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Oral nomegestrol acetate and transdermal 17-beta-estradiol for preventing post-partum relapses in multiple sclerosis:
Sandra Vukusic1, Iuliana Ionescu2, Catherine Cornu3
1Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation et Fondation Eugène Devic EDMUS pour la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon-Bron, France/Centre des Neurosciences de Lyon, INSERM 1028 et CNRS UMR5292, Observatoire Français de la Sclérose en Plaques, Lyon, France/Université Claude Bernard Lyon 1, Villeurbanne, France.
Background:
Sex steroids could explain the course of multiple sclerosis (MS) in pregnancy.
Objective:
To compare the annualized relapse rate (ARR) 12 weeks post-partum in women treated with nomegestrol acetate (NOMAc) and 17-beta-estradiol (E2) versus placebo.
Methods:
POPARTMUS is a randomized, proof-of-concept trial in women with MS, receiving oral NOMAc 10 mg/day and transdermal estradiol 75 µg/week, or placebo.
Results:
Recruitment was stopped prematurely due to slow inclusions (n = 202). No treatment effect was observed on ARR after 12 weeks (sex steroids = 0.90 (0.58-1.39), placebo = 0.97 (0.63-1.50) (p = 0.79)).
Conclusion:
POPARTMUS failed showing efficacy of a NOMAc-E2 combination in preventing post-partum relapses.
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