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Dupilumab in CRSwNP : responder analysis using clinically meaningful efficacy outcome thresholds

Chien‐Chia Chuang, Isabelle Guillemin, Claus Bachert (UGent) , Stella E. Lee, Peter Hellings (UGent) , Wytske J. Fokkens, Nicolas Duverger, Chunpeng Fan, Nadia Daizadeh, Nikhil Amin, et al.
(2022) LARYNGOSCOPE. 132(2). p.259-264
Author
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Abstract
Objectives/Hypothesis Dupilumab, a fully human monoclonal antibody that blocks the shared interleukin (IL)-4/IL-13 receptor component, significantly improved outcomes for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the SINUS-24 and SINUS-52 studies. This post hoc analysis evaluated dupilumab's effect on patient-reported symptoms and objective outcome measures using thresholds of clinically meaningful within-patient change from baseline. Methods Patients with CRSwNP receiving subcutaneous dupilumab or placebo every 2 weeks in SINUS-24/SINUS-52 were analyzed. Patients recorded severity of nasal congestion (NC), loss of smell (LoS), and anterior/posterior rhinorrhea (each within range 0-3) daily. Total Symptom Score (TSS) was calculated as a composite severity score (0-9) for these symptoms. Objective measures included University of Pennsylvania Smell Identification Test (UPSIT; 0-40), nasal polyps score (NPS; 0-8), and Lund-Mackay computed tomography score (LMK-CT; 0-24). Thresholds of within-patient change in scores from baseline at weeks 24 and 52 considered clinically meaningful were >= 1.0 (NC, LoS), >= 3.0 (TSS), >= 8.0 (UPSIT), >= 1.0 (NPS), and >= 5.0 (LMK-CT). Results A total of 724 and 303 patients were included in the week 24 and 52 analyses, respectively. Responder rates were significantly higher with dupilumab versus placebo at week 24 for NC (64% vs. 24%), LoS (63% vs. 14%), TSS (62% vs. 15%), UPSIT (54% vs. 6%), NPS (63% vs. 14%), and LMK-CT (59% vs. 3%); all P < .0001. Results were consistent at week 52. Conclusion Significantly greater proportions of dupilumab-treated patients with CRSwNP compared with placebo demonstrated clinically meaningful improvements in patient-reported sinonasal symptoms and objective outcomes. Level of Evidence 2 Laryngoscope, 2021
Keywords
Otorhinolaryngology, Adult rhinology, quality of life, nose and paranasal sinuses, CHRONIC RHINOSINUSITIS, SURGERY, PREVALENCE, SYMPTOMS

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MLA
Chuang, Chien‐Chia, et al. “Dupilumab in CRSwNP : Responder Analysis Using Clinically Meaningful Efficacy Outcome Thresholds.” LARYNGOSCOPE, vol. 132, no. 2, 2022, pp. 259–64, doi:10.1002/lary.29911.
APA
Chuang, C., Guillemin, I., Bachert, C., Lee, S. E., Hellings, P., Fokkens, W. J., … Kamat, S. (2022). Dupilumab in CRSwNP : responder analysis using clinically meaningful efficacy outcome thresholds. LARYNGOSCOPE, 132(2), 259–264. https://doi.org/10.1002/lary.29911
Chicago author-date
Chuang, Chien‐Chia, Isabelle Guillemin, Claus Bachert, Stella E. Lee, Peter Hellings, Wytske J. Fokkens, Nicolas Duverger, et al. 2022. “Dupilumab in CRSwNP : Responder Analysis Using Clinically Meaningful Efficacy Outcome Thresholds.” LARYNGOSCOPE 132 (2): 259–64. https://doi.org/10.1002/lary.29911.
