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Clinical Trial
. 2025 Feb:193:108159.
doi: 10.1016/j.maturitas.2024.108159. Epub 2024 Nov 26.

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

Marla Shapiro C M  1 , Xi Wu  2 , Xuegong Wang  2 , Kentaro Miyazaki  3 , Antonia Morga  4 , Rossella E Nappi  5 , Petra Stute  6 , Karla Martins  4 , Katrin Schaudig  7
Affiliations
Free article
Clinical Trial

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

Marla Shapiro C M et al. Maturitas. 2025 Feb.
Free article

Abstract

Objective: To report patient-reported quality-of-life (QOL) outcomes in the DAYLIGHT study.

Study design: DAYLIGHT was a phase 3b, randomized, double-blind, 24-week, placebo-controlled study. Participants were women aged ≥40 to ≤65 years with moderate to severe vasomotor symptoms (VMS) considered unsuitable for hormone therapy (HT) (contraindications, caution, stoppers, or averse) randomized 1:1 to placebo or fezolinetant 45 mg once daily.

Main outcome measures: Primary endpoint: mean change in daily VMS frequency of moderate to severe episodes from baseline to week 24. Secondary: patient-reported sleep disturbance (PROMIS SD SF 8b). Exploratory: patient-reported sleep disturbance (Patient Global Impression of Severity/Change in Sleep Disturbance [PGI-S/PGI-C SD]), menopause and VMS-related QOL (Female Sexual Function Index [FSFI], Menopause-Specific Quality of Life [MENQOL], Patient Global Impression of Change in Vasomotor Symptoms [PGI-C VMS], Work Productivity and Activity Impairment questionnaire specific to VMS [WPAI-VMS]), and general QOL (European Quality of Life 5 Dimensions 5 Level Version [EQ-5D-5L], Patient Health Questionnaire for Anxiety and Depression [PHQ-4]).

Results: Overall, 452 women received at least one dose of study drug (placebo n = 226; fezolinetant n = 226): HT contraindicated (50; 11 %), caution (165; 37 %), stoppers (69; 15 %), and averse (168; 37 %). DAYLIGHT results showed statistically significant reductions in VMS frequency/severity in the fezolinetant group versus placebo at week 24. Week 24 improvements were seen in the fezolinetant group versus placebo in: PROMIS SD SF 8b total score (least squares [LS] mean difference: -2.5; 95 % CI: -3.9, -1.1; p < 0.001), MENQOL total score (LS mean difference: -0.44; 95 % CI: -0.69, -0.18; p < 0.001), and WPAI-VMS (activity impairment [p < 0.001], overall work productivity loss [p = 0.036], and presenteeism [p = 0.002] domains). A higher proportion of participants in the fezolinetant group reported positive changes in sleep disturbance (PGI-C SD, p < 0.001), sleep disturbance severity (PGI-S SD, p = 0.042), and VMS (PGI-C VMS, p < 0.001) versus placebo.

Conclusions: Patient-reported outcomes demonstrate that reductions in VMS frequency with fezolinetant treatment were associated with improvements in QOL.

Keywords: Fezolinetant; MENQOL; Neurokinin 3 receptor antagonist; PROMIS; Sleep; Vasomotor symptoms.

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Conflict of interest statement

Declaration of competing interest M.S.C.M. sits on advisory boards for and has received consulting fees and honorariums from Amgen, Aspen, Astellas, BioSyent, Bayer, CCRN, Duchesnay, Eisai, GSK, Idorsia, Merck, Mithra, Novo Nordisk, Organon, Pfizer, Sandoz, and Searchlight; receives support for attending meetings and/or travel from Astellas and The Menopause Society; has a leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid, for the International Menopause Society and Terry Fox Research Institute. X. Wu, X. Wang, K. Miyazaki., A.M., and K. Martins are employees of Astellas Pharma. R.E.N. receives grants/contracts from Fidia; consulting fees from Astellas, Bayer Pharma, Besins Healthcare, Fidia, and Theramex; payment or honorariums for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Abbott, Astellas, Exeltis, Fidia, Gedeon Richter, Merck, Novo Nordisk, Shionogi, Theramex, and Viatris; payment for expert testimony from Vichy Laboratories; and is president of the International Menopause Society. P.S. has received grants or contracts from the University of Bern and Swiss National Foundation; consulting fees from Astellas and Theramex; payment or honorariums for lectures, presentations, speakers bureaus, manuscript writing, or educational events for Astellas, Theramex, and Besins Healthcare; leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid for the European Menopause and Andropause Society, Deutsche Menopause Gesellschaft, and Swiss Society for Anti Aging Medicine and Prevention. K.S. has received payment or honorariums for lectures, presentations, speakers bureaus, manuscript writing, or educational events from aidhere, Astellas Pharma, Bayer/Jenapharm, Besins Healthcare, Exeltis, Fidia, Gedeon Richter Pharma, Novo Nordisk, Organon, Theramex, Viatris, and Laborarztpraxis Rhein-Main; participates on a data safety monitoring board or advisory board for Astellas, Bayer, Exeltis, Besins Healthcare, and Viatris; is President of the German Menopause Society organises and lectures at conferences for the society; lectures and participates in conferences for the professional association of gynaecologists in Germany; is honorary member for the German Society of Obstetrics and Gynecology and lectures, is president at conferences, and participates on committees for the society.

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