AB0402-Table 1. Cardiorenal continuum features of rheumatoid arthritis patients (%) Features Rituximab group Control group PR-C
BackgroundRecently registry data provide evidence about long-term safety and efficacy of TNF inhibitors. However, data on Rituximab (RTX) treatment in daily clinical practice is limited.ObjectivesOur aim was to describe survival rate and effectiveness of RTX therapy in real-life practice conditions in a big cohort of patients with RA from ColombiaMethodsWe included patients with RA treated at Medicarte IPS from May 2008 and November 2015. Medicarte is a referral center for the integral medical care and pharmacosurveillance of patients under biologic therapies in 13 cities in Colombia. Only those patients with systemic rheumatic diseases were enrolled. We only included those patients with at least 1 complete cycle of RTX treatment. Clinical information was obtained from electronic clinical records and medical claims. We defined survival of RTX treatment only those cases who started RTX treatment before 2015 and persist on RTX during the last visit.ResultsFrom a total of 1064 patients treated with Rituximab, 901 patients had a systemic rheumatic disease. 754 (86%) of patients had a diagnosis of RA. The majority of patients were female (87%); mean age was 55.0± 14.1 years and mean disease duration was 14.7±9.1 years. 57 patients were excluded as they had received less than 1 cycle, leaving 697 patients valid for full analysis. Of these, 80.2% received RTX as a first biological therapy. The mean number of cycles was 1.8 cycles (range 1–8). Adverse effect was reported in 85 (11.2%) patients. 318 patients received only 1 cycle, 185 patients 2 cycles, 91 patients 3 cycles, 30 patients 4 cycles, 18 patients 5 cycles and 8 patients 6 or more cycles. A total of 193 (25.5%) of patients remain on RTX treatment. At the last visit, mean DAS-28 score was 2.9± 1.4 and mean HAQ 0.97±0.71. 66% of patients had a low disease activity (DAS-28 <3.2) and 49% of patients were on remission (DAS-28<2.6). A 64% of patients had a good index of functionality (HAQ <1.0). We did not find differences in terms of clinical response or functionality among patients who used RTX as a first line therapy vs patients with previous biologic treatment (Table).Table 1.Comparison among patients with RTX as a first agent vs patients previously treated with biologic therapyRA treated with RTXRTX as a first agentPrevious treatment with biologic agentsP valueN=754N=605N=147Female gender (%)878885NSAge (years)55±1453±1455±13NSMean disease duration (years)15. ±9.615.13±9.814.7±9.47NSBMI25.2±3.925.2±3.824.9±4.4NSNumber of cycles1.8±1.11.7±1.02.0±1.40.002Duration of RTX treatment (years)1.55±1.701.35±1.363.24±1.90.001Last DAS-282.93±1.432.93±1.442.93±1.39NSLast HAQ0.97±0.710.98±0.700.95±0.76NSRemission (DAS28<2.6 )%484947NSIn 2 patients no information about previous biologic treatment was available.ConclusionsIn our cohort with more than 700 Colombian patients with RA treated with RTX, the rate of survival-on-drug in those with more than 1 cycle was 25%. Around half of patients under RTX treatment were on remission with an adequate physical function.Disclosure of I...
effect of ethanol on the development of systemic lupus erythematosus (SLE) remains controversial. This study was performed to determine the potential role of moderate ethanol consumption in SLE pathological progression and clarify its functional mechanism. Methods We used MRL/lpr mice to assess whether ethanol drinking has any impact on the development of SLE and investigated whether ethanol regulates pathologic progression of SLE through inhibiting lipid rafts. Results We found that 10% ethanol in vivo delayed disease progression and organ damage and prolonged survival. In vitro ethanol treatment not only inhibited the aggregation, proliferation, adhesion molecule expression and IFN-g secretion of T cells, but also decreased lipid raft clustering on T cells. In addition, ethanol inhibited SLE serum-induced skin inflammation and monocyte differentiation into dendritic cells (DCs). Furthermore, ethanol treatment of monocytes that were in the process of differentiating into DCs decreased lipid raft clustering. Conclusions These data strongly support the viewpoint that ethanol delays the disease progression of SLE by inhibiting lipid raft clustering and suggest that moderate drinking of ethanol may have a protective value for patients with SLE. Background and aims Type I interferons (IFN-I) are central to the pathogenesis of systemic lupus erythematosus (SLE). BDCA2 is a plasmacytoid dendritic cell (pDC)-specific receptor that, upon engagement, inhibits the production of IFN-I and other inflammatory mediators. In this first-in-patient phase 1b study, biological activity of BIIB059, a humanised anti-BDCA2 monoclonal antibody, was evaluated in SLE subjects with active cutaneous lupus (CLE). Methods 12 adult SLE subjects with active CLE received a single IV administration of either BIIB059 20 mg/kg (n=8) or placebo (n=4). A panel of IFN-responsive genes (IRG) was assessed from whole blood. Cellular infiltration and expression of MxA and IFITM3 were evaluated in skin biopsies from active lesions at baseline and week 4. CLE disease activity was determined using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI). Safety data were also collected. Results BIIB059 decreased the expression of IRG in blood and MxA and IFITM3 proteins in skin. CD45+ cells were reduced in skin biopsies of BIIB059-treated subjects. The reduction in inflammatory cells as well as MxA and IFITM3 expression at week 4 correlated with improvement in CLASI activity score at week 12. BIIB059 was well tolerated with no withdrawals due to AEs. Conclusions The study, confirming the major role played by pDCs in the production of IFN-I in the blood and skin in CLE, supports further development of BIIB059. 83 BIIB059, A MONOCLONAL ANTIBODY TARGETING BDCA2, DEMONSTRATES EVIDENCE OF PROOF OF BIOLOGICAL ACTIVITY IN SUBJECTS WITH CUTANEOUS LUPUS
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