Oral nomegestrol acetate and transdermal 17-beta-estradiol for preventing post-partum relapses in multiple sclerosis: The POPARTMUS study. (August 2021)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Multiple sclerosis. Volume 27:Number 9(2021)
• Page Start: 1458
• Page End: 1463
• Publication Date: 2021-08
• Subjects: Multiple sclerosis -- relapses -- post-partum -- sex hormones -- estradiol -- progesterone; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/1352458520978218
• Languages: English
• ISSNs: 1352-4585

Abstract

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.