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Oral nomegestrol acetate and transdermal 17-beta-estradiol for preventing post-partum relapses in multiple sclerosis: The POPARTMUS study

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Vukusic, Sandra | Ionescu, Iuliana | Cornu, Catherine | Bossard, Nadine | Durand-Dubief, Françoise | Cotton, François | Durelli, Luca | Marignier, Romain | Gignoux, Laurence | Laplaud, David-Axel | Moreau, Thibault | Clavelou, Pierre | de Seze, Jérôme | Debouverie, Marc | Brassat, David | Pelletier, Jean | Lebrun-Frenay, Christine | Le Page, Emmanuelle | Castelnovo, Giovanni | Berger, Eric | Hautecoeur, Patrick | Heinzlef, Olivier | Trojano, Maria | Patti, Francesco | Baulieu, Etienne-Emile | Remontet, Laurent | El-Etr, Martine

Edité par CCSD ; SAGE Publications -

International audience. 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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