Comparative study of the clinical efficacy of four dmards (leflunomide, methotrexate, cyclosporine, and levamisole) in patients with rheumatoid arthritis

Popovic, M; Stefanović, D; Pejnović, Nada; Popović, R; Glisic, B; Obradovic, Slobodan; Dimitrijevic, M

doi:10.1016/s0041-1345(98)01370-0

Cited by 23 publications

(21 citation statements)

References 5 publications

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“…Efficacy ranging from 50 to 87% with monotherapy using various assessment criteria, have been observed in studies in different situations to date, irrespective of the absence of the loading dose. [5][6][7][11][12][13][14][15][16][17] Hematological and biochemical parameters showed no significant change. Few patients had liver enzyme elevation, though it did not reach significance and only one had to discontinue.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of leflunomide alone and in combination with methotrexate in the treatment of refractory rheumatoid arthritis

Antony¹,

Vm²,

Paul³

et al. 2006

Indian J Med Sci

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BACKGROUND: Rheumatoid arthritis patients who develop refractoriness are left with no alternatives other than leflunomide and costly biological response modifiers. Leflunomide, though effective, was associated with adverse events and has not been extensively studied in the Indian population. AIMS: Determination of safety and efficacy of leflunomide alone and if not useful, in combination with methotrexate in patients refractory to conventional disease-modifying agents. SETTING AND DESIGN: Open labeled clinical trial with leflunomide [100 mg, OD x 3 days followed by 20 mg, OD x 6 months], if no improvement at three months, combined with methotrexate [5-7.5 mg, OD x 3 months] at a tertiary care hospital. MATERIALS AND METHODS: The primary endpoint in the improvement in EULAR criteria and secondary endpoints were patient and physician global evaluation, incidence of remission and biochemical and clinical adverse events. STATISTICAL ANALYSIS: Chi square test or Fisher 's exact test and parametric and non-parametric repeat measure ANOVA were used for analysis. RESULTS: Among 84 patients who were included in the study, leflunomide showed improvement and remission in 52 [62%] and 6 [7%] in six months, by intention to treat analysis. Adverse events were observed in 15, discontinuation in 5 and 24 dropped out. With combination in 11 patients, there was improvement and remission in nine [91%] and one [9%] after three months. Adverse events were observed in six and one discontinued. CONCLUSIONS: If regular monitoring of hepatic function and hematological parameters are performed, leflunomide is an effective and safe drug in the Indian population in resistant rheumatoid arthritis patients, especially if used alone.

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Section: Discussionmentioning

confidence: 99%

“…[5][6][7][11][12][13][14][15][16] though incidence of adverse events, especially hepatotoxicity, was high. [7,15,17,19] decrease in red, white and platelet cell counts, probably due to marrow toxicity.…”

Section: Referencesmentioning

confidence: 97%

Efficacy and safety of leflunomide alone and in combination with methotrexate in the treatment of refractory rheumatoid arthritis

Antony¹,

Vm²,

Paul³

et al. 2006

Indian J Med Sci

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“…La dosis usual es de 20 mg/día o 100 mg/semana para los pacientes con esta patología; su uso se soporta en publicaciones y guías de manejo internacionales [11][12][13][14][15] .…”

Section: Introductionunclassified

Nephritis Tubule Interstitial for Leflunomide

Hurtado¹,

Silva

Santacruz

2016

RCN

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ResumenLa asociación entre compromiso renal como nefritis túbulo intersticial y el uso de leflunomide no está descrito en la literatura, pues en la medida en que este medicamento no es reconocido como nefrotóxico, no se realiza seguimiento de la función renal bajo su uso. Presentamos el caso de una paciente que ingresó al Hospital Universitario Clínica San Rafael por síntomas clínicos inespecíficos y deterioro rápido de la función renal. Tras descartar las principales causas fue llevada a biopsia renal, y se comprobó la presencia de nefritis túbulo intersticial severa. En ese momento el único agente exposicional era leflunomida. Con posterioridad a la suspensión del medicamento se evidenció la recuperación completa de la función renal. Es nuestra intención exponer este caso con el fin de llamar la atención sobre la relación entre el uso de leflunomida y nefrotoxicidad, y de tal forma promover la documentación de casos similares.Palabras clave: Nefritis túbulo intersticial, leflunomida.http://doi.org/10.22265/acnef.3.2.229 AbstractThe link between renal Tubule Interstitial Nephritis and the use of Leflunomide has not been described in the literature yet, this drug is not recognized as a nephrotoxic; therefore tracking renal function is not usually performed. We report the case of a patient admitted to the University Hospital of Clinic San Rafael by non-specific clinical symptoms and rapid deterioration of renal function. After ruling out the usual causes, we performed a renal biopsy, documenting the presence of severe tubule interstitial nephritis. By the time the use of Leflunomide was the only unusual precedent. After we suspended the treatment, the patient showed full recovery of the renal function. It is our intention to describe this case to highlight the connection between renal Tubule Interstitial Nephritis and the use of Leflunomide in order to promote keeping track of similar cases.

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“…Although the combination was generally well-tolerated, there was a noted increase in the number of patients in the combination group with elevated liver enzymes, albeit reversible. Currently, LEF is only approved for use in the treatment of rheumatoid arthritis, although it has been demonstrated to evoke significant immunosuppressant activity in preclinical trails or organ transplantation [64][65][66][67][68].…”

Section: Clinical Applicationmentioning

confidence: 99%

New Immunosuppressants: Immunosuppression and Immunomodulation

Ma¹,

Ouyang²,

Chen

2005

MCRO

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Immunosuppressive therapy can be used to prevent graft rejection and to treat autoimmune diseases. Recent advances in the understanding of this immune response have focused on the development of new immunosuppressive medications and new approaches to induction of immunological tolerance and reduction of late graft losses. In this overview, preclinical and clinical studies of the new immunosuppressive agents and their analogs are reviewed from the discovery of cyclosporine. More recently, certain classical immunosuppressants tacrolimus and sirolimus were well used to prevent acute rejection of transplanted organs and to ensure long-term survival of the allografts. However, some immunosuppressants have specific and significant toxic effects, so that drug combination therapy has been of great interest in addition to the introduction of novel small molecule agents, including mycophenolate mofetil; sirolimus analogs, SDZ RAD; 15-deoxyspergualin (DSG) and its analogs, FTY720; malononitrilamide analogs, FK778 and leflunimide; Sanglifehrins A; PG490-88; FK330 and 4-amino-analog of tetrahydrobiopterin of nitric oxide synthase inhibitors; genistein, baohuoside-1 and apigenin of flavonoid family; Prostaglandin E2; CYP3A4, CYP3A5, and P-glycoprotein; vitamin E analogs, α-tocopheryl (PEG-1000) succinate (TPGS). A newer immunomodulation concept and their new drugs will also be described.

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Comparative study of the clinical efficacy of four dmards (leflunomide, methotrexate, cyclosporine, and levamisole) in patients with rheumatoid arthritis

Cited by 23 publications

References 5 publications

Efficacy and safety of leflunomide alone and in combination with methotrexate in the treatment of refractory rheumatoid arthritis

Efficacy and safety of leflunomide alone and in combination with methotrexate in the treatment of refractory rheumatoid arthritis

Nephritis Tubule Interstitial for Leflunomide

New Immunosuppressants: Immunosuppression and Immunomodulation

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