Evaluation of pregnancy outcomes in patients with multiple sclerosis after fingolimod exposure

Geissbühler, Yvonne; Vile, Jere; Koren, Gideon; Guennec, Morgane; Butzkueven, Helmut; Tilson, Hugh H.; MacDonald, Thomas M.; Hellwig, Kerstin

doi:10.1177/1756286418804760

Cited by 34 publications

(24 citation statements)

References 17 publications

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“…Prenatal exposure to second line treatments including natalizumab and fingolimod also appears to be safe 110,111 , however small numbers recruited into past studies mean it is not possible to draw definitive conclusions. Studies into the area of MS treatment during pregnancy have proposed future research into identification and measurement of accurate biomarkers for disease activity and prognosis.…”

Section: Pregnancy Outcomes and Exposure To Ms Disease Modifying Drugsmentioning

confidence: 99%

The association between multiple sclerosis and pain medications

Burkill

Montgomery

Kockum

et al. 2018

Pain

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Section: Pregnancy Outcomes and Exposure To Ms Disease Modifying Drugsmentioning

confidence: 99%

The association between multiple sclerosis and pain medications

Burkill

Montgomery

Kockum

et al. 2018

Pain

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“…We assessed whether DMT use preconception was associated with inflammatory activity on postpartum MRI and found no association (treated n = 84 (70.0%), untreated n = 36 (30.0%), and the presence of either postpartum new Gd+ lesions ( p = 0.73) or new T2 lesions ( p = 0.94). Given the recent reports of increased rebound MS activity peripartum after certain DMTs discontinuation, 8 , 9 we further categorized DMTs as self-injectable (n = 62) vs oral and infusion (n = 20) and found no association between prepartum DMT category and postpartum new Gd+ lesion ( p = 0.32) or new T2 lesion ( p = 0.61). The number of participants in the oral and infusion groups was too small to further stratify and analyze by specific DMT (fingolimod + natalizumab vs others).…”

Section: Resultsmentioning

confidence: 99%

“… 6 In women prospectively observed after the diagnosis of radiologically isolated syndrome (RIS), pregnancy was associated with a significantly shorter time to clinically definite MS. 7 A tendency for rebound activity after discontinuation of certain highly efficacious disease-modifying therapies (DMTs) (e.g., fingolimod and natalizumab) has contributed to an increased relapse rate during pregnancy in some women. 8 , 9 …”

mentioning

confidence: 99%

MRI activity in MS and completed pregnancy

Houtchens

Bove

Healy

et al. 2020

Neurol Neuroimmunol Neuroinflamm

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ObjectiveTo evaluate postpartum MRI activity in patients with MS and a completed pregnancy and to compare these results to an age-matched untreated nonpregnant MS cohort.MethodsPatient with MS from a tertiary care MS center between 2006 and 2015, with prepartum and postpartum neurologic follow-ups and MRI scans were analyzed. Clinical activity and inflammatory brain MRI activity (new T2-hyperintense or gadolinium-enhancing [Gd+] lesions) were assessed peripartum. The results were compared with untreated reproductive-age patients with MS from the placebo arm of the clinical trials.ResultsA total of 123 pregnancies in 123 women (median Expanded Disability Status Scale 1.0) were analyzed. Approximately 7.2% relapsed during pregnancy and 48.7% relapsed postpartum. Of pregnancies with prepartum and postpartum gadolinium (Gd)-enhanced MRI (n = 112), 8% had Gd+ lesions prepartum and 33% had new Gd+ lesions postpartum. Overall, 54.4% had either new T2 or Gd+ lesions postpartum. Seventy-nine percent of subjects with postpartum relapse had new MRI activity compared with 37.1% without relapse (p < 0.001). Twenty-five percent had both clinical and radiographic activity and only 24.9% maintained no evidence of disease activity status postpartum. There was no association between postpartum MRI activity and disease-modifying treatments (DMTs) (p > 0.5). MRI and clinical outcomes were also assessed for 126 nonpregnant untreated female patients with MS. Comparing pregnancy and no pregnancy groups, there was no difference in MRI activity at follow-up.ConclusionsThere was a high level of inflammatory radiographic disease activity which was related to relapses in postpartum patients with MS. Further studies are needed to determine whether hormonal fluctuations vs extended time off DMTs may be the underlying cause of our observations.

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“…In all five cases, fetal exposure to the drug happened in the first trimester of pregnancy. More recently, results of a fingolimod-exposure registry (1,246 pregnancies) that included three prospective database sources showed that the prevalence of major congenital malformations or miscarriages was not higher among pregnant women exposed to fingolimod compared with the general population and the unexposed MS population 132 . In particular, the prevalence of cardiac malformations observed was not significantly different from that of the general population.…”

Section: Fingolimodmentioning

confidence: 99%

“…Consequently the EMA updated the label of fingolimod 133 . It is therefore recommended to discontinue fingolimod at least 2 months prior to conception while using effective contraceptive measures and closely monitor the patient 131,132,134 . In case of unplanned pregnancy, fingolimod should be discontinued immediately and as these are high risk pregnancies, fetal organ screening ultrasound is recommended.…”

Section: Fingolimodmentioning

confidence: 99%

Pregnancy-related issues in women with multiple sclerosis: an evidence-based review with practical recommendations

Canibaño

Deleu

Mesraoua

et al. 2020

Journal of Drug Assessment

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Objective: To review the current evidence regarding pregnancy-related issues in multiple sclerosis (MS) and to provide recommendations specific for each of them. Research design and methods: A systematic review was performed based on a comprehensive literature search. Results: MS has no effect on fertility, pregnancy or fetal outcomes, and pregnancies do not affect the long-term disease course and accumulation of disability. There is a potential risk for relapse after use of gonadotropin-releasing hormone agonists during assisted reproduction techniques. At short-term, pregnancy leads to a reduction of relapses during the third trimester, followed by an increased risk of relapses during the first three months postpartum. Pregnancies in MS are not per se high risk pregnancies, and MS does not influence the mode of delivery or anesthesia unless in the presence of significant disability. MRI is not contraindicated during pregnancy; however, gadolinium contrast media should be avoided whenever possible. It is safe to use pulse dose methylprednisolone infusions to manage acute disabling relapses during pregnancy and breastfeeding. However, its use during the first trimester of pregnancy is still controversial. Women with MS should be encouraged to breastfeed with a possible favorable effect of exclusive breastfeeding. Disease-modifying drugs can be classified according to their potential for pregnancy-associated risk and impact on fetal outcome. Interferon beta (IFNb) and glatiramer acetate (GA) may be continued until pregnancy is confirmed and, after consideration of the individual risk-benefit if continued, during pregnancy. The benefit of continuing natalizumab during the entire pregnancy may outweigh the risk of recurring disease activity, particularly in women with highly active MS. GA and IFNb are considered safe during breastfeeding. The use of natalizumab during pregnancy or lactation requires monitoring of the newborn. Conclusions: This review provides current evidence and recommendations for counseling and management of women with MS preconception, during pregnancy and postpartum.

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Evaluation of pregnancy outcomes in patients with multiple sclerosis after fingolimod exposure

Cited by 34 publications

References 17 publications

The association between multiple sclerosis and pain medications

The association between multiple sclerosis and pain medications

MRI activity in MS and completed pregnancy

Pregnancy-related issues in women with multiple sclerosis: an evidence-based review with practical recommendations

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