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Clinical Trial
. 2024 Jun 1;31(6):512-521.
doi: 10.1097/GME.0000000000002354. Epub 2024 Apr 16.

Treating moderate-to-severe menopausal vasomotor symptoms with fezolinetant: analysis of responders using pooled data from two phase 3 studies (SKYLIGHT 1 and 2)

Rossella E Nappi, Kimball A Johnson  1 , Petra Stute  2 , Martin Blogg  3 , Marci English  3 , Antonia Morga  4 , Ludmila Scrine  3 , Emad Siddiqui  4 , Faith D Ottery  3
Affiliations
Free article
Clinical Trial

Treating moderate-to-severe menopausal vasomotor symptoms with fezolinetant: analysis of responders using pooled data from two phase 3 studies (SKYLIGHT 1 and 2)

Rossella E Nappi et al. Menopause. .
Free article

Abstract

Objectives: The aims of the study were to further characterize the efficacy of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause using responder analysis and to investigate whether efficacy, not adjusted for placebo, resulted in clinically meaningful within-patient change.

Methods: This prespecified analysis used pooled data from two phase 3, randomized, double-blind, placebo-controlled studies (SKYLIGHT 1 and 2). Responders were those experiencing ≥50%, ≥75%, ≥90%, or 100% reduction in VMS frequency from baseline to weeks 4 and 12. Responder analysis was performed for patient-reported outcome (PRO) measures to evaluate participants achieving a clinically meaningful within-patient change (not placebo adjusted) at week 4 and 12 versus baseline. Single responders were based on outcomes of VMS frequency, Patient-Reported Outcomes Measurement Information System Sleep Disturbance-Short Form 8b Total Score, Menopause-Specific Quality of Life (MENQoL) Total Score, and MENQoL VMS Domain Score. Double and triple responder analyses combined VMS frequency plus one or more of the PRO. Patient Global Impression of Change VMS was deemed a suitable anchor measure for meaningful within-patient change in VMS frequency.

Results: A greater proportion of fezolinetant-treated versus placebo-treated participants had ≥50%, ≥75%, ≥90%, or 100% reduction in VMS frequency from baseline to weeks 4 and 12. A greater proportion of responders were observed in the fezolinetant groups versus placebo at week 12 in all four single responder analyses. In the double and triple responder analyses, odds ratios were supportive of a beneficial effect for both doses of fezolinetant versus placebo.

Conclusions: Fezolinetant was associated with significantly higher within-patient clinically meaningful improvement in important PRO, including VMS frequency, PROMIS SD SF 8b Total Score, MENQoL Total Score, and MENQoL VMS Domain Score.

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Conflict of interest statement

Financial disclosure/conflicts of interest: R.E.N. reports past financial relationships (lecturer, member of advisory boards and/or consultant) with Boehringer Ingelheim, Eli Lilly, Endoceutics, Exeltis, Novo Nordisk, Palatin Technologies, Pfizer, Procter & Gamble, Teva Women's Health and Zambon; ongoing relationships with Abbott, Astellas, Bayer HealthCare, Fidia, Gedeon Richter, HRA Pharma, Merck & Co, Organon, Shionogi, Theramex and Viatris; serving as President elect of the International Menopause Society; and is a member of the Fezolinetant Scientific Steering Committee. K.A.J. reports being a study investigator and consultant for Astellas and a study investigator for iResearch Atlanta. P.S. reports being a consultant for Astellas; a board member for DMG and EMAS; President of the SGEM; speaker's fees for Theramex, Exeltis, Gedeon Richter, Besins Healthcare, and Jenapharm; and a member of the Fezolinetant Scientific Steering Committee. M.B., M.E., L.S. and F.D.O. are employees of Astellas Pharma Inc. A.M. and E.S. are employees of Astellas Pharma Europe Ltd.

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