What is the effect of fezolinetant on patient-reported outcomes?

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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)

  • Health-related quality of life (HRQoL) assessments were exploratory endpoints of these studies during the double-blind periods.1,2 

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

  • Improvements in PGI-C VMS were larger for fezolinetant 45 mg versus placebo, including both ‘moderately better’ and ‘much better’ responses (Figure 3).
  • The number of PGI-C VMS responders (those indicating they felt ‘much better’, the highest response category) was greater for fezolinetant than for placebo.
    • At Week 4, the number of PGI-C VMS responders was 140 of 319 (43.9%) in the fezolinetant 45 mg group and 57 of 311 (18.3%) for placebo.
    • At Week 12, 47.5% (144/303 women) in the fezolinetant 45 mg group were responders compared with 23.9% (70/293 women) in the placebo group.

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.

  • At Week 24, the most common response was ‘much better’ on the PGI-C VMS in participants receiving fezolinetant (62.4% [123/197 women] in the fezolinetant group versus 39.9% [71/178 women] in the placebo group) (Figure 6).

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.

  1. 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.

  2. 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.

  3. 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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