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ID PMID Title PublicationDate abstract
23148091 Interaction between oxidative stress and smoking is associated with an increased risk of r 2013 Mar OBJECTIVE: To investigate the relationship between oxidative stress and smoking and development of RA. METHODS: A case-control study was conducted in treatment-naïve early-onset RA patients and healthy controls, matched by age, gender and current smoking habit. Plasma lipid hydroperoxides (LOOH), carbonyl protein (CP) and malonyldialdehyde (MDA) levels were measured to estimate oxidative stress. Smoking exposure was quantified in pack-years. The presence of an interaction between oxidative stress and smoking exposure was investigated using three measures of additive interaction: relative excess risk due to the interaction (RERI), attributable proportion due to the interaction (AP) and the synergy index (S). RESULTS: A total of 65 RA patients and 65 healthy controls were included. Statistically significant differences were observed in RA-related variables, age, BMI and smoking dose between cases and controls. Plasma LOOH and CP levels were associated with RA risk, which was more prominent for LOOH levels >27.9 µM [odds ratio (OR) 18.8] and CP levels >64.3 µM (OR 24.9). A reverse association was observed between MDA levels and RA risk, OR 6.4 for MDA levels <8.5 µM. Having >20 pack-years increased risk for RA with an OR of 19.7. The interaction between smoking and oxidative stress increased RA risk significantly, and RERI between LOOH, CP or MDA and smoke exposure were 8.2, 5.0 and 51.5, respectively. CONCLUSION: These data suggest that the interaction between oxidative stress and smoking increases RA risk.
21945078 Clinical and patient-reported outcomes of patients with four major lower extremity arthrop 2012 Apr Few studies report the outcomes of patients treated with total joint arthroplasty of both hips and both knees. We present the outcomes of 14 patients with total joint arthroplasty of both hips and both knees using validated outcome measures. Eleven patients (79%) were satisfied at final review. Ten patients (71%) required revision surgery of at least one joint. Clinical, functional, radiographic, and patient-reported outcomes were consistent with previously reported outcomes in the literature. Mean Timed Up and Go test was 32 seconds (6-158). Mean Berg Balance Scale was 38.5 (4-55). Good outcomes can be achieved in this group of patients with high levels of satisfaction despite the frequent need for revision surgery. Importantly, it was recognized that these patients have a high risk of falls and must be educated in measures for fall prevention.
20097037 Total hip arthroplasty using a cylindrical cementless stem in patients with a small physiq 2011 Jan We performed total hip arthroplasty using an anatomic medullary locking cementless stem for small-physique patients from 1988 to 1995. We conducted a retrospective study of 50 joints in 44 cases, including 40 developmentally dysplastic hips followed for 12 to 20 years (average, 15.1 years). Average height and body weight were 152 cm and 56 kg (5.0 ft and 124 lb), respectively, with an average body mass index of 24.2. Twelve joints (24%) were revised for acetabular-sided failures. Forty-eight stems (96%) showed bone ingrowth fixation, and there were no unstable stems. The simple cylindrical shape of the distal portion of the AML stem was less affected by deformity of the proximal femur of developmental dysplasia of the hip in patients with a small physique, and both clinically and radiologically good results were confirmed at long-term follow-up.
21383676 Altered influenza virus haemagglutinin (HA)-derived peptide is potent therapy for CIA by i 2011 Jul There has been an increase in interest in the use of altered peptides as antigen-specific therapeutic agents in autoimmune diseases. Here we investigated the inhibitory effect and possible mechanism of an altered influenza virus haemagglutinin (HA)-derived peptide in collagen-induced arthritis (CIA). CIA was induced in DBA/1 mice by immunisation with type II collagen (CII). Altered HA308-317, wild-type HA308-317 or irrelevant peptide was administered intranasally beginning from arthritis onset. Clinical and histological scores were assessed, and cytokine levels in the serum or supernatants from splenocytes were determined. The percentages of Th1 and Th2 cells in response to different peptides were analysed by FACS both in vivo and in vitro. Our results showed that intranasal administration of altered HA308-317 peptide significantly ameliorated CIA. The therapeutic effect of altered HA308-317 peptide was associated with a substantial decrease in production of interferon (IFN)-γ, interleukin (IL)-6, monocyte chemoattractant protein (MCP)-1, anti-CII IgG, IgG1 and IgG2a antibodies, and an markedly increase in production of IL-10 and IL-4 in serum or supernatants from splenocytes treated with altered HA308-317 peptide. The percentage of Th2 (CD4(+)IL-4(+)) cells was upregulated significantly by altered HA308-317 peptide with a decreased percentage of Th1 (T helper 1; CD4(+)INF-γ(+)) cells both in vivo and in vitro. These findings suggest that altered HA308-317 peptide might be a promising candidate for rheumatoid arthritis (RA) treatment.
