Candidate Tool Created to Assess Treatment Response Among Patients With Sjögren’s Syndrome

A consortium of experts has developed composite responder index for patients with primary Sjögren’s syndrome. The candidate Sjögren’s Tool for Assessing Response (STAR) index encompasses all main disease features in a single tool and is designed for use as a primary efficacy endpoint in randomized controlled trials.

To date, there are no disease-modifying antirheumatic drugs licensed for the treatment of patients with primary Sjögren’s syndrome, explained a team of authors associated with the NECESSITY (New clinical endpoints in primary Sjögren’s syndrome: an interventional trial based on stratifying patients) consortium.

“One explanation to this,” they wrote, “is due to limitations of current outcome measures used as primary endpoints, for example, the high placebo response rate, evaluation of either the symptoms or the systemic activity, and important features not being assessed.”

To resolve the issue, the NECESSITY consortium tapped primary Sjögren’s syndrome experts from academia, the pharmaceutical industry, and patient groups to develop a new composite responder index. The group used data-driven methods based on 9 randomized controlled trials and consensus techniques involving 78 experts and 20 patients to develop the candidate STAR index.

“The strength of our work relies on a rigorous process combining both consensus techniques based on the opinion of a large panel and data-driven methods …” the authors reported. “In the analyses performed separately for trials considered negative and positive by the expert consensus, our study demonstrated that the candidate STAR is able to show treatment efficacy in positive trials and did not erroneously detect significant between-arm differences in trials considered negative, as did some alternate options.”

The candidate index next needs to be prospectively validated in an independent population, according to the consortium.

—Jolynn Tumolo

Reference

Seror R, Baron G, Camus M, et al. Development and preliminary validation of the Sjögren's Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjögren's syndrome. Ann Rheum Dis. Published online ahead of print June 10, 2022.