Combination treatment with leflunomide and methotrexate for patients with active rheumatoid arthritis

  title={Combination treatment with leflunomide and methotrexate for patients with active rheumatoid arthritis},
  author={S.-S. Lee and Y.-W. Park and J-J Park and Ym Kang and Ej Nam and Sik Kim Kwang Sik Kim and Jh Lee and Wan-Hee Yoo and S.I.L. Lee},
  journal={Scandinavian Journal of Rheumatology},
  pages={11 - 14}
Objective: To determine the efficacy and safety of the combination of leflunomide and methotrexate for the treatment of patients with active rheumatoid arthritis (RA) in an open, non‐comparative, multicentre trial. Methods: Seventy‐four patients with active RA were enrolled to receive concomitantly leflunomide (no loading dose, 10 mg/day) and methotrexate (starting at 7.5 mg/week and titrating up to 15 mg/week) for 20 weeks. The primary end‐point was a 20% improvement in the American College of… 

Treating rheumatoid arthritis with leflunomide monotherapy versus combination therapy with methotrexate.

The results suggest that the efficacy of the combined treatment with MTX and LFN is similar to that of LFN alone, and no increase in toxicity was observed with the combination therapy.

Therapeutic efficacy and safety of methotrexate + leflunomide in Colombian patients with active rheumatoid arthritis refractory to conventional treatment.

The combination of MTX + LFN is effective for treating RA in patients for whom conventional treatment has failed, and strict medical and laboratory control is to be enforced for safety.


Remission rate among the rheumatoid arthritis patients in response to treatment was overall good in the study and none of the factors studied including the treatment option had any statistically significant relationship with presence of remission among the target population.

Metothrexate Plus Leflunomide Step-Up Therapy in Early Rheumatoid Arthritis Patients with Non-Response to Initial Methotrexate Monotherapy

In early RA patients with non-response to MTX monotherapy, the addition of LEF allowed to achieve remission in 50% of patients, at a median time of 8 months, according to disease activity index of 28 joints.

The SMILE Study — Safety of Methotrexate in Combination with Leflunomide in Rheumatoid Arthritis

The combination of MTX and LEF was well tolerated, with adverse events comparable to those of monotherapy and the other nonbiologic disease-modifying antirheumatic drug treatment group.

Safety and Efficacy Evaluation for the Addition of Either Etanercept or Leflunomide in Korean Rheumatoid Arthritis Patients Inadequately Responding to Methotrexate

The ETN+MTx combination therapy was effective and safe, whereas the LEF+MTX combination therapy resulted in moderate efficacy in only half of the cases, and was accompanied by a high rate of adverse events.

Update 2011: leflunomide in rheumatoid arthritis – strengths and weaknesses

Effectiveness of leflunomide renders it a potent treatment option in rheumatoid arthritis and the known tolerability issues resulting in a less favourable adherence to therapy constitutes a weakness.

Reappraisal of the clinical use of leflunomide in rheumatoid arthritis and psoriatic arthritis

Leflunomide remains one of the most useful of the nonbiologic DMARDs and practical advice informed by evidence is given regarding dosing regimens, safety monitoring, and managing side effects.

Effectiveness of maintenance therapy with methotrexate compared with leflunomide for patients with RA having achieved disease control with both these drugs: results of a predefined sub-analysis of CareRA, a pragmatic RCT

MTX monotherapy seems not significantly more efficacious as maintenance treatment compared with LEF monotherapy but has a better retention rate and is well tolerated in early RA patients in LDA after combination therapy with both.



Pharmacokinetics, safety, and efficacy of combination treatment with methotrexate and leflunomide in patients with active rheumatoid arthritis.

The combination of methotrexate and leflunomide has therapeutic potential in RA and was generally well tolerated clinically, with the exception of elevations of liver enzyme levels.

[Leflunomide in the treatment of rheumatoid arthritis].

It is confirmed that LEF may present another therapeutic choice that is efficacious for the long term treatment of refractory RA and that these results must be evaluated on a larger series.

Concomitant Leflunomide Therapy in Patients with Active Rheumatoid Arthritis despite Stable Doses of Methotrexate

This 24-week, randomized, double-blind, placebo-controlled trial shows that leflunomide added to ongoing stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis improves clinical outcomes compared with methot Rexate alone.

Combination leflunomide and methotrexate (MTX) therapy for patients with active rheumatoid arthritis failing MTX monotherapy: open-label extension of a randomized, double-blind, placebo controlled trial.

Responsibility to therapy was maintained to 48 weeks of treatment in patients who continued to receive LEF and MTX during the extension, and ACR20 response rates after 24 weeks of LEF therapy were similar between patients switched from PLA to LEF without loading dose, and those who received a loading does of LeF at randomization.

Patients with rheumatoid arthritis benefit from early 2nd line therapy: 5 year followup of a prospective double blind placebo controlled study.

The results indicate the existence of a therapeutic window in RA within the first 2 years of the disease.

A meta-analysis of the efficacy and toxicity of combining disease-modifying anti-rheumatic drugs in rheumatoid arthritis based on patient withdrawal.

A systematic review of combination DMARD therapy for RA and a meta-analysis to evaluate the evidence for efficacy and toxicity were carried out.

Influence of disease-modifying therapy on radiographic outcome in inflammatory polyarthritis at five years: results from a large observational inception study.

DMARD treatment was a marker not only of worse disease at presentation but also of the radiographic state and radiographic progression at 5 years, and earlier therapy was shown to have a beneficial effect on outcome.

Radiographic outcome of recent-onset rheumatoid arthritis: a 19-year study of radiographic progression.

Radiographic damage occurs at a constant rate in RA, and is not greater early in RA or reduced later in the course of the illness, as measured by the summary Sharp scores.

The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis.

The revised criteria for the classification of rheumatoid arthritis (RA) were formulated from a computerized analysis of 262 contemporary, consecutively studied patients with RA and 262 control

A Randomized Double-blind Placebo-controlled Trial

The purpose of the present investigation was to evaluate the safety and effectiveness of the antiviral drug amantadine for the treatment of hepatitis C in those who had either previously failed interferon therapy or were not candidates for interferons.