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Background and importance Dupilumab is authorised in the European Union for the treatment of moderate to severe atopic dermatitis (AD) in adult patients who are candidates for systemic treatment. It is a non-funded drug in Spain, so patients can only access this treatment through medication management under special circumstances according to the Spanish Agency for Medicines and Health Products (AEMPS). Aim and objectives To analyse the criteria for use, effectiveness and economic impact of dupilumab in the treatment of moderate to severe AD. Material and methods This was a study of a series of patients diagnosed with moderate to severe AD and treated with dupilumab until October 2019. The data were obtained from the clinical history and the electronic prescription programme (SILICON). The variables recorded were: sex, age, previous treatments, cost of the vial through the medication management website in special situations and number of dispensations. Each case was evaluated by the local Biological and High Impact Medicines Commission (CAL). The criteria used to access the treatment were: diagnosis of moderate to severe AD, defined by a score on the doctor’s global score scale (PGA) ≥3 and the eczema area and severity index (EASI) ≥16, and minimal involvement of the body surface area (BSA) ≥10%, and been treated with glucocorticoids, oral antihistamines and cyclosporine. Effectiveness was assessed as a 75% reduction in EASI (EASI-75) at week 16 and a decrease in immunoglobulin E (IgE). The average cost per patient was calculated. Results Three patients (two men) were included, with a median age of 23 years (17–32). In all cases they had been treated with topical and systemic glucocorticoids, oral antihistamines and cyclosporine. One of the patients had received methotrexate. All patients met the utilisation criteria agreed by the CAL. At week 16, all three patients reached EASI-75, and this was maintained over time. Baseline IgE values were: 1500, 10 004 and 6013. The levels decreased to normal values in the three patients. The average cost per patient was €17 400 over the 26 weeks of treatment. Conclusion and relevance The effectiveness of dupilumab was significantly improved by reducing injuries and itching. The criteria of use allowed the selection of those patients who could obtain the greatest benefit. The analytical determination of IgE could be a criterion to select the most serious patients, and a decrease IgE could be used as a variable to evaluate the effectiveness of dupilumab. References and/or acknowledgements No conflict of interest. |
