Researchers find no clear therapeutic benefit of intravenous immunoglobulin for the prevention of postnatal relapses of multiple sclerosis.
A systematic review of 11 studies found no clear therapeutic benefit of intravenous immunoglobulin (IVIG) for the prevention of postnatal relapses of multiple sclerosis (MS), despite being routinely recommended by some physicians, according to the study authors.
MS is a chronic neurological condition that is predominant among women and has frequent onset during fertile age, making its effects on pregnancy important for research. Despite this need for more research, the investigators said the obvious ethical implications of clinical trials in pregnant women make research difficult, leaving only retrospective observational data and meta-analyses available.
The disease is frequently characterized by demyelination in the central nervous system and can include unilateral vision loss, double vision, limb weakness, sensory abnormalities, lack of coordination, and unsteadiness when walking. All of these issues can impact pregnant women, and the investigators said one of the main concerns in this patient population is the increased risk of a demyelinating relapse after delivery.
The systematic review included 11 articles, although only 6 had data to compare the effect of IVIG on the outcome. The other 5 articles were analyzed and presented using qualitative synthesis. The articles had a total of 380 patients who received immunoglobulin after pregnancy to reduce the number of postpartum relapses and 72 participants were included in the quantitative data analysis.
Of these 72 patients, 11 relapsed within the first 6 months postpartum. The control group included 132 patients who did not receive IVIG, 65 of whom relapsed during the first 6 months after delivery. The investigators found that the odds of relapse postpartum within the first 6 months after delivery were 68% lower in the treatment group than in the control group.
The investigators noted that earlier studies have not always come to the same conclusion, however, making systematic reviews essential. For example, a 1996 cohort study by Achiron et al assessed the effects of IVIG at 0.4 g per day for 5 consecutive days during the first week after gestation and with follow-up administration at 6 and 12 weeks. Of the 3 patients who received this regimen, none relapsed during the first 6 months after gestation, while 12 non-IVIG treated patients relapsed during the same period.
In another study conducted by Hellwig et al, investigators studied the effects of IVIG, no treatment, and conventional disease-modifying therapy in 124 pregnant women. Group 1 received 1 of the 3 different treatment regimens, group 2 received no postpartum treatment, and group 3 received conventional disease-modifying treatment 2 weeks after birth. According to their results, the use of IVIG was not shown to be significantly superior to the other alternatives.
Finally, a dose comparison study of IVIG in postpartum MS compared different IVIG doses in 173 pregnancies. Group 1 received 150 mg/kg on day 1 followed by placebo infusions on days 2 and 3, while group 2 received 450, 300, and 150 mg/kg on days 1, 2, and 3, respectively. After this regimen, both groups received 150 mg/kg 5 times at 4-week intervals. In the first 3 months postpartum, the investigators found no significant differences in relapse rates between the 2 groups.
Based on this review, the authors said the quantitative and qualitative analyses could not establish any advantage of using IVIG in this patient population. They said the range of doses, therapeutic schemes, timing of treatment, and assessment of relapses over time presented serious limitations in reaching conclusions and consensus among the studies and the authors said they could not support the recommendation of IVIG.
Rosa G, O’Brien A, Nogueira E, et al. There is no benefit in the use of postnatal intravenous immunoglobulin for the prevention of relapses of multiple sclerosis: findings from a systematic review and meta-analysis. Arquivos de Neuro-Psiquiatria; February 28, 2018. https://www.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2018000600361&lng=en&nrm=iso&tlng=en. Accessed December 2, 2020.