Rheumatoid arthritis (RA) is a chronic autoimmune joint disease caused by the body’s immune system mistakenly attacking the body’s own joints. RA is characterized by inflammation at the lining of the joints, causing painful swelling which can eventually result in bone erosions and joint deformity, if left untreated. The disease can also cause damage to a wide variety of other body systems, including lungs, skin, eyes, heart, blood vessels and others.

How many have Rheumatoid Arthritis?
RA is the most common autoimmune inflammatory joint disease, affecting approximately 0.5% of the population. Women are about two to three times more likely to get RA than men, but risk factors also include risk factors include age, genetics, smoking status, obesity and environmental factors.

How is Rheumatoid Arthritis treated?
There is no cure for RA, but symptoms and inflammation can be treated using NSAIDs, steroids, or synthetic or biologic DMARDs. The type of treatment will depend on the severity of symptoms and the number of years with RA.

How is Rheumatoid Arthritis diagnosed?
Current diagnoses include physical examination looking for signs of joint inflammation. Current biomarkers used in standard of care diagnosis include c-reactive protein (CRP) or erythrocyte sedimentation rate, which can indicate the presence of an inflammatory reaction. Other blood tests include rheumatoid factor and anti-cyclic citrullinated peptide which is present in some patients.

The medical need for biomarkers in RA today is two-fold. First, the diagnosis of RA remains a challenge because the signs and symptoms mimic those of many other diseases. Current biomarker techniques are imprecise and struggle to determine future prognosis of the patients.

Next, despite great progress in the availability of new and efficacious drugs in the last decades, a significant proportion of patients fail to respond to treatment or lose treatment effect over time. Diagnostic and prognostic biomarkers have the potential to greatly benefit patients, by aiding in early diagnosis of disease and directing the most appropriate treatment at the right time. Furthermore, the use of predictive or prognostic biomarkers to enrich or stratify patients likely to respond to a therapeutic in drug development trials, may reduce trial length, and size required to determine therapeutic efficacy.

Rheumatoid arthritis (RA) is characterized by inflammation and tissue destruction in the joints. 

The tissues of the joint consist mainly of collagens. The collagens are remodeled as part of normal homeostasis of the joint – that is, collagens are broken down and rebuild as part of normal repair and maintenance of the tissue. In RA, the balance between degradation and formation of tissue is interrupted resulting in net degradation of the tissue. Protein fingerprint biomarkers can quantify this tissue turnover directly in a serum sample.

While the RA field has a number of diagnostic and disease activity biomarkers, their capacity for predicting treatment response is limited. There is therefore still a medical and drug development need for biomarkers that are able to characterize and quantify structural tissue change and predict disease progression and treatment response. The tissue-derived Protein Fingerprint biomarkers can be measured in serum and used to accurately quantify changes in tissue turnover in the different joint tissues in the individual patient.

Biomarkers and tissue characterization: Cartilage degradation by type II collagen fragments: C2M, CTX-II Synovial turnover and chronic inflammation : C3M, CRPM, MMP3, VICM Bone erosions and remodeling: CTX-I, alpha-CTX, C1M, ICTP, PRO-C1, osteocalcin Endothelial and epithelial dysfunction: C4M, PRO-C4, C6M, PRO-C6

Protein Fingerprint biomarkers measured in serum are generally increased in RA patients compared to healthy individuals and correlate to disease activity scores such as DAS, and radiographic scores such as JSN.

Protein Fingerprint biomarkers measured in serum are associated with established disease activity parameters, including DAS28, ESR and swollen joint count, generally increased in RA patients compared to healthy individuals and correlate to disease activity scores such as DAS, and radiographic scores such as JSN.

Protein Fingerprint biomarkers measured in serum at baseline are prognostic of radiographic progression including joint space narrowing (JSN), Sharp score (SHP) and Erosion score (ERN).

Protein Fingerprint biomarkers allow pharmacodynamic profiling of novel treatments by measuring protein degradation fragments directly in a serum sample.

Protein Fingerprint biomarkers are suppressed by effective treatments and the level of suppression is predictive of clinical response measured by ACR20, DAS remission or LDA. 

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