Humira

adalimumab

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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 an anti-inflammatory 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 adults with moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin) who need systemic therapy (a treatment given by mouth or injection). It is also used to treat children from 4 years of age with severe plaque psoriasis for whom creams or ointments and light therapies have not worked well or are not suitable.

Humira is also used to treat the following 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 and children from 6 years of age with moderately to severely active Crohn’s disease (a disease causing inflammation of the gut);
  • adults with moderately to severely active ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
  • 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 diseases causing inflammation in the joints).
  • adults with active moderate to severe hidradenitis suppurativa (acne inversa), a chronic skin disease that causes nodules (lumps), abscesses (collections of pus) and scarring on the skin that can lead to hollow passages known as fistulas.

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.

Humira is given as an injection under the skin. The dose and frequency of injection depends on the condition to be treated and, when used in children, bodyweight. After the starting dose, Humira is usually given every two weeks, although it may be given weekly in certain situations or for hidradenitis suppurativa. 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 information on the doses to be used for each condition and other information on the use of Humira, 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 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 attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.

How has Humira been studied?

Twenty main studies involving over 7,000 patients have looked at the effects of Humira in reducing symptoms of inflammatory conditions. These studies compared Humira either with placebo (a dummy treatment) or methotrexate, alone or as an add-on to other treatments. The studies included adult patients for the most part, with children included in studies for Crohn’s disease, plaque psoriasis, polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.

What benefit has Humira shown during the studies?

Humira, when used as directed, has been shown in clinical trials to be more effective than placebo (and, in some cases, methotrexate) at reducing important symptoms of each of the conditions for which it has been recommended.

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. In studies in adults and children with plaque psoriasis, a higher proportion of patients receiving Humira had improvements in symptoms compared with patients receiving methotrexate.

In polyarticular juvenile idiopathic arthritis, around 40% of patients aged between four and 17 years old 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.

In hidradenitis suppurativa, 59% of patients receiving Humira in one main study and 42% of patients in another achieved at least a 50% reduction in abscesses and nodules after 12 weeks, without any increase in abscess count or fistulas. The proportions of patients taking placebo who achieved this goal were 28% and 26% respectively.

More information may be found in the products summary of product characteristics (SmPC), also part of the EPAR.

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.

What measures are being taken to ensure the safe and effective 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 25/05/2016
Humira : EPAR - Summary for the public ES = español 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public CS = čeština 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public DA = dansk 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public DE = Deutsch 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public ET = eesti keel 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public EL = elliniká 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public EN = English 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public FR = français 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public IT = italiano 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public LV = latviešu valoda 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public LT = lietuvių kalba 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public HU = magyar 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public MT = Malti 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public NL = Nederlands 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public PL = polski 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public PT = português 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public RO = română 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public SK = slovenčina 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public SL = slovenščina 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public FI = suomi 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public SV = svenska 23/11/2009 25/05/2016
Humira : EPAR - Summary for the public HR = Hrvatski 23/11/2009 25/05/2016

This EPAR was last updated on 16/06/2016 .

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

Revision46
Date of issue of marketing authorisation valid throughout the European Union08/09/2003

Contact address:

AbbVie Ltd
Maidenhead
SL6 4UB
United Kingdom

Product information

Product information

11/05/2016  Humira -EMEA/H/C/000481 -II/0147

Name Language First published Last updated
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016
Humira : EPAR - Product Information HR = Hrvatski 12/11/2009 25/05/2016

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
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016
Humira : EPAR - All Authorised presentations HR = Hrvatski 23/06/2009 28/01/2016

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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 arthriti

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)

Paediatric plaque psoriasis

Humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.

