This real-life, multicentre, ambispective phase 4 study evaluated the effectiveness and safety of mepolizumab 100 mg every 4 weeks in 621 adults with severe, uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) across 25 Italian tertiary rhinology centres over 12 months.
At 12 months, both nasal polyp score and SNOT-22 dropped significantly from baseline (p<0.0001); disease control was achieved in 42% (206/519) of patients, and 20% (104/519) were on the way to remission. However, 38% (186/495) of patients remained anosmic. Adverse events occurred in only 5% (29/621) of patients, mostly grade 1.
- Ambispective design (partly retrospective) with no control arm limits causal inference. - Study limited to Italian tertiary centres, which may reduce generalisability to other settings or less-severe populations. - Only 12-month data are presented; remission requires a full 12-month sustained period, so true remission rates cannot yet be determined.
Mepolizumab produces meaningful, progressive improvements in polyp burden and quality of life over 12 months in severe CRSwNP, with a good safety profile, but nearly 4 in 10 patients remain anosmic at one year. Patients with lower baseline nasal polyp scores are most likely to progress toward remission, which may help guide expectations when counselling patients.
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