Mepolizumab reduces nasal polyp size and obstruction in patients with severe chronic rhinosinusitis, results from a large international study suggest.
Researchers found that the anti-IL-5 biologic reduced the need for repeat nasal surgery and cut the use of systemic corticosteroids. Patients treated with mepolizumab – who had severe chronic rhinosinusitis with nasal polyps despite continuous treatment and previous surgeries – also reported improved symptoms and quality of life.
Writing in The Lancet Respiratory Medicine, researchers from King’s College London, said the findings from the phase 3 study suggest mepolizumab provides an effective add-on treatment option in these patients.
The results come from the SYNAPSE study of more than 800 patients from 93 centres who received either 100mg mepolizumab subcutaneously or placebo every four weeks, in addition to usual care for a year, which included systemic corticosteroids as needed.
Polyp size significantly reduced over the year with mepolizumab compared with placebo and nasal obstruction symptoms also significantly improved, the researchers reported.
Mepolizumab also significantly reduced the need for nasal surgeries and the use of systemic corticosteroids compared with placebo, and improved nasal symptoms, including loss of smell.
The effects of treatment were seen four weeks after the first dose and were sustained throughout the study period, the researchers reported. No new safety issues were found.
“Evidence to date suggests that mepolizumab treatment reduces nasal polyp size and improves associated symptoms and reduces the need for actual surgery and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps,” the study investigators concluded.
“Given that these are key goals of nasal polyp management, mepolizumab provides an effective add-on treatment option to standard care for patients with chronic rhinosinusitis with nasal polyps.”
An accompanying editorial by Profs Guy Brusselle and Philippe Gevaert, of Ghent University Hospital and Ghent University, agreed that there was a high medical need for new therapies that improve symptoms and quality of life, as well as reducing the use of oral corticosteroids and surgery in these patients.
But they pointed out that only 50% of patients in the study who received mepolizumab had 1-point or higher improvement in nasal polyp score, suggesting that predictors of response to the treatment would be useful.
They added that both omalizumab and dupilumab had been shown to be effective in this group of patients, but variation in study design means comparisons between the treatments cannot easily be made.
“There is a need for pragmatic trials comparing the efficacy of mepolizumab, omalizumab, and dupilumab in patients with chronic rhinosinusitis with nasal polyps or severe eosinophilic asthma, or both; which will pave the way to precision medicine in type 2 airway diseases,” they concluded.
The study was funded by GlaxoSmithKline, which markets mepolizumab. Several study co-authors report receiving speaker fees, advisory board fees, trial funding, and other support from GlaxoSmithKline as well as several other pharmaceutical companies.