RESUMO
Objective:To compare the efficacy and safety of different dosages of new drugs in the treatment of PsA by using network meta-analysis.Methods:Three medical databases (PubMed, Web of Science, Cochrane Library) were searched for the studies that compared the efficacy and safety of 4 new drugs (secukinumab, ixekizumab, apremilast, tofacitinib) with different dosages in the treatment of PsA. Data from included studies were analyzed by Stata 15.0.Results:A total of 16 RCTs were included. The results of the network meta-analysis showed that: (1) Among the overall patients, in terms of ACR20 response rate, the larger the surface under the cumulative ranking (SUCRA), the more effective it is. Secukinumab 300 mg Q4W(96.1%) had the best efficacy, followed by ixekizumab 80 mg Q4W(79.0%), ixekizumab 80 mg Q2W(75.1%), secukinumab 150 mg Q4W(73.2%), apremilast 30 mg BID(50.6%), apremilast 20 mg BID(38.6%), tofacitinib 5 mg BID(18.1%), tofacitinib 10 mg BID(17.7%) and placebo(2.0%). (2) In terms of PASI75 response rate, the larger the area under the SUCRA curve, the more effective it is. Ixekizumab 80 mg Q4W(96.1%) had the best efficacy, followed by ixekizumab 80 mg Q2W(88.7%), secukinumab 300 mg Q4W(75.6%), secukinumab 150 mg Q4W(63.3%), apremilast 30 mg BID(44.5%), apremilast 20 mg BID(38.4%), tofacitinib 10 mg BID(30.0%), tofacitinib 5 mg BID(12.5%) and placebo(1.0%). (3) Among the overall patients, in terms of safety, the smaller the area under the SUCRA curve, the higher the safety it is. Secukinumab 300 mg Q4W (17.3%) has the best safety. (4) The results of subgroup analysis showed that in terms of ACR20 response rate, ixekizumab 80 mg Q2W(85.3%) had the best efficacy in bDMARDs-na?ve patients, while in bDMARDs-IR patients, secukinumab 300 mg Q4W(83.9%) had the best efficacy.Conclusion:Among all patients, secukinumab 300 mg Q4W is the best in terms of ACR20 response rate and safety, but ixekizumab 80 mg Q4W is more effective in improving PsA lesions comparing yo other drugs.
RESUMO
Objective:To analyze and summarize the drug registration clinical trial for rheumatic diseases in China from January 2013 to November 2019.Methods:The website of CDE was searched to obtain the data and statistical analysis was conducted.Results:①The number of drug clinical trials for rheumatic diseases in China increased year by year and the total was 525. The registered indications mainly included diffuse connective tissue disease, spondylo arthritis, metabolic diseases and degenerative diseases, including rheumatoid arthritis (RA) (189), gout (122), osteoarthritis (OA) (89), ankylosing spondylitis (AS) (60) and systemic lupus erythematosus (SLE) (39). ② The phaseⅡ-Ⅲ clinical trials were mainly for biological disease-modifying antirheumatic drugs (bDMARDs). Most of the bioequivalence test (BE) were chemical drugs.③ The domestically developed chemicals and biological included BLyS/APRIL, CD22, JAK1, S1P1 and BTK. ④ Adalimumab and tocilizumab accounted for the largest proportion of biosimilar drugs. The indications were mainly RA. ⑤ The number of international multi-center clinical trials increased year by year, with the indications mainly for RA and SLE.Conclusion:① The overall number of drugs trials for rheumatic diseases in China has been increasing rapidly in recent years. ② The research and development of chemicals and biologics is the trend. ③ Significant achievements have been made in the research and development of biosimilars in China and it is expected to benefit more patients by broaden the indications.