The monoclonal antibody blocks a key inflammatory process involved in the condition, say experts.
New international research suggests that monthly injections of tezepelumab reduce nasal polyp size and nasal congestion in patients with severe chronic rhinosinusitis and nasal polyps.
“Biologic therapies have transformed approaches to treatment by directly addressing the underlying inflammatory mechanisms associated with severe chronic rhinosinusitis associated with nasal polyps,” the researchers wrote in the NEJM.
Tezepelumab, a human monoclonal antibody that blocks the inflammatory effects of thymic stromal lymphopoietin (TSLP) has been found to be effective at treating sinonasal symptoms in patients with severe and uncontrolled asthma. But less is known about its efficacy and safety in patients with chronic rhinosinusitis and nasal polyps, another inflammatory disease affecting the upper airway.
As part of the phase 3 trial, researchers recruited over 400 patients with chronic rhinosinusitis and nasal polyps from over 100 sites in 10 different countries, including Canada, Germany and Japan. Patients received subcutaneous injections of tezepelumab or placebo every four weeks for 12 months.
Patients in tezepelumab group saw improvements in the two primary endpoints compared to placebo, displaying a two point reduction in the expected mean of an endoscopically-assessed nasal polyp score (ranging from zero [no nasal polyps] to four [large polyps causing complete or near-complete obstructions]) and a one point reduction in the expected mean of a self-reported nasal congestion score (ranging from zero [no congestion] to three [severe congestion]).
The improvements in both the nasal polyp and congestion scores were seen within the first month of starting the tezepelumab treatment and continued for the remainder of the assessment period.
The researchers felt that the beneficial effects of tezepelumab could be attributed to its anti-inflammatory effects.
“These findings… suggest that the reduction in multiple downstream inflammatory signalling may modify disease severity,” they wrote.
Tezepelumab also led to a one-point improvement in the expected mean of a self-reported loss of smell score and a 27-point improvement in the 22-item Sinonasal Outcome Test (SNOT-22, ranging from zero to 110 – where higher scores indicate greater symptom severity) total score.
A smaller proportion of patients who received tezepelumab were treated with nasal polyp surgery or systemic glucocorticoids compared to placebo (6% versus 31%).
“Treatment with systemic glucocorticoids and nasal polyp surgery does not address the underlying inflammatory processes in patients with severe chronic rhinosinusitis with nasal polyps. Furthermore, long-term glucocorticoid use is associated with adverse side effects,” the researchers noted.
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Three in four patients reported experiencing adverse events, and there were similar rates of adverse events between the tezepelumab and placebo groups (78% versus 77%). The most common adverse events included nasopharyngitis, upper respiratory tract infection, headache, epistaxis and worsening of chronic rhinosinusitis with nasal polyps – with the last adverse event being more common in patients who received the placebo compared to active treatment (23% versus 5%).
Roughly 70 patients (the majority of whom received the placebo) discontinued treatment. The most common reason for discontinuing treatment across all patients was to undergo nasal polyp surgery.
