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

Abstract

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.

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

“…with methotrexate was the reason for non continuous use. [20][21][22] Quality of life studies, XConsidering the refractory nature of the acceptance of combination by 6 (7%) ray evaluation and maximal signal intensity patients included and lack of an alternative patients. With leflunomide alone for three enhancement by dynamic gadoliniumtreatment and financial constraints, months, EULAR criteria showed improvement enhanced magnetic resonance imaging, have leflunomide can be considered an effective in 6 (54%) and remission in 1 (9%), supported its efficacy.…”

Risk of interstitial lung disease associated with leflunomide treatment in Korean patients with rheumatoid arthritis

“…A number of clinical trials have evaluated the efficacy and safety of leflunomide in patients with rheumatoid arthritis (RA) (2)(3)(4). The evidence available to date does not suggest that leflunomide leads to an increased likelihood of lung problems.…”

Pulmonary Nodulosis Associated with Leflunomide Therapy in Rheumatoid Arthritis: Report of Four Cases and Review of the Literature

“…Leflunomide inhibits dihydroorotate dehydrogenase, a key enzyme of the pyrimidine synthesis in activated lymphocytes. It was shown that leflunomide reduces signs and symptoms of RA with regression in structural damage [7].…”

“…In a study on Japanese patients treated with leflunomide, fatal interstitial lung disease was reported as a rare side effect of leflunomide [5,6]. However, other studies failed to confirm this side effect of leflunomide [7]. It was reported that peripheral nodule development and an increase in the number of nodules were observed in patients with RA received leflunomide therapy [8].…”