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Efficacy and safety of weekly leflunomide for the treatment of early rheumatoid arthritis: a randomized, multi‐center study
Author(s) -
Ren LiMin,
Li Ru,
Chen LiNa,
Zhu Ping,
Gu Fei,
Sun LingYun,
Zhao JinXia,
Liu XiangYuan,
Guo JiaLong,
Bi LiQi,
Hao YanJie,
Zhang ZhuoLi,
Mei YiFang,
Zhang ZhiYi,
Liu HuaXiang,
Li XingFu,
Luo Yan,
Fang YongFei,
Li ZhanGuo,
Su Yin
Publication year - 2016
Publication title -
international journal of rheumatic diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.795
H-Index - 41
eISSN - 1756-185X
pISSN - 1756-1841
DOI - 10.1111/1756-185x.12677
Subject(s) - medicine , leflunomide , rheumatoid arthritis , randomized controlled trial , center (category theory) , physical therapy , chemistry , crystallography
Aim 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 ( DAS 28) ‐ 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 DAS 28 (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 DAS 28 (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 DAS 28 (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. Conclusion 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.