Tezepelumab Shows Promise in Severe Nasal Polyposis and Asthma: Reduces Surgery, Steroid Use, and Inflammation
Tezepelumab Shows Promise in Severe Nasal Polyposis and Asthma: Reduces Surgery, Steroid Use, and Inflammation.
Source: Medscape Medical News
& published in The New England Journal of Medicine and presented at the 2025 AAAAI/WAO annual meeting.
Date: May 15, 2025
1. Study Overview:
• The phase 3 WAYPOINT trial evaluated tezepelumab (Tezspire) in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP).
2. Mechanism of Action:
• Tezepelumab is a first-in-class monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), a key upstream cytokine in airway inflammation.
• Developed by AstraZeneca and Amgen.
3. Trial Design:
• Randomized, double-blind, placebo-controlled, multicenter trial.
• Patients received tezepelumab or placebo for 52 weeks, with a follow-up period of 12–24 weeks.
4. Primary Outcomes:
• Significant reduction in nasal polyp (NP) severity by −2.065 points (P < .0001).
• 88% reduction in systemic corticosteroid use (P < .0001).
• Improvements began as early as week 2 (nasal congestion) and week 4 (NP score), sustained through week 52.
5. Secondary Outcomes:
• 98% reduction in need for nasal polyp surgery (P < .0001).
• Continued 88% corticosteroid use reduction.
• Improved SNOT-22 scores and olfactory function.
6. Expert Commentary:
• Dr. Geoffrey Mortuaire (Lille University Hospital, France) stated tezepelumab shows potential to reduce surgeries and systemic steroid use, with rapid, sustained clinical response.
7. Safety Profile:
• Generally well tolerated, with a safety profile similar to its use in asthma.
• Common adverse events: COVID-19, nasopharyngitis, and upper respiratory infections.
• No significant safety differences between treatment and placebo groups.
8. Current Approval & Future Outlook:
• Already approved for severe asthma in over 60 countries.
• Regulatory applications for severe nasal polyposis under review in multiple regions.
9. Approved Use in Severe Asthma:
• Tezepelumab is approved as an add-on maintenance therapy for severe asthma in adults and adolescents aged 12 years and older.
• It is indicated for patients who remain uncontrolled despite high-dose inhaled corticosteroids and additional maintenance therapies.
• The drug has demonstrated efficacy in reducing asthma exacerbations, improving lung function, and decreasing eosinophilic inflammation — regardless of baseline eosinophil count.
• It is approved in the United States, Europe, Japan, and more than 60 countries worldwide.
