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

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.