Dr Heidi Crayton reviews treatment efficacy and safety considerations for conventional and novel treatment options for patients with relapsing-remitting multiple sclerosis.
Heidi Crayton, MD: I think we all want to know about long-term therapy with products that are new to the marketplace. One thing that is important for patients to understand—because sometimes it's hard for patients to wrap their head around starting on a newer product—people often say, “I don't want to be a guinea pig; I don't want to be the first.” I remind them that back when the initial injectable products came to market, it was based on clinical trials with hundreds of people, and now, by the time a product is approved and hits the marketplace, thousands of people have been exposed and those people continue to be followed in long-term open-label extension trials so that we can capture safety data. It’s important for patients to understand that they are not the first; that there are a lot of people that have preceded them and that have made sure that we can monitor for adverse events. That is important. We have long-term data from several of our oral therapies on the market and newer ones to the market. Cladribine has been around for a very long time—10 years of safety data before it even came to market and was approved—and I find patients have a lot of comfort knowing that. We have ozanimod, which has long-term data and the open-label extension. Both of those products came to market during a time that was very difficult—not a lot of exposure and time to talk about these products. It's nice for patients and HCPs [health care professionals] to know that there's a lot of data that surrounds those products even though they're newer to the market.
With cladribine, there's always conversation about the possible risk of malignancies, that's what held it back from coming to market years back. The long-term safety data has shown us that we don't have anything to be concerned about, and there was no signal for malignancies; there was no cause and effect. That was important for us all to see to be able to embrace cladribine coming to the market.
Transcript Edited for Clarity