Psoriatic arthritis (PsA) is a complex inflammatory disease with heterogeneous clinical features, which complicates psoriasis in 30% of patients. PsA involves multiple tissues and clinical domains including skins and nails as well as arthritis, spondylitis, enthesitis, and dactylitis. Power Doppler (PD) ultrasonography (PDUS) is a sensitive non-invasive imaging technology used to assess disease activity and treatment response in PsA. This is a prospective, observational, open-label study to investigate disease activity, therapeutic response and bone destruction based on ultrasonography findings in patients with PsA.
PsA patients as defined by CASPAR criteria
Patients must be able to comply with the visit schedule, treatment plan, laboratory tests and other study procedures
Patients must be given informed consent
History of other arthritis within the last 12 months
Concomitant disease with acute or chronic infectious diseases
Pregnancy or laction
Poorly tolerated with venipuncture required for blood sampling during the study
Adult PsA patients as defined by CASPAR criteria
Cohort
Prospective
Not listed
Madrid Sonographic Enthesitis Index (MASEI)
MASEI includes six entheses (the bilateral triceps, the quadriceps, both proximal and distal patellar and Achilles tendons and the proximal insertion of the plantar aponeurosis) and six elementary lesions (structure, thickening, erosion, enthesophytes, PD and bursa), with weighted punctuations that can be summed to a maximum score of 136.
DACTylitis glObal Sonographic (DACTOS)
DACTOS score will be used for every affected digit. There are four keys in DACTOS scoring: PTI（Peritendon extensor inflammation） evaluated in B-mode and PD at MCP and PIP joints level (maximum score, 4) STOe（Soft tissue oedema） evaluated in B-mode and PD in the most severely affected area of the digit (maximum score, 6) flexor tenosynovitis evaluated in B-mode and PD in the most severely affected area of the digit (maximum score, 6) EULAR-OMERACT combined score for synovitis evaluated at the MCP, PIP and DIP joints (maximum score, 9) DACTOS score summation ranges from 0 to 25 points. A DACTOS value\<3 identified the US response.
ACR20 Response
American College of Rheumatology (ACR) Response Criteria: An ACR20 response is defined as improvement of ≥20% from Baseline in the number of tender and swollen joints (from an analysis of 78 and 76 joints, respectively) and in three of the following five domains: a patient's global assessment of disease, a physician's global assessment of disease, and a patient's assessment of pain (all three measures evaluated on a visual-analogue scale of 0 to 100 mm), disability score on the Health Assessment Questionnaire-Disability Index (HAQ-DI; scores range from 0 to 3; higher scores indicate greater disability), and acute-phase reactants, as measured by high-sensitivity C-reactive protein (CRP) levels or erythrocyte sedimentation rate. An ACR50 response is defined as ≥50% improvement, and an ACR70 response is defined as ≥70% improvement in the above criteria.
Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR)
DAS28-ESR = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.70 \* ln(ESR) + 0.014 \* GH. GH(mm)is general health using a visual analog scale (VAS) measuring general health (VAS-GH; 0 = best, 100 = worst)
Disease Activity Score 28-C-reactive protein (DAS28-CRP)
DAS28-CRP=0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28)+0.36×ln （CRP+1）+0.014\* GH+0.96. GH(mm)is general health using a visual analog scale (VAS) measuring general health (VAS-GH; 0 = best, 100 = worst)
Disease Activity in PSoriatic Arthritis (DAPSA)
DAPSA score was calculated as the sum of: (1) SJC (range: 0-66), (2) TJC (range: 0-68), (3) patient pain assessment VAS measurement in centimeters (range: 0-10), (4) patient global assessment VAS measurement in centimeters (range: 0-10), and (5) serum acute-phase response, represented by CRP level in mg/dL (range: 0-10 mg/dL). The cut-off points for defining different disease activity are: ≤4, DAPSA-REM; \>4 to ≤14, DAPSA-LDA; ≤14, DAPSA-REM+LDA; \>14 to ≤28, DAPSA-MoDA; DAPSA-HAD, \>28
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Nanjing Medical University
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Sponsor institution
