These data confirm that 1,25(OH)2D3 and its analogs are potent dose-reducing drugs for other immunomodulators, making them potentially interesting for clinical use in autoimmunity and transplantation.
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Leflunomide is an immunosuppressant drug used in rheumatoid arthritis and psoriatic arthritis. This product may cause rare but serious interstitial lung disease that appear at the beginning of treatment. This is why leflunomide should be prescribed and monitored in hospital. We present the case of a 71 years old woman who presented a pleuro-pericarditis with an increase of CA 125 during a treatment with leflunomide. This is the second case reported in the literature. The outcome was favorable after discontinuation of leflunomide.
In a subset of patients who continued treatment long term, leflunomide treatment reduced the rate of radiographic damage.
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No relevant studies were identified.
This study included individuals enrolled in the Early Arthritis inception cohort at the Royal Adelaide Hospital between 2000 and 2013 who received leflunomide. A time-to-event model in nonmem was used to describe the time until leflunomide cessation and the influence of teriflunomide exposure and pharmacogenetic variants. Random censoring of individuals was simultaneously described. The clinical relevance of significant covariates was visualized via simulation.
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The Mediterranean region is vulnerable to climatic changes. A warming trend exists in the basin with changes in rainfall patterns. It is expected that vector-borne diseases (VBD) in the region will be influenced by climate change since weather conditions influence their emergence. For some diseases (i.e., West Nile virus) the linkage between emergence andclimate change was recently proved; for others (such as dengue) the risk for local transmission is real. Consequently, adaptation and preparation for changing patterns of VBD distribution is crucial in the Mediterranean basin. We analyzed six representative Mediterranean countries and found that they have started to prepare for this threat, but the preparation levels among them differ, and policy mechanisms are limited and basic. Furthermore, cross-border cooperation is not stable and depends on international frameworks. The Mediterranean countries should improve their adaptation plans, and develop more cross-sectoral, multidisciplinary and participatory approaches. In addition, based on experience from existing local networks in advancing national legislation and trans-border cooperation, we outline recommendations for a regional cooperation framework. We suggest that a stable and neutral framework is required, and that it should address the characteristics and needs of African, Asian and European countries around the Mediterranean in order to ensure participation. Such a regional framework is essential to reduce the risk of VBD transmission, since the vectors of infectious diseases know no political borders.
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After leflunomide therapy for an average of 4.6months, serum uric acid concentrations had significantly decreased compared to baseline concentrations (p<0.001). Patients treated with a combination of MTX and leflunomide (n=23) showed higher FEUA than those treated with only MTX (n=27) (p=0.007). Differences in serum uric acid concentrations after leflunomide therapy were significantly associated with those in serum creatinine concentrations (B coefficient=3.081, p<0.001), but not with those in acute phase reactants including ESR and CRP.
Good, moderate and non-responder rates were 6.5, 61.8 and 31.5%, respectively. No significant difference was observed between responders and non-responders, regardless of the serum parameters considered. Analysis of dichotomous or continuous variables failed to identify markers predictive of a good or poor response to infliximab.
The present study evaluates the effects of combined leflunomide (LEF) and low dose of prednisone therapy, on selected inflammatory gene expression in peripheral blood mononuclear cells (PBMCs) of early rheumatoid arthritis (ERA) patients by gene microarray analysis and quantitative real time-polymerase chain reaction (qRT-PCR).
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Although conventional radiology is still the gold standard for the evaluation of disease progression in RA, newer techniques are increasingly studied. In particular, standardization of echographic and MRI imaging of the joints is in progress.
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Complete randomized controlled trials research. Lewis rats were immunized with interphotoreceptor retinoid-binding peptide (IRBP) in order to build the model of EAU. Rats were randomized assigned into four groups, that is control group as A, model group without leflunomide as B, model group with leflunomide administrations as C, and model group with cyclosporine A as D. Rats in group C received intragastric administration of three doses of leflunomide at 3mg/kg/d; 6mg/kg/d; 12mg/kg/d. Rats in group D received 10 mg/kg cyclosporin A were considered as a positive control. Each group has 6 to 8 rats. At the second day of immunization with IRBP, rats were intragastric administrated one time every day till day 13. Rats were investigated for EAU symptoms under slit lamp. Enucleated eyes were collected for sections with HE staining as histopathological evidences at the peak point of disease activity day 14. Treatment effectiveness was evaluated referred by Agarwal standard for clinical EAU and histopathological scoring. The expression of IL-17 in ocular sections was detected by immunohistochemistry (SP method). The expression levels of IL-17 and IFN-γ in the serum were quantified by ELISA. Intracellular expression of IL-17 in the activated CD4+T cells was assessed by flow cytometry. Ocular of rats were harvested and mRNA expression of IL-17 and IFN-γ were quantified through RT-PCR. Continuous variables were reported as mean ± SD. The comparison among groups was done by using analysis of students't test. Nonparametric test was used in Hierarchical data comparison and multiple comparison method was Bonferroni.
To assess the safety and clinical efficacy of leflunomide (LEF) and prednisone on refractory nephrotic syndrome (RNS).
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Antirheumatic drugs can have a negative effect on reproduction in both men and women. Possible negative effects are impairment of fertility, harmful effects on the fetus and adverse effects on the breastfed child. In women non-steroidal antiinflammatory drugs (NSAID) and cyclophosphamide can impair fertility. In men infertility can result from the use of salazopyrine and cyclophosphamide. A desire for children should be taken into account before the start of disease modifying drugs (DMARD). Treatment with NSAID is possible at some stages of pregnancy as well as during lactation. A limited number of DMARD is compatible with pregnancy and is presented. Cytostatic drugs and leflunomide must be prophylactically withdrawn before a planned pregnancy. TNF alpha antagonists should be discontinued at the start of pregnancy. Safe birth control must be practised during therapy with drugs that are gonadotoxic or teratogenic. Treatment with immunosuppressive drugs during lactation is limited because of insufficient documentation of safety for the breastfed child.
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To determine the risk of severe infection requiring or complicating hospitalization associated with leflunomide therapy in patients with rheumatoid arthritis (RA).
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Review of the literature in order to present the current relevant clinical documentation of the drug.
Introducción: la infección por citomegalovirus (CMV) es una de las complicaciones más habituales en pacientes trasplantados, que puede desembocar en un fallo multiorgánico. El 80-90% de los pacientes se cura con el tratamiento estándar intravenoso (ganciclovir), o su profármaco oral (valganciclovir). En caso de no responder a ellos existe como alternativa otro antivírico, foscarnet. Un pequeño número de pacientes tampoco responden a este, teniendo un mal pronóstico. Objetivo: describir el caso de una paciente con trasplante bipulmonar por fibrosis quística y recidiva de infección por CMV en la cual el uso de leflunomida consigue disminuir e incluso llegar a niveles indetectables de la carga viral. Descripción del caso: mujer de 22 años, trasplantada bipulmonar por fibrosis quística en marzo del 2014. Las serologías de CMV realizadas fueron positivas en el donante y negativas en el receptor. Los controles de la carga viral durante la profilaxis con valganciclovir fueron negativos en el receptor hasta el sexto mes después del trasplante, momento en el que se detectó carga viral en los controles (2.090 UI/ml). La paciente ingresó en nuestro hospital para recibir tratamiento intravenoso con ganciclovir, persistiendo la carga viral positiva (42.400 UI/ml) al mes del inicio con esta terapia intravenosa. Un estudio de resistencias mostró que era resistente a ganciclovir, y por ello se inició tratamiento con foscarnet intravenoso. Con este fármaco se consiguió negativizar la carga viral, por lo que se suspendió el tratamiento, continuándose con controles quincenales de la carga viral. A los dos meses sin tratamiento se observó un aumento de la carga viral hasta 13.665 UI/ml, motivo por el cual se solicitó al Servicio de Farmacia el uso fuera de ficha técnica de leflunomida, con la intención de que la paciente recibiera terapia oral en lugar de intravenosa. La paciente fue tratada con valganciclovir hasta disponer de la autorización de uso de leflunomida, aunque sin respuesta, ya que en marzo del 2015, al inicio del tratamiento con leflunomida, la paciente presentaba una carga viral de 17.344 UI/ml. La pauta inicial fue de 100 mg de leflunomida al día durante los cinco primeros días, seguida de 20 mg cada 12 horas. A los quince días de tratamiento la carga viral había disminuido hasta 531 UI/ml, volviéndose indetectable antes del mes. Después de cuatro meses de tratamiento, la paciente mantiene la carga viral indetectable sin presentar ningún efecto adverso asociado al mismo. Conclusión: nuestro caso es un ejemplo en el que el uso de leflunomida en infección por CMV resistentes a otras terapias es una alternativa eficaz y conveniente para los pacientes, ya que mantiene indetectable la carga viral con una terapia oral, sin necesidad de ingresar en el hospital para tratamiento intravenoso.
