ST LOUIS (MD Consult) - On April 24, 2009, the US Food and Drug Administration (FDA) announced the approval of Simponi (golimumab), a monthly treatment for adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.
In clinical trials, patients who received Simponi for 1 of these 3 conditions showed improvements in the signs and symptoms common to their form of arthritis.
Simponi is injected subcutaneously. It is intended for use in combination with the immunosuppressant drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for the treatment of psoriatic arthritis and alone in patients with ankylosing spondylitis.
Simponi is in a class of drugs that target and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body as a consequence of chronic inflammatory disease, can cause inflammation and damage to bones, cartilage, and tissue. Like other TNF-α blockers, Simponi labeling includes a boxed warning about the risk of tuberculosis and invasive fungal infections associated with use of the drug.
The FDA also required a risk evaluation mitigation strategy (REMS) for Simponi, as it required for other TNF-α blockers. The REMS for Simponi includes a medication guide for patients and a communication plan to help prescribers understand the drug's risks.
The most common adverse reactions to Simponi include upper respiratory tract infection, sore throat, and nasal congestion.
圣路易斯(MD Consult)——2009年4月24日，美国食品药品管理局(FDA)批准Simponi (golimumab)作为按月份治疗的药物，用于治疗成人中、重度活动型风湿性关节炎、银屑病关节炎及强直性脊柱炎。
在临床实验中，罹患上述三种疾病之一的患者接受Simponi治疗后，关节炎疾病的症状和体征均有所改善。
Simponi是皮下注射制剂。本品与免疫抑制剂甲氨蝶呤(MTX)联用治疗风湿性关节炎, 也可与MTX联用或单用治疗银屑病关节炎；单独用于强直性脊柱炎治疗。
Simponi是一种靶向并中和过量肿瘤坏死因子-α(TNF-α)的药物。当机体因慢性炎症而产生过量TNF-α时，可能导致骨、软骨和组织发生炎症反应而致损伤。同其他TNF-α阻断剂类似，Simponi的说明书包括一个加框警告，提醒患者和医护人员使用该药物可能有导致肺结核及严重霉菌感染的风险。
同其他TNF-α阻断剂一样，美国FDA还要求生产商必须为Simponi提交一份“风险评估与降低计划”(REMS)。该REMS包括对患者的用药指引及医患沟通计划，以帮助处方医师进一步了解该药物的风险。
Simponi最常见的副作用包括上呼吸道感染、喉咙痛和鼻塞。
