Tezepelumab alleviates symptoms in severe chronic rhinosinusitis with nasal polyps

1. In this randomized controlled trial, among patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps, tezepelumab more effectively reduced nasal polyp size and sinonasal symptoms compared to placebo.

2. Tezepelumab led to greater reductions in the use of nasal polyp surgery and systemic glucocorticoids compared to placebo.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Chronic rhinosinusitis with nasal polyps is an inflammatory disease of the upper airway characterized by nasal congestion, facial pain, loss of smell, impaired sleep, and fatigue. Treatment currently involves intranasal glucocorticoids, but these have limited effects on nasal polyp size. More recently, biologics have emerged as a new treatment option, but available biologic treatments show varied efficacy in patients with severe disease, and there remains an unmet need for patients who have an inadequate response to these agents. Thymic stromal lymphopoietin (TSLP) is a key driver of multiple inflammatory cascades and may represent a therapeutic target, with elevated levels of TSLP having been found in nasal polyp tissue samples from patients with chronic rhinosinusitis. Tezepelumab is a human monoclonal antibody that blocks TSLP from interacting with its receptor. The present trial assessed the efficacy and safety of tezepelumab compared with placebo among patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps. Compared with placebo, tezepelumab was more effective in reducing nasal polyp size, nasal congestion severity, and patient-reported sinonasal symptoms. Additionally, tezepelumab was found to be safe, with adverse events being similar between the two groups. Limitations of the study included the lack of characterization of asthma severity despite most participants having coexisting asthma, limiting analyses regarding this patient subgroup. Nevertheless, these findings serve as a valuable step in demonstrating the clinical value of tezepelumab as a therapy for chronic rhinosinusitis with nasal polyps.

Click to read the study in NEJM

In-Depth [randomized controlled trial]: This randomized controlled trial assessed the efficacy and safety of tezepelumab compared with placebo among patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps. Adult patients with physician-diagnosed chronic rhinosinusitis with nasal polyps for at least 12 months prior to screening, at a severity level consistent with a need for surgery, who had been receiving standard-care treatment for at least 30 days were included. The primary outcomes were the changes from baseline in endoscopic total nasal polyp score and patient-reported mean nasal-congestion score at week 52. A total of 408 patients were included in the study, with 203 assigned to receive tezepelumab and 205 assigned to receive a placebo. At 52 weeks, the change from baseline in total nasal-polyp score was significantly greater in the tezepelumab group than the placebo group (least-squares mean difference, -2.07; 95% Confidence Interval [CI], -2.39 to -1.74). The change in nasal-congestion score was also significantly greater in the tezepelumab group compared with placebo (least-squares mean difference, -1.03; 95% CI, -1.20 to -0.86). Tezepelumab was also associated with significantly less nasal-polyp surgery and systemic glucocorticoid use compared with placebo. With regard to safety, serious adverse events occurred in 4.9% of patients in the tezepelumab group compared with 5.9% in the placebo group. In summary, among patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps, tezepelumab was shown to be safe and more effective than placebo, leading to reductions in both nasal polyp size and nasal congestion.

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