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

Tumour necrosis factor-alpha (TNF-α) inhibitors represent an important treatment advance for a number of inflammatory conditions, including inflammatory bowel disease. Since their introduction in 1999, it has become clear that some biological therapies may be associated with an increased risk for bacterial infections. Herein we present the first case of septic arthritis and spine empyema, caused by S. aureus, in a 63 year-old patient with ulcerative colitis, who was under treatment with Infliximab and with 40mg per day of prednisolone.

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Background:Systemic Sclerosis (SSc) is a chronic disease with multi-organ manifestations that may contribute to disability and low quality of life.1 Therefore, anxiety and depression are more frequent in SSc patients than in general population.2Objectives:To assess the prevalence of anxiety and depression in a SSc cohort and to evaluate its correlation with function, quality of life and assessment of gastrointestinal (GI) involvement scores.Methods:A cross-sectional study was conducted evaluating a cohort of SSc patients. All patients answered to the Hospital Anxiety and Depression Scale (HADS) questionnaire. A cut-off score < 8 was considered normal. Health Assessment Questionnaire (HAQ), Scleroderma HAQ (SHAQ), 36-Item Short Form Health Survey (SF-36), EuroQol-5D (EQ-5D) and University Of California, Los Angeles, Scleroderma Clinical Trials Consortium Gastrointestinal Scale (UCLA SCTC GIT) 2.0 questionnaires were also obtained. Clinical data was obtained and analyzed.Results:We included 20 patients, 17 females [n = 17 (85%)], median (min, max) age was 52.5 (28, 75) years-old. Regarding disease classification, 13 (65%) had limited SSc, 4 (20%) had diffuse SSc and 3 (15%) had early SSc. A score ≥ 8 was found in 14 (70%) patients on HADS-A [median (min, max) = 9 (2, 19)] and in 12 (60%) patients on HADS-D [median (min, max) = 8 (1, 15)]. Depressive patients had significantly worst scores on the measures of function, such as HAQ and lung and gastrointestinal involvements and patient global assessment of SHAQ, of quality of life, such as EQ-5D and physical functioning, role physical, bodily pain, vitality, social functioning and mental health domains of SF-36, and on the UCLA SCTC GIT 2.0 scale. Anxious patients had significantly worst scores on social functioning and mental health domains of SF-36 and on the UCLA SCTC GIT 2.0 scale (Table 1).Conclusion:The prevalence of depression and anxiety on SSc patients is high and should not be neglected. Overall disability and multiorgan manifestations, particularly GI involvement, may contribute to a low quality of life and consequently to depression and anxiety.References:[1]Firestein & Kelley’s Textbook of Rheumatology 2-Volume Set, 11th Edition[2]Brett D. Thombs et al. Depression in Patients With Systemic Sclerosis: A Systematic Review of the Evidence. Arthritis & Rheumatism (Arthritis Care & Research) Vol. 57, 2007, pp 1089–1097Table 1.Function, quality of life and gastrointestinal (GI) involvement assessment according to HADS score.Results, median [min, max]HADS-D ≥ 8 (n = 12)HADS-D < 8 (n = 8)P-valueHADS-A ≥ 8 (n = 14)HADS-A < 8 (n = 6)P-valueSHAQ- GI involvement26.5 [0, 90]2 [0, 40]0.00918.5 [0, 90]2.5 [0, 40]0.091- Lung involvement48.5 [5, 90]2.5 [0, 30]0.00118 [0, 90]3 [0, 65]0.126- Patient global assessment67.5 [30, 100]4 [0, 85]0.01153.5 [2, 100]41.5 [0, 85]0.509HAQ1.375 [0.5, 2]0.1875 [0, 1]0.0011.25 [0, 2]0.875 [0, 1.125]0.147EQ5D0.3667 [-0.0573, 0.6937]0.6752 [0.2870, 1]0.0060.4640 [-0.0573, 0.7667]0.6752 [0.287, 1]0.075SF36- Physical functioning25 [15, 75]75 [50, 100]0.00140 [15, 100]72.5 [25, 85]0.106- Role physical31.25 [0, 75]72.875 [31.25, 100]0.02537.5 [0, 100]65.625 [31.25, 100]0.214- Bodily pain41 [0, 74]68 [20, 88]0.01141 [0, 88]61.5 [20, 74]0.428- Vitality25 [0, 43.75]65.625 [25, 75]0.00137.5 [0, 75]65.625 [12.5, 75]0.135- Social functioning37.5 [12.5, 87.5]87.5 [50, 100]0.00250 [12.5, 100]87.5 [87.5, 100]0.003- Mental health45 [25, 80]65.7 [51.4, 85]0.01245 [25, 75]77.5 [51.4, 85]0.005UCLA SCTC GIT 2.0- Reflux0.38 [0, 1.25]0 [0, 1.25]0.0240.25 [0, 1.25]0 [0, 1]0.139- Distension1 [0.5, 2]0.25 [0, 1.5]0.0171 [0.25, 2]0.125 [0, 1]0.024- Total0.44[0.1, 0.99]0.04 [0, 0.97]0.0100.34 [0.04, 0.99]0.02 [0, 0.44]0.018Disclosure of Interests:None declared