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Stapokibart improves quality of life, including sleep, 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 domain scores for nasal, ear/facial, sleep, and emotion compared to placebo during the 24-week double-blind period. These improvements were maintained or further improved during the open-label extension and safety follow-up periods, indicating sustained clinical benefit.

Last updated: Jul 9, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score44/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
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 · 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-4Rα 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:

PubMed: 42402685DOI: 10.13201/j.issn.2096-7993.2026.07.010

Mechanism Graph

Stapokibart binds to IL-4 receptor α subunit
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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 and quality of life domains including sleep

Limitations

  • ⚠Post hoc analysis, not pre-specified primary endpoint
  • ⚠Abstract does not report effect sizes or statistical details for sleep domain specifically

Frequently Asked Questions

What is stapokibart?▼

Stapokibart is an anti-interleukin-4 receptor α (IL-4Rα) monoclonal antibody that blocks IL-4 and IL-13 signaling pathways, used to treat chronic rhinosinusitis with nasal polyps.

How does stapokibart improve sleep in CRSwNP patients?▼

By reducing nasal congestion, rhinorrhea, and facial pain/pressure, stapokibart alleviates symptoms that interfere with sleep, as measured by the SNOT-22 sleep domain.

What is the SNOT-22?▼

The 22-item sinonasal outcome test is a validated questionnaire assessing quality of life in sinonasal conditions, covering domains such as nasal symptoms, ear/facial symptoms, sleep, and emotion.

Is this study based on a randomized controlled trial?▼

Yes, the CROWNS-2 study is a phase 3 randomized controlled trial, but this analysis is a post hoc analysis of that trial.

Products

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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.