Simponi

golimumab

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Simponi?

Simponi is a solution for injection that contains the active substance golimumab. It is available as a prefilled pen and syringe (50 mg).

What is Simponi used for?

Simponi is an anti-inflammatory medicine. It is used in adults to treat the following diseases:

• active rheumatoid arthritis (a disease causing inflammation of the joints). Simponi is used in combination with methotrexate (another anti-inflammatory medicine). It can be used in patients who have not responded adequately to other treatments including methotrexate whose disease is moderate to severe, and in patients who have not previously been treated with methotrexate whose disease is severe and progressive;
• active and progressive psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints). Simponi is used in patients who have not responded adequately to other treatments. It can be used alone or in combination with methotrexate;
• severe active ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine). Simponi is used in patients who have not responded adequately to other treatments.

The medicine can only be obtained with a prescription.

How is Simponi used?

Treatment with Simponi must be initiated and supervised by a qualified doctor who has experience in the diagnosis and treatment of the diseases that Simponi is used to treat. Simponi is given as a once-monthly 50-mg injection, given on the same day of each month, as an injection under the skin. The doctor may consider increasing the dose to 100 mg in patients weighing more than 100 kg, if they do not respond to treatment after three or four doses. After training, patients may inject themselves with Simponi if their doctor agrees. Patients who are treated with Simponi must be given a special alert card that summarises the safety information about the medicine. For more information, see the package leaflet.

How does Simponi work?

The active substance in Simponi, golimumab, 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. Golimumab has been designed to attach to a chemical messenger in the body called tumour necrosis factor alpha (TNF-α). This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Simponi is used to treat. By blocking TNF-α, golimumab reduces the inflammation and other symptoms of these diseases.

How has Simponi been studied?

The effects of Simponi were first tested in experimental models before being studied in humans.

For rheumatoid arthritis, Simponi was compared with placebo (a dummy treatment) in three studies involving 1,542 patients with moderate to severe rheumatoid arthritis, including patients who had not received or responded adequately to other treatments.

For psoriatic arthritis, Simponi was compared with placebo over 24 weeks in one main study involving 405 patients who had not responded adequately to other treatments.

For ankylosing spondylitis, Simponi was compared with placebo over 24 weeks in one main study involving 356 patients who had not responded adequately to other treatments.

The main measures of effectiveness were based on the number of patients who had 20 or 50% reductions in the number and severity of symptoms after 14 weeks or 24 weeks. The other main measure of effectiveness, used in one study, was the improvement in the patient’s ability to carry out everyday tasks (such as dressing, eating, and walking) after 24 weeks.

What benefit has Simponi shown during the studies?

Simponi 50 mg was more effective than placebo in all of the diseases studied.

In the first rheumatoid-arthritis study, in which patients were also given methotrexate, after 14 weeks, 55% of patients who received Simponi (49 out of 89) achieved 20% reductions compared with 33% (44 out of 133) of patients who received placebo. This study also showed that patients who received Simponi had greater improvements in carrying out everyday tasks. In the second rheumatoid-arthritis study, after 14 weeks, 35% of patients who received Simponi alone (54 out of 153) achieved 20% reductions compared with 18% of patients who received placebo (28 out of 155). In the third rheumatoid-arthritis study, in patients who had not been previously treated with either methotrexate or another anti-TNF-α, after 24 weeks, 40% of patients who received Simponi with methotrexate achieved 50% reductions (64 out of 159), compared with 29% of patients who received placebo (47 out of 160) and methotrexate. Data from X-rays taken before and after two years of treatment showed less joint damage in patients receiving Simponi than in those receiving placebo.

In the study of psoriatic arthritis, after 14 weeks, 51% of patients who received Simponi (74 out of 146) had 20% reductions compared with 9% of patients who were given placebo (10 out of 113).

In the study of ankylosing spondylitis, after 14 weeks, 59% of patients who received Simponi (82 out of 138) had 20% reductions compared with 22% of patients who were given placebo (17 out of 78).

What is the risk associated with Simponi?

The most common side effects with Simponi are upper-respiratory-tract infections such as infections of the nose, throat or voice box. The most serious side effects include serious infections, such as sepsis (blood infection), pneumonia (lung infection), tuberculosis and infections due to fungi or yeasts, demyelinating disorders (disorders suggesting damage to the sheath of nerves, such as changes to vision and weak arms or legs), lymphoma (a type of cancer of the white blood cells), re-activation of hepatitis B (a liver disease), congestive heart failure (a heart disease), lupus-like syndrome and blood reactions. For the full list of all side effects reported with Simponi, see the package leaflet.

Simponi should not be used in people who may be hypersensitive (allergic) to golimumab or any of the other ingredients. It must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).

Due to an increased risk of infection, patients taking Simponi must be monitored closely for infections, including tuberculosis, during and for up to five months after treatment.

Why has Simponi been approved?

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

What measures are being taken to ensure the safe use of Simponi?

The company that makes Simponi must provide educational packs for doctors who prescribe Simponi. These packs include information on the safety of the medicine.

Other information about Simponi:

The European Commission granted a marketing authorisation valid throughout the European Union for Simponi to Janssen Biologics B. V. on 1 October 2009. The marketing authorisation is valid for five years, after which it can be renewed.

This EPAR was last updated on 13/06/2013 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

21/03/2013  Simponi -EMEA/H/C/000992 -II/0044

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

Rheumatoid arthritis

Simponi, in combination with methotrexate (MTX), is indicated for:

• the treatment of moderate to severe, active rheumatoid arthritis in patients when the response to disease-modifying-antirheumatic-drug (DMARD) therapy including MTX has been inadequate;
• the treatment of severe, active and progressive rheumatoid arthritis in patients not previously treated with MTX. 

Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.

Psoriatic arthritis

Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.

Ankylosing spondylitis

Simponi is indicated for the treatment of severe, active ankylosing spondylitis in patients who have responded inadequately to conventional therapy.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents