Humoral Vaccine Responses and One-year Follow-up of Infants Potentially Exposed to Ocrelizumab During Pregnancy and Breastfeeding - Part 3

In the final episode of this series, Dr. Justin Abbatemarco and Dr. Ruth Dobson discuss navigating conversations with women and their families about potential ocrelizumab exposure during pregnancy and breastfeeding. 

Read more about this abstract on the AAN website.  

Show transcript:

Dr. Justin Abbatemarco:

Hello and welcome back. This is Justin Abbatemarco on our final episode with Ruth Dobson from Queen Mary University of London on our AAN annual meeting abstract humoral vaccine response and one year follow-up of infants potentially exposed to ocrelizumab during pregnancy and breastfeeding. Our previous two episodes, we've talked about this wider world of monoclonal antibodies during pregnancy and then we've talked about the data specifically around ocrelizumab.

But Ruth, I think the million-dollar question is how do we approach this in clinical care? How can we talk to women and their families during this really exciting time and how do you employ this, especially within the MS space?

Dr. Ruth Dobson:

So it's a really exciting time for women in our families, but it can be really hard to talk about. And many of my patients have loads of anxieties about living with a chronic disease, thinking about pregnancy and breastfeeding, worrying about how to balance effective treatment against wanting not to cause any potential harm or risk to their child. A lot of this is actually about informed decision making and having those discussions and having the data to back up those discussions.

What this data really helps us to do is have those discussions in a way that is meaningful for women so we can say, "Well, actually where you have received treatment up until the point of conception, we can see that babies are being born with normal B cell levels, that the drug is not causing long term effects to the best of our knowledge in your babies." And similarly, when people are thinking about restarting treatment postpartum, we know specifically in MS that the relapse risk is highest in those postpartum three months. So often people feel quite anxious about that and want to get on top of their disease, but don't want to forego breastfeeding for that.

We are now in a situation where women no longer have to choose. We know that the drug doesn't get into breast milk. We can reassure them. Certainly in Europe, we've had a label change around CD20s now being safe for use in breastfeeding. So we can have that discussion and enable people to actually have that pregnancy and breastfeeding experience that they want to have without having to make compromises in the way that maybe people have previously.

Dr. Justin Abbatemarco:

I love that message because our messaging before was compromising. But now we can really have an informed discussion with patients and their families that MS does not define them and does not define their family planning needs.

I love that idea about breastfeeding as well. I think that's a really anxious time. It's a really intimate moment that we as the medical community shouldn't dictate that we should allow that to be a time that the families get to choose on how they want to approach that. And so this data helps so much.

Maybe we could just talk about that label change, how we could think about keeping up with our governing bodies and how they talk about these medications, because it's really challenging if a patient checks on the internet and sees something different from our FDA or other European governing bodies. How do you think through that?

Dr. Ruth Dobson:

Yeah, it's really hard and it creates lots of anxieties for patients. And I think even at the moment, the label washout is different across CD20 drugs. It's different between Europe and America. And that in itself causes anxiety. But in some ways that helps with those discussions to say, these labels, they're not always based in the kind of evidence that we need that's really helped us to recruit women studies to get people taking part in this research. And also in Europe, it shortened the washout period. These studies work in terms of changing that policy.

I think that regulators are increasingly recognizing, certainly in Europe, class effects. They're increasingly recognizing the importance of including people considering pregnancy, lactating mothers in studies so that we can actually better answer these questions without having to wait eight, 10 years for these kind of data to come out before we can allow our patients to really partake in informed decision making.

Dr. Justin Abbatemarco:

And your work, work like it is so important for these conversations. So we'll hopefully have some really great discussions and be able to come back and have better conversations with patients because of it. So Ruth, thanks.

Dr. Ruth Dobson:

Thank you.