International forum of allergy & rhinology · 2026
Early and Sustained Improvements in Sense of Smell With Tezepelumab Treatment in Patients With Chronic Rhinosinusitis With Nasal Polyps (WAYPOINT).
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Mullol Joaquim, Han Joseph K, Laidlaw Tanya M, Hopkins Claire, Peters Anju T, Pfaar Oliver, Desrosiers Martin, Lee Stella E, Lane Andrew P, Chen Claudia, Chon Yun, Ponnarambil Sandhia S, Foster Andrew, Lindsley Andrew W, Ambrose Christopher S
Аннотация
BACKGROUND: Loss of smell is a principal symptom of chronic rhinosinusitis with nasal polyps (CRSwNP), affecting health-related quality of life and posing a safety hazard.
METHODS: WAYPOINT (NCT04851964), a phase 3, multicenter trial in adults with uncontrolled CRSwNP, randomized patients 1:1 to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. Changes from baseline in biweekly mean Nasal Polyposis Symptom Diary (NPSD) loss of smell item, University of Pennsylvania Smell Identification Test (UPSIT), and 22-item Sino-Nasal Outcome Test (SNOT-22) loss of smell/taste item scores, as well as anosmia (UPSIT score ≤18) prevalence, were assessed over 52 weeks.
RESULTS: Among 408 patients (tezepelumab [n = 203]; placebo [n = 205]), significant improvements with tezepelumab versus placebo in NPSD loss of smell item, UPSIT, and SNOT-22 loss of smell/taste item scores were seen at week 4 (least-squares mean [LSM] treatment difference [95% CI]: -0.36 [-0.46, -0.27]; 6.03 [4.72, 7.34]; and -1.01 [-1.22, -0.80], respectively) and week 52 (-1.01 [-1.18, -0.83]; 9.50 [7.84, 11.16]; and -1.90 [-2.20, -1.61]); all nominal p < 0.0001. Between-treatment differences in daily NPSD loss of smell item score were evident from day 7 (LSM treatment difference: -0.08 [95% CI: -0.15, -0.02]; nominal p < 0.01). Improvements in NPSD loss of smell, UPSIT, and SNOT-22 loss of smell/taste item scores were observed across multiple prespecified subgroups. Anosmia prevalence was lower with tezepelumab than placebo at week 4 (43.0% [n/N = 64/149] vs. 80.3% [n/N = 106/132]) and week 52 (31.5% [n/N = 47/149] vs. 75.8% [n/N = 100/132]).
CONCLUSIONS: Tezepelumab provides early and sustained improvements in sense of smell among patients with uncontrolled CRSwNP.
METHODS: WAYPOINT (NCT04851964), a phase 3, multicenter trial in adults with uncontrolled CRSwNP, randomized patients 1:1 to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. Changes from baseline in biweekly mean Nasal Polyposis Symptom Diary (NPSD) loss of smell item, University of Pennsylvania Smell Identification Test (UPSIT), and 22-item Sino-Nasal Outcome Test (SNOT-22) loss of smell/taste item scores, as well as anosmia (UPSIT score ≤18) prevalence, were assessed over 52 weeks.
RESULTS: Among 408 patients (tezepelumab [n = 203]; placebo [n = 205]), significant improvements with tezepelumab versus placebo in NPSD loss of smell item, UPSIT, and SNOT-22 loss of smell/taste item scores were seen at week 4 (least-squares mean [LSM] treatment difference [95% CI]: -0.36 [-0.46, -0.27]; 6.03 [4.72, 7.34]; and -1.01 [-1.22, -0.80], respectively) and week 52 (-1.01 [-1.18, -0.83]; 9.50 [7.84, 11.16]; and -1.90 [-2.20, -1.61]); all nominal p < 0.0001. Between-treatment differences in daily NPSD loss of smell item score were evident from day 7 (LSM treatment difference: -0.08 [95% CI: -0.15, -0.02]; nominal p < 0.01). Improvements in NPSD loss of smell, UPSIT, and SNOT-22 loss of smell/taste item scores were observed across multiple prespecified subgroups. Anosmia prevalence was lower with tezepelumab than placebo at week 4 (43.0% [n/N = 64/149] vs. 80.3% [n/N = 106/132]) and week 52 (31.5% [n/N = 47/149] vs. 75.8% [n/N = 100/132]).
CONCLUSIONS: Tezepelumab provides early and sustained improvements in sense of smell among patients with uncontrolled CRSwNP.