The findings also revealed relapses over the first six months after giving birth in a quarter of women who stopped Gilenya before or after getting pregnant.
The research, “Disease activity during pregnancy after fingolimod withdrawal due to planning a pregnancy in women with multiple sclerosis,” was presented at the 34th congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which took place Oct. 10-12, in Berlin, Germany.
The data were presented by Spalmai Hemat, from St. Josef Hospital, Ruhr University of Bochum, Germany.
Previous studies have shown that the frequency of symptoms’ worsening (relapses) in MS patients declines during pregnancy, creating a sort of natural protection. “In pregnant women with MS, disease activity significantly decreases, especially in the third trimester” Hemat said in the presentation.
However, women with MS who stop treatment with Novartis’ Gilenya and are planning to become pregnant have an unknown risk for relapse or disability, although severe return of disease activity had been described.
Aiming to address this gap, a team from Germany, U.S., Spain, Austria, Italy, and Belgium compared the relapse rate, disability risk, and pregnancy outcomes in women who stopped Gilenya treatment either before (group A) or after (group B) becoming pregnant.
Researchers collected detailed data on the course of MS and pregnancy, relapses, disability, and outcome from the German MS and pregnancy registry (140 patients) and from six international collaborators (16 patients) up to September 2017. Six pregnancies were ongoing when the study finished.
The analysis revealed that 46 women in group A stopped Gilenya 295 days (range 61-312 days) before the last menstrual period (LMP). In group B, 110 women had a median Gilenya exposure of 35.4 days (range 1-123 days) after their LMP.
Ten (21.7%) women in group A had a relapse between stopping Gilenya and becoming pregnant. Group A also showed a higher percentage of women with relapses during pregnancy. According to Hemat, “up to 50% of women treated with Gilenya before or up to pregnancy will experience a relapse during pregnancy.”
She also added that “women who stopped Gilenya for more than 2 months prior to the last LMP, experience more relapses before pregnancy and at the beginning of pregnancy.”
Expanded Disability Status Scale (EDSS) score remained stable and did not indicate permanent disability in most patients, although one woman in group A (5.13%) and nine in group B (7.69%) experienced a marked worsening of two or more EDSS points six months postpartum. (The greater the EDSS score, the worse is the patient’s level of disability.)
“The large majority of women will not experience permanent disability,” Hemat said, “but up to 10-20% will suffer from substantial EDSS worsening 6 months postpartum.”
The 31 patients who restarted Gilenya treatment during the first 30 days postpartum had an insignificant reduction in relapse risk during the first six months.
The only significant predictor for relapses postpartum were relapses during pregnancy.
Overall, the team concluded that, despite the natural protection of pregnancy, up to half of women treated with Gilenya before or up to pregnancy will experience a relapse during pregnancy.
According to Hemat, “more data are needed to investigate if very early (first 14 days) postpartum treatment with Gilenya might reduce postpartum relapse risk.”
Of note, four of the study’s authors received funding/fees from Novartis.