| Background&Objective:Rheumatoid arthritis(RA)is a chronic autoimmune disease,which can lead to different degrees of joint damage and eventually affect all systems of the body,seriously affecting the quality of life of patients and bringing huge economic burden to patients.Although its pathogenesis has not been fully clarified,tumor necrosis factor-α(TNF-α)and interleukin-6(IL-6)have been shown to play an important role in the development of RA.Infliximab(IFX)and tocilizumab(TCZ)are typical drugs for tumor necrosis factor inhibitors and IL-6 receptor inhibitors,respectively.They are commonly used biological agents for clinical treatment of RA patients with poor efficacy of conventional synthetic disease-modifying anti-rheumatic drugs(csDMARDs).However,the direct comparison of the efficacy and safety of the two in the treatment of moderate to severe RA is not sufficient,and there are some contradictions in the relevant research conclusions.The aim of the present study is to evaluate the efficacy and safety of MTX combined with IFX and MTX combined with TCZ in the treatment of RA patients with moderate to severe disease activity,and to provide reference for clinical treatment.Methods:A total of 68 RA patients who met the inclusion and exclusion criteria were collected from Qilu Hospital of Shandong University from 2017 to 2022.They were divided into IFX group and TCZ group according to different treatment methods.The clinical efficacy,disease activity,quality of life and other indicators were observed for 24 weeks according to their respective administration time,and the drug safety during the medication was evaluated.The primary outcome variable of the study was the American College of Rheumatology 20%response rate(ACR20)at 24 weeks of treatment.The secondary outcome variables were the response rates of ACR20(except for 24 weeks),ACR50 and ACR70 at 12 weeks(14 weeks)and 24 weeks,and the improvement of disease activity and quality of life related indicators at 12 weeks(14 weeks)and 24 weeks compared with baseline.The proportion of patients with disease remission and low disease activity based on disease activity score using 28 joint counts(DAS28)and clinical disease activity indices(CDAI)at 24 weeks of treatment,and safety evaluation.Results:Thirty-four patients were included in each group,and there was no statistical difference between the basic characteristics,disease activity index and quality of life index of the two groups at baseline.Within 24 weeks of observation,with the prolongation of treatment time,the response rates of ACR20,ACR50 and ACR70 in IFX group and TCZ group gradually increased,and the disease activity and quality of life related indicators generally showed a downward trend.1.Primary outcome variable:At 24 weeks,the ACR20 response rate was 85.3%in IFX group and 94.1%in TCZ group.There was no statistical difference between the two groups.2.Secondary outcome variables:(1)At 12 weeks(14 weeks)of treatment,the response rates of ACR20,ACR50 and ACR70 in IFX group were 58.8%,47.1%and 17.6%,respectively,and those in TCZ group were 82.4%,44.1%and 29.4%,respectively.The difference in ACR20 response rate between the two groups was statistically significant(P<0.05).At 24 weeks of treatment,the response rates of ACR50 and ACR70 in IFX group were 55.9%and 29.4%,and those in TCZ group were 64.7%and 38.2%.There was no significant difference in ACR50 and ACR70 response rates between the two groups.(2)At 12 weeks(14 weeks)of treatment,the improvement of 28 joint pain and swelling count,medical doctor global assessment(MDGA),erythrocyte sedimentation rate(ESR),CDAI and DAS28 in TCZ group was more significant than that in IFX group(P<0.05).At 24 weeks of treatment,the decrease of ESR and DAS28 in TCZ group was greater than that in IFX group(P<0.01).There was no statistical difference in the improvement of other indicators between the two groups.(3)At 24 weeks of treatment,the proportions of disease remission and low disease activity based on DAS28 in IFX group were 14.7%and 14.7%,and those in TCZ group were 38.2%and 17.7%.The proportion of disease remission in TCZ group was higher than that in IFX group(P<0.05).(4)The proportion of disease remission and low disease activity based on CDAI at 24 weeks was 0%and 29.4%in IFX group,8.8%and 26.5%in TCZ group,respectively.There was no significant difference between the two groups.3.Influencing factors of efficacy:The related factors affecting ACR response at 24 weeks were analyzed,and body mass index(BMI)(OR=0.551,95%CI 0.389-0.780,P=0.001)was found to be an independent risk factor for ACR50.BMI(OR=0.564,95%CI 0.343-0.930,P<0.05),course of disease(OR=0.727,95%CI 0.558-0.948,P<0.05),ESR(OR-0.930,95%CI 0.874-0.989,P<0.05),modified health assessment questionnaire(MHAQ)score(OR=0.021,95%CI 0.001-0.406,P<0.05)were independent risk factors affecting ACR70.4.Safety evaluation:The adverse events in the IFX group were infusion reaction(11.76%),upper respiratory tract infection(8.82%),urinary tract infection(2.94%),elevated transaminase(14.71%),and decreased neutrophil count(11.76%).The adverse events in the TCZ group were elevated blood lipids(26.47%),elevated transaminase(38.24%),decreased neutrophil count(23.53%),and upper respiratory tract infection(11.76%).The adverse events monitored in this study were mild,and no serious adverse events were monitored.Most of them can be relieved by themselves within 4-12 weeks,and a few can be relieved after symptomatic treatment.There is no phenomenon of drug reduction or withdrawal due to adverse events.Conclusion:In terms of efficacy,IFX and TCZ can significantly alleviate the clinical symptoms of patients and reduce the related disease activity indicators,and greatly improve the quality of life of patients;in comparison,TCZ seems to work faster than IFX and has a stronger effect on reducing ESR and DAS28;BMI,course of disease,baseline ESR level and MHAQ score were independent risk factors affecting drug efficacy.As the safety,the adverse reactions monitored in the two groups were mild during the 24-week observation,and no adverse reactions other than reports were found.Both drugs have good safety in the treatment of moderate to severe RA. |
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