[PDF] Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS): development and validation of a novel outcome measure. | Semantic Scholar (2024)

A composite responder index that includes all main disease features in a single tool and is designed for use as a primary endpoint in pSS RCTs is designed.

The history and comments the selection of primary study endpoints including the novel development of composite endpoints are summarised, and an overview of inclusion criteria used for phase II and III trials is given.

This study explored alternative RDs to better discriminate between active treatment and placebo in trials and found completing a trial with an improvement of ≥1.5 points compared with baseline and an ESSPRI score of ≤3 points is a relevant RD for moderate-to-severe systemic Sjögren’s and reduces placebo rates.

The recent development of composite study endpoints (CRESS and STAR) may be a crucial step forward in the search for clinically effective systemic treatment of patients with SjD.

This review summarizes the key development in targeted biological therapies in SS including emerging targets and highlights the challenges in therapeutic development in SS such as disease heterogeneity and defining appropriate disease assessment tools to evaluate therapeutic efficacy.

The safety and efficacy of filgotinib, lanraplenib and tirabrutinib in patients with active SS were characterized and no significant differences vs placebo in primary or secondary end points were observed.

The aim of this qualitative literature review is to summarise the recent advances that have been reported in Primary Sjögren’s syndrome, ranging from the early phases to the established disease and its complications.

Development and preliminary validation of the Sjögren's Tool for Assessing Response (STAR) is presented, a consensual composite score for assessing treatment effect in primary Sj Ögren's syndrome.

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Abatacept treatment did not result in significant clinical efficacy compared with placebo in patients with moderate-to-severe pSS, despite evidence of biological activity.

A core set of outcome measures used in combination suggests that rituximab could be effective and infliximab ineffective in pSS, and the SSRI might prove useful as the primary outcome measure for future therapeutic trials in primary SS.

In this open-label study, abatacept treatment is effective, safe and well tolerated, and results in improved disease activity, laboratory parameters, fatigue and HR-QoL in patients with early and active pSS.

Among patients with primary Sjögren’s syndrome, the use of tocilizumab did not improve systemic involvement and symptoms over 24 weeks of treatment compared with placebo and the efficacy of targeting interleukin 6 receptor was not demonstrated.

It is recommended to use the ESSDAI only in combination with other important outcome measures, such as patient-reported symptoms and glandular function as part of a composite endpoint in clinical trials in pSS patients.

A single set of data-driven consensus classification criteria for primary Sjögren's syndrome performed well in validation analyses and are well suited as criteria for enrolment in clinical trials.

This study determined disease activity levels, PASS and MCII of ESSDAI and ESSPRI, which will help designing future clinical trials in SS and the proposal is to include patients with moderate activity and define response to treatment as an improvement of E SSDAI at least three points.

ESSPRI and ESSDAI are sensitive measures of change in disease activity after therapeutic intervention, which supports the usefulness of these indices for future clinical trials in patients with pSS.

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