RoActemra

tocilizumab

This is a summary of the European Public Assessment Report (EPAR) for RoActemra. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for RoActemra.

What is RoActemra?

RoActemra is a concentrate that is made up into a solution for infusion (drip into a vein). It contains the active substance tocilizumab.

What is RoActemra used for?

RoActemra is used to treat adults (aged 18 years or over) with moderate to severe active rheumatoid arthritis (an immune system disease causing inflammation of the joints). It is used in combination with methotrexate (another medicine used in rheumatoid arthritis) in patients who have not responded adequately to or who could not tolerate other treatments, including conventional medicines for rheumatoid arthritis (such as methotrexate) or tumour necrosis factor (TNF) blockers. RoActemra can be used on its own in patients who cannot take methotrexate.

RoActemra is also used to treat children from two years of age with active systemic juvenile idiopathic arthritis (a childhood disease causing inflammation of the joints) who have not responded to other treatments (NSAIDs and corticosteroids) . It is used in combination with methotrexate or on its own if methotrexate cannot be used.

When used with methotrexate, RoActemra can slow down the damage to the joints and improve physical function (the ability to perform everyday tasks).

The medicine can only be obtained with a prescription.

How is RoActemra used?

Treatment with RoActemra should be started by a doctor who has experience in the diagnosis and treatment of rheumatoid arthritis or active systemic juvenile idiopathic arthritis.

RoActemra is given as an infusion lasting an hour. In rheumatoid arthritis, the recommended dose is 8 mg per kilogram body weight once every four weeks, but doses above 800 mg per infusion are not recommended. Doses above 1,200 mg have not been tested.

In systemic juvenile idiopathic arthritis, RoActemra is given once every two weeks at a dose of 8 mg per kilogram body weight in children weighing 30 kg or more, or 12 mg per kilogram body weight in children weighing less than 30 kg. If no improvement is seen after six weeks it may be appropriate to discontinue treatment.

The dose of RoActemra or methotrexate may need to be adjusted or treatment interrupted in patients who develop liver or blood problems. Doctors should monitor the kidneys carefully in patients with moderate or severe kidney problems.

Patients who receive RoActemra should be given the special alert card that summarises the safety information about the medicine.

How does RoActemra work?

The active substance in RoActemra, tocilizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body. Tocilizumab has been designed to attach to the receptor for a messenger molecule or ‘cytokine’ in the body called interleukin-6. This messenger is involved in causing inflammation and is found at high levels in patients with rheumatoid arthritis. By preventing interleukin-6 attaching to its receptors, tocilizumab reduces the inflammation and other symptoms of rheumatoid arthritis.

How has RoActemra been studied?

In rheumatoid arthritis, RoActemra has been studied in five main studies involving a total of over 4,000 adults with moderate to severe rheumatoid arthritis.

Four of the studies compared RoActemra with placebo (a dummy treatment). In three of these, the medicines were given as an add-on to failing treatment with methotrexate or other conventional rheumatoid arthritis medicines in a total of over 3,000 patients. In the fourth study, the medicines were given in combination with methotrexate in 498 patients who had an inadequate response to previous treatment with TNF blockers. The fifth study compared RoActemra given on its own with methotrexate in a total of 673 patients.

In all five studies, the main measure of effectiveness was the number of patients who had responded to treatment after six months. A response was defined as a reduction in symptom scores of 20% or more as measured using a standard scale for rheumatoid arthritis. One of the studies, which involved 1,196 patients, also looked at the effect of the combination of RoActemra and methotrexate on joint damage and physical function after one and two years of treatment.

Almost 4,000 patients from these studies went on to enter studies looking at the long-term effects of RoActemra treatment.

In systemic juvenile idiopathic arthritis, RoActemra was compared with placebo in one main study involving 112 children who had inadequate responses to NSAID and systemic corticosteroid treatment.

The main measure of effectiveness was the number of patients who had responded to treatment after three months and who had not had any fever for at least seven days.

What benefit has RoActemra shown during the studies?

RoActemra was more effective than the comparator medicines at reducing the symptoms of rheumatoid arthritis. In the studies of patients with an inadequate response to conventional treatments, patients adding RoActemra were around four times more likely to respond to treatment than those adding placebo. In the patients who had an inadequate response to TNF blockers, patients receiving RoActemra with methotrexate were around nine times more likely to respond than those receiving placebo. The fifth study showed that patients receiving RoActemra on its own were more likely to respond than those taking methotrexate on its own.

The combination of RoActemra and methotrexate also slowed down the damage to the joints and improved physical function after up to two years, when compared with the combination of placebo and methotrexate.

The long-term studies showed that the response to RoActemra is maintained for at least two years.
In systemic juvenile idiopathic arthritis, 85% (64 out of 75) patients treated with RoActemra responded to treatment and no longer had fever after three months, compared with 24% (9 out of 37) patients receiving placebo.

What is the risk associated with RoActemra?

The most common side effect with RoActemra (seen in more than 1 patient in 10) is upper respiratory tract infections (colds). For the full list of all side effects reported with RoActemra, see the Package Leaflet.

RoActemra should not be used in people who may be hypersensitive (allergic) to tocilizumab or any of the other ingredients. It must not be used in patients who have an active, severe infection. Doctors should monitor patients carefully for signs of infection during treatment, and should prescribe RoActemra with caution in patients who have had recurring or long-term infections, or diseases that could increase the risk of infections, such as diverticulitis (a disease affecting the gut) or diabetes.

Why has RoActemra been approved?

The CHMP decided that RoActemra’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Which measures are being taken to ensure the safe use of RoActemra?

The company that makes RoActemra must supply all doctors expected to prescribe the medicine with an educational pack containing important information tailored to the needs of doctors, nurses and patients on the safety and correct use of RoActemra.

Other information about RoActemra

The European Commission granted a marketing authorisation valid throughout the European Union for RoActemra on 16 January 2009.

For more information about treatment with RoActemra, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This EPAR was last updated on 30/08/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

01/08/2011  RoActemra -EMEA/H/C/000955 -II/0015

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

RoActemra, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.

RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents