Proposal for Levels of Evidence Schema for Validation of a Soluble Biomarker Reflecting Damage Endpoints in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis, and Recommendations for Study Design

Maksymowych, Walter P.; FitzGerald, Oliver; Wells, George A.; Gladman, Dafna D.; Landewé, Robert; Østergaard, Mikkel; Taylor, William J.; Christensen, Robin; Tak, Paul P.; Boers, Maarten; Syversen, Silje Watterdal; Bathon, Joan M.; Ritchlin, Christopher T.; Mease, Philip J.; Bykerk, V.; Garnero, Patrick; Geusens, Piet; El-Gabalawy, Hani; Aletaha, Daniel; Inman, Robert D.; Kraus, Virginia B.; Kvien, Tore K; Heijde, Desirée van der

doi:10.3899/jrheum090347

Cited by 37 publications

(29 citation statements)

References 22 publications

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“…Higher IL-22 levels even in the axial form of SpA could suggest that it plays a role in active sacroiliitis. In accordance with some published reports, a significant correlation between inter-and intra-clinical and DA indices and between ESR and hs-CRP was also noted (16,17,47). The correlation between serological MMP3 levels and mSASSS, indicative of the role of metalloproteinases in the bone formation process, was an interesting finding and in accordance with data outlined by Maksymowych et al (47) who reported that independently of other indices, serum MMP3 levels were able to predict two-year radiographic progression in the 97 axSpA patients studied.…”

Section: Original Papersupporting

confidence: 77%

“…In accordance with some published reports, a significant correlation between inter-and intra-clinical and DA indices and between ESR and hs-CRP was also noted (16,17,47). The correlation between serological MMP3 levels and mSASSS, indicative of the role of metalloproteinases in the bone formation process, was an interesting finding and in accordance with data outlined by Maksymowych et al (47) who reported that independently of other indices, serum MMP3 levels were able to predict two-year radiographic progression in the 97 axSpA patients studied. Our data also showed that MMP3 is correlated with inflammatory markers (hs-CRP and ESR) and, in agreement with previous studies, it is increased in the serum of patients with active axSpA (24,26,27,47).…”

Section: Original Papersupporting

confidence: 77%

“…The correlations between mSASS values and serum biomarkers require further evaluation by prospective studies. Some authors have reported a correlation between serum MMP3 levels and functional and DA indices (BASFI and BASDAI) (27,47). It has been shown that MMP3 correlates with DA indices even in psoriatic arthritis (PsA) (49 n CONCLUSIONS Significant differences in clinical severity, DA indices, and biomarker levels were not found in the three cohorts of patients diagnosed with early axSpA and presenting different types of axial involvement (presence or absence of radiographic sacroiliitis and of active sacroiliitis on pelvic MRI) studied.…”

Section: Original Papermentioning

confidence: 99%

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Biomarkers, imaging and disease activity indices in patients with early axial spondyloarthritis: the Italian arm of the SpondyloArthritis-Caught-Early (SPACE) Study

Lorenzin¹,

Ortolan

Vio

et al. 2017

Reumatismo

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The study aimed to evaluate biomarkers facilitating early diagnosis of axial spondyloarthritis (axSpA) and correlations between them and disease activity parameters and imaging indexes. Patients with low back pain (LBP) (≥3 months, ≤2 years, onset ≤45 years) participating in the Italian arm of the SpondyloArthritis-Caught-Early SPACE study underwent a physical examination, questionnaires, laboratory tests, X-rays and MRI of the spine and sacroiliac joints (SIJ). An expert rheumatologist formulated axSpA diagnosis in accordance with Assessment of SpondyloArthritis International Society (ASAS) criteria. Disease activity and physical functioning were assessed using imaging, clinical and serological indices. Spine and SIJ MRI and X-rays were scored independently by 2 readers using the SPARCC, mSASSS and NY-criteria. Patients were classified as: subjects with signs of radiographic sacroiliitis (r-axSpA), subjects with signs of sacroiliitis on SIJ-MRI but not on X-rays (nr-axSpA MRI SIJ+) or subjects with no signs of sacroiliitis on MRI/X-rays but with >2 SpA features and signs of bone oedema on MRI spine (nr-axSpA MRI SIJ-/undifferentiated SpA). Significant differences were found in the prevalence of radiographic sacroiliitis, active sacroiliitis on MRI and SPARCC SIJ scores. Biomarker levels were not significantly increased in any of the patient groups. The correlations between IL-17 and IL-23 and other indices were not significant; correlations were found between IL-22 and BASFI, BASG1, HAQ, VAS pain, between mSASSS and MMP3, and between the latter and hsCRP. Although not significantly higher in any of the three groups, IL-22, MMP3 and hsCRP values were correlated with some disease activity indexes and with mSASSS. Large observational studies are required to confirm these preliminary findings.

