Author Of 2 Presentations
P0507 - Treatment of multiple sclerosis during lactation with interferon-beta 1a or glatiramer acetate (ID 877)
Abstract
Background
Interferon-betas (IFN-β) are cytokines, glatiramer acetate (GA) is a synthetic polypeptide. Both substances are large molecules and lack oral bioavailability. As of September 2019, IFN-β are the first and up to now the only multiple sclerosis (MS) therapy approved also during lactation. Published data are restricted but show only minimal concentrations of the drug in human milk. No data on GA excretion are available, but it seems unlikely the substance would pass into breast milk. Although the risk for the infant is most likely negligible, data on breastfeeding under IFN-β or GA are very restricted. The effects on infant development and health as well as on maternal relapse risk postpartum are yet unknown.
Objectives
To assess the safety of maternal IFN-β 1a or GA administration during lactation for the breastfed infant as well as to assess its effect on the occurrence of postpartum relapses.
Methods
So far, we identified 34 infants (one pair of twins) who were breastfed under GA and 28 infants who were breastfed under IFN-β 1a from the German MS and pregnancy registry (DMSKW). Cases were followed-up for at least one year postpartum. Data was generated via standardized interviews, conducted with the mother during pregnancy as well as at 1, 3, 6 and 12 months postpartum.
Results
Identification, inclusion and follow-up of additional cases are still ongoing; updated data as well as analysis of the total cohorts will be presented at the congress. Among the infants breastfed under GA there was no case of developmental delay, in the IFN-β 1a cohort there was one report of a delay regarding motor skills (4 %). Medians of weight, length and head circumference at several medical check-ups during the first year of life lay within the normal range (3rd and 97th percentile) of reference values for both cohorts. Hospitalizations and antibiotic treatments occurred only rarely. Within the first year postpartum 7 (21 %) women relapsed in the GA cohort as well as 7 (25 %) in the IFN-β 1a cohort.
Conclusions
Our preliminary analysis revealed no hints that treatment with GA or IFN-β 1a during lactation negatively affects development or health of breastfed infants. The effect on postpartum relapses has still to be determined. Our results support the recent label extension of IFN-β and suggest that treatment with GA is probably compatible with breastfeeding as well.
P1126 - Impact of interferon-beta exposure during early pregnancy on relapse rate (ID 1074)
Abstract
Background
In disease modifying therapy (DMT)-unexposed pregnancies of multiple sclerosis (MS) patients, relapse rate decreases significantly during pregnancy, followed by an increase in the first 12 weeks postpartum, but little is known about the relapse pattern and the associated steroid use in interferon-β (IFN-β) -exposed pregnancies, which might not show the typical disease course.
Objectives
To determine disease activity during pregnancy in women with MS and IFN-β treatment 12 months prior to the last menstrual period (LMP).
Methods
Pregnancies were prospectively collected in the German MS and pregnancy registry up to 10.2018. Pregnancies with a duration of at least 22 gestational weeks and IFN-β treatment 12 months prior to conception were compared in two groups: pre-LMP group stopping IFN-β between 365 and 1 day before LMP and post-LMP group stopping IFN-β between LMP and 84 days afterwards.
Results
We identified 47 pregnancies in pre-LMP group and 165 pregnancies in post-LMP group, without differences in baseline characteristics (age, BMI, disease duration, IFN-β treatment duration, annualized relapse rate (ARR) before pregnancy) and a median postpartum follow up of 610 days (range 17 – 2,799). 35 of 212 women (16.5%) had at least one relapse during pregnancy, 14 (29.8%) in pre-LMP group and 21 (12.7%) in post-LMP group (p=0.011). 14 (6.6%) women experienced a relapse in trimester 1, 21 (9.9%) in trimester 2 and 7 (3.3%) in trimester 3. Notably, significantly more women in the pre-LMP group experienced a relapse in trimester 2 (OR= 4.68, CI[1.82;12.2], p=0.002). Corticosteroid use did not differ significantly between groups; neither in overall pregnancy (p= 0.399) nor per trimena (trimester 1: p= 0.686, trimester 2: p= 0.266, trimester 3: p= 0.124).
214 pregnancy outcomes were observed (including two twin pregnancies). Preterm births differed significantly with more preterm births in the pre-LMP group (pre-LMP: 8/17.02%; post-LMP: 10/6.06%; OR 3.12, p=0.03). Medically confirmed major malformations did not differ between groups (pre-LMP: 1/47 (2.13%); post-LMP: 7/167 (4.20%); OR: 0.433, p=0.687)). No stillbirth was observed.
Conclusions
The withdrawal of IFN-β before pregnancy is associated with a higher relapse risk, especially in trimester 2 and a higher chance of preterm birth, though not higher steroid use during pregnancy, but more data is needed. At the time of the meeting, updated results on disease activity especially relapse rates will be presented.