Cano, AntonioAntonioCanoNappi, Rossella ERossella ENappiSantoro, NanetteNanetteSantoroStute, PetraPetraStuteBlogg, MartinMartinBloggEnglish, Marci LMarci LEnglishMorga, AntoniaAntoniaMorgaScrine, LudmilaLudmilaScrineSiddiqui, EmadEmadSiddiquiOttery, Faith DFaith DOttery2024-10-262024-10-262024-08https://boris-portal.unibe.ch/handle/20.500.12422/174224OBJECTIVE 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.enfezolinetant health-related quality of life neurokinin 3 receptor antagonist patient-reported outcomes vasomotor symptoms600 - Technology::610 - Medicine & healtharticle10.48350/1926503832096710.1111/1471-0528.17773