Efficacy and safety of weekly XXXX for the treatment of early @entity309 : a randomized, multi-center study.

@entity1 @entity627 @entity6963 @entity309
AIM: The aim of this study was to determine the efficacy and safety of a weekly dose of @entity6963 (50  mg/week) in early @entity309 @entity1 with mild or moderate disease activity. METHODS: The @entity1 of early @entity309 (ERA) with mild or moderate disease activity were randomly selected for inclusion in this study and were assigned to either the treatment group ( @entity6963 50  mg/week, LEF50) or the control group ( @entity6963 10  mg/day, LEF10). All @entity1 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 @entity627 (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 @entity1 who met the inclusion criteria and received at least one medicine dose were analyzed. At the baseline, the DAS28 (ESR) of the ERA @entity1 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. CONCLUSION: A weekly dose of 50  mg @entity6963 showed similar benefits to a daily dose of 10  mg @entity6963 for the treatment of mild-to-moderate early @entity309 .