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Section: Original Papersupporting

confidence: 77%

Section: Original Papersupporting

confidence: 77%

Section: Original Papermentioning

confidence: 99%

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Biomarkers, imaging and disease activity indices in patients with early axial spondyloarthritis: the Italian arm of the SpondyloArthritis-Caught-Early (SPACE) Study

Lorenzin¹,

Ortolan

Vio

et al. 2017

Reumatismo

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“…Recently, draft validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting structural damage in RA have been established (9,33,34). These criteria provide guidance for the types of studies needed to demonstrate the value of CXCL13 as a marker in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Identification of CXCL13 as a marker for rheumatoid arthritis outcome using an in silico model of the rheumatic joint

Meeuwisse

Linden

Rullmann

et al. 2011

Arthritis & Rheumatism

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Objective. Rheumatoid arthritis (RA) is characterized by inflammation and joint destruction, with the degree of damage varying greatly among patients. Prediction of disease severity using known clinical and serologic risk factors is inaccurate. This study was undertaken to identify new serologic markers for RA severity using an in silico model of the rheumatic joint.Methods. An in silico model of a prototypical rheumatic joint was used to predict candidate markers associated with erosiveness. The following 4 markers were chosen for validation: tartrate-resistant acid phosphatase 5b (TRAP-5b), N-telopeptide of type I collagen (NTX), angiopoietin 2 (Ang-2), and CXCL13. Serum from 74 RA patients was used to study whether radiologic joint destruction (total erosion score and total Sharp/van der Heijde score [SHS]) after 4 years of disease was associated with serum levels at the time of diagnosis. Serum marker levels were determined using enzyme-linked immunosorbent assays. For confirmation, baseline serum levels were analyzed for an association with progression of joint damage over 7 years of followup in a cohort of 155 patients with early RA.Results. Comparison of high and low quartiles of erosion score and SHS at 4 years showed a difference in baseline serum CXCL13 level (P ‫؍‬ 0.011 and P ‫؍‬ 0.018, respectively). In the confirmation cohort, elevated baseline CXCL13 levels were associated with increased rates of joint destruction during 7 years of followup (P < 0.001 unadjusted and P < 0.004 with adjustment for C-reactive protein level). Analyzing anti-CCP-2-positive and anti-CCP-2-negative RA separately yielded a significant result only in the anti-CCP-2-negative group (P < 0.001).Conclusion. Our findings indicate that CXCL13 is a novel serologic marker predictive of RA severity. This marker was identified with the help of an in silico model of the RA joint.

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“…There was strong agreement that a checklist (or standardized framework) would be very helpful for imaging and soluble biomarker development and validation. This standardized approach has already been used in other fields 79 . There is also potential for linking imaging and biomarkers with PRO.…”

Section: Broader Understanding Stimulated By Discussionmentioning

confidence: 99%

Updating the OMERACT Filter: Implications for Imaging and Soluble Biomarkers

D'Agostino

Boers²,

Kirwan³

et al. 2014

J Rheumatol

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Objective. The Outcome Measures in Rheumatology (OMERACT) Filter provides a framework for the validation of outcome measures for use in rheumatology clinical research. However, imaging and biochemical measures may face additional validation challenges because of their technical nature. The Imaging and Soluble Biomarker Session at OMERACT 11 aimed to provide a guide for the iterative development of an imaging or biochemical measurement instrument so it can be used in therapeutic assessment. Methods. A hierarchical structure was proposed, reflecting 3 dimensions needed for validating an imaging or biochemical measurement instrument: outcome domain(s), study setting, and performance of the instrument. Movement along the axes in any dimension reflects increasing validation. For a given test instrument, the 3-axis structure assesses the extent to which the instrument is a validated measure for the chosen domain, whether it assesses a patient-centered or disease-centered variable, and whether its technical performance is adequate in the context of its application. Some currently used imaging and soluble biomarkers for rheumatoid arthritis, spondy-loarthritis, and knee osteoarthritis were then evaluated using the original OMERACT Filter and the newly proposed structure. Breakout groups critically reviewed the extent to which the candidate biomarkers complied with the proposed stepwise approach, as a way of examining the utility of the proposed 3-dimensional structure. Results. Although there was a broad acceptance of the value of the proposed structure in general, some areas for improvement were suggested including clarification of criteria for achieving a certain level of validation and how to deal with extension of the structure to areas beyond clinical trials. Conclusion. General support was obtained for a proposed tri-axis structure to assess validation of imaging and soluble biomarkers; nevertheless, additional work is required to better evaluate its place within the OMERACT Filter 2.0

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Proposal for Levels of Evidence Schema for Validation of a Soluble Biomarker Reflecting Damage Endpoints in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis, and Recommendations for Study Design

Cited by 37 publications

References 22 publications

Biomarkers, imaging and disease activity indices in patients with early axial spondyloarthritis: the Italian arm of the SpondyloArthritis-Caught-Early (SPACE) Study

Biomarkers, imaging and disease activity indices in patients with early axial spondyloarthritis: the Italian arm of the SpondyloArthritis-Caught-Early (SPACE) Study

Identification of CXCL13 as a marker for rheumatoid arthritis outcome using an in silico model of the rheumatic joint

Updating the OMERACT Filter: Implications for Imaging and Soluble Biomarkers

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