To Compare The Efficacy And Safety Of Tofacitinib With Methotrexate And Etanercept With Methotrexate In Patients With Active Rheumatoid Arthritis

Objective To compare the clinical efficacy and safety of tofacitinib(trade name:Shang Jie)combined with methotrexate(MTX)and etanercept combined with MTX in patients with active rheumatoid arthritis(RA).Methods In this study,92 patients with active rheumatoid arthritis were randomly selected and divided into three groups.Among them,30 patients in the tofacitinib group were given oral treatment of tofacitinib 5mg twice a day combined with MTX;30patients in the etanercept group were given subcutaneous injection of etanercept 50 mg once a week combined with oral treatment of MTX;32 patients in the control group were given oral treatment of MTX only.The erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),and 28 joint disease activity scores(DAS28-ESR)based on ESR were compared among the three groups before treatment,3 months after treatment and 6 months after treatment.rate of 20/50/70% improvement in American College of Rheumatology criteria(ACR20/50/70)was assessed after 3 and 6 months of treatment.The safety of the drug was evaluated by blood routine examination,liver and kidney function,and any adverse reactions in the clinic.Results1.Enrolled 92 patients,including 32 patients in the control group,23 in females,aged36-82 years;30 patients in the etanercept group,25 in females,age 33-78 years;30patients in the tofacitinib group,21 in females,aged 26-81 years.There were no statistical differences in gender,age,tenderness count,swelling count,ESR,CRP,and DAS28-ESR before treatment among the three groups(P> 0.05),and they were comparable.2.Comparison of ESR,CRP,and DAS28-ESR:(1)Comparison before and after treatment in the control group: ESR,CRP,and DAS28-ESR after 3 months and 6 months of treatment were significantly lower than before treatment,and the difference was statistically significant(P< 0.01).(2)Comparison before and after treatment of the etanercept group: ESR,CRP,and DAS28-ESR after 3 months and 6 months of treatment were significantly lower than those before treatment,and the difference was statistically significant(P<0.01).(3)Comparison before and after treatment of tofacitinib group: ESR,CRP,and DAS28-ESR decreased significantly after treatment for 3 months and 6 months compared with before treatment,and the difference was statistically significant(P <0.01).(4)Comparison of the three groups before and after treatment:After 3 and 6 months of treatment,the ESR,CRP,and DAS28-ESR of the tofacitinib group and the etanercept group were significantly reduced compared with the control group,and the differences were statistically significant(P <0.05),while the tofacitinib group and the etanercept group have no statistical difference in the above indicators.3.Efficacy comparison: The ACR50 response rate at 3 months of treatment was significantly higher in the tofacitinib group than in the control group,and the difference was statistically significant(P <0.05).At 6 months of treatment,the ACR50/70 response rate of the tofacitinib group and the etanercept group was significantly higher than that of the control group,and the difference was statistically significant(P <0.05).There was no significant difference in pairwise comparison of other indicators.4.Safety comparison: in the control group,2 patients had leukopenia,3 patients had elevated transaminase,and 2 patients had gastrointestinal reactions.The incidence of adverse reactions was 21.88%(7/32);In the etanercept group,1patient had leukopenia,4 patients had transaminase elevation,3 patients had gastrointestinal reactions,and 1patient had upper respiratory infections.The incidence of adverse reactions was 30.00%(9/30);In the tofacitinib group,2 patients had leukopenia,2 patients had transaminase elevation,2 patients had gastrointestinal reactions,and 1 patient had upper respiratory infections.The incidence of adverse reactions was 23.33%(7/30).Drug treatment was discontinued,and there was no significant difference in the incidence of adverse reactions between the three groups(P> 0.05).Conclusion1.Tofacitinib combined with MTX in the treatment of active RA is significantly better than MTX alone,compared with etanercept combined with MTX..2.Tofacitinib combined with MTX for active RA patients did not increase adverse reactions compared with etanercept combined with MTX and MTX alone,suggesting that tofacitinib as a drug for RA has good efficacy and stable safety.