REALITI-A study: Real-world oral corticosteroid-sparing effect of mepolizumab in severe asthma

Background: Patients with severe asthma may require maintenance oral corticosteroids (mOCS) for disease control as well as systemic corticosteroid (SCS) bursts for clinically significant exacerbations (CSEs); however, mOCS and SCS use are associated with adverse effects, which increases patient disease burden. Objective: To assess the real-world corticosteroid-sparing effect of mepolizumab in patients with severe asthma. Methods: REALITI-A is a 24-month, international, prospective, observational cohort study involving 84 centers across Europe, Canada, and the USA with a 1-year pre- and post-mepolizumab treatment pre-planned interim analysis. 822 adults with a clinical diagnosis of asthma, and a physician decision to initiate mepolizumab (100 mg subcutaneously) treatment were included. Endpoints included: daily mOCS dose at baseline (penultimate 28 days of pre-treatment) and 1-year post-treatment; percentage reduction from baseline in mOCS dose; patients discontinuing mOCS 1-year post-treatment and rate of CSEs (those requiring OCS for ≥3 days/parenteral administration, and/or emergency room visit and/or hospital admission) pre- and post-treatment. Results: 319 patients received mOCS at baseline (median [interquartile range]: 10.0 [5.0, 15.0] mg/day). At 1 year post-treatment, median mOCS dose reduced by 75% (2.5 [0.0, 5.0] mg/day); 64% of patients had a reduction in mOCS dose ≥50% versus baseline and 43% discontinued mOCS. CSEs decreased between pre- and post-treatment (rate ratio [95% confidence interval] 0.29 [0.26, 0.32] P<0.001). Conclusion: This 1-year analysis demonstrates that real-world mepolizumab treatment is clinically effective in patients with severe asthma, providing disease control while reducing the need for maintenance oral corticosteroids and systemic corticosteroid bursts