European Commission has approved Humira ( Adalimumab ) for the treatment of pediatric patients aged six to 17 years with severely active Crohn's disease who failed, are intolerant to or have contraindications to conventional therapy.
Pediatric Crohn's disease is a chronic, debilitating condition of the gastrointestinal tract that affects up to 200,000 children worldwide.
In addition to symptoms such as chronic abdominal pain, weight loss and loose stools pediatric Crohn's disease can affect children in several ways, including potentially contributing to malnutrition, failure to grow and/or delayed puberty.
Humira is now indicated for the treatment of severe active Crohn's disease in pediatric patients ( 6 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.
Disease progression in children is different from adults, with children developing complications from Crohn's disease at a faster rate.
Crohn's disease is especially difficult in the pediatric population due to its disruptive nature during a key time in physical and social development and can limit patients' opportunity to form relationships with peers and participate in regular activities.
Since there is no known cure for Crohn's disease, the treatment goal of pediatric Crohn's disease is to induce and maintain clinical remission, with restoration and preservation of normal growth as additional therapeutic goals.
The filing was supported by a phase 3 dosing study, the IMAgINE 1 trial, which evaluated weight-based dosing strategies of Adalimumab to induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn's disease.
Important safety information on Adalimumab
Adalimumab is a TNF blocker medicine that affects the immune system and can lower the ability to fight infections. Serious infections have happened in people taking Adalimumab. These serious infections include tuberculosis and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections.
People should be tested for tuberculosis before Adalimumab use and monitored for signs and symptoms of tuberculosis during therapy. People at risk of tuberculosis may be treated with medicine for tuberculosis.
Treatment with Adalimumab should not be started in a person with an active infection, unless approved by a doctor. Adalimumab should be stopped if a person develops a serious infection.
People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had tuberculosis, hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.
For people taking TNF blockers, including Adalimumab, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including Adalimumab, the chance of getting two types of skin cancer ( basal cell and squamous cell ) may increase. These types are generally not life-threatening if treated.
Other possible serious side effects with Adalimumab include hepatitis B infection in carriers of the virus, allergic reactions, nervous system problems, blood problems, certain immune reactions, including a lupus-like syndrome, liver problems, and new or worsening heart failure or psoriasis.
The use of Adalimumab with Anakinra or Abatacept is not recommended. People using Adalimumab should not receive live vaccines.
Common side effects of Adalimumab include injection site reactions ( redness, rash, swelling, itching, or bruising ), upper respiratory infections ( including sinus infections ), headaches, rash, and nausea.
Source: Abbott, 2012