According to a study presented at the American College of Rheumatology (ACR) annual meeting, the newly developed Psoriatic Arthritis 5-Thermometer Scales (PsA-5Ts) is a simple patient-reported outcome tool that can effectively assess psoriatic arthritis in daily clinical practice.
In this exclusive MedPage Today video, Philip Mease, MD, of the University of Washington School of Medicine and the Swedish Medical Center in Seattle, discusses the novel instrument and how it stacked up against established measures.
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 St. Joseph Health, and clinical professor at the University of Washington in Seattle. I had the opportunity to participate in a study that was presented at ACR in which we were testing a new and simplified instrument for a more holistic assessment of the impact of psoriatic arthritis on patients. The abstract was lead-authored by Carlo Selmi from Italy, and I was the senior author.
The new instrument that we were testing is something known as the PsA-5Ts. And what the 5T refers to is five different domains or impacts of psoriatic arthritis measured on a thermometer from 0 to 10. And so these domains, which are very important for patients with psoriatic arthritis, include pain, fatigue, function, depression, and skin symptoms. And all of these are very important and are part of the impact of the disease on a daily basis with this condition, which affects not only the joints and places where tendons insert into bone, but also the spine and the skin in the form of psoriasis and significant nail disease.
So there’s a double whammy of having a painful arthritis condition that can be disabling along with embarrassing skin symptoms and itching that can be quite troublesome to patients, and so one of the important comorbidities is depression. Now typically — and composite measures we measure, say, joints and skin perhaps — but not this whole spectrum of disease impact. So this was a way of trying to develop a simple instrument that could measure this.
So what was done was to take clinical trial data from DISCOVER-1 and -2, and a trial known as COSMOS. In these trials, Tremfya [guselkumab] was tested against placebo in patients with psoriatic arthritis. DISCOVER-1 was a mixed population of patients who were biologically naive as well as patients who are biologically experienced, for example, they might’ve had a previous TNF [tumor necrosis factor] inhibitor medication. The DISCOVER-2 trial were patients that were naive to biologic treatments. And then finally the COSMOS trial was a trial in which all of the patients had previously been exposed to a biologic treatment.
Now, there are various measures that were done in these trials such as the PASDAS [Psoriatic Arthritis Disease Activity Score], which is a composite measure of disease activity. Also, there were measures such as the SF-36 [The 36-Item Short Form Health Survey], which measures quality of life. And there was a specific question in the SF-36 that is: “Have you felt downhearted and depressed?” So that could be used as a comparator, so to speak, with the depression question in this new instrument graded on a scale of 0 to 10. Fatigue in the clinical trials was measured using something called the FACIT [Functional Assessment of Chronic Illness Therapy], which is a well-known and validated fatigue measure. Pain was measured simply as pain, and physical function using the Health Assessment Questionnaire.
So what was done was to correlate the various measures that were done in the clinical trials with these five different thermometers, 0 to 10, measuring pain, fatigue, physical function, depression, and skin symptoms. And what was found was that the measures correlated very well with the five different thermometers, if you will. And so when we looked at how the measure performed, it was shown to work very well. It discriminated between the Tremfya treated arms of the study and placebo arm of the study in a very similar way that the individual more complex instruments that were used in the clinical trial performed.
So what this tells us that this is an instrument that could be used in a reliable way in clinical practice, and it helps give us a metric to assess whether or not our patients are improving and improving in a meaningful way with these different impacts of the disease of psoriatic arthritis.