20858147 Post-approval trials of new medicines: widening use or deepening knowledge? Analysis of 10 2011 May OBJECTIVE: To investigate the main aims of the post-approval randomized controlled trials (RCTs) on etanercept and the extent to which they were designed to gain more comparative information. METHODS: A search of the literature (Medline, Embase), trial registries (Clinical Trials.gov, Controlled Trials.com), and market authorization reports from the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) was carried out to identify all RCTs. A comparison of trial data identified unpublished trials and multiple publications relating to the same study. All RCTs completed and/or published after initial market approval was regarded as post-approval. RESULTS: Up until 2008, we found 84 post-approval trials, 11 (13%) trials on approved extensions of indication, another 30 (36%) trials on the approved indications, and 43 (51%) trials on indications not (yet) approved. Nearly half of the studies on indications not yet approved were initiated and funded by independent sponsors. After the initial approval of etanercept, six head-to-head trials were conducted on the approved indications. Overall, the main objectives of post-approval trials with etanercept were found to confirm efficacy and safety in new indications, and to gather additional information for optimal use on the approved indications. CONCLUSION: Post-approval RCTs on etanercept focus more on studies searching for new indications than on deepening knowledge about use. Ten years after the market entry of etanercept, one of the reasonable demands of clinical practice, for more comparative information, still remains unanswered.
23108887 Tocilizumab in the treatment of the adult-onset Still's disease: current clinical evidence 2013 Jan This study aimed to review and analyze the effectiveness and safety of tocilizumab in the treatment of patients with adult-onset Still's disease (AOSD). We report on two patients with AOSD who were successfully treated with tocilizumab. All published information on the use of tocilizumab in this disease was also retrieved through a systematic review of the English-language literature. Including our cases, 35 patients were given tocilizumab for AOSD (8 mg/kg/month in 22 patients). The main clinical manifestations were arthritis in all 35 patients and systemic symptoms such as fever or skin rash in 28 (80 %). Thirty-three (94 %) patients had unsuccessfully tried other immunosuppressive agents such as methotrexate, tumor necrosis factor-α blockers, or anakinra. Most of the patients achieved a response with tocilizumab, such as a prompt articular improvement in 30/35 (86 %) patients and a disappearance of systemic symptoms in 27/28 (96 %). Twenty-eight (80 %) patients tapered their steroid intakes, including seven (20 %) who were able to discontinue them. Four (11 %) patients relapsed, and two were successfully retreated with tocilizumab. Regarding safety, tocilizumab is a well-tolerated treatment, but severe side effects such as macrophage activation syndrome or cytomegalovirus reactivation are possible and require ongoing vigilance. Our findings suggest that tocilizumab should probably be proposed in refractory AOSD, as it allows for remission to be induced and the dose of steroid intakes to be reduced. It is a well-tolerated treatment that can be administered according to the therapeutic sequence of rheumatoid arthritis. Further prospective studies are required to assess the better use of this treatment (dosage and duration) and its place among other conventional treatments.
21214317 Transarticular screw fixation of C1-2 for the treatment of arthropathy-associated occipita 2011 Feb Two patients with occipital neuralgia due to severe arthropathy of the C1-2 facet joint were treated using atlantoaxial fusion with transarticular screws without decompression of the C-2 nerve root. Both patients experienced immediate postoperative relief of occipital neuralgia. The resultant motion elimination at C1-2 eradicated not only the movement-evoked pain, but also the paroxysms of true occipital neuralgia occurring at rest. A possible pathophysiological explanation for this improvement is presented in the context of the ignition theory of neuralgic pain. This represents the first report of C1-2 transarticular screw fixation for the treatment of arthropathy-associated occipital neuralgia.
21547898 Reduction of in vitro invasion and in vivo cartilage degradation in a SCID mouse model by 2011 Sep OBJECTIVE: Urokinase plasminogen activator (uPA), uPA receptor (uPAR), and PA inhibitor 1 (PAI-1) have pivotal roles in the proliferation and invasion of several cell types, including synovial fibroblasts (SFs). The aim of this study was to investigate the possibility of controlling the invasion of rheumatoid arthritis (RA) SFs in vitro and in vivo by inhibiting uPA and uPAR. METHODS: Normal SFs, SFs from patients with RA, and SFs from patients with psoriatic arthritis (PsA) were used. The levels of uPA, uPAR, and PAI-1 were measured by enzyme-linked immunosorbent assay and reverse transcription-polymerase chain reaction analysis of messenger RNA. The activity of uPA was studied by zymography. Proliferation was measured by cell counting, and cell invasion was measured with a Boyden chamber assembled with Matrigel-coated porous filters. Human cartilage and RA SF implantation in the SCID mouse model of RA were used to study cartilage invasion in vivo. RESULTS: RA SFs and PsA SFs overexpressed uPAR and as a result were more active than their normal counterparts in terms of both Matrigel invasion and proliferation. This effect was counteracted by a specific inhibitor of uPA enzymatic activity (WX-340) and by uPAR antisense treatment. The use of both WX-340 and uPAR antisense treatment in vitro showed cooperative effects in RA SFs that were more intense than the effects of either treatment alone. Significant inhibition of cartilage invasion was obtained in vivo with uPAR antisense treatment, while uPA inhibition was inefficient, either alone or in combination with antisense treatment. CONCLUSION: The decrease in uPAR expression in RA SFs reduced invasion of human cartilage in vitro and in the SCID mouse model.
20955087 Small-area variations in sales of TNF inhibitors in Sweden between 2000 and 2009. 2011 Jan OBJECTIVE: To measure small-area variations in sales per capita of tumour necrosis factor (TNF) inhibitors. METHODS: For 2000-2009, sales data on etanercept, infliximab, and adalimumab were retrieved from the Swedish National Corporation of Pharmacies, which keeps data on drugs dispensed in ambulatory care and hospitals. As points of reference, data were retrieved on all drugs, non-biologic treatments for chronic inflammatory disorders (sulfasalazine, methotrexate, azathioprine), and for a biologic used in a different therapeutic area (trastuzumab). As a corollary measure to sales per capita, penetration of biologics in the rheumatoid arthritis (RA) population was calculated using nationwide registers. Small areas were defined as the 21 counties of Sweden. RESULTS: From 2000 to 2009, annual TNF inhibitor sales increased 9-fold from 195 to 1779 million SEK (0.7-5.0% of total drug expenditure). The county variation in sales per capita, initially 6.2-fold (coefficient of variation 42%), decreased to 2.3-fold in 2009 (24%). During the same period, total drug expenditure per capita remained at a 1.2-fold county variation (4-6%). Sales per capita variations of non-biologic treatments against chronic inflammatory diseases ranged from 1.5 to 1.8 (12-16%). For trastuzumab, a 3.2-fold variation (30%) was observed in 2009. At the patient level, there was a 2-fold county variation (from 10% to 21%) in biologic penetration in RA. County-specific sales per capita were associated with mean RA duration (r = -0.52, p = 0.015) and C-reactive protein at treatment initiation (r = -0.49, p = 0.025), while pain was borderline significant (r = -0.43, p = 0.055). CONCLUSIONS: Despite universal access to treatment, substantial but decreasing small-area variations were observed. Although geographic variations are anticipated initially, their persistence calls for investigation of patient equity and treatment appropriateness as counties seem to have different initiation thresholds.
21955641 [Risk factors for fragility fractures in a cohort of Spanish women]. 2011 Nov INTRODUCTION: Fragility fractures are an important public health issue. The aim of this study was to analyze the association of the main osteoporotic risk factors related to fragility fracture in a cohort of women with an indication of bone densitometry (BD). METHODS: A retrospective cohort was followed-up until a fragile fracture occurred, in a population of women aged 40 to 90 years with a first visit for BD between January 1992 and February 2008. We calculated the incidence rate of fracture per 1000 women-years of follow-up, and the hazard ratio (HR) of fragile fracture using a Cox regression model. RESULTS: A total of 49,735 women were studied. The average age of participants was 57.8 years (SD: 8.5). Of these, 3631 women (7.1%) reported a new fragility fracture in post-baseline visits. Risk factors with higher adjusted HR were age ≥ 75 years compared with age < 55 years (HR: 3.8; 95% CI: 3.3-4.4) and having a BC result evaluated as osteoporosis compared to normal (HR: 2.0; 95% CI: 1.8-2.2). A personal history of humerus, hip or vertebral fractures had an adjusted HR of 1.2 (95% CI: 1.1-1.3). CONCLUSIONS: The main risk factors for fragility fracture were advanced age, BD result and a personal history of fracture, although 74% of fractures were detected with a bone mineral density classified as normal or osteopenia. Other relevant factors were rheumatoid arthritis or having received prolonged corticosteroid therapy.
