Centocor公司宣布他们获得美国食品和药物管理局批准Simponi治疗中度或严重的风湿性关节炎，牛皮癣关节炎和强直性脊柱炎。Simponi是第一个病人自己管理的疗法选择，它主要是对抗肿瘤坏死因子。风湿性关节炎，牛皮癣关节炎和强直性脊柱炎能导致慢性疼痛和炎症，有时候也能引起关节破坏和残疾。这种疾病影响着超过3百万的美国人。 　　“Simponi适用于很多病人，包括那些以前接受过多种疗法的风湿性关节炎，牛皮癣关节炎和强直性脊柱炎患者，并且该药能显著降低疾病的症状和体征。”哈佛大学的Jonathan教授说道，“该药给风湿病学家一个新的对抗肿瘤坏死因子的选择。” 　　在美国，Simponi每个月注射一次来治疗相关疾病，每次剂量为50mg，用药指针主要包括： 　　与甲氨蝶呤联合使用治疗成人中度至重度风湿性关节炎。 　　单独使用或与甲氨蝶呤联合使用治疗成人活动性牛皮癣关节炎。 　　治疗成人强直性脊柱炎。 　　Simponi有两种剂型，其安全性和有效性在一次广泛的临床发展计划中别评估。该临床开发计划同时评估了该药治疗风湿性关节炎，牛皮癣关节炎和强直性脊柱炎的效果。这项临床试验计划包括了2000名以上的患者，并且是被FDA批准的。在该药治疗风湿性关节炎的试验中，其治疗范围非常广泛。与安慰剂组或其他抗风湿病药物组相比，服用50mgSimponi和甲氨蝶呤的治疗过程中，关节炎症状至少减少了20%。 　　在评估Simponi治疗牛皮癣关节炎时，50mgSimponi能显著减少活动性牛皮癣关节炎症状。同时，该药也能减少强直性脊柱炎症状。牛皮癣关节炎和强直性脊柱炎在接受Simponi持续治疗时能获得实质性的疗效。 　　“随着Simponi的批准使用，我们能缓解数百万遭受慢性炎症疾病患者的痛苦，也能提高免疫学科研水平。” Centocor公司的主席泰勒说道，“最重要的是患者的安全，我们已经与FDA合作，开发抗肿瘤坏死因子疗法的危险评估和降低危险策略，确保医生能开出安全处方。” 　　“批准一项新的疗法对关节炎患者来说是好消息，因为不同的病人对不同的疗法耐受性不同 ，并不是所有的患者都适合当前的疗法。” John医生说道，“抗肿瘤坏死因子制剂是治疗关节炎疾病的一个重大进步，每个新药批准对医生和患者都是一个新的选择。” 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. 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. 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), blood dyscrasias, new or worsening CHF, elevated liver enzymes, antibody formation. How is SIMPONI supplied? Single-dose SmartJect autoinjector—1 Single-dose prefilled syringe—1 Related Disease: Ankylosing spondylitis Arthritis~biologic response modifiers Rheumatoid arthritis Related Resources News Similar Drugs Updated Drugs Pharmacology Notes Alerts Charts Xiaflex available for Dupuytren's contracture March 08, 2010 BioSpecifics Technologies and Auxilium Pharmaceuticals announced the availability of Xiaflex (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord. Xiaflex approved for Dupuytren's contracture February 03, 2010 Auxilium Pharmaceuticals announced the approval of Xiaflex (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord. Exel/Exelint infusion set needles recalled January 26, 2010 FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets, and Exel/Exelint "Securetouch+" Safety Huber Infusion Sets due to 'coring,' the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted). Phase 2 study of SBI-087 for treatment of rheumatoid arthritis (RA) January 11, 2010 Trubion Pharmaceuticals announced the initiation of a Phase 2 trial of SBI-087 for the treatment of rheumatoid arthritis (RA). Actemra approved for moderately to severely active rheumatoid arthritis January 11, 2010 The FDA has approved Actemra (tocilizumab, from Roche) for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.