Core Set of Domains for Outcome Measures in Behçet's Syndrome

Hatemi, Gülen; Özgüler, Yeşim; Direşkeneli, Haner; Mahr, Alfred; Shea, Beverly; Cam, Esen; Gül, Ahmet; Yazıcı, Yusuf; Tugwell, Peter; Yazıcı, Hasan; Merkel, Peter A.

doi:10.1002/acr.24511

Cited by 27 publications

(14 citation statements)

References 15 publications

(20 reference statements)

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“…The instrument was deemed credible (face validity), complete (content validity) and feasible. In line, the Outcome Measures in Rheumatology (OMERACT) vasculitis working group developed a core set of domains for BD that includes damage as one of them to be assessed in clinical trials 30 …”

Section: Discussionmentioning

confidence: 99%

Development and validation of a Behçet's Disease Damage Index for adults with BD: An Explicit, Composite and Rated (ECR) tool

et al. 2021

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Background Behçet's disease (BD) is a chronic multisystem variable vessel vasculitis. Disease damage is irreversible and permanent. Validated tools evaluating damage are limited. Enhancements in the clinical treatment of vasculitis will take place from the development of refined and exclusive indices for individual vasculitic syndromes including BD and attempting their international validation. Objectives This aim was to develop and validate a simple BD Damage Index (BDI). Methods This was a nationwide study including 1252 BD patients. The work consisted of 3 stages. Stage 1: items generation for score content. Stage 2: items selection for the draft score was performed by an expert rheumatologist. Stage 3: the content validity of the draft score was assessed and BDI, Vasculitis Damage Index (VDI), Antineutrophil cytoplasmic antibody‐associated Vasculitis Index of Damage (AVID) and Combined Damage Assessment Index (CDAI) were calculated and compared. Results The mean age of the BD patients was 36.1 ± 9.9 years. Stages 1 and 2 resulted in a BDI instrument containing 73 items with a maximum score of 100. Stage 3, the VDI, CDAI, AVID, and BDI were 2.9 ± 2.2, 3.1 ± 2.3, 3.1 ± 2.3 and 5.1 ± 2.9, respectively. High correlations (r = .9) between comparable damage scores assured acceptable concurrent validity. Conclusion The proposed BDI represents a new robust and potentially useful tool when dealing with BD chronic status.

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Section: Discussionmentioning

confidence: 99%

Development and validation of a Behçet's Disease Damage Index for adults with BD: An Explicit, Composite and Rated (ECR) tool

et al. 2021

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“…All the mandatory domains for mucocutaneous involvement in the Core Domain Set for Behçet’s syndrome endorsed by OMERACT, which was developed and voted on by patient participation, were assessed. 27 Safety and efficacy monitoring in both studies were also performed by an independent, external data monitoring committee (DMC) as outlined in the DMC charter. At the time results of this study were made available to the public, investigators were provided with a summary of the results, which was written for the lay person.…”

Section: Methodsmentioning

confidence: 99%

Impact of apremilast on quality of life in Behçet’s syndrome: analysis of the phase 3 RELIEF study

et al. 2022

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ObjectiveTo assess apremilast’s impact on patient quality of life (QoL) in active Behçet’s syndrome and correlations between improvement in patients’ QoL and efficacy measures in the phase 3 RELIEF study.MethodsQoL measures included Behçet’s Disease QoL (BDQoL), 36-Item Short-Form Health Survey V.2 (SF-36v2) Physical/Mental Component Summary (PCS/MCS) and eight subscale scores, focusing on Physical Functioning (PF). Pearson’s correlation coefficients assessed relationships between efficacy endpoints (oral ulcer count, oral ulcer pain, Behçet’s Syndrome Activity Scale (BSAS), Behçet’s Disease Current Activity Form (BDCAF)) and QoL endpoints for apremilast at Week 12.ResultsApremilast (n=104) demonstrated significantly greater improvements versus placebo (n=103) in SF-36v2 PCS (3.1 vs 0.9), MCS (4.6 vs ─0.7) and PF (2.9 vs 0.14), respectively (all p<0.05). Mild correlations were observed in improvements of SF-36v2 measures (PCS, MCS, PF) with oral ulcer count (r=−0.11, PCS), and change in oral ulcer pain from baseline (r=−0.28, PCS; r=−0.10, PF) and BSAS (r=−0.38, PCS; r=−0.20, PF; r=−0.16, MCS). Correlations among BDCAF and SF-36v2 components and BDQoL were variable. BDQoL showed mild/moderate correlations with SF-36v2 components (r=−0.18, PCS; r=−0.13, PF; r=−0.45, MCS).ConclusionsApremilast was associated with significant improvements in QoL measures of SF-36v2 PCS, MCS and PF and BDQoL in patients with Behçet’s syndrome. Correlations of improvement among QoL endpoints support the beneficial clinical effects of apremilast in Behçet’s syndrome.Trial registration numberNCT02307513.

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“…Furthermore, the cohorts published so far were quite small and mostly from a single specialized center. In the future, international registries may be helpful to collect data in larger, multicenter cohorts and the new OMERACT outcome measures will standardize and simplify the evaluation of the course of the diverse manifestations of BS (102).…”

Section: Summary and Perspectivementioning

confidence: 99%

Behçet‘s Syndrome Apart From the Triple Symptom Complex: Vascular, Neurologic, Gastrointestinal, and Musculoskeletal Manifestations. A Mini Review

Kötter

Lötscher

2021

Front. Med.

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Behçet‘s Syndrome (BS) is a variable vessel vasculitis according to the Chapel Hill Consensus Nomenclature (1) and may thus affect any organ, including major and minor arterial and venous vessels to a varying degree and with varying frequency. Although the main features of BS are recurrent oral and genital aphthous ulcers, cutaneous lesions, ocular inflammation and arthritis—major vessel and life—or organ threatening involvement of internal organs and the central and peripheral nervous system occur. In general, BS in Europe appears to form six phenotypes of clinical manifestations (2), which are (1) mucocutaneous only, (2) predominant arthritis/articular involvement, (3) vascular phenotype, (4) ocular manifestations, which are most likely associated with CNS manifestations and HLA-B51, (5) dominant parenchymal CNS manifestations (being associated with the ocular ones), and (6) gastrointestinal involvement. Mucocutaneous manifestations are present in almost all patients/all phenotypes. In the following review, we summarize the current knowledge concerning vascular, neurologic, gastrointestinal and musculoskeletal manifestations of the disease.

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Core Set of Domains for Outcome Measures in Behçet's Syndrome

Abstract: This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as

Cited by 27 publications

References 15 publications

Development and validation of a Behçet's Disease Damage Index for adults with BD: An Explicit, Composite and Rated (ECR) tool

Development and validation of a Behçet's Disease Damage Index for adults with BD: An Explicit, Composite and Rated (ECR) tool

Impact of apremilast on quality of life in Behçet’s syndrome: analysis of the phase 3 RELIEF study

Behçet‘s Syndrome Apart From the Triple Symptom Complex: Vascular, Neurologic, Gastrointestinal, and Musculoskeletal Manifestations. A Mini Review

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