22033211 A fixed-dose combination ibuprofen and famotidine (Duexis). 2011 Oct 31 The FDA has approved Duexis (Horizon), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the H2-receptor antagonist (H2RA) famotidine, for symptomatic relief of osteoarthritis and rheumatoid arthritis and to decrease the risk of developing gastric and duodenal ulcers in patients at risk for NSAID-associated ulcers. Vimovo, a combination of the NSAID naproxen and the proton pump inhibitor (PPI) esomeprazole, is also approved by the FDA for prevention of NSAID-associated gastric ulcers.
23203348 Performance and robustness of penalized and unpenalized methods for genetic prediction of 2013 Feb A central goal of medical genetics is to accurately predict complex disease from genotypes. Here, we present a comprehensive analysis of simulated and real data using lasso and elastic-net penalized support-vector machine models, a mixed-effects linear model, a polygenic score, and unpenalized logistic regression. In simulation, the sparse penalized models achieved lower false-positive rates and higher precision than the other methods for detecting causal SNPs. The common practice of prefiltering SNP lists for subsequent penalized modeling was examined and shown to substantially reduce the ability to recover the causal SNPs. Using genome-wide SNP profiles across eight complex diseases within cross-validation, lasso and elastic-net models achieved substantially better predictive ability in celiac disease, type 1 diabetes, and Crohn's disease, and had equivalent predictive ability in the rest, with the results in celiac disease strongly replicating between independent datasets. We investigated the effect of linkage disequilibrium on the predictive models, showing that the penalized methods leverage this information to their advantage, compared with methods that assume SNP independence. Our findings show that sparse penalized approaches are robust across different disease architectures, producing as good as or better phenotype predictions and variance explained. This has fundamental ramifications for the selection and future development of methods to genetically predict human disease.
22828565 An adult-onset still's disease with autoimmune thyroiditis. 2012 Jul Adult-onset Still's disease is a rare inflammatory disorder of unknown etiology and has same clinical characteristics of the systemic form of juvenile rheumatoid arthritis. A 17 years old white female had arthralgias of multiple joints including small joints of hands. She had fever, rash, hepatosplenomegaly, and CRP-122mg/dl, ESR-91mm in 1st hour. She had also TSH - 6.24μIU/mL, fT3 - 2.1pg/mL, fT4 - 1.36ng/dL and diagnosed as Adult-onset Still's disease with autoimmune thyroiditis. It is an inherited condition and is more common in women than in men.
23061418 Royal jelly acid, 10-hydroxy-trans-2-decenoic acid, as a modulator of the innate immune re 2012 Dec Royal jelly is a food for queen and larvae honeybees. 10-Hydroxy-trans-2-decenoic acid (10H2DA; "royal jelly acid") is the principal lipid component in royal jelly. Several pharmacological activities of 10H2DA have been reported: anti-tumor, anti-biotic, immunomodulatory, estrogenic and neurogenic. We recently revealed an inhibitory effect of 10H2DA in innate immune signals. Despite appreciable advances in studies on innate immune signals after the identification of Toll-like receptors as innate immune receptors, few studies have reported the effect of 10H2DA on innate immune signals. In this review, we focus on recent advances in the evaluation of the biological activities of 10H2DA (especially immunomodulatory activities). We also discuss the molecular mechanisms underpinning these biological activities, which could lead to new therapeutic targets for the treatment of immune disorders.
