Patients with CRSwNP see smaller nasal polyps, less congestion with tezepelumab-ekko
Click Here to Manage Email Alerts
Key takeaways:
- Patients had severe chronic rhinosinusitis with nasal polyps.
- Symptoms persisted prior to the study despite intranasal steroid use.
- Treatment was 52 weeks with a 12- to 24-week follow-up.
Patients with severe chronic rhinosinusitis with nasal polyps experienced significant improvements in their symptoms with tezepelumab-ekko compared with placebo, according to a press release from Amgen and AstraZeneca.
As a complex inflammatory condition, chronic rhinosinusitis with nasal polyps is characterized by persistent inflammation of the nasal mucosa and soft tissue growths, Joseph K. Han, MD, chief of the division of rhinology and endoscopic sinus and skull base surgery and division of allergy at Eastern Virginia Medical School, told Healio.
“Epithelial dysfunction and inflammation are important characteristics of chronic rhinosinusitis and impede the ability of the epithelium to act as a physical and immunological barrier against the external environment,” Han said.
Topical intranasal steroid and/or systemic corticosteroids and sinus surgery are commonly used to manage nasal polyps, he continued, but these therapies do not treat the underlying cause of the disease.
“For more severe disease, oral corticosteroids continue to be used, but are associated with serious systemic side effects,” Han said. “Some biologics have been approved by the FDA and EMA for the add-on therapy for treatment of adults with CRSwNP.”
Additionally, he said, CRSwNP has a negative impact on quality of life with disturbances in smell, taste and sleep as well as in pain, fatigue and depression. Tezepelumab-ekko (Tezspire; Amgen, AstraZeneca), he continued, is effective and safe for use in severe asthma.
Tezepelumab-ekko is unique as it blocks thymic stromal lymphopoietin, which may prevent immune cells from releasing pro-inflammatory cytokines, thereby reducing exacerbations and potentially improving disease control for patients with severe CRSwNP, Han said.
“This has the potential to help address a broad population of severe asthma and CRSwNP patients, irrespective of biomarker levels, by targeting all key drivers of inflammatory diseases,” he said.
The 408 adults with severe CRSwNP in the randomized, double-blind, multicenter, parallel group phase 3 WAYPOINT trial were symptomatic despite using intranasal steroids, which the researchers called the standard of care.
Patients had disease severity consistent with the need for surgery, with a total Nasal Polyps Score (NPS) of 5 or higher and a score of at least 2 for each nostril at screening, as determined by the central reader.
Patients also had a Nasal Congestion Score (NCS) of 2 or higher at the first visit and ongoing documented nasal polyp symptoms such as rhinorrhea and/or reduction or loss of smell for more than 8 weeks before screening.
Treatment included tezepelumab-ekko or placebo, administered through subcutaneous injection using an accessorized pre-filled syringe once every 4 weeks for 52 weeks followed by a 12- to 24-week follow-up period.
The companies reported statistically significant and clinically meaningful reductions in the size of the patients’ nasal polyps based on the endoscopic total NPS and reductions in nasal congestion based on the NCS and daily Nasal Polyposis Symptom Diary with tezepelumab-ekko compared with placebo.
Also, the safety profile and tolerability were consistent with the biologic’s known profile.
The researchers attributed tezepelumab-ekko’s success to its unique capacity for targeting multiple inflammatory pathways by acting directly at the epithelium, which they said yielded meaningful symptom relief that can improve patients’ daily experiences.
The burdens of CRSwNP include repeat surgeries as well as frequent and high doses of oral corticosteroids, the companies said, which have been associated with serious systemic side effects. Tezepelumab-ekko, they continued, may reduce these burdens.
“The results from the WAYPOINT trial support tezepelumab’s potential as an important new treatment to benefit patients whose lives are disrupted by CRSwNP and may signal that it differs from other biologics approved for the treatment of CRSwNP,” Han said.
The companies said they will share the full results with regulatory authorities and the scientific community at an upcoming medical meeting.
“We look forward to sharing full results from the trial with the scientific community and regulatory authorities around the world to bring tezepelumab to CRSwNP patients as quickly as possible,” Han said.