ObjectivesTo assess the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy in psoriatic arthritis (PsA) dactylitis.MethodsMulticentre, investigator-initiated, randomised, double-blind, placebo-controlled, parallel-design phase 3b trial in 11 Portuguese rheumatology centres. Patients with PsA along with active dactylitis and naive to MTX and biologic disease-modifying antirheumatic drugs (bDMARDs) were randomly assigned to golimumab or placebo, both in combination with MTX. The primary endpoint was Dactylitis Severity Score (DSS) change from baseline to week 24. Key secondary endpoints included DSS and Leeds Dactylitis Index (LDI) response, and changes from baseline in the LDI and MRI dactylitis score. Analysis was by intention-to-treat for the primary endpoint.ResultsTwenty-one patients received golimumab plus MTX and 23 MTX monotherapy for 24 weeks. One patient from each arm discontinued. Patient inclusion was halted at 50% planned recruitment due to a favourable interim analysis. Median baseline DSS was 6 in both arms. By week 24, patients treated with golimumab plus MTX exhibited significantly greater improvements in DSS relative to MTX monotherapy (median change of 5 vs 2 points, respectively; p=0.026). In the golimumab plus MTX arm, significantly higher proportions of patients achieved at least 50% or 70% improvement in DSS and 20%, 50% or 70% improvement in LDI in comparison to MTX monotherapy.ConclusionsThe combination of golimumab and MTX as first-line bDMARD therapy is superior to MTX monotherapy for the treatment of PsA dactylitis.Trial registration numberNCT02065713
ObjectivesTo compare definitions of high disease activity of the Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in selecting patients for treatment with biologic disease-modifying antirheumatic drugs (bDMARDs).MethodsPatients from Rheumatic Diseases Portuguese Register (Reuma.pt) with a clinical diagnosis of axial spondyloarthritis (axSpA) were included. Four subgroups (cross-tabulation between ASDAS (≥2.1) and BASDAI (≥4) definitions of high disease activity) were compared regarding baseline characteristics and response to bDMARDs at 3 and 6 months estimated in multivariable regression models.ResultsOf the 594 patients included, the majority (82%) had both BASDAI≥4 and ASDAS ≥2.1. The frequency of ASDAS ≥2.1, if BASDAI<4 was much larger than the opposite (ie, ASDAS <2.1, if BASDAI≥4): 62% vs 0.8%. Compared to patients fulfilling both definitions, those with ASDAS ≥2.1 only were more likely to be male (77% vs 51%), human leucocyte antigen B27 positive (79% vs 65%) and have a higher C reactive protein (2.9 (SD 3.5) vs 2.1 (2.9)). Among bDMARD-treated patients (n=359), responses across subgroups were globally overlapping, except for the most ‘stringent’ outcomes. Patients captured only by ASDAS responded better compared to patients fulfilling both definitions (eg, ASDAS inactive disease at 3 months: 61% vs 25% and at 6 months: 42% vs 25%).ConclusionThe ASDAS definition of high disease activity is more inclusive than the BASDAI definition in selecting patients with axSpA for bDMARD treatment. The additionally ‘captured’ patients respond better and have higher likelihood of predictors thereof. These results support using ASDAS≥2.1 as a criterion for treatment decisions.
