Objective To investigate the effectiveness, safety and cost-effectiveness of leflunomide for rheumatoid arthritis, and formulate an evidence-based treatment plan for a patient with rheumatoid arthritis. Methods We searched the ACP Journal Club, The Cochrane Library (Issue 2, 2007) and MEDLINE (1990 to 2007), and critically appraised the available evidence. Results The available Level A (high quality) evidence showed that the efficacy and adverse events of leflunomide were comparable to those of methotrexate. The total cost of treating patients with leflunomide was significantly higher when compared to methotrexate. The combination of leflunomide and methotrexate in patients with active rheumatoid arthritis unresponsive to methotrexate monotherapy was less costly and more effective than the strategy excluding leflunomide. Given the current evidence, together with our clinical experience and the patient’s preference, methotrexate was administered to the patient. There was an inadequate response after 6 months of treatment. And then, adding leflunomide to methotrexate attained a remarkable response 3 months later. The patient is still being followed up. Conclusion treatment with leflunomide and methotrexate in RA patients can improve the clinical outcomes. Long-term efficacy and toxicity remain to be established.
Objective To evaluate the efficacy and safety of Leflunomide (LEF) in the treatment of Rheumatoid Arthritis (RA), so as to provide scientific proof for applying LEF in China. Methods Randomized controlled trials (RCTs) about the effect of LEF on patients with RA from January 1989 to January 2011 were searched from the following databases, CNKI, WanFang Data, MEDLINE, EMbase and CBM. After two reviewers independently screened the studies according to the inclusion and exclusion criteria, extracted the data and assessed the quality, the data were analyzed by RevMan 5.0 software. Results Among 3247 patients in 16 included RCTs, 1711 patients were in the LEF group, while the other 1536 patients were in the Methotrexate (MXT) group. The results of meta-analyses showed there was no significant difference in the efficacy between LEF and MXT (RR=1.03, 95%CI 0.94 to 1.11, Pgt;0.05), but a significant difference was found in the side reaction (RR=0.67, 95%CI 0.49 to 0.94, Plt;0.05). Conclusion Based on the current studies, Leflunomide is as effective as the commonly-used Methotrexate in the treatment of rheumatiod arthritis at present, much safer than Methotrexate, and thought as a safe and effective SAARD. For the quality restrictions of the included studies, more double blind RCTs with high quality are required to further assess the effects.
Objective To assess effectiveness and safety in rheumatoid arthritis （RA）patients treated with the indigenous leflunomide in comparison with Airohua produced by Cinkate Corp. Methods A double blind and double dummy randomized controlled trial was conducted in the outpatient clinic of rheumatology. Fifty-six Chinese RA patients were divided into two groups who received either indigenous Leflunomide or Airohua of 20 mg daily and the two matching placebo tablets of Airohua or indigenous Leflunomide with the constant dose of Oxaprozin （0.4 g, qd） in the first 6 weeks. Clinical and laboratory data were collected every 6 weeks during 24 weeks of follow-up. Results This study showed that the patients of both groups significantly improved on main variables except erythrocyte sedimentation rate （EXR） at the 12th week . The variables such as ESR, and the level of c-reaction protein in both groups at 24th week showed no statistical difference compared with those at the baseline. There were also no statistical difference in the clinical characteristics and laboratory findings between the two groups at the 12th week and 24th week （P 〉0. 05）. The effcacy of Airohua（37% ） was lower than that of indigenous Leflunomide（64% ） at the 12th week （P 〈0. 05 ） and slightly better than indigenous Leflunomide group at the 24 week （81.5% vs 77.3% , （ P 〉0. 05）. The administration of Airohua and indigenous leflunomide presented a similar pattern and frequency of adverse events. Serious adverse events such as interstitial pneumonitis, pulmonary infiltration, and liver impairment etc. were not reported in either group. Conclusions The study shows that the indigenous Leflunomide has a superior therapeutic effect. Its efficacy and safety are similar to Airohua in the treatment of acfive RA patients in China.