Abstract：
OBJECTIVE: Informing an international task force updating the consensus statement on efficacy and safety of biological disease-modifying antirheumatic drugs (bDMARDs) selectively targeting interleukin-6 (IL-6) pathway in the context of immune-mediated inflammatory diseases.
METHODS: A systematic literature research of all publications on IL-6 axis inhibition with bDMARDs published between January 2012 and December 2020 was performed using MEDLINE, EMBASE and Cochrane CENTRAL databases. Efficacy and safety outcomes were assessed in clinical trials including their long-term extensions and observational studies. Meeting abstracts from ACR, EULAR conferences and results on clinicaltrials.gov were taken into consideration.
RESULTS: 187 articles fulfilled the inclusion criteria. Evidence for positive effect of IL-6 inhibition was available in various inflammatory diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, Takayasu arteritis, adult-onset Still\'s disease, cytokine release syndrome due to chimeric antigen receptor T cell therapy and systemic sclerosis-associated interstitial lung disease. Newcomers like satralizumab and anti-IL-6 ligand antibody siltuximab have expanded therapeutic approaches for Castleman\'s disease and neuromyelitis optica, respectively. IL-6 inhibition did not provide therapeutic benefits in psoriatic arthritis, ankylosing spondylitis and certain connective tissue diseases. In COVID-19, tocilizumab (TCZ) has proven to be therapeutic in advanced disease. Safety outcomes did not differ from other bDMARDs, except higher risks of diverticulitis and lower gastrointestinal perforations. Inconsistent results were observed in several studies investigating the risk for infections when comparing TCZ to TNF-inhibitors.
CONCLUSIONS: IL-6 inhibition is effective for treatment of several inflammatory diseases with a safety profile that is widely comparable to other bDMARDs.
METHODS: A systematic literature research of all publications on IL-6 axis inhibition with bDMARDs published between January 2012 and December 2020 was performed using MEDLINE, EMBASE and Cochrane CENTRAL databases. Efficacy and safety outcomes were assessed in clinical trials including their long-term extensions and observational studies. Meeting abstracts from ACR, EULAR conferences and results on clinicaltrials.gov were taken into consideration.
RESULTS: 187 articles fulfilled the inclusion criteria. Evidence for positive effect of IL-6 inhibition was available in various inflammatory diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, Takayasu arteritis, adult-onset Still\'s disease, cytokine release syndrome due to chimeric antigen receptor T cell therapy and systemic sclerosis-associated interstitial lung disease. Newcomers like satralizumab and anti-IL-6 ligand antibody siltuximab have expanded therapeutic approaches for Castleman\'s disease and neuromyelitis optica, respectively. IL-6 inhibition did not provide therapeutic benefits in psoriatic arthritis, ankylosing spondylitis and certain connective tissue diseases. In COVID-19, tocilizumab (TCZ) has proven to be therapeutic in advanced disease. Safety outcomes did not differ from other bDMARDs, except higher risks of diverticulitis and lower gastrointestinal perforations. Inconsistent results were observed in several studies investigating the risk for infections when comparing TCZ to TNF-inhibitors.
CONCLUSIONS: IL-6 inhibition is effective for treatment of several inflammatory diseases with a safety profile that is widely comparable to other bDMARDs.
摘要：
目的：通知一个国际特别工作组更新关于在免疫介导的炎性疾病背景下选择性靶向白细胞介素-6（IL-6）途径的生物学抗风湿药（bDMARDs）的疗效和安全性的共识声明。
方法：使用MEDLINE对2012年1月至2020年12月发表的关于bDMARDs抑制IL-6轴的所有出版物进行了系统文献研究，EMBASE和CochraneCENTRAL数据库。在临床试验中评估疗效和安全性结果，包括其长期扩展和观察性研究。ACR的会议摘要，考虑了EULAR会议和关于clinicaltrials.gov的结果。
结果：187篇文章符合纳入标准。IL-6抑制的积极作用的证据可用于各种炎性疾病，如类风湿性关节炎，幼年特发性关节炎，巨细胞动脉炎,大动脉炎,成人发作的斯蒂尔病，嵌合抗原受体T细胞治疗和系统性硬化相关间质性肺病导致的细胞因子释放综合征.satralizumab和抗IL-6配体抗体siltuximab等新来者已经扩大了Castleman病和视神经脊髓炎的治疗方法，分别。IL-6抑制在银屑病关节炎中没有提供治疗益处，强直性脊柱炎和某些结缔组织疾病。在COVID-19中，托珠单抗(TCZ)已被证明对晚期疾病具有治疗作用。安全性结果与其他bDMARD没有差异，除了憩室炎和下消化道穿孔的风险较高。在比较TCZ与TNF抑制剂时，在调查感染风险的几项研究中观察到不一致的结果。
结论：IL-6抑制可有效治疗几种炎症性疾病，其安全性与其他bDMARD相当。
方法：使用MEDLINE对2012年1月至2020年12月发表的关于bDMARDs抑制IL-6轴的所有出版物进行了系统文献研究，EMBASE和CochraneCENTRAL数据库。在临床试验中评估疗效和安全性结果，包括其长期扩展和观察性研究。ACR的会议摘要，考虑了EULAR会议和关于clinicaltrials.gov的结果。
结果：187篇文章符合纳入标准。IL-6抑制的积极作用的证据可用于各种炎性疾病，如类风湿性关节炎，幼年特发性关节炎，巨细胞动脉炎,大动脉炎,成人发作的斯蒂尔病，嵌合抗原受体T细胞治疗和系统性硬化相关间质性肺病导致的细胞因子释放综合征.satralizumab和抗IL-6配体抗体siltuximab等新来者已经扩大了Castleman病和视神经脊髓炎的治疗方法，分别。IL-6抑制在银屑病关节炎中没有提供治疗益处，强直性脊柱炎和某些结缔组织疾病。在COVID-19中，托珠单抗(TCZ)已被证明对晚期疾病具有治疗作用。安全性结果与其他bDMARD没有差异，除了憩室炎和下消化道穿孔的风险较高。在比较TCZ与TNF抑制剂时，在调查感染风险的几项研究中观察到不一致的结果。
结论：IL-6抑制可有效治疗几种炎症性疾病，其安全性与其他bDMARD相当。
