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Stapokibart improves sleep quality in patients with chronic rhinosinusitis with nasal polyps

In a post hoc analysis of the phase 3 CROWNS-2 study, stapokibart significantly improved SNOT-22 Sleep domain scores compared with placebo during the 24-week double-blind period. These improvements were maintained and further progressed during the open-label extension and safety follow-up periods, indicating sustained benefit for sleep quality.

Last updated: Jul 7, 2026โ€ข1 RCTsโ€ข๐Ÿ“– Read as article โ†’

Evidence Score

Evidence Score42/100
Human RCTโ˜…โ˜…โ˜†โ˜†โ˜†
Meta-analysisโ˜†โ˜†โ˜†โ˜†โ˜†
Mechanismโ˜…โ˜…โ˜…โ˜…โ˜…
Safetyโ˜…โ˜…โ˜…โ˜…โ˜†
Confidencelow

Study Evidence

Study 1. [Quality of life improvement with stapokibart in chronic rhinosinusitis with nasal polyps: a post hoc analysis of phase 3 CROWNS-2 study].

observational

Yan B, Jin Z, Zhang L, Wang C ยท Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery (2026)

Participants: N/A
Duration: 24 weeks double-blind, plus 28 weeks open-label, plus 8-week follow-up
Intervention: Stapokibart (anti-IL-4Rฮฑ monoclonal antibody) 300 mg every 2 weeks for 24 weeks, followed by open-label extension for 28 weeks
Outcome: 22-item sinonasal outcome test (SNOT-22) domain scores: Nasal, Ear/facial, Sleep, and Emotion
Effect Size: N/A (specific effect sizes not reported in abstract)
Population: Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the phase 3 CROWNS-2 study

Result:

Mechanism Graph

Stapokibart binds to IL-4 receptor ฮฑ subunit
โ†“
Blocks IL-4 and IL-13 signaling pathways
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Reduces type 2 inflammation in nasal and sinus mucosa
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Improves sinonasal symptoms including sleep disturbance

Limitations

  • โš Post hoc analysis, not pre-specified primary endpoint
  • โš No specific sleep quality metrics beyond SNOT-22 domain score
  • โš Limited generalizability due to single study design

Frequently Asked Questions

What is stapokibart?โ–ผ

Stapokibart is an anti-interleukin-4 receptor ฮฑ monoclonal antibody that blocks IL-4 and IL-13 signaling pathways, used for treating chronic rhinosinusitis with nasal polyps.

How was sleep quality measured in this study?โ–ผ

Sleep quality was measured using the Sleep domain of the 22-item Sinonasal Outcome Test (SNOT-22), a validated patient-reported outcome instrument.

How long did the sleep improvements last?โ–ผ

Sleep improvements were maintained and further progressed during the 28-week open-label extension and subsequent 8-week safety follow-up period.

What is the CROWNS-2 study?โ–ผ

CROWNS-2 is a phase 3 randomized controlled trial evaluating stapokibart versus placebo in patients with chronic rhinosinusitis with nasal polyps, with a 24-week double-blind period followed by open-label extension.

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References

  1. 1.Yan B, Jin Z, Zhang L, Wang C. "[Quality of life improvement with stapokibart in chronic rhinosinusitis with nasal polyps: a post hoc analysis of phase 3 CROWNS-2 study].." Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery, 2026. PMID: 42402685 DOI: 10.13201/j.issn.2096-7993.2026.07.010
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.