Multiple sclerosis (MS) predominantly affects women between the ages of 20 and 45 at the time of diagnosis – with an increasing incidence [1,2]. As a result, MS is the most common CNS disease in young adults that can cause disability [1]. In fact, women with this condition also tend to have fewer children than women in the general population [3]. Thanks to optimized therapies, however, this no longer has to be the case today.
Multiple sclerosis is a chronic disease and therefore requires effective therapy. However, its course cannot be precisely predicted due to individual complaints and the heterogeneous clinical picture. Therefore, an early and consistent treatment approach is critical for successful disease management. Adequate therapy always takes into account the individual circumstances. For young women of childbearing age, this includes family planning in addition to symptoms, tolerability, and adherence. The therapy decision should therefore take into account tolerability and safety, also with regard to a possible pregnancy.
During pregnancy, the relapse rate decreases in affected women. However, within one month after delivery, one-third of patients relapse [4]. For this reason, the disease should ideally be under control two years before pregnancy begins. Thus, postpartum thrust can be reduced by 45% [5]. However, 43% of pregnancies occur unplanned [6]. It is also inevitable to resume effective therapy immediately after delivery. Treatment options are now available that allow breastfeeding. It is advisable to have a comprehensive look at the respective technical information in order to elicit the use and benefit-risk assessment of the individual products.
Use during breastfeeding possible
Study data regarding the use of interferon beta during and after pregnancy are currently limited. Therefore, registry data were collected and analyzed from nearly 1000 women from 26 European countries between 2009 and 2017 [7]. The prevalence of pregnancy outcomes was associated with those in the general population. It was shown that the use of interferon-beta-1a and -1b did not increase the incidence of congenital malformations. Overall, 82.0% of pregnancies resulted in a live birth without congenital anomaly. The prevalence of spontaneous abortions was also comparable to those in the general population.
The experts concluded that the data collected do not suggest that IFN-beta exposure before conception and/or during pregnancy adversely increases the rate of congenital anomalies or spontaneous abortions. Accordingly, Plegridy® and Avonex® may be used during pregnancy if clinically necessary. In addition, information on the passage of interferon-beta-1a into breast milk and its chemical and physiological properties suggest that the amounts excreted into breast milk are negligible. No adverse effects have been reported in breastfed infants of women treated with interferon beta-1a. Therefore, both preparations can also be used during breastfeeding [8,9].
Benefit-risk assessment in view
Oral therapies are usually contraindicated for use before, during, and after pregnancy. The preparations should be discontinued months before a planned pregnancy in order to achieve a sufficiently low plasma concentration. Otherwise, an increased prevalence with regard to congenital malformations is to be expected. The terminal half-life of monomethyl fumarate (Tecfidera®) is comparatively short at one hour [10]. After 24 hours, no circulating drug is detectable in the majority of patients. Therefore, if pregnancy begins during treatment, a benefit-risk assessment should be performed. Tecfidera® should be used during pregnancy only if the patient’s clinical findings mandate treatment and the potential benefit justifies the potential risk to the fetus [10,11]. Termination of therapy should be considered. However, initiation of treatment during an existing pregnancy is contraindicated. Whether breastfeeding or treatment should be interrupted after pregnancy must be decided on an individual basis.
No contraception necessary
On average, it takes 7.5 months for an MS patient to become pregnant [12]. Because concomitant contraception is indicated with many treatment regimens, there can be a great deal of time pressure when family planning is pending. In contrast, therapy with natalizumab (Tysabri®) does not require concomitant contraception, which makes family planning possible at any time and without pressure [13]. Also, the preparation does not seem to affect fertility. In an observational study, the results showed no specific pattern of malformations that would indicate a drug effect. The spontaneous abortion rate was also consistent with that of the general population [14]. Natalizumab should not be used during pregnancy unless the patient’s clinical findings necessitate treatment with Tysabri. Because the effect on neonates and infants is not known, breastfeeding should be discontinued during Tysabri® treatment [13].
In summary, MS and family planning should be quite possible these days. It is important to discuss this with patients at an early stage so that therapies can be used according to their possibilities and needs.
Literature:
Abbreviated technical information
This article was written with financial support from Biogen Switzerland AG, Baar.
