Mepolizumab Associated With Significant Improvement of Chronic Rhinosinusitis With Nasal Polyps, Comorbidities

Patients with chronic rhinosinusitis with nasal polyps (CRSwNP), with and without comorbid asthma and aspirin-exacerbated respiratory disease (AERD), exhibited significantly improved outcomes when treated with mepolizumab, according to study findings published in Journal of Allergy and Clinical Immunology.

In the treatment of CRSwNP, the standard of care consists of topical intranasal corticosteroids, short courses of systemic corticosteroids, and endoscopic sinus surgery. Although these treatments may provide short-term relief, researchers said that additional treatment options are needed due to safety and symptom recurrence issues linked with these therapeutic approaches.

“Patients with severe CRSwNP and comorbid asthma, AERD, and patients who present with eosinophilic infiltration experience the greatest burden of disease,” they noted. “Of significance, these patients experience greater numbers of sinus surgeries, high corticosteroid use, and long-term disease recurrence with standard of care than patients without these disease characteristics.”

In findings of the phase 3, randomized, double-blind, 52-week SYNAPSE study, mepolizumab—a targeted, humanized anti–interleukin-5 (IL-5) monoclonal antibody—demonstrated efficacy and safety in the treatment of CRSwNP. Moreover, initial results showed promise in patients with comorbid asthma and a high baseline blood eosinophil count (BEC).

Researchers conducted an exploratory analysis to further assess the efficacy of 4-weekly subcutaneous mepolizumab 100 mg (n = 206) vs placebo plus standard of care (n = 201) in adults with severe, bilateral CRSwNP requiring revision surgery. Participants were stratified by the presence of comorbid asthma or comorbid AERD and by baseline BEC.

Primary end points assessed included the change in total endoscopic nasal polyp score at week 52 and nasal obstruction visual analog scale (VAS) score from weeks 49 to 52. “Subgroup analyses by comorbid asthma and AERD status, and post hoc by BEC, were exploratory,” they added.

Of the 407 patients included in the intention-to-treat population, 289 had comorbid asthma, 108 had AERD, and 371 and 278 reported BEC counts of at least 150 cells/mcL or at least 300 cells/mcL, respectively.

In their findings, a significantly greater proportion of patients from the mepolizumab group exhibited greater than or equal to 1-point improvement from baseline in nasal polyp score compared with the placebo group across comorbid conditions:

• Asthma: 52.9% vs 29.5%
• AERD: 51.1% vs 20.6%
• Baseline BEC subgroup of less than 150 cells/mcL: 55.0% vs 31.3%
• Baseline BEC subgroup of at least 150 cells/mcL: 49.5% vs 28.1%
• Baseline BEC subgroup of less than 300 cells/mcL: 50.7% vs 29.0%
• Baseline BEC subgroup of at least 300 cells/mcL: 50.4% vs 28.1%
  

A similar trend was observed in patients without comorbid asthma or AERD. Regarding the nasal obstruction VAS score, more patients overall showed a improvement greater than 3 points from baseline during weeks 49 to 52 with mepolizumab vs placebo (60.2% vs 36.3%; P < .0001). This trend was also similar patient subgroups, except for those with baseline BEC less than 150 cells/mcL.

Reference

Bachert C, Sousa AR, Han JK, et al. Mepolizumab for chronic rhinosinusitis with nasal polyps: treatment efficacy by comorbidity and blood eosinophil count. J Allergy Clin Immunol. Published online January 7, 2022. doi:10.1016/j.jaci.2021.10.040