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Randomized Controlled Trial
. 2024 Aug;131(9):1296-1305.
doi: 10.1111/1471-0528.17773. Epub 2024 Feb 6.

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

Antonio Cano  1 , Rossella E Nappi  2   3 , Nanette Santoro  4 , Petra Stute  5 , Martin Blogg  6 , Marci L English  7 , Antonia Morga  6 , Ludmila Scrine  6 , Emad Siddiqui  6 , Faith D Ottery  7
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Free article
Randomized Controlled Trial

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

Antonio Cano et al. BJOG. 2024 Aug.
Free article

Abstract

Objective: To assess the effect of fezolinetant treatment on health-related quality of life using pooled data from SKYLIGHT 1 and 2 studies.

Design: Prespecified pooled analysis.

Setting: USA, Canada, Europe; 2019-2021.

Population: 1022 women aged ≥40 to ≤65 years with moderate-to-severe vasomotor symptoms (VMS; minimum average seven hot flushes/day), seeking treatment for VMS.

Methods: Women were randomised to 12-week double-blind treatment with once-daily placebo or fezolinetant 30 or 45 mg. Completers entered a 40-week, active extension (those receiving fezolinetant continued that dose; those receiving placebo re-randomised to fezolinetant received 30 or 45 mg).

Main outcome measures: Mean changes from baseline to weeks 4 and 12 on Menopause-Specific Quality of Life (MENQoL) total and domain scores, Work Productivity and Activity Impairment questionnaire specific to VMS (WPAI-VMS) domain scores, Patient Global Impression of Change in VMS (PGI-C VMS); percentages achieving PGI-C VMS of 'much better' (PGI-C VMS responders). Mean reduction was estimated using mixed model repeated measures analysis of covariance.

Results: Fezolinetant 45 mg mean reduction over placebo in MENQoL total score was -0.57 (95% confidence interval [CI] -0.75 to -0.39) at week 4 and -0.47 (95% CI -0.66 to -0.28) at week 12. Reductions were similar for 30 mg. MENQoL domain scores were also reduced and WPAI-VMS scores improved. Twice as many women receiving fezolinetant reported VMS were 'much better' than placebo based on PGI-C VMS assessment.

Conclusions: Fezolinetant treatment was associated with improvement in overall QoL, measured by MENQoL, and work productivity, measured by WPAI-VMS. A high proportion receiving fezolinetant felt VMS were 'much better' based on PGI-C VMS responder analysis.

Keywords: fezolinetant; health‐related quality of life; neurokinin 3 receptor antagonist; patient‐reported outcomes; vasomotor symptoms.

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