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Abstract Number: 1037

Evaluation of 14-3-3η As a Tool for Diagnosis of Early RA in a European Cohort

Monika Hansson1, Linda Mathsson-Alm2, Anthony Marotta3 and Sascha Swiniarski4, 1Rheumatology Unit, Department of Medicine, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden, 2Thermo Fisher Scientific, Uppsala, Sweden, 3Augurex Life Sciences Corp., Vancouver, BC, Canada, 4ImmunoDiagnostics Division Thermo Fisher Scientific, Phadia GmbH, Freiburg, Germany

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: anti-CCP antibodies, Biomarkers, Diagnosis and rheumatoid arthritis (RA)

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Session Information

Date: Sunday, November 13, 2016

Session Title: Rheumatoid Arthritis – Clinical Aspects I: Pre-RA and Progression to Rheumatoid Arthritis

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: Early diagnosis of rheumatoid arthritis (RA) coupled with an effective treatment strategy is a key imperative in the effective management of disease. Anti-citrullinated peptide antibodies (ACPA) and antibodies against rheumatoid factor (RF) are two serological markers cited in the 2010 RA classification criteria that are commonly used in routine clinical practice. 14-3-3η protein is a mechanistic marker which seems to have a biologic role in the joint erosive process, that assists with the diagnosis of RA. The aim of this study, was to assess the clinical utility of 14-3-3η in the European EIRA (Epidemiological Investigation of Rheumatoid Arthritis) cohort.

Methods: 14-3-3η levels were measured in a total of 505 patient samples, 305 early RA patients samples and 200 control samples from the EIRA cohort using the 14-3-3η ELISA test (Augurex). Control samples included patients with various autoimmune conditions, infections, malignancies, osteoarthritis and healthy subjects. The specificity and sensitivity of 14-3-3η was assessed using the manufacturer’s suggested positivity cut-off of ≥ 0.19 ng/ml and at 2 and 4x of the diagnostic cut-off. The added value of 14-3-3η to CCP2 (Eurodiagnostica) in the diagnosis of RA was determined by examining the additional patients captured by 14-3-3η.

 

Results: As shown in the Table below, CCP2 had a sensitivity of 66.2% and a specificity of 96.5%. For 14-3-3η with a serum cutoff of ≥ 0.8 ng/ml the sensitivity was calculated to 47.2% and the specificity to 94.5%. Adding 14-3-3η resulted in a sensitivity of 74.1% compared to 66,2% for CCP2 alone. Depending upon the selected cut-off, up to 50.5% of the CCP-negative patients within the EIRA cohort could be identified by 14-3-3η.

 

 

CCP2 IgG  (E/ml)

14-3-3η (ng/ml)

Cut off

≥ 25 E/ml

≥ 0.19

≥ 0.40

≥ 0.80

Sensitivity %

66.2

68.2

59.3

47.2

Additional No of Positives to CCP2

 

52

37

24

Added Cohort Sensitivity %

 

17.0

12.1

7.9

Added sensitivity of CCP -ve patients %

 

50.5

35.9

23.3

Specificity

96.5

83.0

90.5

94.5

Loss of cohort specificity %

 

16.0

9.5

4.5

Conclusion: Based on past publications the 14-3-3η protein is more frequently increased in established RA patients than in early RA patients. Nevertheless, even in our early RA cohort we could identify a considerable added value of increased sensitivity compared to CCP2. The 14-3-3η protein used in conjunction with CCP2 improves diagnostic sensitivity in the early diagnosis of RA.

 


Disclosure: M. Hansson, None; L. Mathsson-Alm, None; A. Marotta, Augurex Life Sciences Corpt, 3; S. Swiniarski, None.

To cite this abstract in AMA style:

Hansson M, Mathsson-Alm L, Marotta A, Swiniarski S. Evaluation of 14-3-3η As a Tool for Diagnosis of Early RA in a European Cohort [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/evaluation-of-14-3-3%ce%b7-as-a-tool-for-diagnosis-of-early-ra-in-a-european-cohort/. Accessed March 1, 2021.
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