The American College of Rheumatology Combined Response Index in diffuse cutaneous systemic sclerosis (ACR CRISS) appears to be a consistent and reliable measure of how these patients feel and function, according to data recently presented by Corbus Pharmaceuticals.
Notably, the research suggests that this composite measure, which is frequently used in clinical trials of scleroderma, or systemic sclerosis (SSc), reflected patient-reported outcomes better than another common outcome measure, the modified Rodnan Skin Score (mRSS), which assesses skin thickening.
The data were discussed in a recorded oral presentation titled “Provisional American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) Score Correlates with Changes in Patient-reported Outcomes (PROs)” as part of the sixth Systemic Sclerosis World E-Congress.
“Our results support usefulness of using ACR CRISS score to evaluate clinical burden and benefit to patients in SSc trials,” Barbara White, MD, Corbus’ chief medical officer and head of research, said in a press release.
In particular, Corbus is using this score as a primary measure of effectiveness in Phase 2 (NCT02465437) and Phase 3 (NCT03398837) clinical trials testing its investigational treatment candidate lenabasum in people with diffuse cutaneous systemic sclerosis (dcSSc).
The therapy (formerly known as anabasum) is designed to suppress inflammation and scarring by activating the cannabinoid receptor type 2 (CB2) found on the surface of immune cells and fibroblasts, which are connective tissue cells.
The ACR CRISS score is an outcome measure developed to include different aspects of scleroderma patients’ response to treatment. It is calculated according to weighted changes from the start of a study in mRSS, the Health Assessment Questionnaire – Disability Index (HAQ-DI), patient and physician global assessment of scleroderma-related health, and forced vital capacity — a measure of lung function.
Both the ACR CRISS score and the mRSS have been successfully used as primary and secondary outcome measures in trials evaluating overall improvement in dcSSc patients.
In collaboration with Corbus, researchers in the U.S. assessed how the ACR CRISS score reflected changes in patient-reported outcomes during lenabasum treatment in dcSSc patients, and whether it did so better than the mRSS.
They analyzed data from the ongoing Phase 2 trial evaluating lenabasum’s safety and effectiveness in 42 adults with dcSSc. Participants were randomly assigned to receive either lenabasum or a placebo, plus their stable standard care, for 12 weeks. Patients could then enter the ongoing open-label extension phase, in which all are receiving the therapy.
Previous data showed that lenabasum resulted in greater improvements in patients’ overall health status, measured with the ACR CRISS score; skin health, assessed with the mRSS; and patient-reported outcomes, compared with a placebo.
In the current analysis, the researchers looked at four patient-reported outcomes to assess how patients feel and function: the HAQ-DI and patient global assessment — both included in the ACR CRISS score — the SSc Skin Symptoms Patient-reported Outcome (SSPRO), and the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) score.
Results showed that the ACR CRISS score consistently reflected changes in patient-reported outcomes, including those not captured in its composite score. In addition, this association was stronger than that observed between the mRSS score and patient-reported outcomes.
“These findings clearly demonstrate that ACR CRISS score reflects improvement in multiple measures of how SSc patients feel and function. This may be because the ACR CRISS score itself, unlike change in mRSS, incorporates 2 key patient-reported outcomes,” White said.
The new data were presented by Robert Spiera, MD, the trial’s principal investigator and the director of the vasculitis and scleroderma program at the Hospital for Special Surgery in New York. He is also the first author of two posters concerning additional analyses of the trial’s data, which Corbus also presented at the meeting.
The first poster, “Health Assessment Questionnaire Disability Index (HAQ-DI) and Patient Global Assessment of Health (PtGA) Correlate with Changes in Patient Reported Outcomes (PROs),” showed that the two patient-reported outcomes included in the ACR CRISS score consistently reflected changes in each other and in other patient-reported tools (SSPRO and PROMIS-29) over two years of lenabasum treatment.
These results support the use of the ACR CRISS score as a measure of effectiveness in trials assessing overall improvement in people with dcSSc.
The second poster, “Patient and Physician Opinion of Clinical Benefit at 3 Months in a Clinical Trial Correlate with Patient Reported Outcomes (PROs),” highlighted an association between both patient and physician opinions of lenabasum’s clinical benefits and the overall assessment of scleroderma-related health and skin symptoms at three months of treatment.
“The opinion of the patient and treating physician of the clinical benefit of lenabasum early in the treatment of dcSSc may be important factors for maintaining adherence and persistence in the real-world setting,” the researchers wrote.
In both posters, the scientists said that upcoming results from Corbus’ Phase 3 RESOLVE-1 study may help clarify associations between the different outcomes measures and further support the use of ACR CRISS score as a primary measure of effectiveness in trials with dcSSc patients.
The last patient visit was completed in May for RESOLVE-1, which is assessing the safety and effectiveness of lenabasum in 365 adults with dcSSc. Top-line data are expected later this summer, according to White.
Abstracts of all three presentations will be published in the Journal of Scleroderma and Related Disorders.
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