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
Introduction: The aim of this study was to conduct a systematic review in order to examine the effectiveness of ozone therapy on knee osteoarthritis. The objectives were to evaluate the effect over time of ozone therapy in terms of knee pain, functional improvement and radiographic progression.Material and Methods: A search was carried out on PubMed, Embase, Cochrane Library, Scopus and Web of Science databases to identify randomized and controlled studies focusing on this association. The following descriptors were used in English: ozone therapy, knee osteoarthritis. A descriptive summary and quality assessment was made of all studies included for analysis.Results: Six randomized and controlled studies were identified. The risk of bias assessment demonstrated that one study was considered as having a moderate risk of bias and the remainder a high risk of bias. No quantitative analysis of the data was performed, as the studies included were not sufficiently homogeneous. The participants in the studies were generally elderly patients with mild to moderate knee osteoarthritis.Discussion: The variability of ozone therapy and the comparators demonstrates that there is no standardized therapy. Few studies reported adverse effects, and where they occurred, they were mild and associated with the procedure.Conclusion: Ozone therapy proved effective in the short-term in relation to placebo and when combined with hyaluronic acid, but it was not superior to other current treatments. More randomised and controlled studies are needed to evaluate the risks/benefits of ozone therapy, both in the short term and the medium/long term.
BackgroundPain and stiffness are characteristic clinical features of axial Spondyloarthritis (axSpA), leading to functional impairment. Patients describe beneficial effects of physical activity, suggesting a possible involvement of muscle tissue. Body composition data in young axSpA patients with short disease duration are scarce and its implications in muscle strength are not yet clarified.ObjectivesThe purpose of this study is to assess the muscle strength and body composition of different body segments (trunk, upper and lower limbs), in patients with axSpA and to compare them with healthy controls.MethodsPatients with clinical diagnosis of axSpA meeting the ASAS classification criteria, aged 18 to 50 years, with symptoms duration ≤ 10 years, were included in this study. Healthy individuals matched by gender and age (1:1) were used as control group (HC). Muscle strength was measured by resisted hand-held dynamometer performed by a single reader, in three different body segments: trunk, upper and lower limbs (on both sides). The mean strength of right and left, upper and lower limbs, was calculated and used in the analysis. Strength of each body segment was also normalized to the total lean mass (LM) of the respective segment. Body composition was measured by octapolar multifrequency bioelectrical impedance analysis (InBody770). Physical activity was assessed by the International Physical Activity Questionnaire (IPAQ). Fisher’s exact test or chi-square test and Mann-Whitney U test were used to compare differences between groups.ResultsA total of 27 axSpA patients and 27 HC were included. Mean age was 36.5 ± 1.0 years, 67% were males. There was no significant difference between both groups in terms of age, gender, body mass index and physical activity. AxSpA patients had a mean symptoms duration of 7.0 ± 0.9 years.AxSpA patients had lower muscle strength in the upper limbs (50.55 ± 31.60 vs 71.70±31.41 p=0.023) and lower limbs (52.25±18.45 vs 59.83±9.75, p=0.001), compared to HC. Trunk muscle strength did not show any difference between groups (59.10±26.1 vs 56.45±11.2, p=0.856).There were no significant differences in LM and body water, between both groups, for each segment (upper limbs, lower limbs and trunk). Fat mass was significantly higher in the trunk (10.90±8.80 vs 8.10±5.83, p=0.035) and upper limbs (1.40±1.35 vs 0.88±1.0, p=0.05) of axSpA patients, but not in the lower limbs (3.10±1.90 vs 2.45±1.68, p=0.157).Normalized appendicular muscle strength was lower in axSpA patients (upper limbs: 18.63±8.25 vs 21.21±5.92, p=0.018) (Table).ConclusionYoung patients with short duration have reduced appendicular muscle strength, compared to HC, with no differences in LM, suggesting a possible muscle dysfunction. Further studies are needed to confirm these findings and understand the underlying pathophysiological mechanisms.Abstract THU0395 –Table 1Disclosure of InterestsAgna Neto: None declared, Rita Pinheiro Torres: None declared, Lucia Domingues: None declared, Diana Teixeira: None declared, Santiago Rodrigues-Man...
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