阿达木单抗获准用于新适应证----斑块型银屑病2007年12月20日欧盟接受雅培公司的阿达木单抗(humira)用于中至重度斑块型银屑病的上市申请，这已是阿达木单抗要欧盟获批的第5个适应证。银屑病履属于全身性自体免疫性疾病，症状主要是为皮肤呈斑状凸起，红肿，导致皮肤破损，出血，还有可能导致银屑病关节炎。其常规治疗药物是甲氨蝶呤，阿达木单抗是首个治疗银屑病的生物制剂品。 此次新适应证的批准基于名为CHAMPION和REVEAL的2项多中心，随机对照临床试验结果。在这2项研究中，评估指标以病人受损银屑病殃及的皮损范围扩严重指数（PASI）计。 CHAMPION研究募集了来自欧洲和加拿大的271名银屑病患者，分别以甲氯蝶呤及安慰剂作为阳性和阴性对照，以评价阿达木单抗对该病的疗效。结果表明，阿达木单抗组用药后PASI响应率达75%（即改善率为75%）的患者人数约为甲氨蝶呤组的2倍，安慰剂组的4倍，分别占80%，36%，19%，治疗16周后，这3组PASI响应率达100%（即疾病症状完全消除）的患者人数分别占17%，7%和2%，另外，与治疗前相比，第4周阿达木单抗组的PASI即可平均改善57%。 REVEAL研究评价了阿达木单抗的短期和持续疗效及安全性，试验为52周，研究对象为1200名来自欧洲和加拿大的中至重度慢性斑块型银屑病患者，在用药第16周时，阿达木单抗即可显著改善PASI，阿达木单抗组PASI响应达75%的患者比例明显高于安慰剂组（71%--6.5%）。阿达木单抗组有20%的患者PASI响应率达100%，而只有1%的患者症状完全消除。选择使用阿达木单抗治疗8个月后PASI响应率保持在75%的患者，给其继续使用阿达木单抗或改用安慰剂，结果，在继续服用阿达木单抗的患者中，PASI响应率下降者只占5%，而在改用安慰剂的患者中，PASI响应率下降占28%。 临床试验还发现，阿达木单抗的最常见副作用为鼻咽炎，下呼吸道感染及头痛.  Humira What is Humira? Return to top Humira is type of drug called a tumor necrosis factor (TNF) blocker. It is used to treat moderate-to-severe rheumatoid arthritis (RA) or psoriatic arthritis (PsA). RA is an inflammatory disease of the joints; PsA is an inflammatory disease of the joints and skin. Humira is also used to treat juvenile idiopathic arthritis (JIA), ankylosing spondylitis (a chronic, degenerative inflammatory arthritis, causing eventual fusion of the spine), Crohn's disease (a type of inflammatory bowel disease), and plaque psoriasis. People with these conditions have too much of a protein called TNF in the affected areas of the body. What is the most important information I should know about Humira? Return to top Humira can lower your immune system's ability to fight infection. There is a risk of getting serious infections such as tuberculosis or other infections caused by viruses, fungi, and bacteria. You should be tested and, if positive, treated for tuberculosis before beginning treatment with Humira. Who should not take Humira? Return to top Do not begin treatment with Humira if you have an allergy to any of its ingredients. The needle cover on the prefilled syringe contains dry natural rubber, so tell your doctor if you have any allergies to rubber or latex. What should I tell my doctor before I take the first dose of Humira? Return to top Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Humira. Also, talk to your doctor about your complete medical history, especially if you have or have had any kind of infection (including an open cut or sore) or a systemic infection (such as the flu); if you have ever had tuberculosis (TB), or if you have been in close contact with someone who has had it; or if you experience any numbness or tingling or have ever had a disease that affects your nervous system such as multiple sclerosis. Your doctor should know if you are scheduled to have surgery or have a vaccination. What is the usual dosage? Return to top The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis Adults: The recommended dose of Humira is one 40-milligram (mg) injection every other week. Crohn's Disease Adults: The recommended starting dose of Humira is a 160-mg injection at Day 1 (given as 4 separate 40-mg injections in 1 day or as two 40-mg injections per day for 2 consecutive days), followed by 80 mg 2 weeks later (Day 15). After 4 weeks (Day 29), start maintenance dose of a 40-mg injection every other week. Plaque Psoriasis Adults: The recommended starting dose of Humira is one 80-mg injection, then 1 week after the initial dose, you'll receive a maintenance dose of 40 mg every other week. Juvenile Idiopathic Arthritis Children 4 to 17 years: The recommended dose of Humira (children >66 pounds) is one 40-mg injection every other week. The recommended dose of Humira (children 33 to 66 pounds) is one 20-mg injection every other week. If your child is <33 pounds, speak to your doctor about an appropriate Humira dosage. How should I take Humira? Return to top Your doctor will administer your first injection of Humira in your front thigh or abdomen. If you would like to self-administer, or have a caregiver administer your injection, have the doctor explain the proper injection and discarding technique. What are possible food and drug interactions associated with Humira? Return to top If Humira is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Humira with anakinra What are the possible side effects of Humira? Return to top Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug. Side effects may include: reaction at site of injection (bruising, itching, rash, redness, swelling) Usually, the rash will go away within a few days. If the skin around the area where you injected Humira still hurts or is swollen, try using a towel soaked with cold water on the injection site. If you have pain, redness or swelling around the injection site that doesn't go away within a few days or gets worse, call your doctor right away. Can I receive Humira if I am pregnant or breastfeeding? Return to top The effects of Humira during pregnancy and breastfeeding are unknown. Talk with your doctor before taking this drug if you are pregnant, plan to become pregnant, or are breastfeeding. What should I do if I miss a dose of Humira? Return to top If you forget to take Humira on time, inject the next dose right away. Then, take the following dose when your next scheduled dose is due. How should I store Humira? Return to top Store Humira in a refrigerator in the original container until it is used. Protect from light. Do not freeze Humira; if it has been frozen, do not use. Humira remains safe to use until the expiration date printed on the prefilled syringe or pen. If traveling, store Humira in a cool carrier with an ice pack and protect from light. Do not use if liquid is cloudy, discolored, or has flakes or particles in it.