Use of mepolizumab significantly reduced the need for maintenance oral corticosteroids in adults with severe asthma, based on data from more than 800 individuals.
Many patients with severe asthma require bursts of systemic corticosteroids (SCS) or maintenance oral corticosteroids (mOCS) for disease control, but these strategies are associated with side effects that can increase the disease burden, wrote Charles Pilette, MD, of Cliniques Universitaires Saint-Luc, Brussels, and colleagues.
Previous studies have shown that the humanized, monoclonal anti-interleukin (IL)–5 antibody mepolizumab, which is approved for the treatment of severe asthma, reduced use of SCS and has shown effectiveness in less homogeneous populations, but robust, real-world data on the occurrence and magnitude of these effects are lacking, the researchers said.
In a study known as REALITI-A, the researchers enrolled 822 adults with asthma diagnoses from 82 centers in Europe, Canada, and the United States who initiated mepolizumab at a subcutaneous dose of 100 mg. The study endpoints included daily use of oral corticosteroids at baseline and 1 year, percentage reduction in oral corticosteroid use from baseline, patients discontinuing oral corticosteroids; the primary outcome was the rate of clinically significant exacerbations (CSEs). CSEs were defined as the need for OCS for at least 3 days/parenteral administration, and/or an emergency department or hospital admission before and after treatment. The mean age of the participants was 54 years, 63% were women, and 60% were never-smokers. The mean asthma duration was 19.7 years.
A total of 319 patients (39%), used mOCS at baseline, and dose information was available for 298.
Real-world outcomes
At 1 year, the median mOCS dose in the study population was reduced by 75%, and 64% reduced their mOCS dose by at least 50% from baseline.
In addition, the proportion of patients who discontinued daily mOCS increased from 29% during week 25-28 to 43% during week 53-56.
Overall, 80% of patients remained on mepolizumab at 1 year. Lack of efficacy and patient decision were the top two reasons for discontinuation (6% and 4%, respectively).
The primary outcome of rate of CSE decreased by a clinically significant rate ratio of 0.29 (P < .001).
“The requirement for SCS bursts was also reduced, as observed by a decreased rate of CSEs,” the researchers wrote in their discussion. The results were consistent for patients receiving lower (less than 10 mg/day) or higher (10 mg/day or more) mOCS doses at baseline, they said. No unexpected safety signals were noted during the study period.
“Furthermore, , or those requiring hospitalization or an ER visit, improved symptom control, and lower work productivity and activity impairment,” they added.
The study findings were limited by several factors including the observational design, lack of mepolizumab comparator, and open-label data capture, the researchers noted. However, the results were consistent with similar studies, and support the use of mepolizumab as part of the standard of care for clinically effective disease control in severe asthma patients, they concluded.
The study was funded by GlaxoSmithKline. Lead author Dr. Pilette disclosed fees for advisory boards, speaker meetings, and 42 research grants from GSK, AstraZeneca, Chiesi, Novartis, Teva, and ALK-Abello.