BackgroundPatients with rheumatic inflammatory conditions have an increased risk of premature death due to cardiovascular causes. It can be explained by the unfavourable interaction between the inflammatory process and the traditional cardiovascular risk factors. In obesity, especially if visceral, and in rheumatic diseases, there is production of pro-inflammatory cytokines, which contributes to an increase in cardiovascular risk. The influence of body mass index (BMI) on the evolution, activity and quality of life in rheumatoid arthritis (RA) and in psoriatic arthritis (PsA) has been proven. However, studies evaluating the influence of the abdominal circumference (AC) and metabolic syndrome (MS) are meagre.ObjectivesTo assess the influence of BMI, AC and MS, on disease activity and quality of life in RA and PA, using parameters of inflammatory activity (sedimentation rate (SR) and C-reactive protein (CRP), Activity Score (DAS28), Visual Analogue Pain Scale (VAS) and Health Assessment Questionnaire (HAQ) and to compare patients with RA and PA.MethodsA cross-sectional study, including 150 patients with RA, diagnosed according to the ACR/EULAR criteria and 75 patients with PsA (CASPAR criteria). Assessment of weight, height, AC, SR and CRP of all patients, clinical and demographic data collection. The presence of MS was assessed according to WHO definition. Participants completed HAQ and disease activity was measured by DAS28. SPSS was used for the statistical analysis, significance level was 2-sided p<0.050.ResultsAge, duration of illness, schooling and professional class were similar in RA and PsA. In RA there was a predominance of females (78.7%), while in PsA a predominance of males (53.3%). There were no differences between the quality of life (by HAQ), or in the disease activity (by DAS28 or by inflammatory parameters). PsA patients had significantly higher BMI and AC. The number of comorbidities was higher in cases of PsA. Dyslipidaemia and hyperuricemia were significantly more frequent in this group of patients. Independently the underlying pathology (RA or PsA), the number of comorbidities correlated positively with DAS28, with HAQ, CRP and SR.In RA group, there was a positive correlation of both BMI and AC with HAQ, also MS associated the highest HAQ values. Overweight/obesity (BMI≥25kg/m2) were associated with at least one painful joint. Still, the risk of having at least one swollen joint was 3.4 times higher in patients with increased AC (95% CI: 1.08-10.39). There was an association between the BMI and AC and the CRP value. Patients with BMI≥25 kg/m2 and with increased AC had DAS28 values significantly higher. MS was associated with significantly higher SR.In PsA group Patients with MS had higher CRP values, more joint pain and higher disease activity according to DAS28. Patients with BMI≥25kg/m2 also had more painful joints and higher CRP values. None of the patients with normal BMI had swollen joints, however 20.4% of overweight patients had at least one swollen joint. There was no association betwee...
Objectives To assess the efficacy of biologic DMARDs (bDMARDs) in achieving Assessment of Spondyloarthritis International Society partial remission (ASAS-PR) and/or Ankylosing Spondylitis Disease Activity Score inactive disease (ASDAS-ID), as remission-like surrogates, in axial SpA (axSpA). Methods Data from randomized controlled trials (RCTs), including long-term extensions, were included. A systematic literature review was performed using the MEDLINE database (first search May 2018, updated February 2020) and PICO criteria according to Patients—adults with radiographic or non-radiographic axSpA; Intervention—any bDMARD; Comparator—placebo and/or any different drug; Outcomes—ASAS-PR and/or ASDAS-ID as primary or secondary endpoints. Meta-analysis was performed after assessment of the homogeneity of study designs, populations and outcomes. Results After screening 155 references, a total of 22 RCTs and 28 long-term extensions were retrieved. ASAS-PR was the dominant remission-like definition used. Concerning TNF inhibitors, 14/17 RCTs provided evidence of efficacy in reaching remission at different time points: 12, 16, 24 and 28 weeks (ASAS-PR in 16–62% of patients and ASDAS-ID in 24–40% of patients). With a limited number of studies available, IL-17A inhibitors exhibited remission rates of 15–21% for ASAS-PR and 11–16% for ASDAS-ID at week 16. A meta-analysis regarding ASAS-PR was performed considering RCTs with a similar duration (12, 16 or 24 weeks). The relative risk for achieving remission was 3.864 (95% CI 2.937, 5.085). Conclusion bDMARDs have a clear impact in axSpA remission evaluated by ASAS-PR. Nevertheless, these data show an unmet need for improved reporting of remission-like outcomes.
The anterior or volar compartment of the forearm contains eight muscles: five belong to the superficial group (pronator teres, flexor carpi radialis, palmaris longus, flexor digitorum superficialis and flexor carpi ulnaris), and three to the deep group (flexor digitorum profundus, flexor pollicis longus and pronator quadratus). Knowledge of the topographic anatomy is essential for correct performance of ultrasound (US) examinations and correct interpretation of the images provided.
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