Biologic medications

Tumor necrosis factor alpha (TNF-alpha) is a protein that primarily causes inflammation in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and several other diseases. Etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), certolizumab pegol (Cimzia®) and golimumab (Simponi®) are medications that bind to the joints and help eliminate high levels of TNF.

Enbrel is given at a dose of 50 mg once a week. It now comes in a pre-filled, 50 mg syringe and an auto injecting pen (called SureClick). It also is available in 25 mg vials, which can be given once or twice a week. Common injection sites are the thigh and abdomen.

For helpful patient resources, visit enebrel.com.

Remicade is taken intravenously. The medication dose usually is started at 3 mg/kg to 5 mg/kg. For example, if you weigh 160 pounds (72 kg), the starting dose of Remicade would be 216 mg. Often, the dose is rounded to the nearest 10 mg increment. Traditionally, Remicade is given with infusions at zero, two and six weeks, then every eight weeks. Sometimes the dose needs to be increased or the interval between infusions shortened to obtain maximum benefit. The maximum dose is 10 mg/kg every four weeks. Remicade is an antibody. In the manufacturing process, a small amount of mouse protein is inserted into the antibody. As a result, some people develop antibodies against Remicade, which can interfere with the drug’s action. Most doctors will prescribe methotrexate, or other drugs with Remicade, to prevent these antibodies from forming.

For more information, visit remicade.com.

Humira is given subcutaneously at a dose of 40 mg every two weeks, and can be increased to every week. The vials are 40 mg/0.8 mL. One box contains two vials (a one-month supply). An auto injecting pen is now available.

For helpful patient resources, visit humira.com.

Simponi is given subcutaneously at a dose of 50 mg once a month, either in an autoinjector or a prefilled syringe.

For helpful patient resources, visit www.simponi.com.

Cimzia is given subcutaneously. It comes in 200 mg vials. Initially, its dose is 400 mg (two injections) at weeks zero, two and four, then at 200 mg (one injection) every two weeks thereafter.

For helpful patient resources, visit www.cimzia.com.

Injection, infusion reactions. Enbrel, Humira and Cimzia are given subcutaneously. Sometimes, a red area of skin will occur at the injection site several days later, with mild discomfort. Normally, these are managed with topical hydrocortisone cream and do not necessitate stopping the medicine. If the red area continues to expand, notify your doctor. Remicade is given by infusion. Infusion reactions include hives, elevated blood pressure or lowered blood pressure. Reactions can be treated in a variety of ways, including premedication with Tylenol®, Benadryl®, loratadine (Claritin® or Alavert®) or Solu-medrol®; slowing down the infusion; or giving intravenous fluids. Serious infusion reactions are rare.

Infections. With all TNF blockers, an increased risk of upper respiratory infections (colds, bronchitis) exists. More serious infections, including tuberculosis and certain fungal and bacterial infections, also can occur. If you become ill with fever, seek evaluation by your primary doctor, urgent care or emergency room. During any infection beyond a simple cold or bladder infection, temporarily stop TNF blockers.

Tuberculosis (TB). If TB occurs, it usually happens in patients with previous exposure. For this reason, all patients should have a PPD (tuberculin) skin test before starting treatment with a TNF blocker. Some rheumatologists also will check a chest X-ray to look for evidence of previous lung infections. If the skin test is positive (more than 5 mm), then treatment with a drug for TB would be required before starting a TNF blocker.

Malignancy. Rheumatoid arthritis patients have an increased risk of developing lymphoma, a blood cell cancer, regardless of what treatment they are given. Limited information suggests that treatment with TNF blockers may increase cancer risk. Many of these cancers which can be screened for, such as skin cancer, lymphoma, breast cancer and colon cancer. Screening for such cancers with mammography, colonoscopy, skin exams and lymph node exams can be a regular part of preventive care with your primary doctor. The risk of cancer with TNF blockers appears low and, ultimately, the decision to start TNF blocker therapy needs to balance this and other risks with the potential substantial benefit in preventing joint damage, pain and disability.

Multiple sclerosis-like syndromes. Very rarely, patients on TNF blockers develop multiple sclerosis or other nerve problems.

Congestive heart failure. TNF blockers usually are avoided in patients who have had heart failure, but they do not cause heart failure in otherwise healthy patients with normal heart function.

Lupus-like syndromes. Very rarely, a patient may develop a lupus-like illness that includes rash, joint pain and pleurisy (fluid around the lung). Symptoms usually resolve after stopping the drug.

Blood problems. Rare cases of low white blood cell counts and low platelet counts have been reported with using TNF blockers. If your blood tests are not being monitored for methotrexate or other medications, it may be reasonable to check the blood count once or twice a year while on TNF blockers.

TNF blockers can start working within a few days to a few weeks, but usually several months pass before one can determine maximum benefit. About 70 percent of patients have a significant response to TNF blockers. Besides reducing pain, swelling and stiffness, they can halt or slow down joint damage.

Monitoring blood tests for methotrexate and other drugs are sufficient to monitor for blood problems from TNF blockers. If you are on a TNF blocker and no other medication, then a blood count may be performed once or twice a year.

Our nurses can provide instruction on how to perform self-injections of Enbrel, Humira and Cimzia. The information from the manufacturers of these medications also illustrate the injection technique. TNF blockers are very expensive, ranging from about $12,000 to $40,000 a year. Therefore, it is extremely important that you be approved by your insurance before beginning therapy, and that you understand what your copayment will be. Some copay assistance is provided by the drug manufacturers.

Deciding which TNF blocker to use depends on several factors, including the desired mode of administration (injection or IV), personal cost and frequency of administration (twice a week, weekly, every two weeks, and every one month to two months). One advantage to more frequent injections (Enbrel) is that if you develop an infection, the medication is out of your system faster than with longer-acting TNF blockers (Humira, Cimzia and Remicade).

Stop TNF blockers around the time of major surgery. Enbrel should be stopped seven days to 14 days before and after surgery, Humira two weeks before and after surgery (total of one month), and Remicade for one month before and after surgery.