22177792 Twenty-year survival analysis in total knee arthroplasty by a single surgeon. 2012 Aug Between January 1988 and December 2006, a total of 3014 primary total knee arthroplasties (TKAs) in 2042 patients were performed, and survivorship analysis was performed. Survivorship analysis showed a 10-year survival of 93.8% and a 20-year survival of 70.9%. There was no significant difference in the survival rate according to sex and diagnosis (P = .142 and .443, respectively). The survival rate was higher in the patients older than 60 years (P < .001). The survival rate of Total Condylar IV (TC-IV) was higher than that of Ortholoc (Dow Corning Wright Medical, Arlington, Tenn) (P < .001). Total knee arthroplasty results in satisfactory long-term survival rates. However, the survival rate decreases over time. The risk of requiring revision TKA was related to age and type of implants. Careful consideration is necessary to decide the time for TKA and select type of implants.
21536152 Emerging role for NK cells in the pathogenesis of inflammatory arthropathies. 2011 Aug Natural killer (NK) cells are large, granular lymphocytes devoted to the defense against microbial agents and cancer cells, traditionally recognized as an important arm of the innate immunity, even if more recent data underpin a role also in the responses of acquired immunity. Several studies have led to ascertain that NK cells are involved in the pathogenesis of many immune-mediated diseases, where they may exert both protective and pathogenic roles. In particular, the CD56(bright) NK cell subset, showing immunoregulatory properties, has been found to accumulate in tissue sites of inflammation, such as the skin lesions in psoriatic patients and the synovial membrane in rheumatoid arthritis (RA) patients. In this latter disease, while data on the number of NK cells are still controversial among the different studies, more consensuses exist on the impaired activity of these cells. In another group of inflammatory arthritides, the spondyloarthropathies (SpA), the presence of peculiar allotypes of the killer cell immunoglobulin-like receptors (KIR) superfamily, coding for molecules expressed on NK cells, seems to modulate the susceptibility to this group of diseases, especially ankylosing spondylitis and psoriatic arthritis. Interestingly, in vitro studies showed that NK cells of patients with inflammatory arthropathies might produce pro-inflammatory Th1 cytokines; furthermore, they are involved in bone damage, interact and activate different cell types such as monocytes, dendritic cells and resident fibroblast-like synoviocites cells, thus creating and/or maintaining the inflammatory response. Certainly, these features encourage more research on the role of NK cells in the pathogenesis of inflammatory arthropathies, which could be essential to define potential new therapeutic strategies.
22740051 The Wnt inhibitor secreted Frizzled-Related Protein 1 (sFRP1) promotes human Th17 differen 2012 Oct Wnt/β-catenin signaling plays a crucial role during embryogenesis and tumorigenesis, and in T cells, promotes the differentiation of Th2 cells. However, the role of Wnt signals in the differentiation and maintenance of human Th17 cells remains poorly understood. We found that the higher levels of IL-17 in the synovial fluid of rheumatoid arthritis (RA) patients compared with that of osteoarthritis (OA) patients were associated with a higher concentration of sFRP1 (secreted Frizzled-Related Protein 1), an inhibitor of the Wnt/β-catenin pathway. The addition of sFRP1 during TCR-mediated stimulation induced a significant increase in IL-17 production by both naïve and memory CD4(+) T cells. Moreover, under Th17-differentiation conditions, the addition of sFRP1 significantly reduced the requirement for TGF-β. Mechanistically, we observed that sFRP1 significantly enhanced the phosphorylation of Smad2/3 in CD4(+) T cells upon TGF-β stimulation and that blocking TGF-β signaling abolished the Th17-promoting activity of sFRP1. Our findings reveal a novel function for sFRP1 as a potent inducer of human Th17-cell differentiation. Consequently, sFRP1 may represent a promising target for the treatment of Th17-mediated disease in humans.
