Using data registries from initial trials, companies such as Actelion will be looking to expand research beyond the first first or second year of care in patients with PAH.
With the recent success of different drug classes such as endothelin receptor antagonists (ERAs) and prostacyclin-receptor agonists detailed in large-scale, long-term trials such as SERAPHIN and GRIPHON, respectively, the pulmonary arterial hypertension (PAH) field has plenty data and patient populations to work with in the coming years.
In an interview with MD Magazine® while at the 2018 CHEST Annual Meeting in San Antonio, TX, Gary Palmer, MD, MBA, Vice President of Medical Affairs for Actelion Pharmaceuticals and Victor Tapson, MD, Director of the Venous Thromboembolism & Pulmonary Vascular Disease Research Program at the Cedars-Sinai Medical Center, discussed how progressive studies on macitentan and selexipag will advance through real-world results and the ongoing SERAPHIN and GRIPHON trials.
They also detailed how those results may shape discussion at future CHEST meetings.
MD Mag: What clinical progress will highlight PAH discussion at CHEST 2019?
Tapson: Any registry data we have, we like to take out as far as we can. If we have 1 or 2 years followed and get 3 or 4, it’s very important to be able to do that. In terms of new studies, we still have data coming out of the GRIPHON study—different sub studies that are being presented in published in abstract form and being published from this large file. We're still seeing more of that.
Again, we'll see the TRITON study data eventually, not quite yet, but eventually. So, many more things coming and a lot of them amount to how we can do in patients already on background therapy. It's more challenging to see improvement for patients on 1 or 2 drugs already. We saw that in GRIPHON—it was fantastic, a third of the patients are on to background therapies and we still saw improvement. The rest are on a single background therapy, so being able to add a medication with different mechanism and keep pushing the envelope for it was really important.
I think we'll hear more data, and that is big.
Palmer: There are lots of subpopulations within this disease, and there are lots of gaps in our knowledge still about how some of those subpopulations behave. So, we as a company, with the help of many of our physicians, continue to invest in new clinical trials to produce more data in those areas—to see how patients do with various sometimes comorbidities but other forms of these diseases.
We do that through clinical trials, we do it through registries. As you heard Dr. Tapson say, we'll continue to report our data, both from clinical trials where we complete studies. We've completed a number this year in for the pulmonary indication, looking at right ventricular function. But we have others that are continued to roll out over the next 5 years, and we are following patients longer and longer.
So, you know the initial trials in this area focused on short periods of time—6 months. We now have data actually from the SERAPHIN trial that was referenced earlier, where we've been following patients for up to 7 years. And we see what happens to these patients with treatment with the disease over longer and longer periods of time. And we'll continue to release that data as it becomes available.
Tapson: And I wouldn't just expect a family practice or primary care physician to be able to stay up on all these data. They have so much to do and so many things they need to know. Primary care is very challenging nowadays. If they can be aware of the disease, aware of pulmonary hypertension symptoms, unexplained dyspnea, maybe not being overweight or in poor condition or from some other primary disease. Just simple things on an exam that some people may not notice.
I think primary care doc's really need to know some basic things and make sure they get these patients referred to a pulmonologist or a PAH referral center.
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