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.
Study Type
OBSERVATIONAL
Enrollment
400
Department of Rheumatology and Immunology, Jiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGMadrid 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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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
Time frame: 12 weeks
ACR50 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.
Time frame: 52 weeks
ACR70 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.
Time frame: 52 weeks
Minimal disease activity (MDA)
MDA response was defined as achievement of at least five of the following seven criteria: TJC ≤1 (of 68), SJC ≤1 (of 66), PASI ≤1 or PsO affecting \<3% BSA, patient pain VAS ≤15 mm, patient global disease activity VAS ≤20 mm, HAQ-DI ≤0.5, and tender entheseal points ≤1. Patients who met all seven MDA criteria were classified as achieving VLDA (very low disease activity)
Time frame: 52 weeks
Bone destruction
New bone destruction in x-ray, MRI, CT scan and ultrasonography. Based on New OMERACT definitions of US-detected pathologies, defined as intra- and/or extraarticular discontinuity of bone surface (visible in 2 perpendicular planes).
Time frame: 52 weeks
Bone destruction
New bone destruction in x-ray, MRI, CT scan and ultrasonography. Based on New OMERACT definitions of US-detected pathologies, defined as intra- and/or extraarticular discontinuity of bone surface (visible in 2 perpendicular planes).
Time frame: 104 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.