2020 • 4 years ago

End date

Nov 30, 2020 • 4 years ago

Today

Jan 21, 2025

Sponsors of this trial

Collaborating Sponsors

U

University Hospital, Rouen

L

Lyon Civil Hospitals - Lyon Sud Hospital Center

C

Centre Hospitalier Universitaire de Saint Etienne

T

Tenon Hospital, Paris

L

Lille University Hospital

Data sourced from clinicaltrials.gov