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Leflunomide, an inhibitor of the dihydroorotase dehydrogenase and thereby pyrimidine synthesis, was introduced and licensed for the treatment of rheumatoid arthritis in 1998. In the following years, its antiviral properties were discovered and the drug was used in solid organ transplantation for polyomavirus type BK or cytomegalovirus infection. Owing to its long half-life and weak interaction with the cytochrome system, special considerations apply in the use of this drug. This article summarizes the clinical experience with leflunomide in rheumatology and in the evolving field of transplantation.
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Reduction of serum urate and phosphate levels has been observed in patients receiving leflunomide therapy, but the mechanism for such changes has not been evaluated. Thirty-eight patients with rheumatoid arthritis who began leflunomide were studied. Serum urate, creatinine, and phosphate, and 24-hour uric acid, creatinine, and phosphate were measured before, during, and in some instances after leflunomide treatment. Clearances of urate and creatinine, fractional excretion of urate, and tubular reabsorption of phosphate were calculated. Undissociated urinary uric acid was estimated with a nomogram. Twelve patients gave consent to withdraw leflunomide treatment of a 2-week period and underwent a third study. Decreases in serum urate and phosphate levels were observed, with parallel increases in clearances of urate and in fractional excretion of urate, and a reduction in tubular reabsorption of phosphate. Clearances of creatinine and undissociated urinary uric acid remained unchanged. Two weeks after withdrawing the drug, a partial return toward baseline values was observed, but residual changes were apparent. No case of clinical gout was observed. Leflunomide enhances urate and phosphate loss, an effect that partially persisted after 2-week withdrawal. The long-term effect of mild phosphate wasting warrants further investigation. The urate-lowering effect of leflunomide may be useful in monitoring compliance in leflunomide therapy.
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To estimate the association between exposure to medicinal products and Raynaud phenomenon.
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The study included 3128 patients, mean age 50.26±14.54 years; 46.2% male. During a period of 20 096 person-years 182 HZ events were observed. The crude IR (95% CI) of HZ in the study population was 9.06 per 1000 patient-years, and in Groups A-D 7.36 (5.41 to 9.79), 9.21 (7.5 to 11.21), 8.64 (4.84 to 14.26), 17.86 (10.91 to 27.58), respectively. In a multivariate analysis, age (HR 1.01, 95% CI 1.00 to 1.02), treatment with steroids (HR 1.08, 95% CI 1.04 to 1.13), and a combination of anti-TNF-α agents and c-DMARDs (HR 2.37, 95% CI 1.32 to 4.22) were significantly associated with HZ events.
Spontaneous reports of interstitial lung disease (ILD) in patients with rheumatoid arthritis (RA) treated with leflunomide, a disease-modifying antirheumatic drug (DMARD), have been appearing recently. To assess this risk, we conducted a population-based epidemiologic study.
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Kimura's disease (KD) is a rare, benign, chronic inflammatory disease which typically presents as persisting or recurring tumor-like lesions in the head and neck area that can be easily misdiagnosed. We report one patient with KD treated with leflunomide in combination with glucocorticoids and analyzed the literature on treatment of KD. The patient had a recurrent mass in the left upper arm with eosinophilia and elevated serum IgE but no renal involvement. The clinical manifestations improved markedly within 1 month, and blood eosinophil count and serum IgE normalized. Corticosteroids were then tapered gradually without recurrence or severe side effects in the 2-year follow-up period. Literature analysis identified four different non-drug interventions and 18 different drugs for treating KD, most of which were obtained from case reports. Our use of combination therapy of leflunomide and glucocorticoids suggests the need for a controlled trial for the treatment of this rare disorder.
Multiple antituberculous drugs, with supportive and immune-enhancing therapies cured the patient.
The search for soluble markers in RA patients' sera likely to predict response to infliximab because of their involvement in RA pathogenesis seems disappointing. However, because of the limited power to detect smaller differences in biomarkers, the present study is a preliminary exploratory analysis.
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The CW system was designed to dispose of municipal and agricultural wastes in a way that not merely reduces pollution, but adds to environmental quality by creating accessible parkland for local residents and tourists. Several factors affected the performance of the system at the initial stages of operation: ecological balance between microbes and plants, big seasonal variations, seepage and evaporation reduced the flow in the initial operation of the system. Despite the initial difficulties, the quality of water coming out the system is acceptable for irrigation.
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In the past decade, there has been enormous progress in the understanding of the pathomechanisms of immune-mediated diseases, which has led to major advances in immunotherapeutic strategies. As a consequence, the armamentarium of specific and nonspecific immune-modulating and immunosuppressive drugs for the treatment of skin diseases has been widely extended. Among the nonspecific immunomodulators, mycophenolate mofetil and leflunomide show promising effects in a variety of autoimmune and inflammatory skin disorders. Both compounds inhibit a key enzyme in nucleotide biosynthesis, a step that is pivotal for the production of cytotoxic T cells and antibody formation. They do not act in the nucleus, which may explain their advantageous side-effect profile.
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To describe therapies with disease modifying antirheumatic drugs (DMARD) and biological agents in patients with early rheumatoid arthritis (RA) who were receiving routine clinical care in 2001 in a private practice of 5 rheumatologists in Nashville, TN, USA.
A total of 280 patients with verified RA underwent computerized semi-automated measurements of joint space distance at the finger articulations based on radiographs. The Z-Score, which can differentiate between joint space alterations caused by RA versus age/gender-related changes, was calculated as a comparative parameter. The severity of joint space narrowing was also quantified by the Sharp Score. Sensitivity and specificity of the Z-Score (based on joint space widths differentiated for each peripheral finger joint) were evaluated to reveal the potential for the occurrence of erosions. Additionally, the potential of the Z-Score regarding the differentiation of therapeutic effects on joint space widths in patients under a therapy of methotrexate versus leflunomide was performed.
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Many but not all RA medications may be used during lactation with low risk to the nursing infant; this review summarizes the available data for commonly used medications in order to help guide therapy during the postpartum period.
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These studies reveal that the blood levels of A77 1726 in Lewis rats satisfy in vitro requirements for both inhibition of de novo pyrimidine synthesis and protein tyrosine kinase activity. Our data also illustrate that the in vivo mechanism of immunosuppression by leflunomide is complex and is affected by at least the following four factors: type and vigor of the immune response, availability of uridine for salvage by proliferating lymphocytes, species being investigated, and concentration of serum A77 1726.
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Oral administration of leflunomide effectively suppressed IRBP-induced uveitis in rats, not only reduced exudation in iris but also alleviated the infiltration damage of inflammation cells in fundus. It might be ascribed to the effect that leflunomide could treat inflammation by down-regulating the expressions of IL-17 and IFN-γ. Therefore, it suggested that leflunomide had protective effects against EAU in Lewis rats.
Leflunomide is a new immunosuppressive medicine that has been effectively used in the therapy of rheumatoid arthritis and subsequently used with success in animal models and patients with systemic lupus erythematosus (SLE). However, its use has also been associated with significant and serious adverse reactions involving hematological, hepatic, immune, dermatological and respiratory systems. In the current review, we attempt to describe the two sides of this drug in the treatment of SLE.
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Leflunomide appears to be promising as adjunctive treatment of BKVAN in renal transplant patients. Due to the lack of controlled randomized trials, however, use of leflunomide as first-line treatment cannot be routinely recommended.
To investigate the effects of leflunomide (LEF) on modulating interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor- alpha (TNF-alpha) production induced by lipopolysaccharide (LPS) in peritoneal macrophages (PMphi) in adjuvant arthritis rats and elucidate the possible mechanisms of antiinflammatory and antirheumatoid effects of LEF.
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Leflunomide is a beneficial agent in the severe form of acute pancreatitis in rats and should be considered as a potential agent for treatment of acute pancreatitis.
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Mast cells release many inflammatory mediators that play an important role not only in allergic diseases but also in chronic inflammatory diseases, autoimmune diseases, and others. A lot of mast cells exist in synovium of rheumatoid arthritis, and it is known that synovitis does not occur in mast cell-deficient mice. Thus, it is thought that mast cells play a very important role in rheumatoid arthritis pathogenesis. Leflunomide is a drug used clinically in the treatment of rheumatoid arthritis. We used clinical doses of 2-cyano-3-hydroxy-N-(4-trifluoromethylphenyl)-butenamide (A77 1726), which is an active metabolite of leflunomide, and decreased the number of viable human primary mast cells in a concentration-dependent manner. This decrease was not reversed by uridine. Inhibition of pyrimidine synthesis by dihydro-orotic acid dehydrogenase inhibition, which is the primary mechanism of action of A77 1726, was not involved. A77 1726 dramatically induced apoptosis of human mast cells and inhibited the phosphorylation of Akt, an important survival signal of mast cells, in a concentration-dependent manner. Caspases 3 and 9, downstream molecules of Akt survival pathway, were also fragmented by A77 1726. In addition, it became evident for the first time that the mechanism involved in this result was the concentration-dependent inhibition of PDK1 phosphorylation, which controls the activation of Akt. These results indicate a new way of controlling mast cells and may therefore be the basis for innovative approaches to the treatment of various diseases related to mast cells.
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Using data from a proprietary database of pharmacy and medical claims for 75 U.S. health plans, RA patients newly treated with infliximab between June 2000 and June 2002 were selected and assigned an .index date. based on the first infusion. A pretreatment period of 6 months was created; patients were also followed for a minimum of 6 months after the initial infusion. Follow-up was allowed to vary beyond this minimum 6 months in order to preserve all available patient data. A maintenance number of infliximab vials was determined as of the second infusion; patients with 1 subsequent increase in vials used or 2 intervals between infusions of <49 days were considered to have had an upward dose adjustment. Differences (i.e., between those with upward dose adjustment and those with no upward dose) in patient characteristics were examined using descriptive statistics. In addition, time to upward dose adjustment and factors influencing its likelihood were analyzed using Kaplan-Meier and Cox proportional hazards techniques. Finally, differences in RA-related and unrelated costs (medication, outpatient, inpatient, and total, expressed in 2003 dollars) were examined using Wilcoxon rank-sum tests and were also stratified by a number of patient characteristics found to differ between the 2 groups.
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Leflunomide is an antirheumatic drug. One of its main features is its ability to inhibit de novo pyrimidine ribonucleotide biosynthesis. It has been reported as an effective drug in the treatment of patients with Rheumatoid Arthritis. Recently pilot studies have demonstrated the benefit of leflunomide in systemic lupus erythematosus patients. Herein we describe the successful treatment of two lupus patients with leflunomide and review the current literature.
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Autoimmune diseases make up a large proportion of chronic disease care. Inducing remission by immunosuppression remains the cornerstone of long-term management. This article reviews the place of leflunomide in clinical practice and outlines its potential applications beyond its licenced indication, rheumatoid arthritis.
BK virus nephropathy is emerging at an alarming rate and requires increasing awareness. The uses of current treatment options are still questionable. Our audit confirms that reducing immunosuppression appears to be the criterian standard for the treatment of BK nephropathy.
Leflunomide is a new immunomodulatory agent by selectively inhibiting the de novo pyrimidine synthesis. Its active metabolite (A77 1726) is highly bound to plasma protein and has a long half life. Through several large trials describing its efficacy and safety including retardation of radiographic progression in comparison with both sulfasalazine and methotrexate and with placebo have been published in Europe and the United States, leflunomide was shown to improve primary and secondary outcome measures with satisfactory safety profile. The most common treatment-related adverse reactions were diarrhea, nausea, and abnormal plasma liver enzyme levels. Leflunomide may be a useful addition to the current management of rheumatoid arthritis.
The dehydro-orotate dehydrogenase inhibitor leflunomide is used for the treatment of rheumatoid arthritis. In the present study, its influence on host resistance to Candida albicans infection in mice with collagen-induced arthritis (CIA) was investigated. Leflunomide administered at a dose of 5 mg/kg for 5 consecutive days in mice with CIA inhibited collagen-specific cellular and humoral responses. The drug did not change the severity of primary C. albicans infection evaluated by kidney and liver colonization. At the early stage of infection leflunomide inhibited IFN-gamma production and enhanced IL-4 secretion. The effect of the drug on IL-4 production was less pronounced at the late phase of infection. Leflunomide enhanced anti-Candida IgM antibody production and diminished anti-Candida IgG antibody synthesis. This correlated with impaired resistance to reinfection. Results demonstrate that leflunomide administration to mice with collagen-induced arthritis might affect mechanisms of the late immune response to C. albicans infection.
Combination of methotrexate and hydroxychloroquine is equivalent to leflunomide in terms of efficacy in reducing disease activity in the initial treatment of severe rheumatoid arthritis.
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Recent evidence indicates that the antimalarial agent artesunate (ART) has immunomodulatory properties that may be useful for treating rheumatoid arthritis (RA). However, the effects of ART on the RA animal model have not been described. The current study aimed to evaluate the antiarthritic effect of ART and explore the potential mechanism on type II collagen-induced arthritis (CIA) in rats. From the day of arthritis onset, rats were treated daily by gavage with leflunomide (Lef) or ART at a dosage of 10 mg/kg/d or 5 mg/kg/d, respectively, for 16 days. The severity of arthritis and levels of pro- and anti-inflammatory cytokines in site were measured. The expression and activity of metalloproteinase (MMP)-2 and MMP-9 were determined. The activation of nuclear factor kappa B and mitogen-activated protein kinase signaling pathways was investigated in rats with CIA and in Raw264.7 cells. Our results showed that ART treatment significantly attenuated inflammation symptoms and prevented cartilage and bone destruction. ART decreased expression of the proinflammatory cytokines interleukin-1β, tumor necrosis factor-α, and interleukin-17α. Both expression and activity of MMP-9 were efficiently inhibited by ART. ART significantly inhibited the degradation of IκB and activation of extracellular signal-regulated kinase and c-Jun N-terminal kinase in rats with CIA and in lipopolysaccharide-stimulated Raw264.7 cells. The present study demonstrated that ART ameliorated rat CIA. The antiarthritic effect might be achieved by inhibiting the action of proinflammatory cytokines and the activity of MMP-9 via suppression of nuclear factor kappa B and mitogen-activated protein kinase signaling pathway. These results show that ART may be used as an adjuvant therapy for patients with RA.
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On average, patients were 47.9 (± 10.4) years of age, mostly female (89.1%) and Hispanic (55.2%). Methotrexate (MTX) and leflunomide (LEF) users took the shortest time to initiate biologic DMARDs (207  days and 188  days, respectively). LEF users had the highest mean adherence of 37.5% (27.5%), which was similar to MTX users (35.7% [26.9%]), whereas dual-therapy users had the lowest mean adherence at 17.1% (14.4%). Sulfasalazine users (108  days) had the lowest persistence, whereas LEF (227  days) and MTX (211  days) users had the longest persistence. Nonbiologic DMARD monotherapy users were more adherent than dual-therapy users (32.6% [25.8%] vs 17.1% [14.4%]).
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Combined antiviral and immunosuppressant therapy can improve the proteinuria in HBV-GN patients without altering HBV replication or damaging liver and renal functions.