Safety and effectiveness of leflunomide in the treatment of patients with active rheumatoid arthritis

Mladenovic, Vlastimir; Domljan, Z; Rozman, B; Jajić, Ivo; Mihajlovic, Dimitrije; Dordevic, Jovan; Popovic, M; Dimitrijevic, M; Živković, Milutin; Campion, G.; Musikic, Predrag; Löw-Friedrich, Iris; Oed, Christine; Seifert, Hildegard; Strand, Vibeke

doi:10.1002/art.1780381111

Cited by 269 publications

(169 citation statements)

References 27 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%

“…Earlier studies have shown liver enzyme elevation, which subsequently normalized. [6,7,[15][16][17] Twenty four (29%) patients dropped out of the study and an adverse event was observed in 15 patients, of which five withdrew. Skin reactions observed were more of type B adverse event, which were unpredictable.…”

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: 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%

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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“…Several randomized controlled clinical trials have established leflunomide as an alternative to MTX as monotherapy, especially for patients who cannot tolerate MTX or are experiencing an inadequate response to MTX (62,63,75,(86)(87)(88)(89). The reduction in RA disease activity and in the rate of radiologic progression achieved by leflunomide appears to be equivalent to that of a modest dosage of MTX.…”

Section: Pharmacologic Treatment Of Ramentioning

confidence: 99%

Guidelines for the management of rheumatoid arthritis: 2002 Update

2002

Arthritis & Rheumatism

1,172

176

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“…In a phase II study (154), 402 patients with active RA were enrolled in a 6-month, multicenter, double-blind comparison of three dose levels of leflunomide (5, 10, or 25 mg) with placebo. Statistically significant improvement in primary and secondary outcome measures occurred in the 10-and 25-mg groups compared to placebo.…”

Section: Leflunomidementioning

confidence: 99%

Update in Internal Medicine

López-Jiménez

Brito

Aude

et al. 2000

Archives of Medical Research

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More than 500,000 new medical articles are published every year and available time to keep updated is scarcer every day. Nowadays, the task of selecting useful, consistent, and relevant information for clinicians is a priority in many major medical journals. This review has the aim of gathering the results of the most important findings in clinical medicine in the last few years. It is focused on results from randomized clinical trials and well-designed observational research. Findings were included preferentially if they showed solid results, and we avoided as much as possible including only preliminary data, or results that included only non-clinical outcomes.Some of the most relevant findings reported here include the significant benefit of statins in patients with coronary artery disease even with mean cholesterol level. It also provides a substantial review of the most significant trials assessing the effectiveness of IIb/IIIa receptor blockers. In gastroenterology many advances have been made in the H. pylori eradication, and the finding that the cure of H. pylori infection may be followed by gastroesophageal reflux disease. Some new antivirals have shown encouraging results in patients with chronic hepatitis. In the infectious disease arena, the late breaking trials in anti-retroviral disease are discussed, as well as the new trends regarding antibiotic resistance. This review approaches also the role of leukotriene modifiers in the treatment of asthma and discusses the benefit of using methylprednisolone in patients with adult respiratory distress syndrome, among many other advances in internal medicine.

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Safety and effectiveness of leflunomide in the treatment of patients with active rheumatoid arthritis

Cited by 269 publications

References 27 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

Guidelines for the management of rheumatoid arthritis: 2002 Update

Update in Internal Medicine

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