Fezolinetant therapy effective for women with menopausal vasomotor symptoms: Study

A recent study published in the Menopause journal found promising outcomes for women who undergo moderate-to-severe vasomotor symptoms (VMS) due to menopause. The research further characterize the efficacy of fezolinetant in treating these symptoms by focusing on whether the treatment resulted in clinically meaningful changes for patients without adjusting for placebo effects.

The analysis was based on pooled data from two phase 3, randomized, double-blind, placebo-controlled studies, known as SKYLIGHT 1 and 2. These studies involved a detailed responder analysis to measure the effectiveness of fezolinetant. The participants were considered responders if they underwent reductions in VMS frequency by 50%, 75%, 90% or 100% from baseline to weeks 4 and 12.

To evaluate the efficacy of fezolinetant, the study utilized patient-reported outcome (PRO) measures. They assessed clinically meaningful changes at week 4 and week 12 when compared to baseline. These measures included the frequency of VMS, the Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form 8b Total Score (PROMIS SD SF 8b), the Menopause-Specific Quality of Life (MENQoL) Total Score and the MENQoL VMS Domain Score.

The study also conducted double and triple responder analyses. These analyses combined VMS frequency with one or more PRO measures to further substantiate the effectiveness of fezolinetant. Also, the Patient Global Impression of Change VMS was used as an anchor measure to assess meaningful within-patient change in VMS frequency. 

The outcomes demonstrated a significant difference in the proportion of responders between the fezolinetant-treated groups and the placebo-treated groups. The participants receiving fezolinetant showed greater reductions in VMS frequency across all responder thresholds (50%, 75%, 90% and 100%) at both week 4 and week 12.

At week 12, a higher proportion of responders was observed in the fezolinetant groups for all four single responder analyses when compared to the placebo groups. The double and triple responder analyses further supported the beneficial effects of fezolinetant, with favorable odds ratios indicating its efficacy over placebo.

The study concluded that fezolinetant is associated with significantly higher within-patient clinically meaningful improvements in several important patient-reported outcomes. These include VMS frequency, sleep disturbance scores, overall quality of life, and menopause-specific quality of life domains.

The findings from this study illuminated the potential of fezolinetant as an effective treatment option for women with menopausal vasomotor symptoms by providing substantial relief and improving their overall quality of life. This finding could lead to improved management of menopause symptoms and a better quality of life for many women. This data indicates that fezolinetant reduces the frequency of VMS and leads to meaningful improvements in related quality of life measures for the individuals affected by menopausal symptoms.

Reference:

Nappi, R. E., Johnson, K. A., Stute, P., Blogg, M., English, M., Morga, A., Scrine, L., Siddiqui, E., & Ottery, F. D. (2024). Treating moderate-to-severe menopausal vasomotor symptoms with fezolinetant: analysis of responders using pooled data from two phase 3 studies (SKYLIGHT 1 and 2). In Menopause (Vol. 31, Issue 6, pp. 512–521). Ovid Technologies (Wolters Kluwer Health). https://doi.org/10.1097/gme.0000000000002354