Humira

adalimumab

  • Email
  • Help

About

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

What is Humira?

Humira is a medicine that contains the active substance adalimumab. It is available as a solution for injection in a pre‑filled syringe or pre‑filled pen, and a vial for use in children only, all containing 40 mg adalimumab.

What is Humira used for?

Humira is used to treat the following diseases in patients who have not responded adequately to other treatments or cannot use them:

  • adults with moderate to severe active rheumatoid arthritis (a disease causing inflammation of the joints), and severe active and progressive rheumatoid arthritis;
  • adults with active and progressive psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
  • adults with axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine), including patients with:
    • severe active ankylosing spondylitis;
    • severe axial spondyloarthritis without evidence in the X-ray of ankylosing spondylitis but with objective signs of inflammation;
  • adults with moderately to severely active Crohn’s disease (a disease causing inflammation of the gut);
  • adults with psoriasis (a disease causing red, scaly patches on the skin);
  • adults with moderately to severely active ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
  • children with severe active Crohn’s disease from 6 years of age;
  • patients with active polyarticular juvenile idiopathic arthritis from 2 years of age and active enthesitis-related arthritis from 6 years of age (both are rare childhood disease causing inflammation of many joints).

The medicine can only be obtained with a prescription.

How is Humira used?

Treatment with Humira must be started and supervised by a doctor who has experience in the treatment of the diseases that Humira is used to treat.

In adults, the recommended dose of Humira is 40 mg given every two weeks. For adults with Crohn’s disease and psoriasis, an initial (induction) dose of 80 mg is given followed one week later by 40 mg every two weeks (maintenance dose), while for ulcerative colitis the first two doses are 160 mg and 80 mg given two weeks apart followed by 40 mg every two weeks. Adult patients who need a more rapid response for Crohn’s disease may also need to start with these two higher doses, although this might increase the risk of side effects.

In children aged two to 12 with polyarticular juvenile idiopathic arthritis, the recommended dose is 24 mg per square metre body surface area (calculated using the patient’s height and weight), up to a maximum dose of 20 mg for children under four years old and up to 40 mg for children aged four to twelve, given every two weeks. In adolescents aged 13 to 17 with polyarticular juvenile idiopathic arthritis the dose is 40 mg every two weeks. In children and adolescents aged six to 17 with Crohn’s disease, the usual induction dose is 80 mg followed two weeks later by 40 mg every two weeks in children weighing at least 40 kg. These doses are halved in those weighing less than 40 kg, although the dose and frequency may be increased in certain circumstances. In children with enthesitis-related arthritis, the recommended dose is 24 mg per square metre body surface area, up to a maximum dose of 40 mg, given every two weeks.

Humira is given as an injection under the skin. After training, patients or their carers may inject Humira if their doctor considers it appropriate. Patients who receive Humira must be given a special alert card that summarises the safety information about the medicine. Patients may be given other medicines during treatment with Humira, such as corticosteroids (other anti‑inflammatory medicines).

For more information on how Humira is used to treat the different conditions, see the package leaflet.

How does Humira work?

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

How has Humira been studied?

Humira has been studied in five main studies of adult patients with moderate to severe rheumatoid arthritis. In four of these studies, Humira was compared with placebo (a dummy treatment), either alone or as an add-on to other anti‑inflammatory medicines and methotrexate, in over 2,000 patients. The fifth study compared the combination of Humira and methotrexate with methotrexate alone or Humira alone in 799 patients who had not taken methotrexate before.

For psoriatic arthritis, Humira was compared with placebo over 12 weeks in two main studies involving 413 adult patients. The medicines were taken alone or in combination with another anti‑inflammatory medicine.

For ankylosing spondylitis, Humira and placebo as an add-on to existing treatment were compared over 12 weeks in two main studies involving 397 adult patients. For axial spondyloarthritis without evidence in the X-ray of ankylosing spondylitis, Humira was compared with placebo over 12 weeks in a main study involving 192 adult patients who have not responded adequately or cannot take NSAIDs.

For Crohn’s disease, the effectiveness of the first two doses of Humira (induction) was compared with that of placebo in two main studies involving 624 adult patients over four weeks. Another main study involving 854 adult patients looked at the long-term effects (maintenance) of Humira over up to 56 weeks. A further main study involving 192 children aged six to 17 looked at the effectiveness of two different induction and maintenance doses of Humira, and compared the results with those seen in adults.

For psoriasis, Humira was compared with placebo over 16 weeks in a main study involving 1,212 patients. A second main study involving 271 patients compared Humira with methotrexate and with placebo over 16 weeks.

