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, in a pre-filled syringe or in a pre-filled pen.
What is Humira used for?
Humira is an anti-inflammatory drug indicated for the treatment of the following groups of patients:
- adults with moderate to severe active rheumatoid arthritis (a disease that leads to inflammation of the joints) who have not responded adequately to other therapies, and adults with severe and progressive rheumatoid arthritis not previously treated with methotrexate (a medicine that acts on the system immune). Humira is given in combination with methotrexate, or on its own if the patient cannot take methotrexate;
- adolescents aged 13 to 17 years, suffering from polyarticular juvenile idiopathic arthritis (rare disease that affects children and causes inflammation in many joints), which have not responded adequately to other treatments. Humira is given in combination with methotrexate, or on its own if the patient cannot take methotrexate;
- adults with active and progressive psoriatic arthritis (a disease that manifests itself with patches on red-colored skin covered with scales and inflammation of the joints) that have not responded adequately to other therapies;
- adults with severe and active ankylosing spondylitis (a disease that causes inflammation and pain in the joints of the spine) in which the response to other treatments was not adequate;
- adults with severe and active Crohn's disease (a condition that causes inflammation of the intestine) who have not responded adequately to other therapies;
- adults with psoriasis (a disease that manifests itself with patches on red-colored skin covered with scales) that have not responded adequately to other therapies.
For more details, see the summary of product characteristics (also included with the EPAR).
The medicine can only be obtained with a prescription .
How is Humira used?
Treatment with Humira must be started and monitored by a doctor experienced in treating the conditions for which Humira is indicated.
The recommended dose of Humira is 40 mg given as an injection given every two weeks under the skin (under the skin), but for Crohn's disease and psoriasis, an initial dose of 80 mg is given, followed by 40 mg every two weeks. Patients requiring 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-inflammatories). If the doctor agrees, the appropriately trained patients can inject themselves. Patients treated with Humira must be given a special alert card that summarizes the information on the safety of the medicine. For more information, 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) designed to recognize and bind to a specific structure (the antigen) in the body. Adalimumab was designed to bind to a chemical messenger present in the body called tumor necrosis factor (TNF). This messenger is responsible for inflammation and is found in high concentrations in the body of patients suffering from diseases that can be treated with Humira. By blocking TNF, adalimumab relieves inflammation and other symptoms of these diseases.
How has Humira been studied?
Humira has been studied in five studies in 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 drugs including methotrexate, was compared with a placebo (a dummy treatment). The fifth study compared the combination of Humira and methotrexate with methotrexate alone or Humira alone and involved 799 patients never previously treated with methotrexate therapy.
Regarding polyarticular juvenile idiopathic arthritis, Humira was compared with a placebo, alone or in combination with methotrexate, in a main study involving 171 patients aged between four and 17 years. All patients were given Humira for 16 weeks before either Humira or a placebo was given for another 32 weeks.
For psoriatic arthritis, Humira was compared with placebo for 12 weeks in two studies involving 413 patients. Medicines were taken alone or in combination with another anti-inflammatory drug.
For ankylosing spondylitis, Humira and placebo as an ongoing treatment adjuvant therapy were compared for 12 weeks in two studies involving 397 patients.
For Crohn's disease, the efficacy 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 examined the long-term (maintenance) effects of Humira on 854 patients up to 56 weeks.
For psoriasis, Humira was compared with placebo for 16 weeks on 1 212 patients. A second study compared Humira with methotrexate and with placebo on 271 patients for 16 weeks.
In all the studies, the main measure of effectiveness of the medicine was the change in symptoms.
What benefit has Humira shown during the studies?
For all the diseases examined, Humira was more effective than placebo.
For rheumatoid arthritis, major symptom reductions were observed in studies examining Humira as an adjuvant in methotrexate therapy: approximately two thirds of the patients adding Humira reported, after six months of treatment, a reduction of at least 20 % of symptoms compared to a quarter of placebo subjects. Patients treated with Humira also showed fewer joint injuries and reported less reduction in physical function
after a year of treatment. In patients never previously treated with methotrexate, the combination of Humira and methotrexate was more effective than methotrexate alone.
Regarding polyarticular juvenile idiopathic arthritis, about 40% of patients taking Humira alone or in combination with methotrexate suffered an attack of arthritis compared to about 69% of those taking placebo. However, fewer patients taking Humira in combination with methotrexate developed antibodies; therefore the results supported the use of Humira with methotrexate rather than Humira alone. The 40 mg fixed dose of Humira, the only one available at present, was considered suitable only for patients aged 13 years or older.
Humira has also shown a more sensitive improvement in symptoms than placebo in studies related to psoriatic arthritis, ankylosing spondylitis, induction and maintenance phases of therapy for Crohn's disease and proriasis.
What is the risk associated with Humira?
During the studies the most frequent side effects reported with Humira (seen in more than 1 patient in 10) were respiratory infections (infections of the lungs and respiratory tract), leukopenia (reduction in the number of white blood cells), increase in the level of lipids (fats), headaches, abdominal pain (stomach ache), nausea and vomiting, rash, musculoskeletal pain (pain in joints and muscles), reactions at the injection site (including redness). Due to the increased risk of infection, patients treated with Humira should be carefully monitored for infections, including tuberculosis, during and up to five months after treatment. For the full list of all side effects reported with Humira, see the Package Leaflet.
Humira must not be used in people who may be hypersensitive (allergic) to adalimumab or any of the other substances. Humira should not be used in patients with Tuberculosis, other serious infections, or heart failure (an inability of the heart to pump enough blood into the body) moderate to severe.
Why has Humira been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined 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 produces Humira will provide information packages to the doctors who will prescribe Humira. These packages will contain information on the safety of the medicine.
More information about Humira:
On 8 September 2003, the European Commission granted a marketing authorization valid throughout the EU for Humira to Abbott Laboratories Ltd. This authorization was renewed on 8 September 2008.
For the full EPAR for Humira, click here.
Last update of this summary: 07-2009.
