Comparative Effectiveness And Safety Of Anti-TNF Agent And Glucocorticoid For Moderate And Severe Rheumatoid Arthritis

Objective Comparison effectiveness and safety of tumour necrosis factorinhibitor versus glucocorticoids in the treatment of moderate and severe rheumatoidarthritis.Methods This is a open-labeled,sequential,randomized and controlledprospective trial.Observation period is24weeks.63patients with moderate and severerheumatoid arthritis were randomly and averagely divided into MTX group,MTX-TNFI group and MTX-Pred group.Intervention:All groups tookhydorxychloroquine0.2g bid,MTX12.5mg qw,and folic acid10mg qw at another dayfollowing each MTX administration.Nonsteroidal anti-inflammatory drugs (NSAID)were allowed.At week12,if patients in the MTX group reach DAS28partialremission (DAS28decrease30%of the first visit),then the therapy should becontinued;if not,then the patients should be switched into MTX-TNFI group orMTX-Pred group.The patients in MTX-TNFI group was hypodermicly injectedEtanercept50mg qw.12weeks later,it could reduce to25mg qw according to theefficacy.The patients in MTX-Pred group took prednisone30mg qd for2weeks andthen tap to15mg qd.Assessment:Primary efficacy endpoint was the rate ofachievement of20%improvement in the American College of Rheumatology criteria(ACR20) at week24and the change of ultrasonic assessments.Secondary efficacyendpoint included the rate of achievement of ACR20%,ACR50%,ACR70%improvements and EULAR response (The European League Against Rheumatismresponse) at week4,12and24.Primary safety endpoint was the proportion ofdiscontinuations due to adverse events.Secondary safety endpoints includedpercentage of all the adverse events.Results At24weeks, ESR,CRP,DAS28,HAQ and ultrasonic assessments in boththe MTX-TNFI group and the MTX-Pred group were significantly better than thosebefore treatment (P<0.05).At4weeks,12weeks and24weeks,ESR,CRP,DAS28,HAQ,ACR20,ACR50,ACR70and EULAR response had no significant difference inboth groups (P>0.05).But the ultrasonic assessments of the MTX-TNFI group were superior to the MTX-Pred group(P<0.05).At24weeks,15patients in the MTX groupwere switched into the MTX-Pred group.The rates of adverse reaction of two groupshad no significantly difference(P>0.05).Conclusion No significant difference in clinical efficacy was shown betweenEtanercept and prednisone respectively combined with MTX in moderate and severerheumatoid arthritis,but ultrasonographic analysis shows better improvement inadministration with Etanercept.Ultrasonographic evaluation with power doppleranalysis is an emerging standardized tool that is more accurate to monitor effects ofdrugs.