Efficacy and safety of weekly leflunomide for the treatment of early rheumatoid arthritis: a randomized, multi-center study.
OBJECTIVE
The aim of this study was to determine the efficacy and safety of a weekly dose of leflunomide (50 mg/week) in early rheumatoid arthritis patients with mild or moderate disease activity.


METHODS
The patients of early rheumatoid arthritis (ERA) with mild or moderate disease activity were randomly selected for inclusion in this study and were assigned to either the treatment group (leflunomide 50 mg/week, LEF50) or the control group (leflunomide 10 mg/day, LEF10). All patients were treated for 24 weeks. Clinical efficacy was assessed using the disease activity score in 28 joints (DAS28) - erythrocyte sedimentation rate (ESR) and European League Against Rheumatism (EULAR) response. A Chi-squared test, Fisher's exact-test and paired t-tests were used to analyze the data.


RESULTS
A total of 244 patients who met the inclusion criteria and received at least one medicine dose were analyzed. At the baseline, the DAS28 (ESR) of the ERA patients were 4.41 ± 0.69 in LEF 50 group and 4.52 ± 0.64 in LEF 10 group, respectively. At week 24, the DAS28 (ESR) in two groups ( 2.94 ± 1.10 and 3.02 ± 1.14 ) were significant decreased compare with the baseline, respectively (P<0.01). There was no significant difference in DAS28 (ESR) between the LEF50 and LEF10 groups at week 24. (P > 0.05). At weeks 8, 12 and 24, the EULAR response (good responses + moderate responses) were 47.6%, 58.7% and 59.5%, in the LEF50 group and 43.2%, 49.1% and 53.4% in the LEF10 group, respectively. There was no significant different of EULAR response rates in the two groups at week 8, 12, and 24, respectively (P>0.05). There was no serious adverse events during the study.


CONCLUSIONS
A weekly dose of 50 mg leflunomide showed similar benefits to a daily dose of 10 mg leflunomide for the treatment of mild-to-moderate early rheumatoid arthritis.
Department of Rheumatology and Immunology, People's Hospital of Peking University, Beijing, China.
Li-Min
LM
Ren
Department of Rheumatology and Immunology, People's Hospital of Peking University, Beijing, China.
Ru
R
Li
Department of Rheumatology, Xijing Hospital, Fourth Military Medical University, Xian, China.
Li-Na
LN
Chen
Department of Rheumatology, Xijing Hospital, Fourth Military Medical University, Xian, China.
Ping
P
Zhu
Department of Rheumatology, Nanjing Drum Tower Hospital, Nanjing, China.
Fei
F
Gu
Department of Rheumatology, Nanjing Drum Tower Hospital, Nanjing, China.
Ling-Yun
LY
Sun
Department of Rheumatology, Peking University Third Hospital, Beijing, China.
Jin-Xia
JX
Zhao
Department of Rheumatology, Peking University Third Hospital, Beijing, China.
Xiang-Yuan
XY
Liu
Department of Rheumatology, China-Japan Union Hospital of Jilin University, Changchun, China.
Jia-Long
JL
Guo
Department of Rheumatology, China-Japan Union Hospital of Jilin University, Changchun, China.
Li-Qi
LQ
Bi
Department of Rheumatology, Peking University First Hospital, Beijing, China.
Yan-Jie
YJ
Hao
Department of Rheumatology, Peking University First Hospital, Beijing, China.
Zhuo-Li
ZL
Zhang
Department of Rheumatology, the First Hospital Affiliated to Harbin Medical University, Harbin, China.
Yi-Fang
YF
Mei
Department of Rheumatology, the First Hospital Affiliated to Harbin Medical University, Harbin, China.
Zhi-Yi
ZY
Zhang
Department of Rheumatology, Qi Lu Hospital of Shandong University, Jinan, China.
Hua-Xiang
HX
Liu
Department of Rheumatology, Qi Lu Hospital of Shandong University, Jinan, China.
Xing-Fu
XF
Li
Department of Rheumatology, Southwest Hospital, the Third Military Medical University, Chongqing, China.
Yan
Y
Luo
Department of Rheumatology, Southwest Hospital, the Third Military Medical University, Chongqing, China.
Yong-Fei
YF
Fang
Department of Rheumatology and Immunology, People's Hospital of Peking University, Beijing, China.
Zhan-Guo
ZG
Li
Department of Rheumatology and Immunology, People's Hospital of Peking University, Beijing, China.
Yin
Y
Su
D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D001799:Blood Sedimentation; D016009:Chi-Square Distribution; D002681:China; D004334:Drug Administration Schedule; D042241:Early Diagnosis; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage* / Q000009:adverse effects; D000077339:Leflunomide; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011237:Predictive Value of Tests; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D018501:Antirheumatic Agents; D007555:Isoxazoles; D000077339:Leflunomide
leflunomide; rheumatoid arthritis; weekly regimen