Long-Term Use of Glatiramer Acetate by 11 Pregnant Women with Multiple Sclerosis

Abstract

No deleterious effects from glatiramer acetate were observed in these pregnant women with MS or in their offspring. No increment in postnatal relapse rate was observed. However, the use of glatiramer acetate during pregnancy should be restricted to the most difficult cases, in which the benefits clearly outweigh the risks.

The Effects of Multiple Sclerosis and Disease Modifying Therapy on Pregnancy

“…Similar to IFN, GA does not seem to affect the rate of conception nor the rate of spontaneous abortion when compared to women without MS, and no major concerns have been reported when GA has been used in pregnancy [22]. Women who have used GA during breast-feeding report no adverse effects, although it is still recommended to abstain from GA during lactation [24]. Fingolimod Fingolimod (trade name Gilenya®) acts to reduce the number of lymphocytes present in the central nervous system by preventing their release from lymph nodes.…”

Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance

“…Pregnancy loss not observed (n = 31 [13], n = 46 [61] and n = 17 [62]) Decreased fetal growth not observed (n = 31 [13] and n = 17 [62]) Teratogenicity not observed (n = 31 [13], n = 46 [61] and n = 17 [62]) Impaired development of the newborn not observed (n = 11 [16] Recommend discontinuation prior to conception or once pregnancy is known [7,8] with some suggesting a washout period of at least 1 month prior to conception [60] for women with mild MS Use until conception or into pregnancy may be recommended for women with severe or highly active MS [6] Use not recommended in breastfeeding [6] Natalizumab Contraception required for women with childbearing potential; recommend discontinuation at least 3 months prior to conception [6] Use not recommended in breastfeeding [6,11] MS: Multiple sclerosis.…”

“…IFN-β exposure was not associated with low birthweight (<2500 g), cesarean delivery, congenital anomaly or spontaneous abortion [12]. Fewer studies (with limited sample size) were available regarding the safety of GA [13][14][15][16] or natalizumab [17]. Therefore, while GA exposure was not associated with lower mean birthweight, congenital anomaly, preterm birth or spontaneous abortion [13], and natalizumab did not appear to increase the risk of shorter birth length, lower birthweight or lower gestational age [17], conclusive statements surrounding safety cannot be made.…”

“…For example, when classifying DMD exposure, some defined in utero DMD exposure as within 1 month prior to conception, whereas others used the estimated time of conception. All these issues outlined here could contribute to the differences in reported findings between studies -with some studies reporting harm [12,13,[25][26][27] and others not [14][15][16][17][27][28][29][30][31][32][33]. Some of the best available studies are prospective, which, by their nature, minimize reporting and recall bias (a common challenge in pregnancy-related pharmacovigilance studies).…”

“…Of these, two had relatively large sample sizes (n = 69 [13] and 88 [12]), which also allowed for adjustment of important confounders (including gestational age, parity, socioeconomic status and smoking or alcohol use) to better estimate the true effect of IFN-β exposure. In addition, some studies investigated DMD exposure late in pregnancy; three small studies (n = 9 [14], 11 [16] and 12 [15] pregnancies) reported on GA exposure up to the third trimester of pregnancy, whereas others followed long-term developmental outcomes beyond the immediate perinatal period in offspring exposed to GA [16] or IFN-β [12,26] in utero. Individual studies have also investigated maternal natalizumab exposure during pregnancy [17] and paternal DMD use around conception [28] -both represent the first cohort studies published on these topics.…”