Background and Importance Omalizumab is indicated in children aged 6 years and older as adjunctive therapy to improve the control of uncontrolled severe allergic asthma (SAA).

Aim and Objectives To assess the effectiveness of omalizumab optimisation in paediatric patients with SAA.

Material and Methods Retrospective descriptive study including all paediatric patients who received omalizumab for the treatment of SAA. The initial dose of omalizumab was determined according to IgE levels (IU/mL) and body weight (Kg). Optimisation strategies: reduction of the dose received while maintaining the administration interval or maintaining the dose and increasing the administration interval, until discontinuation if possible. The following variables were recorded: sex, age, initial dose, optimisations, treatment time to optimisation and treatment discontinuation. Effectiveness was measured as the maintenance of stable disease after optimisation. Safety was assessed by adverse reactions (AR).

Results Thirty-eight patients, 25 males, with a median age of 10 (6–13) years were included. 22 patients started treatment every 4 weeks (Q4W) and 16 patients every 2 weeks (Q2W). The median duration of treatment with omalizumab was 59 (3–96) months. Thirty-six patients underwent treatment optimisations. The median time from omalizumab initiation to optimisation was 36 (12–84) months. The number of optimisations performed were: 1 (n=14), 2 (n=5), ≥3 (n=8). 26 patients achieved treatment discontinuation due to disease stability, 9 of them without prior optimisation. Since treatment optimisation, 10 patients experienced loss of asthma stability due to exacerbation of the disease, 3 of them resumed the previously used regimen. All of them subsequently achieved asthma stabilisation. Six patients had some AR: four had headaches, one had weight gain and one had flu-like syndrome.

Conclusion and Relevance Omalizumab optimisation guidelines in patients with allergic asthma with stable disease have been effective in most patients, achieving drug withdrawal in more than half of the patients. This omalizumab optimisation strategy could reduce the risk of AR of omalizumab in children and helps to decrease the costs associated with the drug.

Conflict of Interest No conflict of interest.