Reduced need for surgery in severe nasal polyposis with mepolizumab: randomised trial

Publication date: Available online 4 July 2017
Source:Journal of Allergy and Clinical Immunology
Author(s): Claus Bachert, Ana R. Sousa, Valerie J. Lund, Glenis K. Scadding, Philippe Gevaert, Shuaib Nasser, Stephen R. Durham, Marjolein E. Cornet, Harsha H. Kariyawasam, Jane Gilbert, Daren Austin, Aoife C. Maxwell, Richard P. Marshall, Wytske J. Fokkens
BackgroundPatients with eosinophilic nasal polyposis frequently require surgery, and recurrence rates are high.ObjectiveTo assess the efficacy and safety of mepolizumab vs placebo for severe bilateral nasal polyposis.MethodsThis randomised, double-blind, placebo-controlled trial recruited patients aged 18−70 years with recurrent nasal polyposis requiring surgery. Patients received intravenous mepolizumab 750 mg or placebo every 4 weeks for a total of six doses, in addition to daily topical corticosteroid treatment. The primary endpoint was the number of patients no longer requiring surgery at Week 25, based on a composite endpoint of endoscopic nasal polyp score and nasal polyposis severity visual analogue scale (VAS) score. Secondary endpoints included change in nasal polyposis severity VAS score, endoscopic nasal polyp score, improvement in individual VAS symptoms (rhinorrhoea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes (PRO), and safety.Results105 patients received mepolizumab (n=54) or placebo (n=51). A significantly greater proportion of patients in the mepolizumab group compared with the placebo group no longer required surgery at Week 25 (16[30%] vs 5[10%], respectively; P=0.006). There was a significant improvement in nasal polyposis severity VAS score, endoscopic nasal polyp score, all individual VAS symptom scores, and sino-nasal outcome test [SNOT]-22 PRO score in the mepolizumab group compared with placebo. Mepolizumab’s safety profile was comparable to placebo.ConclusionIn patients with recurrent nasal polyposis on topical corticosteroids who required surgery, mepolizumab treatment led to a greater reduction in the need for surgery and a greater improvement in symptoms than placebo.Clinical implicationsResults suggest that mepolizumab treatment has the potential to improve quality of life and reduce surgery-associated burden for patients with severe nasal polyposis.

Teaser

This was the first study to show that mepolizumab treatment added to daily nasal corticosteroids offers a viable alternative to surgery in patients with severe, recurrent nasal polyposis requiring surgery.


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