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Clinical Question
Does mepolizumab treatment reduce the need for surgery in adults with severe nasal polyposis?
Bottom line
Treatment with mepolizumab (Nucala) reduces the need for repeat surgery in adults with severe recurrent nasal polyposis recalcitrant to intranasal or systemic steroids. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry
Setting: Outpatient (specialty)
Synopsis
Intranasal and systemic corticosteroids are the mainstays of treatment for nasal polyposis, with surgery reserved for patients who do not respond to medical treatment. These investigators identified adults, aged 18 to 70 years, with severe recurrent bilateral nasal polyposis, defined as being refractory to intranasal steroids or oral steroids for 3 or more months and with a history of at least one previous nasal polyp removal surgery. Eligible patients (N = 107) who met a defined criteria for repeat surgery (including an endoscopic nasal polyp score and a nasal polyposis severity visual analog scale [VAS] score) randomly received (concealed allocation assignment) an intravenous infusion of mepolizumab 750 mg every 4 weeks for 6 doses or matched placebo. Intranasal steroids were continued throughout the study period. Individuals who assessed outcomes remained masked to treatment group assignment. Follow-up occurred for 98.1% of patients at 25 weeks. Using intention-to-treat analysis, significantly more patients in the mepolizumab group than in the placebo group no longer met the criteria for repeat surgery at week 25 (30% vs 10%; number needed to treat = 5.0; 95% CI 2.9 - 19.5). In addition, the mepolizumab group had improvement in VAS symptom scores, nasal polyp scores, and individual symptom scores (rhinorrhea, mucus in throat, nasal blockage, and loss of smell). No serious adverse events occurred, and study discontinuation rates due to treatment-related adverse events were similar between the 2 groups.
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
Good poem
Malgré le fait que les résultats sont bons, je demanderais tout de même à mes collègues ORL avant de prescrire ce traitement.
It would be nice to see financial comparison and potential side effects of the industry sponsored medication.
bad poem
No assessment of the cost of the new Rx. A quick search shows cost of 8000 to 32000 per year ... and a per month wholesale cost of 2500. Not sure Canadian price is exactly -- but not cheap for sure. Given NTT is 5 .. the cost probably pales in comparison with the cost of surgery.
There is a limit to what we as a society afford ... cost effectiveness of any new treatment should be front and center or at least a strong second place.
Excellent