In this month’s The Regueiro Report, I’d like to highlight two exciting FDA approvals for moderately to severely active ulcerative colitis. Both approvals occurred this past October after two successful randomized, double-blind, placebo-controlled, phase 3 clinical trials.
The first I’d like to highlight is etrasimod (Velsipity, Pfizer). Supported by data from the ELEVATE trials, this drug is the second-in-class sphingosine-1-phosphate modulator treatment, following the FDA’s earlier approval of ozanimod (Zeposia, Bristol Myers Squibb) for treating moderately to severely active UC. Both are once-daily oral pills, and both work to prevent the egress of lymphocytes from lymphoid organs into the colon, which, in turn, reduces inflammation.
There are no head-to-head studies comparing the efficacy and safety of etrasimod with ozanimod, so we can’t say that one is better than the other for certain patients. But we can say that etrasimod is a new oral medicine in our tool kit to help people with moderate to severe UC. Hopefully the fact that there are two oral medication options increases the chance that a patient’s insurance plan will cover one or the other of these treatments, if not both.
The second recent approval I highlight is mirikizumab (Omvoh, Lilly), which also received approval for treating moderate to severe UC following positive data from the LUCENT trials. Mirikizumab is the first selective interleukin-23 (IL-23) inhibitor approved for treating UC. Risankizumab (Skyrizi, AbbVie) is an IL-23 inhibitor approved to treat Crohn’s disease but not UC. The IL-12/-23 inhibitor ustekinumab (Stelara, Janssen) is approved to treat both UC and Crohn’s disease.
Now that we have so many good therapies for our patients, including the two discussed in this report, we will need to consider the ethics of giving people placebo in randomized controlled trials when we know we can give them a treatment that will likely make their lives better. That’s something to consider in our clinical trial designs going forward. Meanwhile, we should celebrate these new options for our patients.