In an interview with Pharmacy Times®, Christian Ruff, MD, director of general cardiology at Brigham and Women's Hospital, highlights the role of pharmacists in educating patients about abelacimab (Anthos Therapeutics), a factor XI inhibitor, and its potential impact on anticoagulation therapy for atrial fibrillation (Afib) patients at risk of stroke. Ruff emphasizes that abelacimab’s once-monthly injection offers a simple transition from traditional anticoagulants and significantly reduces bleeding risks. Ruff discusses ongoing phase 3 trials that aim to confirm abelacimab's efficacy, with potential approval in the coming years.
Pharmacists stand to play a significant role in the appropriate counseling of patients with Afib at heightened risk of stroke regarding abelcimab's treatment benefits compared with standard of care therapies.
Closed captions in this video were auto-generated by artificial intelligence.
Pharmacy Times: How can pharmacists play a role in educating patients regarding its use and managing transitions from traditional anticoagulants to abelacimab?
Key Takeaways
1. Pharmacists will be crucial in educating patients about abelacimab’s safety benefits and ensuring adherence.
2. A safer anticoagulant could increase anticoagulation use in Afib patients, reducing stroke risk.
3. Phase 3 trials are underway, with approval potentially in the next few years.
Ruff: These are really important points because, hopefully, if this drug is approved and other factor XI inhibitors, it will really be important to figure out how do we get the message out there and get these therapies to patients who need them. Luckily, the transition is quite simple. Whenever you would take your next dose of your blood thinner, whether that's a DOAC, you would simply start the abelacimab on that day, and it's a once-monthly injection. It's a pretty seamless transition. I think what's important about abelacimab in particular is really the education to the medical community and pharmacists that this drug works in a very different way than other anticoagulants or blood thinners patients have been taking, and it's far safer. We know that if you look at patients who are given a prescription for an anticoagulant, many times they don't fill them or they stop them soon after taking. I think we really must get the message out there, and pharmacists can really help us with this, to say that this drug is far safer with respect to anticoagulation than any drug they may have been on in the past. I think that that's a really important message because we know that these drugs will enable us to treat patients who routinely either weren't prescribed it or discontinued it. And I think we'll be learning as we do these trials because the drugs are so safe. One of the things that we thought a lot about is one of the issues that pharmacists are always dealing with, and we are as physicians as well, is how do you manage these drugs in and around procedures or other things where there's a bleeding risk? But I think there's an opportunity with abelacimab, when we have some data we've presented initially, that may really transform how we think about anticoagulation and may allow us to leave people on anticoagulants as they go about their routine daily life and all the procedures that an elderly Afib patient may undergo. It may be far safer to kind of leave patients on these therapies even when they have scheduled or unscheduled procedures. This is obviously a field we're learning much more about, and we'll share more data in the future, but pharmacists will really be important to help us figure out exactly how to use these medications and how to get them into patients who routinely, I think, would be given a prescription but not take it.
Pharmacy Times: How do you see these findings influencing prescribing decisions among clinicians and pharmacists, especially for patients with Afib at risk of stroke?
Ruff: Yeah, and we know that if you take a garden variety Afib patient, predominantly because they're in their 70s and they have various comorbidities, about 90% or more meet a class 1 guideline indication for anticoagulation. We should at least be considering anticoagulation in almost all the patients we see with Afib. If you look at who does not receive an anticoagulant or stops taking it, it's either they've bled before or the fear of bleeding. And the decision about which anticoagulant their take is almost entirely driven by perception—real or not—of the bleeding risk of the anticoagulant. We know that bleeding, or the fear of bleeding, really drives a lot of the decision-making about even prescribing an anticoagulant in the first place and which one you would select. I think if abelacimab, in phase 3 trials, demonstrates its efficacy, because it's so much safer, I think there's going to be tremendous enthusiasm for a drug like this from both patients and providers. Because if you could deliver effective anticoagulation far safer than we've ever been able to do, I think that gives a lot of comfort to both patients and their families and the health care community.
Pharmacy Times: What are the next steps in abelacimab’s clinical development, and how soon might pharmacists see this therapy in practice?
Ruff: As I mentioned, AZALEA-TIMI 71 was really a trial to establish the bleeding profile of abelacimab compared to the standard of care, in this case rivaroxaban, and obviously it came through with flying colors. It just is tremendously safer. The next step is obviously the phase 3 trials, where abelacimab demonstrates its efficacy definitively. We're also leading a trial in Afib, the LILAC-TIMI 76 trial, which is looking at abelacimab against placebo in very, very high-risk Afib patients who have been deemed ineligible for currently available anticoagulation, so the biggest unmet need that I spoke about, and that's one of the phase 3 trials. There are also 2 other phase 3 trials of using abelacimab in another disease state, in venous thromboembolism, cancer-associated venous thromboembolism; again, a very high-risk patient population, a high risk of recurrent venous thromboembolism, as well as bleeding. And obviously, if those 3 trials are successful, and we have every hope and indication they will be, then hopefully that will lead to the approval of abelacimab in the next several years. Obviously, we await on the data of the phase 3 trials. You have to do those trials; you have to demonstrate their efficacy in a randomized clinical trial. But we may see abelacimab available in the next few years. And we're just very excited about these ongoing trials, and we look forward to sharing those results with you in the upcoming years.