近日，美国食品药品管理局（FDA）批准治疗成人中重度风湿性关节炎、活动型银屑病性关节炎及活动型强直性脊柱炎的长效药物Simponi上市。
这3类关节炎均属慢性自身免疫性疾病，可造成患者关节强直、疼痛以及活动受限。
FDA药品评价及研究中心麻醉镇痛和风湿病产品办公室主任称，Simponi的上市为这3类患者提供了新的治疗选择，同时FDA采取的风险最小化措施也将给患者提供与其他同类治疗药物相同的安全保障。
Simponi为人源化单克隆抗体，属生物制品，皮下注射，每月用药一次。它与免疫抑制剂甲氨蝶呤（MTX）联用于治疗风湿性关节炎, 也可与甲氨蝶呤联用或单用于治疗银屑病关节炎，并单用于强直性脊柱炎的治疗。
Simponi的临床试验表明，接受治疗患者的关节炎症状和体征普遍得到改善。
由于慢性炎症性疾病会导致肿瘤坏死因子α（TNF-α）在体内过量产生，引起炎症反应以及骨、软骨和组织损伤，而Simponi则以 TNF-α为靶点抑制其作用。
与其他TNF-α抑制剂类似，Simpon的说明书中以黑框警示形式提醒患者和医务人员使用该药存在造成结核及侵入性真菌感染的风险。同时，FDA还要求为该药制定风险评估与降低计划方案(REMS)，其中包括对患者的用药指导以及与医生等专业人员的沟通交流，以使他们充分了解用药风险的方案。 
该药最常见的不良反应为上呼吸道感染、咽喉痛及鼻充血。

Simponi – An Effective New Treatment for Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis。

TORONTO — Health Canada issued a Notice of Compliance to Centocor Ortho Biotech Inc on April 7th, 2009 for the biological therapy Simponi – golimumab – which is a tumor necrosis factor α inhibitor for treatment of Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis.

SIMPONI

Indications for SIMPONI

Moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate (MTX). Active psoriatic arthritis (PsA), alone or with MTX. Active ankylosing spondylitis (AS).

Adult dose for SIMPONI

50mg SC once monthly. Rotate sites.

Children's dosing for SIMPONI

<18yrs: not recommended.

Warnings/Precautions for SIMPONI

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal). Active infections: do not initiate therapy. Chronic or history of recurring or opportunistic infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test for and treat latent TB prior to initiating therapy. Monitor closely if new infection, reactivation of hepatitis B virus (HBV), or blood dyscrasias develop; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, new or worsening CHF, or hematological abnormality (eg, cytopenias) develops. CHF (monitor). Immunosuppression. CNS demyelinating disorders. Malignancies. Latex allergy. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions for SIMPONI

Concurrent abatacept, anakinra, live vaccines, or other TNF blockers: not recommended. Immunosuppressants increase risk of infection. Monitor CYP450 substrates with narrow therapeutic index.

Adverse Reactions for SIMPONI

Inj site reactions, infections (may be serious), upper respiratory tract infection, nasopharyngitis, hypertension; rare: malignancies (eg, lymphoma, esp children), blood dyscrasias, new or worsening CHF, elevated liver enzymes, antibody formation, exacerbation or new onset of psoriasis.

How is SIMPONI supplied?

Single-dose SmartJect autoinjector—1
Single-dose prefilled syringe—1