492 research outputs found
Ultrasound-guided corticosteroid injection in rheumatology: accuracy or efficacy?
[No abstract available
Inter-observer reliability of ultrasound detection of tendon abnormalities at the wrist and ankle in patients with rheumatoid arthritis
OBJECTIVE: To assess inter-observer reliability in US detection of tendon inflammatory and structural changes at wrists and ankles in RA patients.
METHODS: Fourteen consecutive RA patients underwent bilateral US assessment of the extensor carpi ulnaris (ECUT) and tibialis posterior tendons (TPTs) by two blinded rheumatologists, with different level of experience in musculoskeletal (MS) US. Grey scale and power Doppler (PD) US assessment was focused on detection of tenosynovitis, tenosynovial and intra-tendon PD signal and structural lesions (i.e. tendinosis, tendon erosion, partial or total rupture).
RESULTS: The frequency of US findings detected by Investigator 1 was 28.6% for inflammatory changes and 51.8% for structural damage changes while Investigator 2 detected 34 and 53.6% for the corresponding abnormalities. A high overall agreement (82.7%) was found for inflammatory pathology and 89.7% for structural lesions in all tendons. Mean kappa (κ) values for all tendons and pathology was moderate (κ = 0.42), with fair level of agreement for the wrist region (0.27-0.34) and moderate to good values for the ankle region (κ = 0.47-0.62). Subclinical abnormalities were detected in 37.5% of the tendons by Investigator 1 and 28.6% of the tendons by Investigator 2.
CONCLUSIONS: MSUS showed high overall agreement and fair to moderate inter-observer κ-values between investigators with different levels of experience in detection of tendon pathology at the wrist and ankle in RA patients. Further standardization of scanning method and pathology definitions may improve MSUS reproducibility
Design of a Phase 4 Randomized, Double-Blind, Placebo-Controlled Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels, and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Patients (PREDICTRA)
Introduction: The current American College of Rheumatology and European League Against Rheumatism treatment recommendations advise tapering biological disease-modifying antirheumatic drug (bDMARD) therapy in patients with rheumatoid arthritis (RA) who achieve stable clinical remission while receiving bDMARDs. However, not all patients maintain remission or low disease activity after tapering or discontinuation of bDMARDs. The aim of the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) study, or PREDICTRA, is to generate data on patient and disease characteristics that may predict the clinical course of a fixed dose-tapering regimen with the bDMARD adalimumab. Methods and analysis: PREDICTRA is an ongoing, multicentre, phase IV, randomised, double-blind, parallel-group study of adalimumab dose tapering controlled by withdrawal in participants with RA who achieved stable clinical remission while receiving adalimumab. The study includes a screening period, a 4-week lead-in period with open-label adalimumab 40 mg every other week and a subsequent 36-week double-blind period during which participants are randomised 5:1 to adalimumab 40 mg every 3 weeks (taper arm) or placebo (withdrawal arm). The primary explanatory efficacy variables are lead-in baseline hand and wrist MRI-detected synovitis and bone marrow oedema scores, as well as a composite of both scores; the dependent variable is the occurrence of flare up to week 40. Additional efficacy variables, safety, pharmacokinetics, biomarkers and immunogenicity will also be assessed, and an ultrasound substudy will be conducted. Ethics and dissemination: The study is conducted in accordance with the International Conference on Harmonisation guidelines, local laws and the ethical principles of the Declaration of Helsinki. All participants are required to sign a written informed consent statement before the start of any study procedures
Ultrasound in the study and monitoring of osteoarthritis
This review addresses the use of ultrasound (US) as an imaging technique for the evaluation and monitoring of the osteoarthritic joint. US complements both the clinical examination and radiological imaging by allowing the rheumatologist to recognize not only the bony profile but also to visualize the soft tissues. Systematic US scanning following established guidelines can demonstrate even minimal abnormalities of articular cartilage, bony cortex and synovial tissue. US is also extremely sensitive in the detection of soft tissue changes in the involved joints including the proliferation of the synovium and changes in the amount of fluid present within the joint. Monitoring the amount of fluid in the hip and knee joint with osteoarthritis may be a potentially useful finding in the selection of patients for clinical investigation and for assessing their response to therapeutic interventions. © 2008
How does a cadaver model work for testing ultrasound diagnostic capability for rheumatic-like tendon damage?
