RESUMO
Objective To evaluate the research of Recombinant Human Tumor Necrosis Factor-αReceptorⅡ:IgG Fc Fusion Protein for Injection in the treatment of patients with ankylosing spondylitis in serum ESR and CRP.Methods 48 cases of patients with ankylosing spondylitis from October 2013 to October 2015 in our hospitol were randomly divided into the control group and treatment group , 24 cases in each group.The control group was treated with sulfasalazine enteric-coated Tablets orally, 1.0 g/time,bid;the experimental group was treated with rhTNFR:Fc for subcutaneous injection, 25 mg/time, two times/week.erythrocyte sedimentation rate (ESR), serum C reactive protein (CRP) level, efficiency of treatment and safety of two groups were compared before and after treatment.Results After treatment, compared with the control group, the ESR and the serum level of CRP were lower in the experimental group (P<0.05); the treatment efficiency of the experimental group 95.84% was significantly higher than that of the control group 75.00% (P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups.Conclusion The rhTNFR:Fc can significantly reduce the ESR and the serum level of CRP in patients with ankylosing spondylitis, improve clinical symptoms,the clinical efficacy and safety were high.
RESUMO
Objective To evaluate the efficacy and safety of recombinant human tumor necrosis factor-α receptor Ⅱ IgG: Fc fusion protein for injection (rhTNFR: Fc) treatment in Chinese patients with early rheumatoid arthritis (ERA) and active spondyloarthritis. Methods This was a large-scale, multicenter, open-label, phase Ⅳclinical observational study. The dosage of rhTNFR: Fc was 50 mg per week, combined or not combined with other drugs. The primary endpoint of efficacy included the proportion of patients with low disease activity [simplified disease activity index (SDAI)≤11] at 3 month and 6 month. Secondary endpoint variables included clinical disease activity index (CDAI), disease activity score 28 based on C-reactive protein (DAS28-CRP) and health assessment questionnaire(HAQ). The primary endpoint of SpA was the ankylosing spondylitis disease activity score (ASDAS-CRP) at month 3. The secondary endpoints were the proportion of subjects achieving ASDAS<1.3 and ASDAS<2.1, Bath AS functional index (BASFI) and CRP. All subjects in the study were evaluated for safety. T test, χ2 test and rank sum test were used for satistical analysis. Results One thousand two hundred and seventy subjects with ERA were studied. The difference between the baseline and month 3 after treatment in SDAI, CDAI, DAS28-CRP were 26 ±16, 23 ±15, 1.86 ± 1.01 respectively (P<0.01). The above parameters 6 months after treatment were similar to those at 3 months after treatment, which demonstrated the persistence of drug efficacy. Two thousand three hundred and twenty eight subjects of SpA were studied. The difference between the baseline and 3 months after treatment in ASDAS, BASFI was 2.6 ±1.7, 3.4 ±3.8 respectively (t=73 .54, t=42 .36, P<0.01). The overall incidence of adverse events was 8.03%(289/3 598), including the common adverse events such as injection site reactions, skin rash and elevated liver enzyme levels. Adverse events were improved after proper treatment, without severe infections and tumor. These data confirmed that the overall safety of rhTNFR: Fc was good. Conclusion The study confirms that rhTNFR: Fc is effective for the treatment of ERA and SpA, and it is safe and well-tolerated.