A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis

Emery, Paul; Breedveld, F. C.; Lemmel, E.-M.; Kaltwasser, J. P.; Dawes, P. T.; Gömör, B; Bosch, Filip Van den; Nordström, Dan; Bjørneboe, Olav; Dahl, R; Hørslev‐Petersen, Kim; Serna, Arturo Rodríguez de la; Molloy, Miriam; Tikly, Mohammed; Oed, Christine; Rosenburg, Ronald; Loew-Friedrich, Iris

doi:10.1093/rheumatology/39.6.655

Cited by 394 publications

(296 citation statements)

References 14 publications

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“…In fact, when reviewing results from the various leflunomide clinical trials, ACR response rates of patients receiving leflunomide monotherapy were similar, if not superior, compared with the addition of leflunomide to MTX therapy (33)(34)(35) (Table 1). Again, comparing clinical trials has its limitations, but the results are clearly consistent with this interpretation.…”

Section: Study Design Issuesmentioning

confidence: 99%

Superior efficacy of combination therapy for rheumatoid arthritis: Fact or fiction?

Smolen

Aletaha

Keystone

2005

Arthritis & Rheumatism

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Section: Study Design Issuesmentioning

confidence: 99%

Superior efficacy of combination therapy for rheumatoid arthritis: Fact or fiction?

Smolen

Aletaha

Keystone

2005

Arthritis & Rheumatism

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“…Several recent phase III studies demonstrated the efficacy and safety of leflunomide for up to 2 years in patients with active RA (9)(10)(11)(12)(13)(14)(15). Leflunomide was shown to be more effective than placebo and at least as effective as methotrexate and sulfasalazine in improving individual signs and symptoms of RA (9)(10)(11)(12)15).…”

mentioning

confidence: 99%

“…Leflunomide was shown to be more effective than placebo and at least as effective as methotrexate and sulfasalazine in improving individual signs and symptoms of RA (9)(10)(11)(12)15). In addition, the American College of Rheumatology 20% (ACR20) response rate (16) was achieved much sooner with leflunomide than with methotrexate or sulfasalazine (9,11). Leflunomide was also shown to be more effective than both methotrexate and sulfasalazine in improving functional activity over a 2-year period (12,13), as measured by the Stanford Health Assessment Questionnaire (HAQ) disability index (17).…”

mentioning

confidence: 99%

The efficacy and safety of leflunomide in patients with active rheumatoid arthritis: A five‐year followup study

Kalden¹,

Schattenkirchner²,

Sörensen³

et al. 2003

Arthritis & Rheumatism

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114

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Results. A total of 214 patients (mean age 57 years) were treated with leflunomide for >2 years; 74.8% of the patients were female. The mean disease duration was 4.1 years (range 0.1-26.6 years), and in 44% of patients, RA was first diagnosed within 2 years of entry into the phase III studies. The mean duration of leflunomide treatment was 4.6 years (range 2.8-5.8 years), and 32% of patients had received no previous treatment with disease-modifying antirheumatic drugs. ACR20, ACR50, and ACR70 response rates and HAQ scores at 1 year were maintained through year 4 or until the end point. No new types of adverse events were observed, and liver function was normal at baseline and at the end point in the majority of patients.Conclusion. The improvements in both functional ability and physician-based efficacy measures seen with leflunomide after 1 year were maintained for up to 5 years (maximum treatment duration 5.8 years), demonstrating that the early efficacy of leflunomide in patients with RA is sustained long-term, and that the long-term safety profile of leflunomide is no different from that observed in phase III trials.

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“…Leflunomide, a new DMARD, has demonstrated efficacy in the treatment of RA, both clinically and in slowing radiographic progression (14,17,18). Leflunomide is a prodrug rapidly converted into the active metabolite A77 1726, which acts predominantly by inhibiting dihydroorotate dehydrogenase, an enzyme critical for the de novo biosynthesis of pyrimidine, thus prohibiting the clonal expansion of activated T cells (19).…”

mentioning

confidence: 99%

Comparative assessment of leflunomide and methotrexate for the treatment of rheumatoid arthritis, by dynamic enhanced magnetic resonance imaging

Reece¹,

Kraan²,

Radjenovic³

et al. 2002

Arthritis & Rheumatism

103

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Objective. Ethical constraints on the conduct of placebo-controlled trials evaluating new therapies for serious chronic diseases, such as rheumatoid arthritis (RA), indicate the need for discerning methods to assess treatment effect in active-controlled clinical trials. Dynamic gadolinium-enhanced magnetic resonance imaging (DEMRI) is a sensitive technique for the detection of synovial inflammation in RA. Therefore, this investigation was undertaken to evaluate DEMRI as an efficacy assessment tool for differentiating treatment effect in a randomized, active-controlled trial comparing leflunomide and methotrexate.Methods. Patients with active RA (n ‫؍‬ 39) were randomized in a 2-center, prospective, double-blind clinical trial to receive either leflunomide (n ‫؍‬ 18) or methotrexate (n ‫؍‬ 21) therapy for 4 months. DEMRI scans were obtained at baseline and at 4 months, and the initial rate of enhancement (IRE) and the maximal signal intensity (SI) enhancement (ME) were calculated from the SI curves. Clinical improvement was assessed by conventional outcome measures.Results. Thirty-four patients (17 treated with leflunomide and 17 with methotrexate) had usable baseline and end point DEMRI scans. Leflunomide treatment was associated with a significantly greater improvement in IRE compared with methotrexate treatment (P < 0.05). Average values of ME indicated reduction of inflammation with both leflunomide and methotrexate. The improvement in clinical signs and symptoms, as measured by traditional assessments, was comparable for both active treatments.Conclusion. Results of this study validate the sensitivity of DEMRI in detecting inflammatory changes in active RA in response to treatment. Improvement in synovial inflammation as measured by IRE was significantly better with leflunomide than with methotrexate over 4 months of therapy.

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A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis

Cited by 394 publications

References 14 publications

Superior efficacy of combination therapy for rheumatoid arthritis: Fact or fiction?

Superior efficacy of combination therapy for rheumatoid arthritis: Fact or fiction?

The efficacy and safety of leflunomide in patients with active rheumatoid arthritis: A five‐year followup study

Comparative assessment of leflunomide and methotrexate for the treatment of rheumatoid arthritis, by dynamic enhanced magnetic resonance imaging

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