ATLANTA, GA—Mepolizumab (Nucala; GlaxoSmithKline) is effective for patients with nasal polyps and severe eosinophilic asthma (SEA), confirmed findings from a meta-analysis of data from the placebo-controlled DREAM (NCT1000506) and MENSA (NCT01691521) clinical trials presented at the 2017 AAAAI Annual Meeting.
“Efficacy of mepolizumab was not affected by the presence of nasal polyps, making it a viable treatment option for patients with concurrent SEA and nasal polyps,” said lead study author Mark C. Liu, MD, an associate professor of medicine at Johns Hopkins Medicine, Baltimore, MD.
Eosinophilic inflammation underlies both SEA and nasal polyps, Dr. Liu noted. Mepolizumab is an approved agent for SEA but it has not been clear whether or not coexisting nasal polyps affect efficacy. To find out, the authors conducted a meta-analysis of data pooled for 884 study participants who received treatment with 75mg IV or 100mg SC of mepolizumab or placebo. Patients included in the studies were at least 12 years of age, were using high-dose inhaled corticosteroids and other controller medication(s), and had experienced at least 2 exacerbations treated with corticosteroids in the previous year. Of the total patients, 120 (14%) had nasal polyps at study enrollment. The primary endpoint of the study was the annual rate of clinically significant exacerbations.
“Patients with nasal polyps had higher blood eosinophil counts at baseline than patients without nasal polyps,” the authors noted. “The reduction in exacerbations with mepolizumab compared with placebo was 59% for patients with nasal polyps and 48% for patients without nasal polyps” (rate ratio [RR] 0.41; 95% CI: 0.25, 0.67 and 0.52; 95% CI: 0.42, 0.64, respectively).
“Mepolizumab improved ACQ-5, SGRQ, pre- and post-bronchodilator FEV1 vs. placebo in both groups, with a larger point estimate in the nasal polyps group,” they reported. Data showed that for patients with nasal polyps, mepolizumab changed the ACQ-5 score by -0.47 (95% CI: -0.83, -0.10) from placebo, compared to a change of -0.32 (95% CI: -0.47, -0.17) in patients without nasal polyps. The authors also reported that the SGRQ score change from placebo in patients with nasal polyps was -10.9 (95% CI: -17.1, -4.8) vs. -5.8 (95% CI: -8.9, -2.7) in those without nasal polyps. Data from the study also found that in patients with nasal polyps, pre- and post-bronchodilator FEV1 was 130mL (95% CI: -56, 316) and 199mL (95% CI: 19, 379), respectively. For those without nasal polyps, pre- and post-bronchodilator FEV1 was 80mL (95% CI: 18, 143) and 85mL (95% CI: 20,150), respectively.
“Clinician- and patient-rated responses to therapy were more favorable with mepolizumab vs. placebo treatment in both patients with and without nasal polyps,” the authors added. For patients with nasal polyps, an odds ratio (mepolizumab/placebo) for clinician-rated response to therapy was reported as 3.29 (95% CI: 1.61, 6.74), compared to 2.25 (95% CI: 1.72, 2.94) for those without nasal polyps. Additionally, an odds ratio for patient-rated response to therapy was reported as 3.03 (95% CI: 1.48, 6.21) for patients with nasal polyps vs. 2.04 (95% CI: 1.56, 2.67) for those without nasal polyps.
Findings from this study indicated that mepolizumab is effective in treating patients with nasal polyps as well as severe eosinophilic asthma.
The study was funded by GlaxoSmithKline.