Add-on Mepolizumab Effective for Chronic Rhinosinusitis With Nasal Polyps

Compared with placebo, mepolizumab significantly improved nasal polyp size and nasal obstruction in adults with recurrent, refractory severe chronic rhinosinusitis with nasal polyps, according to a recent study.

“These findings suggest that mepolizumab provides an effective add-on treatment option to standard of care in this population,” the researchers wrote.

The double-blind, phase 3 SYNAPSE trial included 407 patients from 93 sites in 11 countries. Participants were adults with recurrent, refractory, severe, bilateral nasal polyp symptoms who, despite standard-of-care treatment, were eligible for repeat nasal surgery and who had undergone at least 1 nasal surgery in the past 10 years.

A total of 206 participants were randomly assigned to receive 100 mg of mepolizumab subcutaneously every 4 weeks, and 201 participants to placebo, over 52 weeks. Participants also received standard treatment as required.

From baseline to week 52, total endoscopic nasal polyp score significantly improved compared with placebo (the researchers reported an −0.73 adjusted difference in medians). Additionally, nasal obstruction visual analogue scale score during weeks 49 through 52 significantly improved with mepolizumab compared with placebo (−3.14 adjusted difference in medians).

The trial identified no new safety indications for mepolizumab. Treatment-related adverse events were reported in 15% of participants receiving mepolizumab and 9% of participants receiving placebo. Serious adverse events occurred in 6% of participants in each treatment group. In the mepolizumab group, none were considered related to treatment. In the placebo group, one participant had died from a myocardial infarction unrelated to treatment.

—Jolynn Tumolo

Reference

Han JK, Bachert C, Fokkens W, et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021;9(10):1141-1153. https://doi.org/10.1016/s2213-2600(21)00097-