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Mepolizumab improves sense of smell in severe chronic rhinosinusitis with nasal polyps: SYNAPSE
J Mullol1, V J Lund2, M Wagenmann3
1Department of Otorhinolaryngology, Hospital Clinic, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Catalonia, Spain.
Background:
Loss of smell is one of the most bothersome and difficult-to-treat symptoms in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP).
Methodology:
SYNAPSE was a 52-week Phase III study of 4-weekly mepolizumab (100 mg subcutaneously) plus standard of care in adults with severe bilateral CRSwNP. This post hoc analysis assessed changes from baseline to study end in loss of smell visual analogue scale (VAS) symptom score, in patients stratified by several baseline clinical characteristics. SinoNasal Outcomes Test (SNOT)-22 sense of smell/taste item and University of Pennsylvania Smell Identification Test (UPSIT) scores were also assessed.
Results:
SYNAPSE enrolled 407 patients (mepolizumab=206; placebo=201) with impaired sense of smell at baseline. Improvements from baseline to study end in loss of smell VAS score were greater with mepolizumab versus placebo (treatment difference: -0.37) and most notable in patients with fewer or more recent prior surgeries (treatment difference: 1 vs 2 vs more than 2 prior surgeries,-1.29 vs -0.23 vs -0.07; =3 years since last surgery, -.89 vs 0.22). Approximately 25% of patients had baseline UPSIT scoresavailable; among those scoring =19 by study end. The SNOT-22 sense of smell/taste item score improved with mepolizumab versus placebo.
Conclusions:
Mepolizumab treatment improved patients' perceived sense of smell, as measured by loss of smell VAS score and SNOT-22 sense of smell/taste item score in patients with severe refractory CRSwNP.
Insights
Mepolizumab improved sense of smell in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP). This treatment demonstrated significant benefits in perceived smell, offering relief for a challenging symptom.
Area of Science:
- Otolaryngology
- Immunology
- Clinical Trials
Background:
- Severe chronic rhinosinusitis with nasal polyps (CRSwNP) significantly impacts quality of life, particularly due to olfactory dysfunction.
- Loss of smell is a persistent and difficult-to-manage symptom in CRSwNP patients.
Purpose of the Study:
- To evaluate the efficacy of mepolizumab in improving olfactory function in adults with severe bilateral CRSwNP.
- To assess changes in patient-reported smell loss and objective smell identification scores.
Main Methods:
- A 52-week, Phase III, randomized, placebo-controlled study (SYNAPSE) involving 407 adults with severe bilateral CRSwNP.
- Patients received mepolizumab (100 mg subcutaneously) or placebo, alongside standard care.
- Post hoc analysis focused on changes in smell visual analogue scale (VAS), SinoNasal Outcomes Test (SNOT)-22, and University of Pennsylvania Smell Identification Test (UPSIT) scores.
Main Results:
- Mepolizumab showed greater improvement in loss of smell VAS scores compared to placebo (treatment difference: -0.37).
- Improvements were most pronounced in patients with fewer prior surgeries or those more recently operated on.
- The SNOT-22 sense of smell/taste item score also improved with mepolizumab treatment.
Conclusions:
- Mepolizumab is an effective treatment for improving perceived sense of smell in patients with severe refractory CRSwNP.
- The study confirms mepolizumab's benefit in addressing olfactory dysfunction, a key symptom of CRSwNP.
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