AMSTERDAM – A new way to assess clinically meaningful, multiorgan changes in patients receiving treatment for systemic sclerosis has transformed the way new drugs for this disease are judged.
The Combined Response Index for Systemic Sclerosis (CRISS) “will change how we look at drugs” for systemic sclerosis, Daniel E. Furst, MD, said at the European Congress of Rheumatology.
Mitchel L. Zoler/MDedge News
Dr. Daniel E. Furst
Dr. Furst was one of several researchers who collaborated on developing the CRISS (Arthritis Rheumatol. 2016 Feb;68:299-311). As the authors said in their 2016 report, the CRISS “was developed with the goal of summarizing changes in clinical and patient‐reported outcomes in a single composite score that conveys the likelihood (or probability) that a patient with diffuse cutaneous systemic sclerosis [dcSSc] has improved. The purpose of the CRISS is to assess whether new pharmacologic agents have an impact on overall disease activity/severity. Our hope is that its use in clinical trials of dcSSc will greatly facilitate the interpretation of results and form the basis for drug approvals.”
The CRISS was close to 10 years in the making. “First we had to decide what measures were important, then we had to run a prospective study entering all the data, and then we had to do a very sophisticated statistical analysis and put the results in front of experts and ask: Does this make sense?” Dr. Furst recalled in an interview. Now the combined endpoint measure has been “fully validated,” and is under consideration by the Food and Drug Administration as an endpoint for drug trials, he noted.
“I think that now, after 10 years, we finally came up with what will be the equivalent” of the American College of Rheumatology 20% improvement (ACR 20) in core-set measures of rheumatoid arthritis (Arthritis Res Ther. 2014 Jan 3;16:101). “I think CRISS will make a huge difference because when you do a combined measure, like the ACR 20, it becomes more clinically and statistically powerful,” said Dr. Furst, professor of medicine (emeritus) at the University of California, Los Angeles, an adjunct professor at the University of Washington, Seattle, and research professor at the University of Florence (Italy). He is also in part-time practice in Los Angeles and Seattle.
In a talk he gave at the meeting on recent clinical studies of new drugs for treating patients with systemic sclerosis, many of the reports included CRISS as a measure of patient response to treatment.
The CRISS involves a two-step assessment of how a patient has responded to therapy. First, patients are considered not improved by their treatment if they develop any one of these four outcomes following treatment if it appears linked to the disease process:
A new scleroderma renal crisis.
A decline in forced vital capacity of 15% or more of predicted.
A new decline of left ventricular ejection fraction to 45% or less.
New onset of pulmonary arterial hypertension that requires treatment.