In pooled data from the Phase 3 SKYLIGHT 1 and 2 trials, although disturbed sleep was not a prerequisite for study inclusion, a beneficial effect of fezolinetant was observed on four measures of patient-reported sleep disruption: PROMIS SD SF 8b total score, PROMIS SRI SF 8a total score, PGI-C SD, and PGI-S SD

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In pooled data from the Phase 3 SKYLIGHT 1 and 2 trials, although disturbed sleep was not a prerequisite for study inclusion, a beneficial effect of fezolinetant was observed on four measures of patient-reported sleep disruption: PROMIS SD SF 8b total score, PROMIS SRI SF 8a total score, PGI-C SD, and PGI-S SD

In the Phase 3 SKYLIGHT 1 and 2 trials, patient-reported sleep disturbance and impairment were assessed using one key secondary endpoint (Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b [PROMIS SD SF 8b]), and three exploratory endpoints (PROMIS Sleep-Related Impairment - Short Form 8a [PROMIS SRI SF 8a], Patient Global Impression of Change - Sleep Disturbance [PGI-C SD] and Patient Global Impression of Severity - Sleep Disturbance [PGI-S SD]).^1–3
In SKYLIGHT 1, improvements in patient-reported sleep disturbance in fezolinetant-treated participants were observed but generally did not reach statistical significance.²
In SKYLIGHT 2, fezolinetant 45 mg significantly reduced PROMIS SD SF 8b total score from baseline at Weeks 4 and 12 compared with placebo (p ≤ 0.007).¹

Detailed results for patient-reported sleep disturbance measures from the SKYLIGHT 1 and 2 12-week placebo-controlled study period

PROMIS SD SF 8b assesses sleep disturbance over the previous seven days and includes perceptions of restless sleep, satisfaction with sleep, refreshing sleep, difficulties sleeping, getting to sleep or staying asleep, amount of sleep, and sleep quality.⁶
PROMIS SRI SF 8a assesses the impact of sleep impairments over the previous seven days.⁴
PGIC SD assesses how well participants were sleeping at that time compared with the start of the study and PGI-S SD assesses the severity of any current problems while sleeping at night.^1,2
The following data are all based on the full analysis set (all randomized participants assessed according to the randomization at first dose).
Table 1. Mean change in PROMIS SD SF 8b total score^a from baseline to Weeks 4 and 12 of SKYLIGHT 1²

	Placebo (n = 175)	Fezolinetant 30 mg (n = 173)	Fezolinetant 45 mg (n = 174)
Week 4
LS mean change from baseline, mean (SE)	-2.3 (0.5)	-3.3 (0.5)	-4.1 (0.5)
LS mean difference vs placebo (SE)	--	-1.0 (0.7)	-1.8 (0.7)
P-value vs placebo	--	0.16	0.008
Week 12
LS mean change from baseline, mean (SE)	-3.2 (0.5)	-3.7 (0.6)	-4.2 (0.5)
LS mean difference vs placebo (SE)	--	-0.5 (0.8)	-1.1 (0.7)
P-value vs placebo	--	0.49	0.16

Table 2. Mean change in PROMIS SD SF 8b total score^a from baseline to Weeks 4 and 12 of SKYLIGHT 2¹

	Placebo (n = 167)	Fezolinetant 30 mg (n = 166)	Fezolinetant 45 mg (n = 167)
Week 4
LS mean change from baseline, mean (SE)	-2.6 (0.5)	-3.9 (0.5)	-5.3 (0.5)
LS mean difference vs placebo (SE)	--	-1.30 (0.7)	-2.7 (0.7)
P-value vs placebo	--	0.082	< 0.001
Week 12
LS mean change from baseline, mean (SE)	-3.4 (0.5)	-4.1 (0.5)	-5.5 (0.5)
LS mean difference vs placebo (SE)	--	-0.7 (0.7)	-2.0 (0.7)
P-value vs placebo	--	0.381	0.007

Figure 1. Change in PROMIS SD SF 8b total score from baseline to Weeks 4 and 12 in a pooled analysis of SKYLIGHT 1 and 2⁴

Figure 2. Change in PROMIS SRI SF 8a total score from baseline to Weeks 4 and 12 in a pooled analysis of SKYLIGHT 1 and 2⁴

Figure 3. Distribution of the PGI-C SD at Weeks 4 and 12 in a pooled analysis of SKYLIGHT 1 and 2⁴

Fezolinetant 30 mg: n = 339, fezolinetant 45 mg: n = 341, placebo: n = 342.

Please note that these pooled analyses are not adjusted for multiplicity; p values therefore do not confer statistical significance and should be considered indicative, not confirmatory, and are for the purposes of hypothesis generation.

Adapted from: Shapiro M, Maturitas 2024.

Figure 4. Distribution of the PGI-S SD at baseline, Week 4, and Week 12 in a pooled analysis of SKYLIGHT 1 and 2⁴

Johnson KA, Martin N, Nappi RE, et al. Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocr Metab. 2023;108(8):1981-1997. Available at: https://doi.org/10.1210/clinem/dgad058.
Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023;401(10382):1091-1102. Available at: https://doi.org/10.1016/s0140-6736(23)00085-5.
Data on file.
Shapiro M, Cano A, Nappi RE, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024; Available at: https://doi.org/10.1016/j.maturitas.2024.107999.

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Detailed results for patient-reported sleep disturbance measures from the SKYLIGHT 1 and 2 12-week placebo-controlled study period

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