Speaking at Teva Central Nervous System Weekend (TCW 19), key investigator in glatiramer acetate (GA) trials, Professor Andrew Goodman, Professor of Neurology, Chief of the Neuroimmunology Division and Director of the Multiple Sclerosis Center at the University of Rochester and Professor Jeannette Lechner-Scott, Conjoint Professor at the University of Newcastle spoke of their cumulative experience with GA, including the long-term safety profile and growing body of evidence for treatment continuing during pregnancy.

“The longest clinical trial follow-up data of any of the multiple sclerosis (MS) therapies really gives us confidence in the long-term safety of GA” – Prof. Goodman

“This confidence also extends into the pregnancy space” – Prof. Lechner-Scott

Prof. Goodman set the scene for delegates, describing the history of GA in MS. “It holds a highly significant place in the era of MS therapeutics, even though we still don’t have a complete understanding of everything it does.¹ But what we do have confidence in is the long-term efficacy and safety of this drug,”^2,3 he explained.

Walking the audience through the data, Prof. Goodman said: “Considering the environment at the time, this drug has a pretty good retention rate.³ He noted the overall takeout was that there were no new safety signals that emerged over the last 20 years and that the long-term safety and efficacy for GA lends confidence to clinical decisions.³

“When thinking about starting patients on treatment, pregnancy is something that needs to be addressed head on by clinicians” – Prof. Lechner-Scott

Following on from Prof. Goodman, Prof. Lechner-Scott made the point that when starting patients on disease-modifying therapy (DMT), clinicians needed to be proactive in bringing up the subject of family planning and pregnancy. “There’s a lot of uncertainty out there among patients, and possibly clinicians too, around how to manage pregnancy in MS,” said Prof. Lechner-Scott.

“Considering more young women are being diagnosed with MS than ever,⁴ and 51% of pregnancies are unplanned,⁵ we cannot and must not wait for the patient to bring up the subject” – Prof. Lechner-Scott

“If the patient decides to become pregnant, keep in mind that it might take a while, so don’t just discontinue therapy without a plan be aware of reactivation of disease after stopping especially lymphocyte trafficking therapies,” she warned. “Preventing relapse during pregnancy is very important as there are limitations with the use of acute therapies,^6,7 particularly in comparison to the data we have now on treatments like GA.”

Prof. Lechner-Scott dispelled the myth that pregnancy is bad news for patients with MS. “In fact, there is probably a protective effect of pregnancy on the course of MS (evidenced by AusImmune and MSBase data),^8-11 although the precise mechanism is not clear. What the evidence does suggest is there are likely to be better outcomes if the patient is stable for at least 2 years before planning pregnancy,”¹⁰ she said. Prof. Lechner-Scott noted there was some evidence to suggest that IVF may increase disease activity.I recommend consulting the IVF specialist in those circumstances. Mode of delivery does not appear to affect the patient and the evidence remains unclear as to whether breastfeeding has a protective effect or not.^13,14 All in all, we should be reassuring our patients that pregnancy itself isn’t going to make their MS worse.”

“We have more data than ever that shows GA poses no increased risk of spontaneous abortion or teratogenetic effects,¹⁵ there is no need to take patients off treatment when they fall pregnant if they are at high risk of relapse” – Prof. Lechner-Scott

Prof. Lechner-Scott then covered the body of evidence for GA and other DMTs in pregnancy. She noted that the safety of GA is well proven in pregnancy,^8-11 less so with other DMTs. “In response to the large body of evidence showing GA poses no increased risk of spontaneous abortion or teratogenicity, the pregnancy contraindication for GA has been removed¹⁵. Of course, DMTs are not the only medication the patient may be on during pregnancy. There are risks with antidepressants, for example, but you would not take a patient off during pregnancy. necessarily.”

In her concluding remarks, Prof. Lechner-Scott said she wanted to make it clear that “we don’t need to make patients anxious about being on therapy and falling pregnant. In trials, some patients elected to have abortions because of a potential risk to the baby. But what registry data shows us is that rates of spontaneous abortion and stillbirth are no higher than the general population for patients on GA.”¹⁶

This article was sponsored by TEVA, which has no control over editorial content. The content is entirely independent and based on published studies and experts’ opinions, the views expressed are not necessarily those of TEVA.

References:

1. Martin R et al. Eur J Immunol 2016;46: 2078-2090.
2. Johnson KP et al. Neurology 1995;45:1268-1276.
3. Ziemssen T et al. Expert Opin Drug Saf 2017;16(2):247-255.
4. Ribbons K et al. Mult Scler 2017;23(8):1063-1071.
5. Marie Stopes. https://www.mariestopes.org.au/wp-content/uploads/Real-Choices-Key-Findings.pdf
6. Alroughani R et al. Neurology 2018;90 e840-e846.
7. Coyle PK. Ther Adv Neurol Disorder 2016;9:198-210.
8. Ponsonby AL et al. Neurology 2012;78:867-874.
9. Jokubaitis VG et al. Ann Neurol 2016;81(1):89-100.
10. Hughes S et al.  Mult Scler 2014,739-746.
11. Portaccio E et al. J Neurol Neurosurg Psych 2014;85(8):845-850.
12. Hellwig K, Correale J. Clin Imm 2013;149(2):219-224.
13. Harazim H et al. Brain Behav 2018;8(9):e01082.
14. Zuluaga MI et al. Neurology 2019;92:e1-e10.
15. Copaxone (glatiramer acetate) Product Information.
16. Sandberg-Wollheim Int J MS Care. 2018; 20:9-14.