It is also important that UC patients properly manage their nutrition because fluids, nutrients and electrolytes can be lost due to rectal bleeding and diarrhea. Additionally, 25 percent of UC patients will require surgery during the course of the disease.
"Since the first FDA approval of HUMIRA in late 2002, Abbott has continued to investigate the medication in multiple conditions with the goal of bringing this treatment option to more patients who may benefit from it," said
John M. Leonard
, M.D., senior vice president, Global Pharmaceutical Research and Development, Abbott. "This approval underscores Abbott's commitment to investing in and advancing our pipeline to benefit patients with IBD."
About the HUMIRA UC Phase 3 Clinical Program
Abbott's submission for HUMIRA was supported by results from two phase 3 studies, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled adult patients who had moderately to severely active UC despite concurrent or prior treatment with immunosuppressants (i.e., corticosteroids, azathioprine, or 6-mercaptopurine).
The primary endpoint of both studies was the proportion of patients achieving clinical remission at specified time points (week 8 in ULTRA 1 and weeks 8 and 52 in ULTRA 2). Remission was defined as a Mayo score of
2 and no individual subscore > 1. The Mayo score is calculated based on subscores of stool frequency, rectal bleeding, physician's global assessment and endoscopy. In the FDA-approved dose, both studies achieved their primary endpoints. The safety results from both studies were consistent with the known safety profile of HUMIRA and no new safety signals were identified.
Other Approved HUMIRA Indications
HUMIRA is a prescription medicine used:
To reduce the signs and symptoms of:
To treat moderate to severe chronic plaque psoriasis (Ps)
- Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to the bones and joints and may help the ability to perform daily activities.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
- Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to the bones and joints and may help the ability to perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments. HUMIRA is also for these adults who have lost response to or are unable to tolerate infliximab.
in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
Important Safety Information
HUMIRA 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 HUMIRA. These serious infections include tuberculosis (TB) 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 TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA 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 TB, hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.
For people taking TNF blockers, including HUMIRA, 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 HUMIRA, 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.