A dose comparison study of IVIG in postpartum relapsing-remitting multiple sclerosis
Judith Haas1
Otto Roelf Hommes2*
1 Jüdisches Krankenhaus Berlin, Abteilung für
Neurologie, Heinz-Galinski-Str. 1, 13347 Berlin, Germany
2 European Charcot Foundation, Hoeveveld 18A, 6584 GG Molenhoek (Nijmegen
area), The Netherlands
* To whom correspondence should be addressed.
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Abstract |
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Untreated patients with relapsing-remitting multiple sclerosis (RRMS) have an
elevated risk of exacerbation in the first 3 months postpartum. Pregnant patients
(n=173) with RRMS and with at least one relapse in the two years
before pregnancy were enrolled in this multinational, multicentre, randomized
double-blind clinical trial investigating different doses of intravenous
immunoglobulin (IVIG) treatment in the 6 months postpartum. Group I (unloaded)
received 150 mg/kg body weight (BW) IVIG on Day 1, then placebo infusions on Day 2
and Day 3. Group II (loaded) received 450, 300 and 150 mg/kg BW on Days 1, 2 and 3
respectively. Both groups then received 150 mg/kg BW five times in four-weekly
intervals. The ratio of patients remaining relapse-free during the first 3 months
postpartum did not differ significantly between both groups (81.5% in Group II
versus 75.6% in Group I). The ratio of relapse-free patients was independent of
dosage in the subgroup of patients breastfeeding for at least 3 months (89% in Group
I versus 90% in Group II). The mean annualized relapse rate (ARR) after pregnancy
did not show an increased risk for exacerbation, but returned to prepregnancy level
within 3 months independent of dosage. The treatment was well tolerated.
Key Words:
clinical trial, immunoglobulin, intravenous, multiple sclerosis, postpartum, relapsing-remitting
