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Randomized Controlled Trial
. 2023 Mar;78(3):812-821.
doi: 10.1111/all.15434. Epub 2022 Jul 27.

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

Wytske J Fokkens  1 , Joaquim Mullol  2 , David Kennedy  3 , Carl Philpott  4   5 , Veronica Seccia  6 , Robert C Kern  7 , André Coste  8 , Ana R Sousa  9 , Peter H Howarth  10   11 , Victoria S Benson  12 , Bhabita Mayer  13 , Steve W Yancey  14 , Robert Chan  9 , Simon B Gane  15   16
Affiliations
Randomized Controlled Trial

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

Wytske J Fokkens et al. Allergy. 2023 Mar.

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.

Keywords: chronic rhinosinusitis with nasal polyps; mepolizumab; recurrence; refractory; sinonasal surgery.

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References

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