Fezolinetant improves vasomotor symptom severity, associated sleep disturbances
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Women taking fezolinetant for moderate to severe vasomotor symptoms experienced a reduction in symptom severity and sleep disturbances, according to data presented at the NAMS Annual Meeting.
Notably, fezolinetant (Astellas Pharma) was associated with reduced vasomotor symptoms across racial subgroups as well as across the entire study population.
“This is really exciting because it is truly the first time that we have a treatment that is specifically targeted at what we know causes hot flashes,” Genevieve Neal-Perry, MD, PhD, a member of the Fezolinetant Scientific Advisory Committee for Astellas and chair of the department of obstetrics and gynecology at University of North Carolina School of Medicine, told Healio. “There is great opportunity to meet unmet needs for patients who can’t use hormones, such as breast cancer survivors and patients with blood clot disorders.”
Efficacy by racial group
Neal-Perry and colleagues evaluated the efficacy of the nonhormonal, investigational selective neurokinin-3 receptor agonist among Black and non-Black participants in two phase 3 studies, SKYLIGHT 1 and SKYLIGHT 2. Overall, both double-blind, placebo-controlled trials found fezolinetant — which was administered once daily in 30 mg or 45 mg doses for 12 weeks — to be efficacious and well tolerated by participants.
According to Neal-Perry, Black women experience hot flashes more frequently and over a greater length of time compared with white women and are more likely to have hot flashes before menopause.
“And so why does this really matter?” Neal-Perry said. “It matters because we know that women who have hot flashes are more likely to have heart disease, they’re more likely to have cognitive problems in terms of being able to do daily functions because of the disruption of sleep and the impact on general quality of life.”
In total, 1,022 women took at least one dose of fezolinetant or placebo. Compared with non-Black women, Black women reported hot flashes more frequently at baseline. Black women and non-Black women following either fezolinetant regimen reported significant reductions in the frequency of hot flashes at weeks 4 and 12 compared with their counterparts taking placebo.
Additionally, compared with placebo, 45 mg fezolinetant was associated with a significant reduction in severity of vasomotor symptoms across the study population and among Black and non-Black participants at weeks 4 and 12.
These findings show that despite differences in drug metabolism between white and Black women, “fezolinetant works, it’s highly effective and race does not have an impact on its effectiveness,” Neal-Perry said.
Sleep disturbances
A second study was conducted by Marla Shapiro, MDCM, CCFP, MHSc, FRCP, FCFP, NCMP, an associate professor in the department of family and community medicine at the University of Toronto, and colleagues to identify the impact fezolinetant had on sleep disturbances associated with vasomotor symptoms. Again, the researchers used data from SKYLIGHT trials 1 and 2 for their analyses.
The Patient-Reported Outcomes Measurement Information System Sleep Disturbance – Short Form (PROMIS SD SF) 8b Total Score, Patient Global Impression of Change – Sleep Disturbance (PGI-C SD) and PGI of Severity – Sleep Disturbance (PGI-S SD) were used to assess sleep disturbances among 1,022 participants who had taken fezolinetant or placebo at least once.
Compared with placebo, women who took 45 mg fezolinetant had significant improvements in scores for sleep disturbances on all three assessments at weeks 4 and 12, according to the researchers. Among women taking 30 mg fezolinetant, significant improvements in sleep were observed at week 4 using the PROMIS SD SF and PGI-S SD, and at weeks 4 and 12 using the PGI-C SD.
“We still need to do some additional studies to understand more about who will benefit in terms of sleep,” Neal-Perry said. “[For example], is it possible that people who have more night-time hot flashes are the ones who benefit in terms of overall sleep patterns?”
References:
- Neal-Perry G, et al. Abstract P-53. Presented at: North American Menopause Society Annual Meeting; Oct. 12-15, 2022; Atlanta.
- Shapiro M, et al. Abstract P-74. Presented at: North American Menopause Society Annual Meeting; Oct. 12-15, 2022; Atlanta.