Mepolizumab effectiveness for patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps in Italy (MEPOREAL): a real-life, multicentre, phase 4 trial.
Eugenio De Corso, Giancarlo Ottaviano, Veronica Seccia et al.
✦ AI-curated · Sources linked
In 30 seconds
MEPOREAL was a real-life, multicentre, ambispective phase 4 study of mepolizumab in patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps at 25 Italian referral clinics. Among 621 patients starting mepolizumab 100 mg every 4 weeks, nasal polyp and SNOT-22 scores decreased significantly from baseline by 12 months (p<0·0001), with improvements in major symptoms and olfaction. Disease control was reached by 206 (42%) of 519 patients; 104 (20%) of 519 were on the way to remission. Adverse events occurred in 29 (5%) of 621 patients.
Key findings
- At 12 months, median nasal polyp and SNOT-22 scores had decreased significantly from baseline (p<0·0001).
- Disease control was reached by 206 (42%) of 519 patients at 12 months.
- At 12 months, 104 (20%) of 519 patients met the study definition of being on the way to remission.
- Adverse events occurred in 29 (5%) of 621 patients; grade 1 events were most common.
Why it matters
The findings provide multicentre real-life evidence that mepolizumab can improve symptoms, olfaction, and endoscopic disease measures over the first year in severe, uncontrolled CRSwNP. However, control and progression towards remission were not achieved by most patients at 12 months, and a substantial proportion of assessed patients remained anosmic, underscoring the variability of response.
What to keep in mind
The report covers only the first 12 months, and the ambispective real-life design does not establish comparative efficacy. Long-term prospective studies are needed to clarify control and remission beyond this period.