Background Omalizumab’s labelled indication is the treatment of IgE-mediated asthma. It has been used in our hospital since 2008. In 2011 it became necessary to develop a protocol that clarified patient selection and criteria for withholding treatment.
Purpose To describe the patients treated with omalizumab, focusing on whether they match our protocol’s use criteria or not.
Materials and Methods All patients treated with omalizumab for asthma in our hospital were included. Data were obtained in October 2012 from electronic clinical records: treatment period, patient smoker or not, other medicines for asthma, basal IgE, adherence to treatment, omalizumab dosage and hospitalizations and emergency department visits before and after treatment.
Our omalizumab use protocol states these patient selection criteria: uncontrolled severe asthma with previous optimised therapy, basal IgE > 76 IU/mL and at least three emergency department visits or one hospitalisation in the previous year. Treatment withholding criteria are: evaluation after 16 weeks and stop if treatment shows no benefit.
Two different pharmacists examined each patient’s information to establish if treatment was being effective and whether the hospital’s protocol was being followed.
Results 31 patients were studied, 7 children and 24 adults. Treatment was stopped in 9 patients, due to lack of efficacy in 8 of them and to adverse effects in the other (diarrhoea, fever and skin reaction). Previous treatments included montelukast or theophylline in 19 patients (61%). Basal IgE was below 76 IU/mL in one patient. Median duration of treatment was 637 days (72–1624). Regarding patients’ adherence to treatment, 23% of patients missed a dose, 13% missed two and 6% missed three or more. 13 patients had had no pre-treatment hospitalizations or emergency department visits.
Treatment was evaluated as effective in 14 of the 22 patients who continued receiving omalizumab (64%).
Conclusions Our patients still need to be selected better. Protocol compliance is lower than desirable.
No conflict of interest.
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