Objective To determine whether a treatment strategy based on structured ultrasound assessment would lead to improved outcomes in rheumatoid arthritis, compared with a conventional strategy.Design Multicentre, open label, two arm, parallel group, randomised controlled strategy trial.Setting Ten rheumatology departments and one specialist centre in Norway, from September 2010 to September 2015.Participants 238 patients were recruited between September 2010 and April 2013, of which 230 (141 (61%) female) received the allocated intervention and were analysed for the primary outcome. The main inclusion criteria were age 18-75 years, fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis, disease modifying anti-rheumatic drug naivety with indication for disease modifying drug therapy, and time from first patient reported swollen joint less than two years. Patients with abnormal kidney or liver function or major comorbidities were excluded.Interventions 122 patients were randomised to an ultrasound tight control strategy targeting clinical and imaging remission, and 116 patients were randomised to a conventional tight control strategy targeting clinical remission. Patients in both arms were treated according to the same disease modifying anti-rheumatic drug escalation strategy, with 13 visits over two years.Main outcome measures The primary endpoint was the proportion of patients with a combination between 16 and 24 months of clinical remission, no swollen joints, and non-progression of radiographic joint damage. Secondary outcomes included measures of disease activity, radiographic progression, functioning, quality of life, and adverse events. All participants who attended at least one follow-up visit were included in the full analysis set.Results 26 (22%) of the 118 analysed patients in the ultrasound tight control arm and 21 (19%) of the 112 analysed patients in the clinical tight control arm reached the primary endpoint (mean difference 3.3%, 95% confidence interval −7.1% to 13.7%). Secondary endpoints (disease activity, physical function, and joint damage) were similar between the two groups. Six (5%) patients in the ultrasound tight control arm and seven (6%) patients in the conventional arm had serious adverse events.Conclusions The systematic use of ultrasound in the follow-up of patients with early rheumatoid arthritis treated according to current recommendations is not justified on the basis of the ARCTIC results. The findings highlight the need for randomised trials assessing the clinical application of medical technology.Trial registration Clinical trials NCT01205854.
Objective.The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Magnetic Resonance Imaging (MRI) scoring system (RAMRIS), evaluating bone erosion, bone marrow edema/osteitis, and synovitis, was introduced in 2002, and is now the standard method of objectively quantifying inflammation and damage by MRI in RA trials. The objective of this paper was to identify subsequent advances and based on them, to provide updated recommendations for the RAMRIS.Methods.MRI studies relevant for RAMRIS and technical and scientific advances were analyzed by the OMERACT MRI in Arthritis Working Group, which used these data to provide updated considerations on image acquisition, RAMRIS definitions, and scoring systems for the original and new RA pathologies. Further, a research agenda was outlined.Results.Since 2002, longitudinal studies and clinical trials have documented RAMRIS variables to have face, construct, and criterion validity; high reliability and sensitivity to change; and the ability to discriminate between therapies. This has enabled RAMRIS to demonstrate inhibition of structural damage progression with fewer patients and shorter followup times than has been possible with conventional radiography. Technical improvements, including higher field strengths and improved pulse sequences, allow higher image resolution and contrast-to-noise ratio. These have facilitated development and validation of scoring methods of new pathologies: joint space narrowing and tenosynovitis. These have high reproducibility and moderate sensitivity to change, and can be added to RAMRIS. Combined scores of inflammation or joint damage may increase sensitivity to change and discriminative power. However, this requires further research.Conclusion.Updated 2016 RAMRIS recommendations and a research agenda were developed.
The proposed OHOA-MRI score could reliably assess HOA features. However, further validation is needed.
Patients with RA in remission by any established criteria can experience radiographic progression. An increased number of visits in remission was associated with reduced radiographic damage.
ObjectivesTo compare the presentation of seropositive and seronegative early rheumatoid arthritis (RA) in disease-modifying antirheumatic drug (DMARD)-naïve patients classified according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria.MethodsAll patients had symptom duration from first swollen joint <2 years and were DMARD naïve with an indication for DMARD treatment. Patients were stratified as seropositive (positive rheumatoid factor (RF)+ and/or anticitrullinated peptide antibody (ACPA)+) or seronegative (RF− and ACPA−), and disease characteristics were compared between groups.ResultsA total of 234 patients were included, and 36 (15.4%) were seronegative. Ultrasonography (US) scores for joints (median 55 vs 25, p<0.001) and tendons (median 3 vs 0, p<0.001), number of swollen joints (median 17 vs 8, p<0.001), disease activity score (DAS; mean 3.9 vs 3.4, p=0.03) and physician global assessment (mean 49.1 vs 38.9, p=0.006) were significantly higher in seronegative patients compared with seropositive. Total van der Heijde-modified Sharp score, Richie Articular Index and patient-reported outcome measures were similar between groups.ConclusionsSeronegative patients had higher levels of inflammation, assessed both clinically and by US, than seropositive patients. These differences may reflect the high number of involved joints required for seronegative patients to fulfil the 2010 ACR/EULAR classification criteria for RA.Trial registration numberNCT01205854; Pre-results.
Objective.To develop and test the interreader reliability of the OMERACT Hand Osteoarthritis Magnetic Resonance Scoring System (HOAMRIS) for assessment of structural and inflammatory hand OA features in the interphalangeal joints.Methods.The HOAMRIS was developed through an iterative process. Selection of features and their scaling was agreed upon through consensus by members of the OMERACT Magnetic Resonance Imaging (MRI) Task Force, using the Oslo Hand Osteoarthritis (OA) MRI Score system as a template. Two reliability exercises were performed, in which 6 and 4 readers participated, respectively. After the first exercise, an atlas was developed and used in the second exercise to facilitate reading. In each exercise, readers independently scored 8 MRI scans from the Oslo Hand OA cohort (coronal/axial short-tau inversion recovery and coronal/axial/sagittal T1-weighted fat-suppressed pre-/post-Gadolinium images). Interreader reliability was assessed by intraclass correlation coefficients (ICC), percentage exact and close agreement (PEA/PCA).Results.The preliminary OMERACT HOAMRIS included assessment of synovitis, erosive damage, cysts, osteophytes, cartilage space loss, malalignment, and bone marrow lesions (BML), of which all were scored on a 0–3 scale for normal, mild, moderate, and severe (increments of 0.5 for synovitis, erosive damage, and BML). In the first exercise, most features showed good to very good ICC values (0.64–0.94), except synovitis (0.34). In the second exercise using the atlas, the ICC values were > 0.74 for all MRI features, and the PEA/PCA values were higher than in the first exercise.Conclusion.A preliminary HOAMRIS with good to very good interreader reliability was developed. Longitudinal studies are needed to assess its sensitivity to change.
The association between joint damage and disability in rheumatoid arthritis (RA), especially in the later stages of disease, is a main reason why radiographic joint damage is a common and valid outcome measure in RA clinical trials. Most studies have assessed the effect of global joint damage, which has limited our knowledge regarding the individual effects of erosions and cartilage damage on physical function. However, recent data have indicated that joint space narrowing is more closely related to functional status than erosions. Modern imaging techniques that provide improved assessment of the cartilage itself, instead of only joint space narrowing, might help disentangle the separate associations of erosive bone damage and cartilage damage with physical function in patients with RA. The aim of this article is to discuss the current knowledge within this field and the clinical consequences thereof.
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