2012 在类风湿关节炎及其他炎性疾病中白细胞介素-6受体抑制剂阻断白细胞介素-6作用的专家共识
Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions.
2013-03-01
2012年风湿病年鉴发表了由Smolen SJ教授发起的专家委员会提出的关于类风湿关节炎(rheumatoid arthritis，RA)患者应用白细胞介素(IL)一6受体抑制剂托珠单抗治疗的专家共识Onn Rheum Dis，2013，72：482-492)。托珠单抗(tocilizumab)是一种IL-6受体抑制剂，被美国食品药品管理局(FDA)批准应用于RA及幼年特发性关节炎(JIA)的治疗，目前已有多个关于托珠单抗及其他针对IL-6受体和配体的靶向药物的临床试验评估了在RA和其他炎性疾病治疗抑制IL-6通路的疗效。本共识基于临床试验结果及专家意见，阐述了使用托珠单抗治疗RA的注意事项。AbstractBACKGROUND:Since approval of tocilizumab (TCZ) for treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA), interleukin 6 (IL-6) pathway inhibition was evaluated in trials of TCZ and other agents targeting the IL-6 receptor and ligand in various RA populations and other inflammatory diseases. This consensus document informs on interference with the IL-6 pathway based on evidence and expert opinion.METHODS:Preparation of this document involved international experts in RA treatment and RA patients. A systematic literature search was performed that focused on TCZ and other IL6-pathway inhibitors in RA and other diseases. Subsequently, incorporating available published evidence and expert opinion, the steering committee and a broader expert committee (both including RA patients) formulated the current consensus statement.RESULTS:The consensus statement covers use of TCZ as combination- or monotherapy in various RA populations and includes clinical, functional and structural aspects. The statement also addresses the second approved indication in Europe JIA and non-approved indications. Also early phase trials involving additional agents that target the IL-6 receptor or IL-6 were evaluated. Safety concerns, including haematological, hepatic and metabolic issues as well as infections, are addressed likewise.CONCLUSIONS:The consensus statement identifies points to consider when using TCZ, regarding indications, contraindications, screening, dose, comedication, response evaluation and safety. The document is aimed at supporting clinicians and informing patients, administrators and payers on opportunities and limitations of IL-6 pathway inhibition.
