Simponi

golimumab

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This is a summary of the European public assessment report (EPAR) for Simponi. 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 Simponi.

What is Simponi?

Simponi is a medicine that contains the active substance golimumab. It is available as pre-filled pens and syringes (50 and 100 mg) containing a solution for injection.

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;
  • axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine), including:

- patients with severe active ankylosing spondylitis who have not responded adequately to other treatments;

- patients with severe non-radiographic axial spondyloarthritis (when there are objective signs of inflammation but no abnormalities seen on x-ray) who have not responded adequately or are intolerant to anti-inflammatory medicines called non-steroidal anti-inflammatory drugs (NSAIDs);

  • moderately to severely active ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut). Simponi is used in patients who have not responded adequately to, or cannot use, conventional treatment.

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. For rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, Simponi is given as a once-monthly 50 mg injection under the skin, given on the same day of each month. 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. For ulcerative colitis, an initial ‘induction’ dose of 200 mg is given, followed by a dose of 100 mg after 2 weeks, then a stable ‘maintenance’ dose of either 50 mg or 100 mg every four weeks depending on body weight.

After training, patients may inject themselves with Simponi if their doctor agrees. 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-a). 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-a, golimumab reduces the inflammation and other symptoms of these diseases.

How has Simponi been studied?

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.

For non-radiographic axial spondyloarthritis, Simponi was compared with placebo over 16 weeks in one main study involving 198 patients who had the disease without evidence of ankylosing spondylitis but with signs of inflammation and who had not responded adequately to treatment with NSAIDs.

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, 16 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.

For ulcerative colitis, Simponi was compared with placebo in two main studies in patients who had not responded to or could not use other treatments. The first study, involving 1,065 patients, compared different doses of Simponi with placebo as induction treatment. The second study, involving 1,228 patients, compared Simponi 50 or 100 mg with placebo as maintenance treatment. The main measure of effectiveness was the number of patients who responded to treatment, based on the number and severity of symptoms. This was assessed after 6 weeks in the first study and after 54 weeks in the second study.

What benefit has Simponi shown during the studies?

Simponi 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 % 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-a, 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).

In the study of axial spondyloarthritis, after 16 weeks, 71% of patients who received Simponi (69 out of 97) had 20% reductions compared with 40% of patients who were given placebo (40 out of 100).

In the first study of ulcerative colitis, around 51% of patients receiving induction treatment with Simponi (starting at 200 mg) responded to treatment after 6 weeks, compared with around 30% of patients given placebo. In the second study, around 50% of patients receiving maintenance treatment with Simponi 100 mg and around 47% of those given Simponi 50 mg responded to treatment after 54 weeks, compared with around 31% of patients given placebo.

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 protective sheath around nerves, such as changes to vision and weak arms or legs), re-activation of hepatitis B (a liver disease), congestive heart failure (a heart disease), lupus-like syndrome, blood reactions, severe allergic reactions, vasculitis (swollen blood vessels), and lymphoma and leukaemia (types of cancer of the white blood cells). For the full list of all side effects reported with Simponi, see the package leaflet.

Simponi 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. For the full list of restrictions with Simponi, see the package leaflet.

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 and effective use of Simponi?

A risk management plan has been developed to ensure that Simponi is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Simponi, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Simponi must provide educational packs for doctors who prescribe Simponi with information on the safety of the medicine. Patients treated with Simponi must also be given a special alert card that summarises the safety information about the medicine.

Other information about Simponi

The European Commission granted a marketing authorisation valid throughout the European Union for Simponi on 1 October 2009.

For more information about treatment with Simponi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Simponi : EPAR - Summary for the public BG = bălgarski 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public ES = español 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public CS = čeština 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public DA = dansk 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public DE = Deutsch 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public ET = eesti keel 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public EL = elliniká 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public EN = English 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public FR = français 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public IT = italiano 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public LV = latviešu valoda 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public LT = lietuvių kalba 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public HU = magyar 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public MT = Malti 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public NL = Nederlands 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public PL = polski 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public PT = português 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public RO = română 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public SK = slovenčina 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public SL = slovenščina 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public FI = suomi 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public SV = svenska 20/10/2009 04/03/2016
Simponi : EPAR - Summary for the public HR = Hrvatski 20/10/2009 04/03/2016

This EPAR was last updated on 04/03/2016 .

Authorisation details

Product details

Product details for Simponi
NameSimponi
Agency product numberEMEA/H/C/000992
Active substance

golimumab

International non-proprietary name (INN) or common name

golimumab

Therapeutic area Spondylitis, AnkylosingArthritis, RheumatoidColitis, UlcerativeArthritis, Psoriatic
Anatomical therapeutic chemical (ATC) code L04AB06

Publication details

Publication details for Simponi
Marketing-authorisation holder

Janssen Biologics B.V.

Revision23
Date of issue of marketing authorisation valid throughout the European Union01/10/2009

Contact address:

Janssen Biologics B.V.
Einsteinweg 101
NL-2333 CB Leiden
The Netherlands

Product information

Product information

19/11/2015  Simponi -EMEA/H/C/000992 -II/0065/G

Name Language First published Last updated
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016
Simponi : EPAR - Product Information HR = Hrvatski 20/10/2009 04/03/2016

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.


Name Language First published Last updated
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013
Simponi : EPAR - All Authorised presentations HR = Hrvatski 20/10/2009 23/10/2013

Name Language First published Last updated
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  
Simponi : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 20/10/2009  

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

  • Arthritis, rheumatoid
  • Axial spondyloarthritis:

- Spondylitis, ankylosing

- Non‑radiographic axial spondyloarthritis (nr‑Axial SpA)

  • Arthritis, psoriatic
  • Colitis, ulcerative

Assessment History