Patients with treatment-resistant active psoriatic arthritis (PsA) had meaningful improvements in pain, physical function, and fatigue with guselkumab (Tremfya) through 6 months, according to presented at the American College of Rheumatology (ACR) annual meeting.
In this exclusive 51˶ video, Philip Mease, MD, of the University of Washington School of Medicine and the Swedish Medical Center in Seattle, discusses the study results and why real-world data are important for clinicians.
Following is a transcript of his remarks:
Hello, my name is Dr. Philip Mease, I'm the director of rheumatology research at Swedish Medical Center, Providence Health in Seattle. I'm also clinical professor at the University of Washington. The is a large registry that has been in existence since 2003. It was previously known as the Corona Registry. Since 2013, we've had a dedicated collection of data on patients with psoriatic arthritis and spondyloarthritis. In this particular study, we looked at patients who were starting Tremfya on-label, using it with a loading dose, and then treatment with every 8 weeks subcutaneous dosing. And looking at the key outcomes at a 6-month time interval.
The importance of looking at data in real-world evidence registries is that we are interested in knowing whether in actual practice we are seeing similar results, or not, as we see in the randomized clinical trials. Patients going into trials are typically more severely involved with disease, they may have more comorbidities, whereas the patients in registries are more akin to what we see from day-to-day in actual practice. So it's important to have both types of evidence so that clinicians, when they're counseling patients, can really have the best data to make their judgments.
So in this study, there were 90 patients that met this definition and had 6 months [of] data. And what we saw is that the majority of patients were able to complete and have outcome measures done. And the key measures are measures like improvement of pain, improvement of function, and what we call patient global. And what was shown was that almost 40% of patients had meaningful improvements of pain. That is at least a 30% improvement of pain. And also a meaningful improvement of physical function as measured by the health assessment questionnaire, and also improvement of what we call patient global -- that is evaluating all the ways the psoriatic arthritis affects you.
Furthermore, approximately 20% of patients had what I would call major changes. That is at least 50% improvement of pain, for example, as well as more significant improvements in physical function and overall global assessment of their disease state.
The overall profile was of the tolerability and safety was very good. And so it helps contextualize and compliment that the similar data that we've been seeing in clinical trials with Tremfya.
So now we know that an IL [interleukin]-23 inhibitor that can be very effective for all of the domains of psoriatic arthritis, including musculoskeletal and skin, can be highly effective in patients in a real-world registry setting.