Pregnancy Outcomes from the Branded Glatiramer Acetate Pregnancy Database

Sandberg‐Wollheim, Magnhild; Neudorfer, Orit; Grinspan, Augusto; Weinstock‐Guttman, Bianca; Haas, Judith; Izquierdo, Guillermo; Riley, Claire; Ross, Amy Perrin; Baruch, Peleg; Drillman, Talya; Coyle, Patricia K.

doi:10.7224/1537-2073.2016-079

Cited by 75 publications

(49 citation statements)

References 30 publications

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“…Research undertaken as part of the DMF clinical development program has indicated no increased risk of foetal abnormalities or other adverse pregnancy outcomes relative to the general population when women are exposed to DMF during pregnancy 108 . There is also evidence to show the use of GA during pregnancy is likely to be safe, with no increased risk of congenital abnormalities found for infants prenatally exposed to GA relative to those with no prenatal exposure 109 .…”

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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“…Currently glatiramer is considered a safer option during pregnancy compared to other DMARDs, although its use during this period should only be recommended if the benefit to mother outweighs any risk for the foetus. 5 This appraisal also recommended the use of interferon beta-1b (Extavia) for patients with secondary progressive MS but who continue to have relapses; this is the only treatment currently recommended by NICE for this specific clinical scenario. 6 Retaining the variety of treatment options for patients with relapsing-remitting MS is valuable.…”

Section: Discussionmentioning

confidence: 99%

Beta interferons and glatiramer acetate for treatment of MS: TA guidance 2018

Gaber¹,

Shippen²,

Cheng³

2018

Prog Neurol Psychiatry

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A recent NICE technology appraisal has updated the 2002 guidelines on the use of beta interferons and glatiramer for the treatment of multiple sclerosis. Initial draft guidance in December 2017 proposed not recommending the use of glatiramer and other beta interferons apart from interferon beta‐1b (Extavia) as interferon beta‐1a and glatiramer were deemed to be not cost effective. Many clinicians and patients disagreed with that conclusion and NICE has duly agreed to revisit the data, integrating best supportive care measures rather than relying completely on a head‐to‐head comparison with the newer medication options.

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“…According to the Food and Drug Administration, Copaxone ® is a “Category B” drug, meaning that no risks have been shown in animal fetuses, but there are no well-controlled studies related to human pregnancy. Reports on over 5000 cases of branded Copaxone ® exposure during pregnancy reinforce the lack of teratogenic effects [ 112 , 113 ]. These findings provide important knowledge for better counseling for women with MS who intend to become pregnant and should not forgo the use of DMDs while attempting to conceive.…”

Section: Self-injectable Dmdsmentioning

confidence: 99%

Practical Evidence-Based Recommendations for Patients with Multiple Sclerosis Who Want to Have Children

et al. 2018

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Multiple sclerosis (MS) management presently aims to reach a state of no (or minimal) evidence of disease activity. The development and commercialization of new drugs has led to a renewed interest in family planning, since patients with MS may face a future with reduced (or no) disease-related neurological disability. The advice of neurologists is often sought by patients who want to have children and need to know more about disease control at conception and during pregnancy and the puerperium. When MS is well controlled, the simple withdrawal of drugs for patients who intend to conceive is not an option. On the other hand, not all treatments presently recommended for MS are considered safe during conception, pregnancy and/or breastfeeding. The objective of the present study was to summarize the practical and evidence-based recommendations for family planning when our patients (women and men) have MS.Funding TEVA Pharmaceutical Brazil.

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Pregnancy Outcomes from the Branded Glatiramer Acetate Pregnancy Database

Abstract: These data provide evidence that branded GA exposure during pregnancy seems safe, without teratogenic effect.

Cited by 75 publications

References 30 publications

The association between multiple sclerosis and pain medications

The association between multiple sclerosis and pain medications

Beta interferons and glatiramer acetate for treatment of MS: TA guidance 2018

Practical Evidence-Based Recommendations for Patients with Multiple Sclerosis Who Want to Have Children

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