Infliximab

Infliximab is a tumor necrosis factor (TNF-alpha or TNF-α) blocker and a chimeric monoclonal IgG1 antibody composed of human constant (75%) and murine variable (25%) regions . Infliximab is produced by a recombinant cell line cultured by continuous perfusion. Tumor necrosis factor-alpha (TNF-α) is a key proinflammatory cytokine involved in chronic inflammatory diseases . Its hyperactivity and enhanced signalling pathways can be observed in inflammatory diseases where it activates further pro-inflammatory cascades. By binding to both the soluble subunit and the membrane-bound precursor of TNF-α , infliximab disrupts the interaction of TNF-α with its receptors and may also cause lysis of cells that produce TNF-α .

Infliximab was first approved by the FDA in 1998 under the market name Remicade as an intravenous injection. It is indicated for the treatment of various inflammatory disorders such as adult or pediatric Chron's disease, adult or pediatric ulcerative colitis, rheumatoid arthritis in combination with methotrexate, ankylosing spondyliti, psoriatic arthritis, and plaque psoriasis . In clinical trials, multiple infusions of infliximab displayed in a reduction of signs and symptoms of inflammatory diseases and induction of remission in patients who have had an inadequate response to alternative first-line therapies for that disorder .

There are currently two biosilimars of infliximab available in the US market that demonstrate a high degree of similarity to the reference product, Remicade. They are approved for all eligible indications of the reference product. Inflectra, a first biosimilar drug product, was approved in 2016. In December 2017, Ixifi, a second biosimilar that was developed by Pfizer, was granted approval by the FDA.

用于治疗：

⑴类风湿性关节炎：本品常与甲氨蝶呤合用于中重度活动性类风湿性关节炎；

⑵克罗恩病及瘘管性克罗恩病；

⑶强直性脊柱炎等自身免疫性疾病，以减轻症状和体征，改善身体机能，预防患者残疾。

⑷用于银屑病关节炎的治疗【美国FDA已批准；英国风湿病学会/英国风湿病卫生专业人员协会《BSR／BHPR—应用生物制剂治疗银屑病关节炎指南》2012版；欧洲抗风湿病联盟《EULAR—银屑病关节炎药 物治疗管理建议》2011版

】。

⑸用于6岁及以上儿童溃疡性结肠炎的治疗【美国FDA已批准；中华医学会内科学会《炎症性肠病诊断与治疗的共识意见》；中华医学会消化病学分会炎症性肠病学组《英夫利西治疗克罗恩病的推荐方案（2011年】。