For ulcerative colitis, Humira was compared with placebo in two main studies involving 1,093 patients looking at induction and maintenance treatment with Humira. The effects of the induction dose were measured after eight weeks and the effects of maintenance treatment were assessed after 52 weeks.

For polyarticular juvenile idiopathic arthritis, Humira was compared with placebo, alone or as an add-on to methotrexate, in one main study involving 171 patients aged between four and 17 years. All of the patients received Humira for 16 weeks before being given Humira or placebo for a further 32 weeks. Humira was also investigated in a main study involving 32 children aged two to four (or over four years old but weighing under 15 kg) with polyarticular juvenile idiopathic arthritis. The study lasted 24 weeks. For enthesitis-related arthritis, Humira was compared with placebo in one main study over 12 weeks and involving 46 patients aged six years and above.

In all of the studies, the main measure of effectiveness was based on the change in symptoms.

What benefit has Humira shown during the studies?

Humira was more effective than placebo in all diseases studied.

In rheumatoid arthritis, the greatest reductions in symptoms were seen in the studies examining Humira as an add-on to methotrexate: around two thirds of the patients adding Humira had at least a 20% reduction in symptoms after six months, compared with a quarter of those adding placebo. Patients adding Humira also had less joint damage and experienced less reduction in physical function after a year. In patients who had not taken methotrexate in the past, the combination of Humira and methotrexate was also more effective than methotrexate alone. 

Humira also produced a greater improvement in symptoms than placebo in studies of psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis without evidence in the X-ray of ankylosing spondylitis but with objective signs of inflammation, and induction and maintenance phases of treatment for Crohn’s disease, psoriasis and ulcerative colitis.

For polyarticular juvenile idiopathic arthritis, in patients aged between four and 17 years old around 40% of the patients receiving Humira, either alone or in combination with methotrexate, had a flare-up of arthritis, compared with around 69% of those receiving placebo. However, fewer patients receiving Humira with methotrexate developed antibodies against Humira (which can prevent its action), so the results favoured the use of Humira with methotrexate over Humira used alone. The study in younger children (aged two to four) showed that the majority of children responded well to Humira treatment and this response was maintained after 24 weeks. For enthesitis-related arthritis, treatment with Humira resulted in a larger decrease in the number of swollen and tender joints compared with placebo.

What is the risk associated with Humira?

In studies, the most common side effects with Humira (seen in more than 1 patient in 10) were respiratory tract infections (infections of the lungs and airways), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), increased blood levels of lipids (fats), headache, abdominal pain (stomach ache), nausea (feeling sick) and vomiting, rash, musculoskeletal pain (pain in the muscles and bones), injection site reactions (including redness) and increased levels of liver enzymes. For the full list of all side effects reported with Humira, see the package leaflet.

Humira must not be used in patients with active tuberculosis, other severe infections, or moderate to severe heart failure (an inability of the heart to pump enough blood around the body). For the full list of restrictions with Humira, see the package leaflet.

Why has Humira been approved?

The CHMP decided that Humira’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 Humira?

A risk management plan has been developed to ensure that Humira 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 Humira, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Humira must provide educational packs for doctors who will prescribe Humira. These packs will include information on the safety of the medicine and an alert card to be given to patients.

Other information about Humira

The European Commission granted a marketing authorisation valid throughout the European Union for Humira on 8 September 2003.

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

Name Language First published Last updated
Humira : EPAR - Summary for the public BG = bălgarski 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public ES = español 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public CS = čeština 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public DA = dansk 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public DE = Deutsch 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public ET = eesti keel 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public EL = elliniká 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public EN = English 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public FR = français 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public IT = italiano 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public LV = latviešu valoda 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public LT = lietuvių kalba 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public HU = magyar 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public MT = Malti 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public NL = Nederlands 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public PL = polski 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public PT = português 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public RO = română 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public SK = slovenčina 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public SL = slovenščina 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public FI = suomi 23/11/2009 14/10/2014
Humira : EPAR - Summary for the public SV = svenska 23/11/2009 14/10/2014

This EPAR was last updated on 14/10/2014 .