Chicago author-date (all authors)
Chuang, Chien‐Chia, Isabelle Guillemin, Claus Bachert, Stella E. Lee, Peter Hellings, Wytske J. Fokkens, Nicolas Duverger, Chunpeng Fan, Nadia Daizadeh, Nikhil Amin, Leda P. Mannent, Asif H. Khan, and Siddhesh Kamat. 2022. “Dupilumab in CRSwNP : Responder Analysis Using Clinically Meaningful Efficacy Outcome Thresholds.” LARYNGOSCOPE 132 (2): 259–264. doi:10.1002/lary.29911.
Vancouver
1.
Chuang C, Guillemin I, Bachert C, Lee SE, Hellings P, Fokkens WJ, et al. Dupilumab in CRSwNP : responder analysis using clinically meaningful efficacy outcome thresholds. LARYNGOSCOPE. 2022;132(2):259–64.
IEEE
[1]
C. Chuang et al., “Dupilumab in CRSwNP : responder analysis using clinically meaningful efficacy outcome thresholds,” LARYNGOSCOPE, vol. 132, no. 2, pp. 259–264, 2022.
@article{8732777,
  abstract     = {{Objectives/Hypothesis Dupilumab, a fully human monoclonal antibody that blocks the shared interleukin (IL)-4/IL-13 receptor component, significantly improved outcomes for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the SINUS-24 and SINUS-52 studies. This post hoc analysis evaluated dupilumab's effect on patient-reported symptoms and objective outcome measures using thresholds of clinically meaningful within-patient change from baseline. Methods Patients with CRSwNP receiving subcutaneous dupilumab or placebo every 2 weeks in SINUS-24/SINUS-52 were analyzed. Patients recorded severity of nasal congestion (NC), loss of smell (LoS), and anterior/posterior rhinorrhea (each within range 0-3) daily. Total Symptom Score (TSS) was calculated as a composite severity score (0-9) for these symptoms. Objective measures included University of Pennsylvania Smell Identification Test (UPSIT; 0-40), nasal polyps score (NPS; 0-8), and Lund-Mackay computed tomography score (LMK-CT; 0-24). Thresholds of within-patient change in scores from baseline at weeks 24 and 52 considered clinically meaningful were >= 1.0 (NC, LoS), >= 3.0 (TSS), >= 8.0 (UPSIT), >= 1.0 (NPS), and >= 5.0 (LMK-CT). Results A total of 724 and 303 patients were included in the week 24 and 52 analyses, respectively. Responder rates were significantly higher with dupilumab versus placebo at week 24 for NC (64% vs. 24%), LoS (63% vs. 14%), TSS (62% vs. 15%), UPSIT (54% vs. 6%), NPS (63% vs. 14%), and LMK-CT (59% vs. 3%); all P < .0001. Results were consistent at week 52. Conclusion Significantly greater proportions of dupilumab-treated patients with CRSwNP compared with placebo demonstrated clinically meaningful improvements in patient-reported sinonasal symptoms and objective outcomes. Level of Evidence 2 Laryngoscope, 2021}},
  author       = {{Chuang, Chien‐Chia and Guillemin, Isabelle and Bachert, Claus and Lee, Stella E. and Hellings, Peter and Fokkens, Wytske J. and Duverger, Nicolas and Fan, Chunpeng and Daizadeh, Nadia and Amin, Nikhil and Mannent, Leda P. and Khan, Asif H. and Kamat, Siddhesh}},
  issn         = {{0023-852X}},
  journal      = {{LARYNGOSCOPE}},
  keywords     = {{Otorhinolaryngology,Adult rhinology,quality of life,nose and paranasal sinuses,CHRONIC RHINOSINUSITIS,SURGERY,PREVALENCE,SYMPTOMS}},
  language     = {{eng}},
  number       = {{2}},
  pages        = {{259--264}},
  title        = {{Dupilumab in CRSwNP : responder analysis using clinically meaningful efficacy outcome thresholds}},
  url          = {{http://doi.org/10.1002/lary.29911}},
  volume       = {{132}},
  year         = {{2022}},
}
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