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    Home > Active Ingredient News > Immunology News > Development and initial validation of the Sjögren's Syndrome Response Assessment Tool (STAR): a composite score for assessing treatment effects in primary Sjögren's syndrome

    Development and initial validation of the Sjögren's Syndrome Response Assessment Tool (STAR): a composite score for assessing treatment effects in primary Sjögren's syndrome

    • Last Update: 2022-05-14
    • Source: Internet
    • Author: User
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    For decades, evidence-based treatment of primary Sjögren's syndrome (pSS) has been largely based on Sjogren's features or patient-reported outcomes (PROs)
    .
    Over the past 20 years, the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) and the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) have been developed and validated by the parties under the auspices of the European Union of Societies in Rheumatology (EULAR)

    .
    Both have become reference standards for measuring systemic activity and patient symptoms, respectively

    .
    Therefore, ESSDAI has been used as the primary endpoint of a recent randomized controlled trial (RCT) testing biologics, and in pSS, for the first time, four RCTs met their primary endpoint

    .
    ESSDAI has shown promising capabilities for monitoring changes in disease activity and assessing treatment effects

    .

    Nonetheless, several trials failed to show improvement with ESSDAI, possibly due to the drug's ineffectiveness, but also due to the relatively high placebo response rate observed with ESSDAI
    .
    Furthermore, the lack of efficacy may be due to the failure to assess important features of ESSDAI, such as the patient's symptoms and glandular function

    .
    Recent RCTs suggest that improvements in ESSDAI do not necessarily translate into improvements in PROs

    .
    Therefore, as a unique primary endpoint, ESSDAI did not capture all important disease characteristics

    .
    These limitations are inherent in the scale structure and underscore the need for composite endpoints that can assess disease on a global scale

    .

    The NECESSITY (New Clinical Endpoints in Primary Sjögren's Syndrome: Interventional Trials Based on Patient Stratification) Consortium (https:// includes pSS experts from academia, pharmaceutical industry and patient groups, The experts aimed to develop a new composite responder index, Sjögren's Response Assessment Tool (STAR)
    .
    STAR is designed to address issues with current outcome measures in pSS and is intended to be used as an efficacy endpoint in clinical trials
    .
    We report on its development here
    .

    The NECESSITY (New Clinical Endpoints in Primary Sjögren's Syndrome: Interventional Trials Based on Patient Stratification) Consortium (https:// includes pSS experts from academia, pharmaceutical industry and patient groups, These experts aim to develop a new NECESSITY (New Clinical Endpoints in Primary Sjögren's Syndrome: Interventional Trials Based on Patient Stratification) consortium (https:// including from academia, pSS experts from the pharmaceutical industry and patient groups aiming to develop a new composite responder index, Sjögren's Response Assessment Tool (STAR)
    .
    Composite Responder Index, Sjögren's Response Assessment Tool (STAR)
    .
    STAR is designed to address issues with current outcome measures in pSS and is intended to be used as an efficacy endpoint in clinical trials
    .
    STAR is designed to address issues with current outcome measures in pSS and is intended to be used as an efficacy endpoint in clinical trials
    .
    We report on its development here
    .
    We report on its development here
    .

    The development and initial retrospective validation of STAR followed the OMERACT (Outcome Measurements in Rheumatology) guidelines14 and consisted of three steps (Figure 1), combining a data-driven approach (Table 1) and a consensus approach from nine RCTs
    .
    The Delphi group consisted of 78 pSS international experts (57 clinicians, 21 scientists) and 20 pSS patients (Supplement 1 online)
    .

    The development and initial retrospective validation of STAR followed the OMERACT (Outcome Measurements in Rheumatology) guidelines14 and consisted of three steps (Figure 1), combining a data-driven approach (Table 1) and a consensus approach from nine RCTs
    .
    The Delphi group consisted of 78 pSS international experts (57 clinicians, 21 scientists) and 20 pSS patients (Supplement 1 online)
    .
    The development and initial retrospective validation of STAR followed the OMERACT (Outcome Measurements in Rheumatology) guidelines14 and consisted of three steps (Figure 1), combining a data-driven approach (Table 1) and a consensus approach from nine RCTs
    .
    The Delphi group consisted of 78 pSS international experts (57 clinicians, 21 scientists) and 20 pSS patients (Supplement 1 online)
    .

    Objectives: To develop a composite response index for primary Sjögren's syndrome (pSS): The Sjogren's Response Assessment Tool (STAR)
    .

    Ultimately, the Delphi team identified five core domains (systemic activity, patient symptoms, lacrimal gland function, salivary gland function, and biological parameters) and selected 227 STAR options combining these domains to test for sensitivity to changes
    .
    After two rounds of Delphi, a meta-analysis was performed on the remaining 20 options

    .
    Candidate STARs were then selected by final voting based on metrological properties and clinical relevance

    .

    The candidate STAR is a composite response index that includes all major disease characteristics in one tool and is intended to be used as the primary endpoint in pSS RCTs
    .
    A rigorous and consistent development process ensures the validity of its surface and content

    .
    Candidate STARs showed good sensitivity to change and will be prospectively validated in a dedicated RCT by the NECESSITY consortium

    .

    Use Online: Sjögren's Syndrome Treatment Response Score (STAR)

    Original source:

    Seror R, Baron G, Camus M, Cornec D, Perrodeau E, Bowman SJ, Bombardieri M, Bootsma H, Gottenberg JE, Fisher B, Hueber W, van Roon JA, Devauchelle-Pensec V, Gergely P, Mariette X, Porcher R ; NECESSITY WP5 - STAR development working group; NECESSITY WP5- STAR development working group.
    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.
    2022 Apr 7:annrheumdis-2021-222054

    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.


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