Objective. To investigate the validity, reproducibility, and responsiveness of a simplified power Doppler ultrasound (PDUS) assessment of joint inflammation compared with a comprehensive 44-joint PDUS assessment in patients with rheumatoid arthritis (RA) who started therapy with a biologic agent. Methods. A total of 160 patients with active RA who started a biologic agent were prospectively recruited in 18 Spanish centers. The patients underwent clinical and laboratory assessment and blinded PDUS examination at baseline and 6 months. A PDUS examination of 128 synovial sites in 44 joints was performed. US synovitis and PD signal were semiquantitatively graded from 1 to 3 in all synovial sites. US count and index for synovitis and PD signal were obtained. PDUS intraobserver and interobserver reliability were evaluated. A process of data reduction based on the frequency of involvement of synovial sites by both synovitis and PD signal was conducted. Construct and discriminant validity of a simplified PDUS assessment was investigated. Results. A PDUS simplified assessment including 24 synovial sites from 12 joints detected 100% of patients with synovitis and 91% of patients with PD signal. There was a highly significant correlation between the 44-joint count and index for synovitis and PD signal and the 12-joint count and index for synovitis and PD signal at baseline and 6 months (r ؍ 0.84 -0.90, P < 0.0005). The smallest detectable difference was lower than the mean change in simplified PDUS variables. Conclusion. A 12-joint PDUS assessment of RA joint inflammation may be a valid, feasible method for multicenter monitoring of therapeutic response to biologic agents.
To establish practical recommendations for the management of patients with psoriatic arthritis (PsA) with particular clinical situations that might lead to doubts in the pharmacological decision-making. A group of six expert rheumatologists on PsA identified particular clinical situations in PsA. Then, a systematic literature review (SLR) was performed to analyse the efficacy and safety of csDMARDs, b/tsDMARDs in PsA. In a nominal group meeting, the results of the SLR were discussed and a set of recommendations were proposed for a Delphi process. A total of 65 rheumatologists were invited to participate in the Delphi. Agreement was defined if ≥ 70% of the participants voted ≥ 7 (from 1, totally disagree to 10, totally agree). For each recommendation, the level of evidence and grade of recommendation was established based on the Oxford Evidence-Based Medicine categorisation. Particular clinical situations included monoarthritis, axial disease, or non-musculoskeletal manifestations. The SLR finally comprised 131 articles. A total of 16 recommendations were generated, all but 1 reached consensus. According to them, it is crucial to carefully analyse the impact of individual manifestations on patients (disability, quality of life, etc.), but also to recognise the impact of each drug singularities on selected clinical phenotypes to adopt the most appropriate treatment strategy. Early diagnosis and treatment to target approach, along with a close risk management, is also necessary. These recommendations are intended to complement gaps in national and international guidelines by helping health professionals address and manage particular clinical situations in PsA.