To establish whether a cadaver model can serve as an effective surrogate for the detection of tendon damage characteristic of rheumatoid arthritis (RA). In addition, we evaluated intraobserver and interobserver agreement in the grading of RA-like tendon tears shown by US, as well as the concordance between the US findings and the surgically induced lesions in the cadaver model. RA-like tendon damage was surgically induced in the tibialis anterior tendon (TAT) and tibialis posterior tendon (TPT) of ten ankle/foot fresh-frozen cadaveric specimens. Of the 20 tendons examined, six were randomly assigned a surgically induced partial tear; six a complete tear; and eight left undamaged. Three rheumatologists, experts in musculoskeletal US, assessed from 1 to 5 the quality of US imaging of the cadaveric models on a Likert scale. Tendons were then categorized as having either no damage, (0); partial tear, (1); or complete tear (2). All 20 tendons were blindly and independently evaluated twice, over two rounds, by each of the three observers. Overall, technical performance was satisfactory for all items in the two rounds (all values over 2.9 in a Likert scale 1-5). Intraobserver and interobserver agreement for US grading of tendon damage was good (mean κ values 0.62 and 0.71, respectively), with greater reliability found in the TAT than the TPT. Concordance between US findings and experimental tendon lesions was acceptable (70-100 %), again greater for the TAT than for the TPT. A cadaver model with surgically created tendon damage can be useful in evaluating US metric properties of RA tendon lesions
Inter-observer agreement of standard joint counts in early rheumatoid arthritis: a comparison with grey scale ultrasonography—a preliminary study
Objectives. The aims of the present study were to assess the inter-observer agreement of standard joint count and to compare clinical examination with grey scale ultrasonography (US) findings in patients with early rheumatoid arthritis (RA). Methods. The study was conducted on 44 RA patients with a disease duration of <2yrs. Clinical evaluation was performed independently by two rheumatologists for detection of tenderness in 44 joints and swelling in 42 joints. All patients underwent US assessment by a rheumatologist experienced in this method and blinded to the clinical findings. Joint inflammation was detected by US when synovial fluid and/or synovial hypertrophy was identified using OMERACT preliminary definitions. The inter-observer reliability was calculated by overall agreement (percentage of observed exact agreement) and kappa (� )-statistics. The reliability of US was calculated in 12 RA patients. Results. There was fair to moderate inter-observer agreement on individual joint counts for either tenderness or joint swelling apart from the glenohumeral joint. US detected a higher number of inflamed joints than did clinical examination. The mean (� S.D.) US joint count for joint inflammation was 19.1 (� 4.1), while the mean (� S.D.) number of swollen joints was 12.6 (� 3.6), with a significant difference of P ¼0.01. Conclusions. Our results provide evidence in favour of the hypothesis that clinical examination is far from optimal for asessing joint inflammation in patients with early RA. Furthermore, this study suggests that US can considerably improve the detection of signs of joint inflammation both in terms of sensitivity and reliability
Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study
Objective: To investigate the association between baseline disease activity and the occurrence of flares after adalimumab tapering or withdrawal in patients with rheumatoid arthritis (RA) in sustained remission.
Methods: The PREDICTRA phase IV, randomised, double-blind (DB) study (ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels, and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Patients) enrolled patients with RA receiving adalimumab 40 mg every other week who were in sustained remission ≥6 months. After a 4-week, open-label lead-in (OL-LI) period, patients were randomised 5:1 to DB adalimumab taper (every 3 weeks) or withdrawal (placebo) for 36 weeks. The primary endpoint was the association between DB baseline hand and wrist MRI-detected inflammation with flare occurrence.
Results: Of 146 patients treated during the OL-LI period, 122 were randomised to taper (n=102) or withdrawal (n=20) arms. Patients had a mean 12.9 years of active disease and had received adalimumab for a mean of 5.4 years (mean 2.2 years in sustained remission). Overall, 37 (36%) and 9 (45%) patients experienced a flare in the taper and withdrawal arms, respectively (time to flare, 18.0 and 13.3 weeks). None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering. Approximately half of the patients who flared regained clinical remission after 16 weeks of open-label rescue adalimumab. The safety profile was consistent with previous studies.
Conclusions: Approximately one-third of patients who tapered adalimumab versus half who withdrew adalimumab experienced a flare within 36 weeks. Time to flare was numerically longer in the taper versus withdrawal arm. Baseline MRI inflammation was not associated with flare occurrence.
Trial registration number: NCT02198651, EudraCT 2014-001114-26
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