Pregnancy outcomes during the clinical development programme of cladribine in multiple sclerosis (MS): an integrated analysis of safety for all exposed patients

Author(s):  
Andrew Galazka
Drug Safety ◽  
2020 ◽  
Vol 43 (7) ◽  
pp. 635-643 ◽  
Author(s):  
Gavin Giovannoni ◽  
Andrew Galazka ◽  
Regina Schick ◽  
Thomas Leist ◽  
Giancarlo Comi ◽  
...  

Neurology ◽  
2014 ◽  
Vol 82 (8) ◽  
pp. 674-680 ◽  
Author(s):  
G. Karlsson ◽  
G. Francis ◽  
G. Koren ◽  
P. Heining ◽  
X. Zhang ◽  
...  

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S088-S089
Author(s):  
M C Dubinsky ◽  
U Mahadevan ◽  
L Charles ◽  
S Afsari ◽  
A Henry ◽  
...  

Abstract Background Ozanimod, an oral sphingosine 1-phosphate (S1P) receptor modulator selectively targeting S1P1 and S1P5, has demonstrated efficacy in patients with relapsing multiple sclerosis (rMS) and ulcerative colitis (UC), and is being studied in Crohn’s disease (CD). S1P1-3 receptors are involved in vascular formation during embryogenesis. Within studies in the ozanimod clinical development program, female participants of childbearing potential were required to use effective contraception while receiving and up to 3 months after discontinuing ozanimod; treatment discontinuation was required if pregnancy was confirmed. Here we review pregnancy outcomes data with ozanimod use in rMS, UC, and CD. Methods All pregnancies, including participant and partner pregnancies, in the ozanimod clinical development program with an initial diagnosis prior to a cut-off date of September 30, 2020 were assessed for pregnancy outcomes. Results At cut-off, safety data on 4131 participants were available. A total of 83 pregnancies were reported in the safety database of participants treated with ozanimod or their partners (Table). All pregnancy exposures occurred during the first trimester. Of the 60 pregnancies in ozanimod clinical trials, 9 were reported in patients with UC, and 3 in patients with CD. Participants discontinued study medication promptly except for those who elected pregnancy termination and did not discontinue study medication. Among all pregnancies in the ozanimod clinical development program, the incidence of spontaneous abortion in clinical trial participants was 15%; the rate in the general population is between 12% and 22%. The rate of preterm birth was 10.7% of live births; as reference, the global population estimate is 10.6% and the European estimate is 8.7%. No teratogenicity was observed. Outcomes in patients with UC included 2 live births that resulted in 2 full-term healthy newborns, 2 ongoing pregnancies, 2 spontaneous early losses, and 3 elective terminations. Conclusion While pregnancy should be avoided in patients on and 3 months after stopping ozanimod and clinical experience with ozanimod during pregnancy is limited, there has been no increased event of foetal abnormalities or adverse pregnancy outcomes seen with ozanimod exposure in early pregnancy.


2021 ◽  
Vol 10 (3) ◽  
Author(s):  
Jordis Trischler ◽  
Ivan Bottoli ◽  
Reinhold Janocha ◽  
Christoph Heusser ◽  
Xavier Jaumont ◽  
...  

Digestion ◽  
1990 ◽  
Vol 47 (1) ◽  
pp. 54-58 ◽  
Author(s):  
A. Walan

Author(s):  
Tetiana Pohuliaieva

For the fi rst time in Ukraine, was explored the eff ect of pregnancy, childbirth and the postpartum period on the further course of multiple sclerosis (MS) in sporadic and family forms of women giving birth at the preclinical stage (group 1) and against the background of the disease (group 2). Through the use of questioning method and clinical and neurological examination the following phenomena were studied. Namely, premonitory history; features of the course of the disease; the duration between labor and development of the onset of the illness in women of the 1st group and between the onset and labor in women of the 2nd group; obstetric and gynecological history; the eff ect of pregnancy and childbirth on the further course of MS. A total of 82 women were examined, 51 of them were giving birth at preclinical stage (group 1) and 31 — against the background of MS (group 2). In the 1st group with remitting course (RC), 26 women had a sporadic form and 5 — a family form; with progressive course (PC) — in 14 — sporadic and in 6 — family form. In the 2nd group with RC, 23 women had sporadic and 1 family form; with PC — 6 had sporadic and 1 family. Research has shown, the disease of majority of women from the first group has been developed after childbirth. Women from the second group with RC were giving birth most often after 5—10 years of the disease onset; with PC — after more than 10 years. According to the obstetric and gynecological history, differences were obtained during pregnancy, childbirth and the postpartum period between two groups of women with different types of course. An assessment of the effects of pregnancy, childbirth and the postpartum period of women from the 2nd group made it possible to identify criteria for various options for the further course of MS (such as improvement, stabilization, improvement through worsening, worsening), which are closely interrelated with the types of course of the disease. To sum up, an integrated analysis of the above mentioned outcome shows a positive eff ect of pregnancy and childbirth in the vast majority of women with RC and a high incidence of decline of women with PC. Key words: multiple sclerosis, types of course, sporadic and familial form, pregnancy and childbirth, obstetric and gynecological history, complications during pregnancy and childbirth


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