Authorisation details

Product details

Product details for Humira
NameHumira
Agency product numberEMEA/H/C/000481
Active substance

adalimumab

International non-proprietary name (INN) or common name

adalimumab

Therapeutic area Spondylitis, AnkylosingArthritis, RheumatoidColitis, UlcerativeCrohn DiseaseArthritis, PsoriaticPsoriasisArthritis, Juvenile Rheumatoid
Anatomical therapeutic chemical (ATC) code L04AB04

Publication details

Publication details for Humira
Marketing-authorisation holder

AbbVie Ltd

Revision36
Date of issue of marketing authorisation valid throughout the European Union08/09/2003

Contact address:

AbbVie Ltd
Maidenhead
SL6 4XE
United Kingdom

Product information

Product information

19/09/2014  Humira -EMEA/H/C/000481 -IAIN/0135

Name Language First published Last updated
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014
Humira : EPAR - Product Information SV = svenska 12/11/2009 14/10/2014

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
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011
Humira : EPAR - All Authorised presentations SV = svenska 23/06/2009 19/05/2011

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis

Humira, in combination with methotrexate, is indicated for:

  • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs)including methotrexate has been inadequate;
  • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Humira 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.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis

Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. (for the efficacy in monotherapy see section 5.1). Humira has not been studied in patients aged less than 2 years.

Enthesitis-related arthritis

Humira is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).

Axial spondyloarthritis

Ankylosing spondylitis (AS)

Humira is indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy.

Axial spondyloarthritis without radiographic evidence of AS

Humira is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein and / or magnetic resonance imaging, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.

Psoriatic arthritis

Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Humira 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.

Psoriasis

Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultraviolet-A.

Crohn's disease

Humira is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.

Paediatric Crohn's disease

Humira is indicated for the treatment of severe active Crohn's disease in paediatric patients (six to 17 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.

Ulcerative colitis...

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Humira-H-C-481-II-127 : EPAR - Assessment Report - Variation SV = svenska 14/10/2014  
Humira : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 11/11/2009 14/10/2014
Humira-H-C-481-II-125 : EPAR - Assessment Report - Variation SV = svenska 04/08/2014  
CHMP post-authorisation summary of positive opinion for Humira SV = svenska 25/07/2014  
Humira-H-C-481-II-102 : EPAR - Assessment Report - Variation SV = svenska 15/04/2013  
Humira-H-C-481-II-82 : EPAR - Assessment Report - Variation SV = svenska 23/04/2012 06/03/2013
Humira-H-C-481-II-88 : EPAR - Assessment Report - Variation SV = svenska 04/02/2013  
CHMP post-authorisation summary of positive opinion for Humira SV = svenska 18/01/2013  
Humira-H-C-481-P46-76 : EPAR - Assessment Report SV = svenska 14/12/2012  
CHMP post-authorisation summary of positive opinion for Humira SV = svenska 19/10/2012  
Humira-H-C-481-II-94: EPAR - Assessment Report - Variation SV = svenska 26/09/2012  
Humira-H-C-481-II-85 : EPAR - Assessment Report - Variation SV = svenska 11/09/2012  
CHMP post-authorisation summary of positive opinion for Humira SV = svenska 20/07/2012  
CHMP post-authorisation summary of positive opinion for Humira SV = svenska 22/06/2012  
CHMP post-authorisation summary of positive opinion for Humira SV = svenska 17/02/2012  
Humira-H-C-481-II-81-G : EPAR - Assessment Report - Variation SV = svenska 19/05/2011  
CHMP post-authorisation summary of positive opinion for Humira SV = svenska 18/02/2011  
Humira-H-C-481-II-39 : EPAR - Assessment Report - Variation SV = svenska 02/10/2008  
CHMP post-authorisation summary of positive opinion for Humira on 24 July 2008 SV = svenska 28/07/2008  
Humira-H-C-481-II-43 : EPAR - Scientific Discussion - Variation SV = svenska 18/02/2008  
Humira-H-C-481-II-38 : EPAR - Scientific Discussion - Variation SV = svenska 04/02/2008  
Humira-H-C-481-II-33 : EPAR - Scientific Discussion - Variation SV = svenska 02/07/2007  
Humira-H-C-481-II-26 : EPAR - Scientific Discussion - Variation SV = svenska 31/07/2006  
Humira-H-C-481-II-22 : EPAR - Scientific Discussion - Variation SV = svenska 30/03/2006  
Humira-H-C-481-II-21 : EPAR - Scientific Discussion - Variation SV = svenska 30/03/2006  
Humira-H-C-481-II-06 : EPAR - Scientific Discussion - Variation SV = svenska 30/03/2006  

Initial marketing-authorisation documents

Name Language First published Last updated
Humira : EPAR - Procedural steps taken before authorisation SV = svenska 30/03/2006  
Humira : EPAR - Scientific Discussion SV = svenska 30/03/2006