Actemra     Tocilizumab     TCZ

Actemra is a biologic drug used to treat the symptoms of rheumatoid arthritis. It is also approved for giant cell arteritis, polyarticular juvenile idiopathic arthritis (PJIA), systemic juvenile idiopathic arthritis (SJIA) and cytokine release syndrome (CRS).

Response to expect with Actemra                                                                    At 24 weeks of weekly injections, 69% of those with RA had a 20% improvement in symptoms. Additionally, 47% had a 50% improvement and 24% had a 70% improvement. That leaves 31% with no improvement. None of the biologics work for everyone.

Pill, shot or IV? Actemra is a rheumatoid arthritis drug that is a large molecule. What that means is that Actemra would not work as a pill and must be given as an injection. Actemra is given once every two weeks initially. Depending on the response, it may then be given weekly. It is given under the skin subcutaneously. This is the same method used for diabetics giving themselves insulin using a syringe.  Easy and painless. Actemra comes in a prefilled syringe, and it also comes in an ACTpen which is an autoinjector. It must be stored under refrigeration until 30-45 minutes before use.

Actemra may also be given as an infusion which is an IV given in a medical facility over several hours.

In preparation for Actemra. A TB test is required. Tests for hepatitis are also given. It is recommended that the newer shingles vaccine Shingrix be given. It is given in two doses over two two six months. It is not live so may be given before or during Actemra use. A flu vaccine is also recommended which is also not live.

Pregnancy and lactation                                                                                      The effects of Actemra on the fetus during pregnancy or the on the breast milk are unknown.

Common Side effects                                                                                            The most common side effects of Actemra are upper respiratory infections (common cold, sinus infection), headache, increased blood pressure and injection site reactions.

Black box warning                                                                                                This warning for Actemra is given for serious, maybe deadly, infections. Infections may include tuberculosis, invasive fungal infections, bacterial, viral and other infection due to opportunistic pathogens. Infection is a serious problem for those with rheumatoid arthritis.

Additional serious side effects                                                                             Infections must be taken very seriously. A person on an RA biologic will have a compromised immune system. Tuberculosis, if present in the body, may be reactivated. A TB test will reveal the presence of TB. If positive, a person should be treated before starting Actemra. A person with a history of chicken pox should have the new shingles vaccine. Otherwise, there is a risk of shingles. A person with a history of diverticulitis should pay attention to new abdominal symptoms, as gastrointestinal perforation has occurred while on Actemra during clinical trials. Cholesterol lab values may increase on Actemra and should be monitored.

Cost                                                                                                                             Four prefilled syringes of 162 mg of Actemra without coverage would cost about $4500.00 a month in 2019 at Walgreen’s according to wellrx.com. It is similar in cost to Orencia. It is hard to assess insurance copays as they are different in the various insurance plans. There can be no generic drug for Actemra. The drug is made from a live cell not a chemical formula that can be duplicated. There is not a biosimilar for Actemra. A biosimilar is a drug that is made in a similar but not exact same way as the original. There are a few RA biologics that have biosimilars. The difference in cost is not huge.

History                                                                                                               Interleukin 6 (IL-6) and its receptor components were discovered and cloned by Japanese immunologist, Tadamitsu Kishimoto.  Dr Kishimoto was a successful pioneer in the field of cytokine research and was instrumental in the development of Actemra.

In 2005 Japanese Chugai Pharmaceuticals launched Actemra. Chugai is in an alliance with Roche(Switzerland) and  Genentech (USA). Actemra is sold by Chugai in Japan and Asia, Roche in Europe and by Genentech in the USA. In 2010 the FDA approved Actemra for rheumatoid arthritis. It was approved for children with polyarticular juvenile idiopathic arthritis in 2013 and systemic juvenile idiopathic arthritis in 2017. Both are forms of juvenile RA.

Action                                                                                                                IL-6 is produced by synovial and endothelial cells in the joint and contributes to the inflammatory process. Actemra is a humanized interleukin-6 receptor-inhibiting monoclonal antibody that suppresses the inflammation activity of rheumatoid arthritis. As a targeted drug, Actemra may be a magic bullet for someone suffering with rheumatoid arthritis.

Our immune system has many components. Various drugs have been designed to affect individual overactive factors in our immune systems. Actemra affects IL-6.  Humira and Embrel affect TNF (tumor necrosis factor). Orencia affects T cells. Rituxan affects B cells. Each are designed to suppress a particular overactive molecule in our immune system.

Do not be discouraged if one immunosuppressive drug doesn’t work for you. Try another.  It might work better. There doesn’t seem to be a test to determine which molecules in the immune system are causing an individual’s RA or which biologic will work best.

It is good to review the package insert for the drugs you are taking. It looks more complicated than it is and worth the effort. The drug’s website also has helpful information about the drug.

RA biologics are magic bullets for many of us. But they come with serious cautions. It is a smart person who checks out the cautions and determines two things. First, she needs to determine what is her individual risk and what she will need to do to protect herself. Second, she needs to weigh her need for relief with the cost of the biologic and with the possible complications. Doctors recommend, but we need to determine what is the right choice for us.