Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, shares why his study comparing the safety and efficacy of Cyltezo, an adalimumab biosimilar, with the originator (Humira) matters for patients with gastroenertology conditions.
Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, highlights the importance of his study comparing an adalimumab (Cyltezo) with the refrence product (Humira) patients with gastroenterology conditions.
What role can your trial play in improving patient and provider confidence in using adalimumab biosimilars for Crohn disease and ulcerative colitis?
The study actually provides additional reassurance regarding the biosimilarity and the potential of patients switching from either the [reference product] to the biosimilar or substituting the biosimilar from the onset.
Why are more clinical studies on anti-TNF [tumor necrosis factor] medications in gastroenterology conditions needed and how can providers and health systems be better advocates for these types of trials?
Firstly, there still is room for improvement in efficacy within the TNF class. We're not getting 100% remission rates and we know that remission rates can be improved with the addition of immunomodulators for instance, or dose escalation in some situations. In addition, we are seeing newer TNF formulations—for instance, of subcutaneous infliximab—as a maintenance therapy. So, as additional biosimilars are coming out, we also have additional new products of the same class that are being evaluated and offer patients different opportunities, for instance, of intravenous versus subcutaneous formulations at different intervals.