A multi-center,double-blind,randomized,placebo-controlled study on the efficacy and safety of etanercept and methotrexate in the treatment of active rheumatoid arthritis / 中华风湿病学杂志

ABSTRACT

Objective To compare the efficacy and safety ofetanercept injection 50 mg once weeklycombined with methotrexate (MTX) therapy for patients withactive rheumatoid arthritis.Methods This studyconsists of 2 parts：a 12-week double-blind treatmentperiod (part A) followed by a 12-week open-labelsafety study period (part B).The randomization oftreatments in double-blind treatment period was completedthrough the clinical operations randomization environment(CORE) system.During part A,the subjects wererandomly assigned to the etanercept 50 mg or placebo group. The dosage regimen for etanercept was 50 mgadministered subcutaneously once weekly while MTX wasadministered orally.All subjects who completed partA received 50 mg etanercept once weekly and MTX1 during theopen-label treatment.The primary endpointwas ACR 20 response at week 12.Secondary endpoint variablesincluded physician／patient global assessmentsof disease activities,duration of morning stiffness,painvisual analog scale (VAS),health assessment questi onnaire (HAQ),CRP level and tender and swollen joint counts .The results of safety between the two groupswere compared.The primary endpoint and other secondarybinary endpoints were analyzed using the Fisher’sexact test.For continuous endpoints.the change frombaseline was analyzed with analysis of covariance.Results One hundred and fifty six subjects satisfiedmodified intent-to-treat (mITT) population were enrolled during part A,of which 77 subjects were in theetanercept+MTX group,and 79 subjects were in theplacebo+MTX group respectively.A total of 149 subjectscompleted part A.As early as week 4.the ACR 20response achieved 39％ (30,77) in the etanerceptgroup,which was significantly higher than that of theplacebogroup [16％(13／79),P<0.001].At week 12,the ACR 20respouse achieved 62％(48,77)in the etanercept group and 23％(18／79) in the placebo group (P<0.01).Fromweek 4,other study endpoints including physician global assessment,patient globalassessment,duration of morning stiffness,painVAS,HAQ,CRPlevel,tender joint counts,swollen joint counts were alsocompared.The results showed that all above efficacyendpoints in the etanercept+MTX group were better than thoseof the placebo+MTX group(P<0.01).Butthere Was no significant difference in the total adverseeriects between the two groups.ConclusionEtanercept 50 mg once weekly + MTX treatment for 24 weeks iswell tolerated.During the first 12-weektreatment period,the etanercept group has shown a rapidefficacy onset and a significantly better therapeuticeffect compared to that of the placebo group.