By Jill Stein
Special to DG News
PARIS, FRANCE -- April 23, 2001 -- The use of immunomodulating therapy (IMT) appears to be safe during the critical first trimester and the remainder of pregnancy in women with multiple sclerosis (MS), according to the results of a small case series described at the 11th Meeting of the European Neurological Society.
Most female MS patients present during childbearing years. While beta-interferons and glatiramer acetate are used for relapsing MS, there have been no studies on IMT use during pregnancy in women with MS.
Against this background, Dr. Omar Khan and co-workers at Wayne State University School of Medicine in Detroit, Michigan, conducted a study in which 49 women with MS were asked about the use of IMT during pregnancy. In addition, a detailed history regarding pregnancy and the neonate was obtained from each patient.
The study included two groups of patients. Eleven patients (group 1) reported voluntarily electing to use IMT during the entire pregnancy whereas another 38 patients (group 2) discontinued IMT as soon as they discovered that they were pregnant.
In group 1, five patients received interferonB-1a (30 mcg intramuscularly weekly), two received interferonB-1a (44 mcg subcutaneously thrice weekly), and four received glatiramer acetate (20 mg subcutaneously daily). At the time of pregnancy, the mean age, disease duration, and duration of therapy on IMT were 28.5 years, 19.2 months, and 3.8 months, respectively.
There were no relapses during pregnancy in group 1 patients, and only two relapses during the post-partum period. Ten women had normal deliveries, and one required a Caesarean-section. No developmental abnormalities were reported after a mean follow-up of 15.2 months in all infants.
Of the group 2 patients, 28 received glatiramer acetate, seven received interferonB-1a (30 mcg intramuscularly weekly), and three received interferonB-1b (250 mcg subcutaneously daily). All 38 patients discontinued treatment with IMT as soon as they learned they were pregnant.
At the time of pregnancy, the mean age, disease duration, and duration of therapy were 29.6 years, 23.4 months, and 6.4 months, respectively. The mean exposure to IMT at the time the women learned they were pregnant was 2.5 months during which no relapses occurred. During the remainder of their pregnancy, 14 patients experienced a relapse which was treated with steroids in all cases. Nine patients experienced relapses during the post-partum period. All women had normal deliveries.
No developmental abnormalities were reported after a mean follow-up of 12.4 months in 32 of 38 infants. No follow-up was available in the remaining six infants.
"While the results may be reassuring to women who are concerned about fetal exposure to IMT, we are not suggesting that IMT should be used routinely during pregnancy until more data on its safety during pregnancy are available," Dr.. Khan cautioned.
His group is planning to set up an Internet- based International Multiple Sclerosis Pregnancy Registry that will collect prospective standardized information across MS centers worldwide on MS patients who become pregnant. The database will include information on the disease course during pregnancy and the post-partum period as well as the developmental history of the newborn.