Maturitas · 2024
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.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Shapiro C M Marla, Wu Xi, Wang Xuegong, Miyazaki Kentaro, Morga Antonia, Nappi Rossella E, Stute Petra, Martins Karla, Schaudig Katrin
Аннотация
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.
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.