The prospective, observational, single-arm REALITI-A study investigated the real-world benefits of mepolizumab in patients with SEA (n=823). Patients received 12 months of pre-treatment prior to enrolment, standard-of-care plus mepolizumab, and were subsequently followed for 24 months. Outcomes included the rate of CSEs, the use of maintenance oral corticosteroids (mOCS), and exacerbations leading to hospital or emergency department (ED) admissions. The results after 1 year of follow-up have been reported previously.1 Dr Rupert Jakes (GSK, UK) presented the trial results after an additional 12 months of follow-up.2
After 2 years of follow-up, 73% of the study population still received mepolizumab. Of those who had discontinued the study drug, 9% did this because of a perceived lack of efficacy. The clinical benefits of mepolizumab that had been reported after 1 year of follow-up were maintained after 2 years of follow-up. Compared with the pre-treatment period, the rate of CSEs (rate ratio 0.26; P<0.001) and the rate of exacerbations requiring hospitalisations or ED visits (rate ratio 0.21; P<0.001) were reduced significantly. Moreover, a 100% reduction in the daily median mOCS dose was recorded at 2 years of follow-up; 57% of the participants using mOCS at baseline had discontinued this therapy by week 101–104. According to Dr Jakes, no unexpected safety issues had been observed.
In total, 90 treatment-related adverse events (AEs) were reported, of which 18 led to the discontinuation of the study drug. One of the 7 treatment-related serious AEs, a case of diffuse liver malignancy, resulted in the death of a patient.
Overall, the 2-year follow-up results of the REALITI-A trial confirmed the clinical benefits of mepolizumab in patients with SEA.