Mepolizumab improves outcomes in patients with asthma, related comorbidities

Key takeaways:

• Median doses of maintenance oral corticosteroids fell by 50% or more.
• Asthma Control Questionnaire-5 scores fell by 0.63 points or more.
• The full cohort and each subgroup had increases in FEV₁.

Outcomes improved for patients with severe asthma who took mepolizumab regardless of their other comorbidities, according to a study published in The Journal of Allergy and Clinical Immunology: In Practice.

Patients with chronic rhinosinusitis with nasal polyps saw additional benefits, Mark C. Liu, MD, associate professor of medicine, divisions of allergy and clinical immunology, pulmonary and critical care medicine, Johns Hopkins Asthma and Allergy Center, and colleagues wrote.

The REALITI-A study comprised 822 adults (mean age, 54 years; 63% women) with severe asthma who were treated with 100 mg subcutaneous doses of mepolizumab (Nucala, GlaxoSmithKline) for 1 year at 84 centers in seven countries.

Comorbidities included CRSwNP for 321 of 822 patients (39%), gastroesophageal reflux disease for 309 of 801 patients (39%), depression/anxiety for 203 of 785 patients (26%) and COPD for 81 of 808 patients (10%).

The patients who had CRSwNP and those who had COPD had generally similar rates of clinically significant asthma exacerbations (CSEs) during the pretreatment period compared with those patients who did not have CRSwNP or COPD.

Also during the pretreatment period, the patients who had GERD and those who had depression/anxiety had higher rates of CSEs than those who did not have these comorbidities.

After treatment with mepolizumab, though, rates of CSEs fell across the full cohort and across each comorbidity group. Patients with CRSwNP had a numerically greater decrease in their CSE rates compared with the patients who did not have CRSwNP.

Specifically, CSE rates fell by 75% for those with and 69% for those without CRSwNP; 71% for those with and 71% for those without GERD; 63% for those with and 75% for those without anxiety/depression; and 64% for those with and 72% for those without COPD.

The patients who did not have COPD and depression/anxiety had numerically greater decreases in CSE rates than those patients who did have COPD and depression, but the results for the COPD group had large confidence intervals, the researchers said.

Additionally, patients with increased blood eosinophil counts at baseline and CRSwNP or COPD had a small trend of greater reductions in CSE rates compared with patients who did not have CRSwNP or COPD. The patients with GERD and depression/anxiety did not experience any increase in effect size with increased levels of blood eosinophils.

Between weeks 53 and 56 after treatment, median daily doses of maintenance oral corticosteroids (OCS) fell by at least 50% for the 298 patients who used them.

Decreases included 83% for those with and 50% for those without CRSwNP; 50% for those with and 75% for those without GERD; 50% for those with and 72% for those without anxiety/depression; and 50% for those with and 75% for those without COPD. Total median OCS daily doses had similar results, the researchers said.

At weeks 53 to 56, 32% to 47% of patients across the treated population as a whole and across the comorbidity groups discontinued their maintenance OCS doses. The CRSwNP and COPD groups had greater proportions of patients who discontinued their doses than the GERD and depression/anxiety groups.

The depression/anxiety group had the greatest difference in and the smallest proportion of patients who discontinued maintenance OCS. Overall, the researchers continued, results were similar for total OCS use.

The full cohort and the individual comorbidity groups also experienced reductions in least square mean Asthma Control Questionnaire-5 (ACQ-5) scores at month 12. The CRSwNP had the greatest reduction, and the COPD group had the smallest reduction, the researchers said, with large confidence intervals. These reductions all exceeded the minimum clinically important difference of 0.5 points as well.

Additionally, least square mean FEV1 totals increased from baseline through months 9 to 12 for the full cohort and across each comorbidity groups. The patients with each comorbidity had greater increases than those patients who did not have those respective comorbidities. The COPD group had the largest increase, the researchers said, but the confidence intervals were large.

Based on these findings, the researchers concluded that mepolizumab reduced exacerbations and OCS use, and improved asthma control and lung function, in patients with severe asthma regardless of their comorbidities, particularly for those patients with CRSwNP.