Terminated clinical registry of patients suffering from severe persisting allergic asthma who were treated with omalizumab (Xolair®).
start of the project: January 2011
end of the project: September 2018
The CAR (Czech Anti-IgE Registry) project was focused on monitoring of patients suffering from severe persisting allergic asthma who were treated with anti-IgE monoclonal antibody (omalizumab), as well as on the observation of risk factors and prognostic factors in these patients, treatment progress and results.
Omalizumab (Xolair®) is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 < 80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily highdose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Due to financial restraints, the State Institute for Drug Control (SUKL) defined several conditions that had to be met for the prescription of omalizumab (the patient had to be a non-smoker, his/her pre-treatment serum IgE had to be between 30-700 IU/ml, etc.). This project examined the target population that met these criteria and established the conditions for a good response to this treatment. These data subsequently facilitated future negotiations with health insurance companies.
Objectives of the project:
Other important information: