Omalizumab can be safely withdrawn in more than one-third of patients with severe allergic asthma (SAA) who are classified as Global Initiative for Asthma (GINA) step V and receiving oral corticosteroids, according to the results of the recent single-center, open-label intervention OmaAlizumab Dose Reduction (OMADORE) study published in the British Journal of Clinical Pharmacology.
The objective of the OMADORE study was to evaluate the viability of a step-down protocol for omalizumab therapy in patients with SAA. A total of 35 patients with SAA who were treated for a minimum of 1 year with oral corticosteroid therapy (equivalent to a mean daily dose of methylprednisolone 4 mg) were enrolled in the study. To be eligible for the protocol, patients needed to have received omalizumab treatment for at least 1.5 years, have reached their lowest tolerated dose of oral corticosteroid, and have spirometry values greater than or equal to the values they had at baseline.
The interventions in the study included reducing the omalizumab dose by half, reducing the dose in half again at 6 months following the first dose reduction if patients were stable, and if repeated oral corticosteroid boosters were needed and/or if spirometry worsened by ≥10%, the omalizumab dose was increased to the previous level until the patient was stabilized.
Study participants were ≥18 years of age and mean age was 52.5 years. The median monthly oral corticosteroid dose was 120 mg. Regarding pulmonary function, mean forced vital capacity (FVC) was 79.7%±20.2%, mean forced expiratory volume in 1 second (FEV1) was 64.8%±21.7%, and mean FEV1/FVC ratio was 61.7%±13.8%.
Approximately 34% of patients were able to have omalizumab withdrawn. Overall, 22.9% of patients tolerated an omalizumab dose reduction, and the dose could not be modified in 42.9% of the participants. Follow-up time after dose reduction or dose withdrawal ranged from 12 months to 30 months. No severe asthma exacerbations requiring emergency assistance or hospitalization were reported.
The investigators concluded that based on the use of a progressive dose reduction protocol, in order to avoid severe disease exacerbations, omalizumab can be safely reduced or withdrawn. According to the protocol, the time to withdrawal is related to or dependent on a patient’s initial omalizumab dose, with the time being longer in patients receiving higher omalizumab doses. Overall, treatment can be discontinued between year 2 and year 4 of omalizumab initiation.
Domingo C, Pomares X, Navarro A, et al. A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patients [published online October 18, 2017]. Br J Clin Pharmacol. doi:10.1111/bcp.13453