Objectives: Vasomotor symptoms (VMS) are a burden for women in menopause. Despite the availability of hormone therapy (HT), many cannot or do not wish to utilise it. The efficacy of the neurokinin receptor antagonists fezolinetant and elinzanetant has been established in clinical trials. Matching-adjusted indirect comparison (MAIC), which controls for the differences in treatment effect modifiers between trials and provides robust estimates of relative treatment effects, was used here to compare the efficacy of fezolinetant and elinzanetant in individuals with VMS associated with menopause. Study design: Patient-level data from the fezolinetant SKYLIGHT-1/2 trials were used to match the population and study design of elinzanetant OASIS-1/2 trials. Treatment effect modifiers were identified and MAIC analyses were performed. Main outcome measures: VMS frequency and severity, Patient-Reported Outcomes Measurement Information System Sleep Disturbance – Short Form 8b (PROMIS SD SF 8b), Menopause Specific Quality of Life Questionnaire (MENQOL). Results: The OASIS-1/2 trial populations had higher mean VMS frequency/severity and greater sleep disturbance at baseline. Fezolinetant and elinzanetant had comparable efficacy in reducing VMS frequency and severity. Sleep disturbance improved with both drugs but more with elinzanetant. Improvement in sleep disturbance did not translate into a significant difference in overall QoL, as measured by MENQOL. Conclusions: MAIC analysis found that fezolinetant and elinzanetant had a similar efficacy profile for reduction of VMS frequency and severity. Differences in reduction of sleep disturbances did not result in differences in QoL. Neurokinin receptor antagonists provide an alternative to HT and other non-HT options for the treatment of VMS associated with menopause.

Fezolinetant compared with elinzanetant for the treatment of vasomotor symptoms associated with menopause: A matching-adjusted indirect comparison

Nappi, Rossella E
2026-01-01

Abstract

Objectives: Vasomotor symptoms (VMS) are a burden for women in menopause. Despite the availability of hormone therapy (HT), many cannot or do not wish to utilise it. The efficacy of the neurokinin receptor antagonists fezolinetant and elinzanetant has been established in clinical trials. Matching-adjusted indirect comparison (MAIC), which controls for the differences in treatment effect modifiers between trials and provides robust estimates of relative treatment effects, was used here to compare the efficacy of fezolinetant and elinzanetant in individuals with VMS associated with menopause. Study design: Patient-level data from the fezolinetant SKYLIGHT-1/2 trials were used to match the population and study design of elinzanetant OASIS-1/2 trials. Treatment effect modifiers were identified and MAIC analyses were performed. Main outcome measures: VMS frequency and severity, Patient-Reported Outcomes Measurement Information System Sleep Disturbance – Short Form 8b (PROMIS SD SF 8b), Menopause Specific Quality of Life Questionnaire (MENQOL). Results: The OASIS-1/2 trial populations had higher mean VMS frequency/severity and greater sleep disturbance at baseline. Fezolinetant and elinzanetant had comparable efficacy in reducing VMS frequency and severity. Sleep disturbance improved with both drugs but more with elinzanetant. Improvement in sleep disturbance did not translate into a significant difference in overall QoL, as measured by MENQOL. Conclusions: MAIC analysis found that fezolinetant and elinzanetant had a similar efficacy profile for reduction of VMS frequency and severity. Differences in reduction of sleep disturbances did not result in differences in QoL. Neurokinin receptor antagonists provide an alternative to HT and other non-HT options for the treatment of VMS associated with menopause.
2026
Comitato scientifico
Inglese
Internazionale
205
Elinzanetant; Fezolinetant; Matching-adjusted indirect comparison; Neurokinin 3 receptor antagonist; Vasomotor symptoms due to menopause
11
info:eu-repo/semantics/article
262
Stute, Petra; Shapiro C M, Marla; Morga, Antonia; Tai, Ting-An; Ajmera, Mayank; Muresan, Bogdan; Martins, Karla; Hua, Yechu; Zhao, Angela; Liu, Jingyi...espandi
1 Contributo su Rivista::1.1 Articolo in rivista
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11571/1549092
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