Abbott's Humira (adalimumab) has become the first and only self-injectable biologic therapy approved in the UK for adults with moderately to severely active ulcerative colitis (UC).
Following approval from the European Medicines Agency (EMA), Humira is now approved for use in the UK in such patients who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to, or have medical contraindications for, such therapies.
This approval marks the seventh indication for Humira in the European Union (EU) since the product's first approval in 2003, says Abbott.
UC is a chronic inflammatory bowel disease that causes ulcers in the colon and may lead to life-threatening complications. It is estimated that the disease affects up to 120,000 people in the UK, with 6,000-12,000 new cases diagnosed every year. There is no known cure for UC other than surgical removal of the colon, and it is estimated that around one in four people with UC will require surgery at some point during their illness, the firm adds.
"Ulcerative colitis is a chronic disease which, when active, has a significant impact on a patient's quality of life and ability to work," commented James Lindsay, consultant physician and gastroenterologist at Barts and The London Hospital. "For patients who do not respond to standard therapies, this new treatment option provides hope for clinical remission or low disease activity, with the convenience of self-administering at home," said Dr Lindsay.
The approval was based on two Phase III clinical trials (ULTRA 1 and ULTRA 2) involving more than 800 patients across North America, Europe, Australia, New Zealand and Israel.
These trials demonstrate that Humira induces and maintains remission in a higher percentage of patients compared with placebo, further supporting the product as a new treatment option for people with UC and extending its versatility in treating a wide range of immune-mediated inflammatory diseases, added Abbott's medical director, Jon Ryland.
- Humira’s other EU approvals include its use, in combination with methotrexate, for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDS), including methotrexate, has been inadequate and the treatment of severe, active and progressive RA in adults not previously treated with methotrexate. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Humira is also indicated:
- in combination with methotrexate, for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged 4-17 who have had an inadequate response to one or more DMARDs;
- for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy;
- for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARDS has been inadequate;
- for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to or are intolerant to, other systemic therapy including cyclosporine, methotrexate and psoralen and ultraviolet A radiation (PUVA); and
- for the treatment of severe to active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant, or who are intolerant to or have medical contraindications for such therapies.