What important information do I need to know about taking ENBREL?

ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections.

All medicines have side effects, including ENBREL. Possible side effects of ENBREL include:

• Serious infections
  • Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes
  • Some serious infections have been fatal
  • Rare cases of tuberculosis have occurred
    • What not to do
      • Do not start ENBREL if you have an infection such as an open sore or the flu, or are allergic to ENBREL or its components
    • What to do
      • Tell your doctor if you are prone to infection
      • Stop ENBREL if a serious infection occurs
      • Contact your doctor if you have questions about ENBREL or develop an infection
      • Tell your doctor if you have ever been treated for heart failure
• Serious nervous system disorders such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes
  • Tell your doctor if you have ever had any of these disorders or if you develop them after starting ENBREL
• Rare reports of serious blood disorders (some fatal)
  • Contact your doctor immediately if you develop symptoms such as persistent fever, bruising, bleeding, or paleness
• In medical studies of all TNF blockers, including ENBREL, a higher rate of lymphoma (a type of cancer) was seen compared to the general population. The risk of lymphoma may be up to several fold higher in rheumatoid arthritis and psoriasis patients
  • The role of TNF blockers, including ENBREL, in the development of lymphoma is unknown
• ENBREL can cause injection site reactions.

If you have any questions about this information, be sure to discuss them with your doctor. Please see full Prescribing Information.

Rheumatoid Arthritis (RA)
ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.
ENBREL can be initiated in combination with methotrexate (MTX) or used alone.

• In medical studies, ENBREL was shown to be effective in about 2 out of 3 adults with moderately to severely active RA who used it, and has been shown to begin working in as few as 2 weeks, with most patients receiving benefit within 3 months.

Polyarticular-Course Juvenile Rheumatoid Arthritis (JRA)
ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more DMARDs.

• In medical studies, ENBREL was shown to be effective in about 3 out of 4 children with JRA who used it. For these JRA patients, ENBREL has been shown to begin working in approximately 2 to 4 weeks.

Psoriatic Arthritis
ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.

• In medical studies, ENBREL was shown to be effective in about 50% of psoriatic arthritis patients who used it. Clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.

Ankylosing Spondylitis (AS)
ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

• In medical studies, ENBREL was shown to be effective in about 3 out of 5 adults with AS who used it. Clinical responses were seen by 2 weeks in 40% of patients, with most patients receiving maximum benefit within 8 weeks.

Psoriasis
ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

• In medical studies, nearly half of patients saw a significant improvement in their plaque psoriasis within 3 months of using ENBREL. Overall, 3 out of 4 patients saw improvement. ENBREL can work fast; many patients saw improvement within 2 months. ENBREL has been shown to be effective through 12 months of therapy.

银屑病,Enbrel可能成为治疗银屑病的第一个抗-TNF药

Amgen公司与Wyeth Pharmaceuticals公司的抗TNF融合蛋白Enbrel(etanercept)(Ⅰ)在向美国FDA申请增补性BLA后有可能成为用于银屑病的第一个批准的TNF抑制剂。

该公司申请的是用于中、重度斑块型银屑病的许可证。有两项Ⅲ期试验的资料支持。(Ⅰ)目前销售用于类风湿性关节炎、青年型类风湿性关节炎及银屑病性关节炎。如获批准,银屑病将是继关节强硬性脊椎炎后(Ⅰ)治疗的第5个炎症性疾病，对强直性脊椎炎的使用也在接受FDA的审查。

如获批准，(Ⅰ)将与银屑病市场中较新的生物药竞争，但它的优点是已对其它适应症销售使用五年，知道其安全性。Biogen公司的能降低T细胞过度活性的Amevive(alefacept)已于2月在美国上市用于银屑病，早已为皮肤病医师熟悉。另一个新的生物药，Genentech/Xoma公司的人源化CD-11a Mab，Raptiva(efalizumab)也在等待FDA用于银屑病的许可证。Centocor/Scheriag-Plough公司的抗-TNF产品，Remicade(inflixionab)则在此适应症作临床试验。

Amgen公司在1月公布了这项申请的第一项Ⅲ期试验的资料。第二项583例病人的多中心试验是日前在国际银屑病专题会上宣读的。研究发现，接受(Ⅰ)50mg或25mg，每周二次的病人与安慰剂组病人比较，在12周后银屑病面积和严重程度指数改善75%(PASI 75)或以上的病人分别为49％、34％及3％