Background Omalizumab is indicated as add-on treatment to improve asthma control in patients with severe persistent allergic asthma who have reduced lung function as well as frequent symptoms.

Purpose To assess the use and efficacy of omalizumab in a regional hospital.

Materials and methods We conducted a retrospective study from April 2007 to August 2013. We included all patients who were treated for at least 16 weeks with omalizumab.

To evaluate use and efficacy we reviewed: baseline IgE levels, volume exhaled during the first second of a forced expiration (FEV1), use of inhaled and/or oral corticosteroids before and after treatment and disease evaluation after 16 weeks. It was considered that patients with baseline IgE lower than 76 IU/ml were less likely to experience benefit as stated in the omalizumab SPC. We defined reduced lung function as FEV1 lower than 80%.

Results Total patients: 10 (9 females); mean age 52 (39–77); 9 patients with allergic asthma and 1 with chronic urticaria.

There were 4 patients with moderate persistent allergic asthma and the remainder with severe asthma. Mean basal IgE 177.2 IU/mL (47–431.6). 4 patients were prescribed omalizumab with IgE lower than 76 IU/mL. The FEV1 value was only determined in 5 patients before starting treatment with omalizumab: 3 patients had FEV1 lower than 80% (49, 69 and 59), and it increased in all cases after omalizumab initiation (75, 72 and 71). 2 patients had FEV1 higher than 80% (104 and 96), which increased in the first case and decreased in the other after commencing omalizumab (117 and 78). Both had baseline IgE levels less than 76 IU/mL. After starting omalizumab all patients continued treatment with inhaled corticosteroids and 3 also with oral corticosteroids. 1 patient was completely asymptomatic, 2 had improved respiratory status, 5 were stable from a respiratory standpoint and 1 experienced non-respiratory changes with the introduction of omalizumab. Of the patients who started omalizumab with IgE levels higher than 76 IU/mL, 4 were stable from a respiratory standpoint and 1 had an improved respiratory status.

We had 1 patient diagnosed with chronic urticaria with IgE 518.4 IU/mL on treatment with omalizumab 300 mg every 6 weeks (off label). The patient is currently without skin rash or need to take antihistamines.

Conclusions Only 33% (3/9) patients experienced an improvement in respiratory status and 55% (5/9) were stable from a respiratory standpoint. These data are lower compared with other studies ⁽¹⁾ reporting up to 55% effectiveness. No patients discontinued treatment with corticosteroids. Is necessary to develop a protocol to ensure that omalizumab is used in the most suitable patients and review effectiveness after starting treatment to avoid unnecessary exposure to the drug in non-responders. Omalizumab treatment for chronic urticaria has been effective.

Reference

1. Padeulles Zamora N, et al. Estudio observacional retrospectivo de la utilización de Omalizumab en el tratamiento del asma grave persistente. Farm Hosp. 2013;37(5):399-405

No conflict of interest.