21406456 Fcγ receptor profile of monocytes and macrophages from rheumatoid arthritis patients and 2011 Jun OBJECTIVE: To analyse Fcγ receptor (FcγR) expression on monocytes and macrophages from rheumatoid arthritis (RA) patients versus healthy controls (HC), and to compare their responses to immune complexes containing RA-specific anti-citrullinated proteins auto antibodies (ACPA). METHODS: Monocytes and monocyte-derived macrophages were obtained from the peripheral blood of 34 RA patients and 69 HC. FcγR expression was studied by flow cytometry. Cells were stimulated with ACPA-containing immune complexes, and tumour necrosis factor alpha (TNFα) was assayed in culture supernatants. RESULTS: Variations distinguished RA from HC monocytes, corresponding to a 5% and 6% decrease in the percentages of monocytes expressing FcγRI and FcγRII, respectively, and a 7% increase in the proportion of FcγRIII-positive monocytes. Although in both HC and RA patients macrophage differentiation was accompanied by a dramatic increase in the percentage of FcγRIII-expressing cells (72% vs 74.5%), the parallel decline in the proportion of FcγRI-positive cells was markedly smaller in RA (7% vs 43%). Monocytes and macrophages from patients were responsive to ACPA-containing immune complexes but TNFα production in both cell types neither differed from that observed with the corresponding cells from HC, nor correlated with FcγR expression or clinical or biological data. In RA as in HC, ACPA-containing immune complexes induced secretions of more TNFα in macrophages than in paired monocytes (ninefold). Finally, the proinflammatory potential of ACPA-containing immune complexes was confirmed in CD14-positive monocyte macrophages from the synovial fluid of four RA patients. CONCLUSIONS: ACPA-containing immune complexes induce TNFα secretion by blood and synovial fluid-derived macrophages from RA patients, fitting with their probable involvement in RA pathophysiology.
22990378 The cost-effectiveness of TNF-inhibitors for the treatment of rheumatoid arthritis in Swed 2013 Dec OBJECTIVE: The objective was to estimate the cost-effectiveness of TNF-inhibitors for the treatment of rheumatoid arthritis in Swedish clinical practice, both as a first and second biological treatment, with or without the combination of conventional DMARDs. Further sub-group analysis of etanercept treatment was performed. METHODS AND MATERIALS: Patient level data were obtained from three regions of the Swedish Rheumatology Registers. The dataset contained 2,558 patients who had started TNF-inhibitor treatment, 1,049 with etanercept as their first biological treatment. A total of 819 patients had switched to a second TNF-inhibitor, of which 425 to etanercept. A Markov cohort model was used in which health states of disease severity were classified according to HAQ and DAS28. Disease progression and discontinuation rates of TNF-inhibitors were based on the registry and for the comparator on published literature. Mortality, costs and utilities were based on Swedish data. The main analysis had a societal perspective over 20 years and efficacy was measured in quality-adjusted life-years (QALYs). RESULTS: TNF-inhibitor treatment was associated with an increase in QALYs and an incremental cost compared to no biological treatment. The cost per QALY gained with the three TNF-inhibitors ranged from euro 50,000 to euro 120,000, with lower estimates for TNF-inhibitors used in combination with MTX and as a first biologic. At a progression of 0.045 for the comparator, most values remain within the accepted range for cost-effectiveness. CONCLUSIONS: These results demonstrate that the cost per QALY for TNF-inhibitors was higher than in previous assessments based on registry data and that the results were sensitive to the HAQ progression of the comparator.
22763150 Efficacy of leflunomide 100mg weekly compared to low dose methotrexate in patients with ac 2012 Sep OBJECTIVE: To determine the clinical efficacy and safety of Leflunomide (LFN) 100 mg/week compared to low dose Methotrexate (MTX) 10 mg/week in a double-blind, randomized, controlled trial with 52 weeks of follow up in Rheumatoid Arthritis (RA) patients. PATIENTS AND METHODS: Patients who met ARC1987 criteria for RA were included. All patients had medical records, including laboratory tests and hand X-rays. Clinical evaluations for improvement and ACR and EULAR response criteria were performed. Statistical analysis for independent's samples between both groups defined a P value of ≤.05. Safety was evaluated by comparing the proportion of adverse events (AE) registered. RESULTS: Of 90 patients screened; five were withdrawn; the remaining 85 patients were randomised: 43 LFN and 42 MTX. Sixty-three patients completed the study; 72% in the LFN group and 74.4% in the MTX group. ACR20 improvement criteria were achieved by LFN group in 90.3%, and in MTX 78.1% (P=.14) at week 52. EULAR improvement criteria applied at the end point showed a DAS28 score for the LFN group of 3.45, and for the MTX group was 3.67(P=.43). Total withdrawals, including loss during follow up, AE and lack of efficacy for each group was 12 patients in the LFN group, and 10 patients in the MTX group. Regarding safety, no serious AE of a life threatening nature were reported. CONCLUSIONS: These outcomes confirm that LFN 100 mg/week offers an adequate and sustained improvement effect on the clinical manifestations of RA, similar to low dose treatment with MTX 10 mg/every week after 52 weeks of follow up; it may be a good therapeutic option alone or in combination with others anti-rheumatic drugs.