In the Phase 3 trials SKYLIGHT 1 and 2 (pooled data) and DAYLIGHT, fezolinetant demonstrated improvements over placebo in Menopause-Specific Quality of Life (MENQoL) Total and Domain scores, and Patient Global Impression of Change in vasomotor symptoms (PGI-C VMS)
Note that the below analyses do not control the type I error rate, i.e. without multiplicity adjustment, so p-values do not confer statistical significance. Rather, the p-values were used for the purposes of hypothesis generation.
Pooled SKYLIGHT 1 and 2 data
Figure 1: Change from Baseline to Weeks 4 and 12 in MENQoL Total Scorea1
All randomized participants assessed according to the randomization at first dose (fezolinetant 30 mg n = 339; fezolinetant 45 mg n = 341; placebo n = 342). Negative change indicates an improvement from baseline. aComprises all four domains and 29 items. Adapted from: Cano A, BJOG 2024.
Figure 2. Change from baseline to Week 12 in MENQoL Domain Scores1
All randomized participants assessed according to the randomization at first dose (fezolinetant 30 mg n = 339; fezolinetant 45 mg n = 341; placebo n = 342). Negative change indicates an improvement from baseline. Adapted from: Cano A, BJOG 2024.
PGI-C VMS
Figure 3: PGI-C VMS distribution at Week 4 and 121
Week 4:
Week 12:
p < 0.001 for fezolinetant 30 mg versus placebo and for fezolinetant 45 mg versus placebo at Weeks 4 and 12. Pvalues were obtained using Cochran-Mantel-Haenszel test with modified ridit scores. Adapted from: Cano A, BJOG 2024
DAYLIGHT data
Figure 4. Change from baseline to Week 24 in MENQoL Total Scorea2
All randomized participants assessed according to the randomization at first dose (fezolinetant 45 mg n = 226; placebo n = 226). Negative change indicates an improvement from baseline. aComprises all four domains and 29 items. Adapted from: Shapiro M, Maturitas 2024.
Figure 5. Change from baseline to Week 24 in MENQoL Domain Scores2
All randomized participants assessed according to the randomization at first dose (fezolinetant 45 mg n = 226; placebo n = 226). Negative change indicates an improvement from baseline. Adapted from: Shapiro M, Maturitas 2024.
Figure 6. PGI-C VMS distribution at Week 243
All randomized participants assessed according to the randomization at first dose (fezolinetant 45 mg n = 226; placebo n = 226). Adapted from: Schaudig K, BMJ 2024.
Cano A, Nappi RE, Santoro N, et al. Fezolinetant impact on health‐related quality of life for vasomotor symptoms due to the menopause: Pooled data from SKYLIGHT 1 and SKYLIGHT 2 randomised controlled trials. BJOG: Int. J. Obstet. Gynaecol. 2024; Available at: https://doi.org/10.1111/1471-0528.17773.
Shapiro M, Wu X, Wang X, et al. Effect of fezolinetant on patient-reported quality-of-life outcomes: Data from a phase 3b study (DAYLIGHT) of the treatment of moderate to severe vasomotor symptoms associated with menopause in women considered unsuitable for hormone therapy. Maturitas. 2024; Available at: https://doi.org/10.1016/j.maturitas.2024.108159.
Schaudig K, Wang X, Bouchard C, et al. Efficacy and safety of fezolinetant for moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy: phase 3b randomised controlled trial. BMJ (Clin. Res. ed). 2024;387:e079525. Available at: https://doi.org/10.1136/bmj-2024-079525.
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