CAR

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:

• assessment of therapeutic results of treatment with omalizumab (Xolair®) under the prescription criteria as defined by the State Institute for Drug Control (SUKL), the regulatory authority responsible for drug reimbursements in the Czech Republic,
• identification of prognostic factors which could help define patients expected to respond to this treatment.

Other important information:

• Expert guarantor: Vratislav Sedlak, MD (University Hospital Hradec Kralove)
• Funding: Novartis Ltd.
• Partners: 16 pulmonary and allergology centres in the Czech Republic (the comprehensive list – in Czech language only – is available on the website of the CAR project)
• Brief overview of results: you can find more detailed information – in Czech language only – on the website of the CAR project