BackgroundGreater knowledge of the behavior of rheumatoid arthritis in his response to biological therapy and the need to improve the resource efficiency of national health systems has led in recent years to implement optimization strategies with the treatments most overburdened financially to social security systems.ObjectivesThe aim of this study is to describe what the status of such optimization and clinical conditions that takes place in a hospital serving the healthcare demands of nearly one million inhabitants.MethodsAll patients with a diagnosis of RA (ACR/EULAR 2010), served in the Clinical Management HUVR in Seville, during the period January 2008 to May 2014 and received at least one dose of etanercept with indication sheet in Spain.Design: Observational, longitudinal, retrospective and analytical study.Patients and methods: Five rheumatologists, after defining the project and the variables to obtain reviewed the medical records of patients and collected them in a database designed exprofeso sociodemographic variables, RA and clinics. As part of clinical management, to achieve remission defined as =1 =1 and swollen joint painful joint sustained for at least two consecutive visits, was decided to reduce the biological dose.Statistical analysis: descriptive, univariate tests according to the distribution of variables anResultsResults: 130 patients were included, excluded 4 (3%) by incomplete data for analysis. The median age (p25-p75) of the 126 (97%) patients was 55.9 (47-65), 79% female, 72% FR +, 49% received etanercept as first biological and the rest as second or third 44% were treated with concomitant MTX and 28% with low doses of corticosteroids. The duration of RA was 10.9 (6.9 to 20) years. Remission was found and it was possible to reduce the dose of etanercept in 92 (73%) cases. Of these, only 1 (0.8) discontinued treatment due to persistence of remission and the majority (48%) received doses of 25 mg of etanercept every 7 days. The main characteristics of the two groups of patients are shown in the table. In multivariate analysis that shorter duration of RA greater chance of remission (OR 0.98 95% CI 0.97 to 1.001) and smoking as a factor of no remission (OR 2.54 95% CI 1,1 5 found, 8), but the predictive capabilities of the models were low (11%).Conclusion: In patients with RA treated in routine clinical practice and appropriate response to etanercept, remission is possible and reduces the dose of biological two-thirds of patients with RA, although the definitive discontinuation is rare.In multivariate analysis that shorter duration of RA greater chance of remission (OR 0.98 95% CI 0.97 to 1.001) and smoking as a factor of no remission (OR 2.54 95% CI 1,1 5 found, 8), but the predictive capabilities of the models were low (11%).ConclusionsIn patients with RA treated in routine clinical practice and appropriate response to etanercept, remission is possible and reduces the dose of biological two-thirds of patients with RA, although the definitive discontinuation is rare.Disclosure of InterestNo...
BackgroundCertolizumab PEGol (CZP) differs from other anti-TNFs in that it is monovalent and it lacks the Fc region found in monoclonal antibodies. CZP is also PEGylated. Its efficacy in patients with rheumatoid arthritis (RA) has been evaluated in previous clinical trials.ObjectivesThe purpose of the current study is to assess effectiveness, safety and survival rate in patients with RA after 12 months of treatment and also within specific subgroups, in clinical practice settings.MethodsObservational longitudinal prospective study of RA patients from 40 sites in Spain. Variables (baseline, 3- and 12 month assessment): socio-demographics, smoking status, previous synthetic DMARD (sDMARD) and biological DMARD (bDMARD) use; TJC, SJC, ESR, CRP, DAS28. Response variables EULAR Moderate/Good Response and DAS28 remission and Safety were assessed. Descriptive, comparative and Logistic regression analyses were performed. Kaplan-Meier survival curve was performed.ResultsA total of 501 patients were included: 78.6% women, mean age 53.6 year (±13.2 SD) and 77% were aged <65 year Mean disease duration 7.5 year (±7.3 SD) and 27.7% having early RA. Baseline features are shown in table 1. Mean number of prior sDMARD 1.5 (±1.1 SD). Mean number of prior bDMARD was 0.8 (±1.2 SD). Mean duration of exposure to CZP was 9.8 months (±3.4 SD); Concomitant steroids intake 12.6%, sDMARD 24.2% and sDMARD plus steroids 54.9%; Smoking status: 69.8% never smoked, 12.9% former smoker and 17.3% current smoker.Baseline predictors of response: lower prior number sDMARD; low number prior bDMARD; higher CRP, ESR, TJC, SJC and DAS28 (p<0.05) scores.Patients<65 year had shown better DAS28 Remission rates as well as those who had previously received <2 sDMARDs, those who were “bionaïve” at CZP initiation and those who used CZP in combination.CZP survival rates are shown in Figures 1 and 2.Adverse effects from treatment were reported in 65 patients (13%), mostly mild.ConclusionsCZP showed benefit in active RA patients, with clear improvement in all clinical parameters, mostly in <65 yo patients and those who had received low number of previous sDMARD and bDMARD. Survival rate at 12 month assessment was high, demonstrating a reasonable safety profile.Reference[1] Torrente-Segarra V, et al; (RENACER StudyGroup). RENACER study:Assessment of 12-month efficacy and safety of 168 certolizumab PEGol rheumatoidarthritis-treated patients from a Spanish multicenter national database. ModRheumatol2015Nov 7:1–6.Disclosure of InterestNone declared
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