What is Humira?
Humira is a medicine that contains the active substance adalimumab. It is a solution for injection containing 40 mg of adalimumab available in a vial, pre-filled syringe or pre-filled pen.
What is Humira used for?
Humira is an anti-inflammatory drug indicated for the treatment of the following patient groups:
- adults with moderate to severe active rheumatoid arthritis (a disease involving inflammation of the joints) who have not responded adequately to other treatments, and adults with severe and progressive rheumatoid arthritis not previously treated with methotrexate (a medicine that acts on the immune). Humira is given in combination with methotrexate, or alone if the patient cannot take methotrexate;
- adolescents aged 13-17 with polyarticular juvenile idiopathic arthritis (a rare disease affecting children and causing inflammation of many joints) who have not responded adequately to other treatments. Humira is given in combination with methotrexate, or alone if the patient cannot take methotrexate;
- adults with active and progressive psoriatic arthritis (a disease that presents with scaly red patches on the skin and inflammation of the joints) who have not responded adequately to other therapies;
- adults with severe, active ankylosing spondylitis (a disease that causes inflammation and pain in the joints of the spine) whose response to other treatments has not been adequate;
- adults with severe and active Crohn's disease (a disease causing inflammation of the bowel) who have not responded adequately to other therapies;
- adults with psoriasis (a disease that occurs with red, scaly patches on the skin) who have not responded adequately to other treatments.
For further details, see the Summary of Product Characteristics (also attached to the EPAR).
The medicine can only be obtained with a prescription.
How is Humira used?
Humira therapy should be started and monitored by a doctor who has experience in the treatment of the conditions for which Humira is indicated.
The recommended dose of Humira is 40 mg given as an injection every two weeks subcutaneously (under the skin), however for Crohn's disease and psoriasis, a starting dose of 80 mg is given, followed by 40 mg every two weeks. Patients who need a faster response to Crohn's disease can start treatment with two higher doses (160 mg followed by 80 mg), although this may increase the risk of side effects. During treatment with Humira , patients may be given other medicines, such as corticosteroids (other anti-inflammatory drugs). If the doctor agrees, patients, properly trained, can perform the injection themselves. Patients taking Humira should be given a special injection. alert card summarizing the safety information for the medicine See the package leaflet for more information.
How does Humira work?
The active substance in Humira, adalimumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize and attach to a specific structure (the antigen) in the body. Adalimumab is designed to attach to a chemical messenger in the body called tumor necrosis factor (TNF). This messenger is responsible for inflammation and is found in high concentrations in the bodies of patients with diseases that can be treated with Humira. By blocking TNF, adalimumab relieves the inflammation and other symptoms of these diseases.
How has Humira been studied?
Humira has been studied in five studies involving patients with moderate to severe rheumatoid arthritis. In four of these studies involving over 2,000 patients, Humira, taken alone or in combination with other anti-inflammatory medicines including methotrexate, was compared with placebo (a dummy treatment). The fifth study compared the combination of Humira and methotrexate with methotrexate alone or Humira alone and involved 799 patients who had never received methotrexate in the past.
For polyarticular juvenile idiopathic arthritis, Humira was compared with placebo, alone or in combination with methotrexate, in one main study involving 171 patients aged four to 17. All patients were given Humira for 16 weeks before they were given Humira or a placebo for another 32 weeks.
For psoriatic arthritis, Humira was compared with placebo for 12 weeks in two studies involving 413 patients. The medicines were taken alone or in combination with another anti-inflammatory medicine.
For ankylosing spondylitis, Humira and placebo as adjuvant therapy to ongoing treatment were compared for 12 weeks in two studies involving 397 patients.
For Crohn's disease, the effectiveness of the first two doses of Humira (induction) was compared with that of placebo in two studies involving 624 patients for four weeks. A further study looked at the long-term effects. (maintenance) of Humira in 854 patients for up to 56 weeks.
For psoriasis, Humira was compared with placebo for 16 weeks in 1,212 patients. A second study compared Humira with methotrexate and placebo in 271 patients for 16 weeks.
In all studies, the main measure of the medicine 's effectiveness was the change in symptoms.
What benefit has Humira shown during the studies?
For all diseases examined, Humira was more effective than placebo.
For rheumatoid arthritis, the greatest reductions in symptoms were seen in studies examining Humira as an adjuvant to methotrexate therapy: approximately two-thirds of patients adding Humira experienced a reduction of at least 20% after six months of treatment. % of symptoms compared to a quarter of those treated with placebo. Patients treated with Humira also showed fewer joint injuries and reported less reduction in physical function
after one year of treatment. In previously untreated patients with methotrexate, the combination of Humira and methotrexate was more effective than methotrexate alone.
In polyarticular juvenile idiopathic arthritis, approximately 40% of patients taking Humira alone or in combination with methotrexate experienced a bout of arthritis compared to approximately 69% of those taking placebo. Patients taking Humira in combination with methotrexate developed antibodies, so the results supported using Humira with methotrexate rather than Humira alone. The 40 mg fixed dose of Humira, the only one available at the time, was considered suitable only for patients 13 years of age and older.
Humira also showed more marked improvement in symptoms than placebo in the studies involving psoriatic arthritis, ankylosing spondylitis, induction and maintenance phases of Crohn's disease therapy, and proriasis.
What is the risk associated with Humira?
During the studies, the most frequent side effects seen with Humira (seen in more than 1 in 10 patients) were respiratory tract infections (lung and respiratory tract infections), leukopenia (reduced white blood cell count), increased blood level lipid (fat), headache, abdominal pain (stomach pain), nausea and vomiting, rash, musculoskeletal pain (pain in the joints and muscles), injection site reactions (including redness). Because of the increased risk of infection, patients treated with Humira should be closely monitored for infections, including tuberculosis, during and up to five months after treatment. For the full list of side effects reported with Humira, please see to the package leaflet.
Humira must not be used in people who may be hypersensitive (allergic) to adalimumab or any of the other substances. Humira must not be used in patients with tuberculosis, other serious infections, or moderate to severe heart failure (inability of the heart to pump enough blood around the body).
Why has Humira been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Humira's benefits are greater than its risks for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and psoriasis. The Committee therefore recommended that Humira be given marketing authorization.
What measures are being taken to ensure the safe use of Humira?
The pharmaceutical company that makes Humira will provide educational packs for doctors who will prescribe Humira. These packs will contain information on the safety of the medicine.
Other information about Humira:
On September 8, 2003, the European Commission granted Abbott Laboratories Ltd. a marketing authorization valid throughout the European Union for Humira. This authorization was renewed on 8 September 2008.
For the full version of the Humira EPAR, click here.
Last update of this summary: 07-2009.
The information on Humira - adalimumab published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
