Tocilizumab (RoActemra, Actemra): biologic treatment for arthritis and giant cell arteritis

Tocilizumab is a biological therapy. The RoActemra leaflet describes it as a protein made from specific immune cells, a monoclonal antibody, that blocks the action of a cytokine called interleukin-6. This protein is involved in inflammatory processes, and blocking it can reduce inflammation. Arthritis UK adds that in children too much IL-6 can cause fever and rashes.

It is one of several biologic drugs used in rheumatology. Arthritis UK says it may be the first biological therapy you are given, or you may have tried others first, such as an anti-TNF treatment or rituximab. The leaflet says it is not recommended for use with other biological medicines for these conditions, because of a lack of clinical experience.

The leaflet says treatment will be prescribed and started by healthcare professionals experienced in diagnosing and treating these conditions.

In rheumatoid arthritis, the leaflet lists adults with moderate to severe active disease if previous therapies did not work well enough, and adults with severe, active and progressive disease who have not had methotrexate. It says tocilizumab helps reduce pain and swelling, slows damage to cartilage and bone and improves daily activities, and is usually given with methotrexate but can be given alone if methotrexate is inappropriate. Arthritis UK says it can be used in severe arthritis that has not responded to intensive therapy with a combination of conventional DMARDs.

In giant cell arteritis (GCA), the leaflet explains the disease is inflammation of the body’s largest arteries, especially those supplying the head and neck, with symptoms including headache, fatigue and jaw pain and effects that can include stroke and blindness. Steroids are usually effective but have side effects at high doses for a long time, and reducing the dose can cause a flare-up. Adding tocilizumab means steroids can be used for a shorter time while still controlling GCA.

Arthritis UK says tocilizumab is recommended as an option for GCA in adults if used with steroids that are gradually decreased, and can then be used alone after glucocorticoids are stopped, but only if the condition has not responded to steroids alone or has relapsed and if tocilizumab has not been used before. It should not be continued for more than one year in GCA.

In children and adolescents aged 12 and over, it is used for systemic juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis, according to the leaflet. It can be given with methotrexate or alone.

Arthritis UK sets out the schedules. For rheumatoid arthritis, a weekly subcutaneous injection, or an intravenous infusion taking about an hour once every four weeks. For giant cell arteritis, a weekly injection in the thigh or upper arm. For systemic JIA aged 12 or over, weekly or every two weeks by injection depending on weight, or every two weeks by infusion. For polyarticular JIA aged 12 or over, every two or three weeks by injection depending on weight, or every four weeks by infusion.

The leaflet says the adult dose for RA or GCA with the pre-filled pen is 162 mg once a week, that it is injected under the skin, and that you may be trained to inject yourself. Parents and carers get training for children who cannot inject themselves.

Arthritis UK says it will work within three to six months if it is going to work at all, though some people feel better as early as two weeks. It is a long-term treatment: keep taking it even if it does not seem to be working at first, unless side effects occur.

Tocilizumab can reduce the body’s ability to respond to infections. Arthritis UK says it has been shown to increase the risk of infections in rheumatoid arthritis, including upper respiratory tract infections, cold sores, shingles, skin infections such as cellulitis and pneumonia, and that infections should be treated as soon as possible. Because the usual signs may be masked, seek advice if you are unsure. If you are prescribed antibiotics, speak to your rheumatology team; infusions may need to be cancelled or injections paused until the infection clears.

Before starting, your doctor will check whether you have previously been exposed to tuberculosis and you may need treatment for latent TB first. Adults are screened for hepatitis B and C and may have a chest X-ray before starting and six months afterwards. The leaflet asks you to tell your doctor if you have had TB, intestinal ulcers or diverticulitis, liver disease, cancer, cardiovascular risk factors or kidney problems, and says you should not use it if you have an active, severe infection.

Arthritis UK recommends carrying a biological therapy alert card so anyone treating you knows you are on tocilizumab. You can get one from your rheumatology department.

Common side effects listed by Arthritis UK include a cough or sore throat, blocked or runny nose, headaches or dizziness, mouth ulcers, high blood pressure, raised cholesterol, allergic reactions, weight gain or swollen ankles, skin rashes, itching and stomach irritation or abdominal pain. The leaflet asks you to tell the doctor immediately about allergic reactions such as chest tightness, wheezing, severe dizziness, swelling of the lips, tongue or face, hives or rash, and not to take the next dose until the doctor says so.

Because it can increase cholesterol and affect liver function tests, a blood test is needed every four weeks. The leaflet says a blood test before treatment checks for a low white blood cell count, low platelet count or high liver enzymes. Dizziness may affect driving.

Arthritis UK says there is no good evidence that tocilizumab increases cancer risk, but tell your team if you have had cancer.

Arthritis UK says people on tocilizumab should usually avoid live vaccines including yellow fever, varicella-zoster, typhoid, rotavirus, MMR and BCG, while the shingles vaccination, pneumococcal vaccine and yearly flu vaccines are safe and recommended. Where possible, routine childhood vaccinations should be given before starting.

If you have an operation, intravenous tocilizumab should be stopped at least four weeks before surgery and subcutaneous tocilizumab at least two weeks before, so tell the surgical team early.

In pregnancy, Arthritis UK says tocilizumab should be avoided unless essential, as it is not known how it affects an unborn baby; the leaflet says women of childbearing potential must use effective contraception during and up to 3 months after treatment. Arthritis UK says it should be OK to breastfeed but research is limited, while the leaflet says to stop breastfeeding and leave a gap of at least 3 months after the last treatment. The documents differ, so ask your rheumatologist.

Biologic therapies are started by specialist teams, usually rheumatology, and the leaflet says treatment is started by healthcare professionals experienced in these conditions. This applies on the NHS and in private practice alike. Whichever route, regular monitoring and an alert card are essential.