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We assessed the immunomodulatory effect of leflunomide (LEF) in a heterotopic abdominal model of rat heart transplantation using a major histocompatibility mismatch (DA X LEW). The endpoint of this study was cardiac rejection assessed by abdominal palpation of the ventricular impulse and confirmed by laparotomy and histology. In this study, LF was investigated using four dosages (5, 10, 20 and 30 mg/kg per day orally) against cyclosporine (CsA) (15 mg/kg per day orally) and FK 506 (1 mg/kg per day orally). The ability of LEF to prevent rejection and reverse ongoing acute rejection was assessed. The results showed that untreated hearts were fully rejected by day 5 and that LEF at 5 mg/kg was significantly better than any other dose tested, was superior to FK 1 mg/kg, and was as effective as CsA 15 mg/kg in preventing rejection after a short course of treatment. After a longer course, 10 and 20 mg/kg LEF proved more effective than 5 mg/kg in controlling rejection and as efficacious as 1 mg/kg FK and 15 mg/kg CsA. In the control of ongoing established early rejection. LEF proved to be equally effective, even at lower doses (5 mg/kg), to CsA 15 mg/kg and FK 1 mg/kg. In the control of ongoing established late rejection, 20 mg/kg LEF proved to be superior to 10 mg/kg LEF and 15 mg/kg CsA, and was as effective as FK 1 mg/kg. However, when higher doses of CsA (25 mg/kg) and FK (2 mg/kg) were tested against 20 mg/kg LEF in this mode of rescue, LEF proved as effective as CsA and superior to FK. In the assessment of drug toxicity using body weight as a parameter, 20 mg/kg LEF proved safer than any other LEF dose tested, and safer than 15 mg/kg CsA and 1 mg/kg FK in both short- and long term administration. We conclude that LEF is a relatively safe and potent immunosuppressant with promising clinical potential.
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Based on some structural analogies with leflunomide and brequinar, two well-known inhibitors of dihydroorotate dehydrogenase (DHODH), a new series of products was designed, by joining the substituted biphenyl moiety to the 4-hydroxy-1,2,5-oxadiazol-3-yl scaffold through an amide bridge. The compounds were studied for their DHODH inhibitory activity on rat liver mitochondrial/microsomal membranes. The activity was found to be closely dependent on the substitution pattern at the biphenyl system; the most potent products were those bearing two or four fluorine atoms at the phenyl adjacent to the oxadiazole ring. A molecular modeling study suggested that these structures might have a brequinar-like binding mode. The greater potency of fluorinated analogs may depend partly on enhanced interactions with the hydrophobic ubiquinone channel, and partly on the role of fluorine in stabilizing the putative bioactive conformation.
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To compare the impact of leflunomide on resource utilization and costs relative to that of etanercept and infliximab among patients with rheumatoid arthritis (RA) in a managed care setting.
After treatment the numbers of joint tenderness, numbers of joint swelling, VAS scores, ESR, CRP, and RF all decreased, showing statistical difference when compared with those before treatment (P < 0.05). The morning stiffness time was shortened in the heat-dampness blocking collateral type, cold-dampness blocking collateral type, and stagnant blood blocking collateral type, showing statistical difference (P < 0.05). Of them, the numbers of joint tenderness, the numbers of joint swelling, the morning stiffness time, RF, VAS scores, and the improvement of the total effective rate were obviously better in the heat-dampness blocking collateral type, cold-dampness blocking collateral type, and stagnant blood blocking collateral type than in the Shen-qi deficiency cold type and Gan-Shen yin deficiency type, showing statistical difference (P < 0.05).
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Sixty-one (1.2%) of 5054 RA patients who received LEF were reported to have development and/or exacerbation of ILD as an adverse drug reaction to LEF, judged by the attending physicians. Multivariable logistic regression analysis identified pre-existing ILD [odds ratio (OR) 8.17; 95% CI 4.63, 14.4], cigarette smoking (3.12; 95% CI 1.73, 5.60), a low body weight (<40 kg vs >50 kg) (2.91; 95% CI 1.15, 7.37) and the use of a loading dose (3.97; 95% CI 1.22, 12.9) as independent risk factors for LEF-induced ILD.
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We included 78 women (88%) and 10 men. The age was 51.3 ± 12.4 years, and the evolution of disease was 8 ± 6.8 years. Patients had active disease, which was indicated by a median of IQR of 10.0 (7.0-13.0) for swollen and of 14.0 (18.0-10.0) for tender joints for the whole group. The ACR responses achieved at week 24 were: ACR20: 76.0%; ACR50: 67.1%; ACR70: 23.9%. There was improvement in the activity of disease: DAS-28 score: 5.8 ± 1.2 at baseline vs. 3.8 ± 1.6 at week 24 (P = 0.000). The most significant adverse event was elevation of transaminases in eight patients (26%). Eight patients were withdrawn due to adverse events: four due to the elevation of transaminases, and one each due to diabetes insipidus, rash, diabetes mellitus and osteomuscular pain.
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The records were reviewed from all patients treated at a tertiary sarcoidosis center from July 2002-July 2003, and information from patients treated with either leflunomide or methotrexate was analyzed for efficacy and toxicity.