Clinical Analysis Of SMO3 Monoclonal Antibody In Combination With Methotrexate To Treat Rheumatoid Arthritis

Objective: Observe the patients with rheumatoid arthritis who were treated by SMO3 in combination with methotrexate, include clinical manifestations、routine urine, blood biochemistry and immunology indicators. analysis and evaluate the treatment by SM03 in combination with methotrexate MTX efficacy and security.Methods: Select rheumatoid arthritis patients who’s Clinical course and background characteristics meet the relevant conditions in December 2014-July 2015.Observe the treatment of CD22 monoclonal ant body(SMO3) 24 weeks. All patients divided into three groups by 1: 1: 1 proportion randomizly: the observation group 1(MTX+ ullage dose SM03), the observation group 2(MTX+ full dose SM03) and control group(MTX alone). Group 1 inject SM03 600 mg at 0 week, 2 week, 12 week, 14 week, and group 2 inject SM03 600 mg at 0 week, 2 week, 4 week, 12 week, 14 week and 16 week. Control group don’t inject SM03. Three groups of patients throughout the clinical observation of treatment were oral methotrexate(MTX) as a basis for treatment.Each group focuses on treatment for 12 weeks of treatment-related data and joint evaluation of the patient’s pain evaluation, VAS eye chart, HAQ- disability index, ACR20, ACR50, ACR70, etc. to evaluate the efficacy, observe and measure clinical symptoms after 24 weeks, signs including will be routine urine, blood biochemistry laboratory tests and adverse events to judge their safety.Results: 1, all patients over time related treatment indicators improved during the first 24 weeks observation group 2(MTX+ full dose SM03) and were better than the control group(MTX alone), the observation group 2(MTX+ full dose SM03) ESR and CRP excellent indicators in the observation group 1(MTX+ ullage dose SM03), a statistically significant;2, three groups of patients during the first 12, 24 weeks of treatment in the observation group 2(MTX+ full dose SM03) reached ACR20 / 50/70 ratio was significantly higher(P <0.05), with significant difference;3, the main adverse events observed during the entire treatment have liver aminotransferase increased, urinary tract infections, gastrointestinal tract and upper respiratory tract infections. These adverse events were mostly mild or moderate, the most improved after discontinuation of all patients no deaths occurred.Conclusion: Treating rheumatoid arthritis by SM03 in combination with methotrexate can improve the therapeutic effect and reduce the DAS28 score, improve their quality of life. This combination means should be promoted the use in clinical practice.