Italy: A large real-world Italian study has found that mepolizumab (Nucala) improved disease outcomes in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP). At 12 months, 42% of patients achieved disease control, while about 20% showed signs of progressing toward remission. The findings reinforce mepolizumab’s effectiveness in routine clinical practice, although longer-term studies are needed to determine whether these benefits are sustained or increase beyond 12 months.

The study, published in The Lancet Respiratory Medicine, was led by Prof Eugenio De Corso, Department of Medicine and Surgery, Section of Otorhinolaryngology, University of Perugia, Italy, and colleagues. Researchers evaluated the real-world effectiveness and safety of mepolizumab in patients with severe, uncontrolled CRSwNP across multiple specialist centres in Italy.
CRSwNP is a chronic inflammatory condition characterized by nasal polyps, persistent nasal symptoms and impaired smell, and can substantially affect quality of life. The study focused on patients with severe disease who began treatment with mepolizumab 100 mg every four weeks.
The phase 4, ambispective study involved 25 Italian tertiary rhinology centres experienced in managing severe CRSwNP and biological therapies. Clinical information, including symptom severity, smell function, nasal endoscopic findings, laboratory measurements and coexisting conditions, was assessed at baseline and at 1, 3, 6, 9 and 12 months.
Between December 1, 2023, and March 15, 2024, 621 patients receiving mepolizumab were enrolled. The primary outcomes were changes in nasal polyp score and Sino-Nasal Outcome Test-22 (SNOT-22) scores, while researchers also assessed symptoms, olfactory function, blood eosinophil counts, disease control and progression towards remission.
At 12 months, both nasal polyp scores and SNOT-22 scores had significantly decreased from baseline (p<0.0001), indicating improvement in disease severity and health-related quality of life. Major nasal symptoms and smell function also improved during treatment.
However, 186 of 495 patients (38%) remained anosmic at 12 months, showing that complete recovery of smell did not occur in a substantial proportion of patients.
Key findings:
  • 206 of 519 patients (42%) achieved disease control at 12 months.
  • 104 patients (20%) met criteria indicating progression towards remission.
  • Patients with coexisting asthma experienced greater or faster improvements in SNOT-22 and self-reported symptoms.
  • A lower baseline nasal polyp score independently predicted progression towards remission at 12 months (OR 0.72).
  • Mepolizumab was generally well tolerated, with adverse events reported in 29 patients (5%).
  • Most adverse events were grade 1, indicating mild severity.
The researchers noted that mepolizumab produced progressive improvements during the first year of treatment. However, prospective long-term studies are needed to establish whether disease control and remission rates continue to improve after 12 months and whether these benefits can be maintained over time.
Reference:
De Corso, E., Ottaviano, G., Seccia, V., Pipolo, C., Canevari, F. R. M., Maggiore, G., Cantone, E., Pagella, F., Anastasi, F., Pasquini, E., Torretta, S., Garzaro, M., Gallo, S., Loperfido, A., D’Ascanio, L., Moffa, A., Cavaliere, C., Caruso, M., Anzivino, R., . . . Pacaj, K. (2026). Mepolizumab effectiveness for patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps in Italy (MEPOREAL): A real-life, multicentre, phase 4 trial. The Lancet Respiratory Medicine. https://doi.org/10.1016/S2213-2600(26)00197-9


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Article Source : The Lancet Respiratory Medicine

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Medha Baranwal

Medha Baranwal holds a Bachelor’s degree in Biomedical Sciences from the University of Delhi and a Master’s degree in Biotechnology from Amity University. Since May 2018, she has been contributing to Medical Dialogues, writing and editing medical news articles that translate complex research into clear, accessible information for healthcare professionals.

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