Paediatric Crohn's disease

Humira is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Humira : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 11/11/2009 25/05/2016
Humira-H-C-481-P46-0091 : EPAR - Assessment Report HR = Hrvatski 16/06/2016  
Humira : EPAR - Paediatric investigation plan compliance statement HR = Hrvatski 25/05/2016  
Humira-H-C-481-II-0149 : EPAR - Assessment Report - Variation HR = Hrvatski 26/04/2016  
CHMP post-authorisation summary of positive opinion for Humira HR = Hrvatski 01/04/2016  
CHMP post-authorisation summary of positive opinion for Humira HR = Hrvatski 26/02/2016  
Humira-H-C-481-P46-0088 : EPAR - Assessment Report HR = Hrvatski 10/11/2015  
Humira-H-C-481-P46-0087 : EPAR - Assessment Report HR = Hrvatski 15/10/2015  
Humira-H-C-481-II-0137 : EPAR - Assessment report - Variation HR = Hrvatski 09/10/2015  
CHMP post-authorisation summary of positive opinion for Humira HR = Hrvatski 26/06/2015  
Humira-H-C-481-II-0134 : EPAR - Assessment Report - Extension HR = Hrvatski 12/05/2015  
Humira : EPAR - Paediatric investigation plan compliance statement HR = Hrvatski 12/05/2015  
CHMP post-authorisation summary of positive opinion for Humira HR = Hrvatski 27/02/2015  
Humira-H-C-481-PSUV-0131 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation HR = Hrvatski 18/12/2014  
Humira-H-C-481-II-00127 : EPAR - Assessment Report - Variation HR = Hrvatski 14/10/2014  
Humira-H-C-481-II-0125 : EPAR - Assessment Report - Variation HR = Hrvatski 04/08/2014  
CHMP post-authorisation summary of positive opinion for Humira HR = Hrvatski 25/07/2014  
Humira-H-C-481-II-0102 : EPAR - Assessment Report - Variation HR = Hrvatski 15/04/2013  
Humira-H-C-481-II-0082 : EPAR - Assessment Report - Variation HR = Hrvatski 23/04/2012 06/03/2013
Humira-H-C-481-II-0088 : EPAR - Assessment Report - Variation HR = Hrvatski 04/02/2013  
CHMP post-authorisation summary of positive opinion for Humira HR = Hrvatski 18/01/2013  
Humira-H-C-481-P46-0076 : EPAR - Assessment Report HR = Hrvatski 14/12/2012  
CHMP post-authorisation summary of positive opinion for Humira HR = Hrvatski 19/10/2012  
Humira-H-C-481-II-0094: EPAR - Assessment Report - Variation HR = Hrvatski 26/09/2012  
Humira-H-C-481-II-0085 : EPAR - Assessment Report - Variation HR = Hrvatski 11/09/2012  
CHMP post-authorisation summary of positive opinion for Humira HR = Hrvatski 20/07/2012  
CHMP post-authorisation summary of positive opinion for Humira HR = Hrvatski 22/06/2012  
CHMP post-authorisation summary of positive opinion for Humira HR = Hrvatski 17/02/2012  
Humira-H-C-481-II-0081-G : EPAR - Assessment Report - Variation HR = Hrvatski 19/05/2011  
CHMP post-authorisation summary of positive opinion for Humira HR = Hrvatski 18/02/2011  
Humira-H-C-481-II-39 : EPAR - Assessment Report - Variation HR = Hrvatski 02/10/2008  
CHMP post-authorisation summary of positive opinion for Humira on 24 July 2008 HR = Hrvatski 28/07/2008  
Humira-H-C-481-II-43 : EPAR - Scientific Discussion - Variation HR = Hrvatski 18/02/2008  
Humira-H-C-481-II-38 : EPAR - Scientific Discussion - Variation HR = Hrvatski 04/02/2008  
Humira-H-C-481-II-33 : EPAR - Scientific Discussion - Variation HR = Hrvatski 02/07/2007  
Humira-H-C-481-II-26 : EPAR - Scientific Discussion - Variation HR = Hrvatski 31/07/2006  
Humira-H-C-481-II-22 : EPAR - Scientific Discussion - Variation HR = Hrvatski 30/03/2006  
Humira-H-C-481-II-06 : EPAR - Scientific Discussion - Variation HR = Hrvatski 30/03/2006  
Humira-H-C-481-II-21 : EPAR - Scientific Discussion - Variation HR = Hrvatski 30/03/2006  

Initial marketing-authorisation documents

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

Authorised

This medicine is approved for use in the European Union

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