Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): In-depth sinus surgery analysis.

Abstract

BACKGROUND:

Patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) often require repeat sinus surgery. Mepolizumab reduced the need for sinus surgery in the SYNAPSE trial; this analysis sought to provide a more in-depth assessment of surgery endpoints in SYNAPSE.

METHODS:

SYNAPSE was a double-blind Phase III trial (NCT03085797) in adults with recurrent, refractory, severe, CRSwNP eligible for repeat sinus surgery despite standard of care treatments and previous surgery. Patients were randomized (1:1) to mepolizumab 100 mg subcutaneously or placebo, plus standard of care, every 4 weeks for 52 weeks. Time to first inclusion on a waiting list for sinus surgery and time to first actual sinus surgery (both up to week 52) were assessed; the latter endpoint was also analyzed post hoc according to time since last sinus surgery before study screening and baseline blood eosinophil count.

RESULTS:

Among 407 patients (mepolizumab: 206; placebo: 201), mepolizumab versus placebo reduced the risk of being included on a waiting list for sinus surgery (week 52 Kaplan-Meier probability estimate [95% confidence interval]: 13.9% [9.8%, 19.5%] vs. 28.5% [22.7%, 35.4%]). Mepolizumab versus placebo reduced the risk of sinus surgery irrespective of time (<3 vs ≥3 years) since patients' last sinus surgery prior to study screening (hazard ratios [95% confidence intervals] 0.28 [0.09, 0.84] and 0.50 [0.26, 0.98], respectively) and baseline blood eosinophil count.

CONCLUSIONS:

Mepolizumab reduced the risk of further sinus surgery in patients with recurrent, refractory, severe CRSwNP, irrespective of the patient baseline characteristics assessed.

• Authors: Wytske J Fokkens, Joaquim Mullol, David Kennedy, Carl Philpott, Veronica Seccia, Robert C Kern, André Coste, Ana R Sousa, Peter H Howarth, Victoria S Benson, Bhabita Mayer, Steve W Yancey, Robert Chan, Simon B Gane
• Journal: Allergy (Allergy) Vol. 78 Issue 3 Pg. 812-821 (03 2023) ISSN: 1398-9995 [Electronic] Denmark
• PMID: 35822924 (Publication Type: Randomized Controlled Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2022 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

Chemical References

• mepolizumab
• Antibodies, Monoclonal, Humanized

Topics

• Adult
• Humans
• Nasal Polyps (complications, drug therapy, surgery)
• Sinusitis (complications, drug therapy, surgery)
• Chronic Disease
• Antibodies, Monoclonal, Humanized (adverse effects)
• Rhinitis (complications, drug therapy, surgery)