Abbott's HUMIRA (Adalimumab) Receives License For The Treatment Of Chronic Plaque Psoriasis In The UK
Psoriasis is a non-contagious chronic disease, which causes the development of raised, and often distinct, lesions of reddened skin tissue which may crack and bleed, and can afflict any part of the body (the elbows, knees and the scalp are usual sites).2 The disease may occur among people of all ages and can be both physically painful as well as seriously impacting a person's daily life.
"Psoriasis is a disease that causes great distress physically and emotionally to patients," said Professor Christopher Griffiths, of The University of Manchester. "Anti-TNF treatments are a promising development for those with moderate-to-severe disease and the availability of a new treatment option is a big step forward. The licensing of adalimumab is a welcome announcement and provides an additional tool for physicians to treat those who are seriously affected by the disease."
Clinical trials have evaluated the efficacy and safety of adalimumab in a range of moderate-to-severe plaque psoriasis patients, measuring and evaluating response using the standard Psoriasis Area and Severity Index (PASI) among other measures. Clinical trials have shown:
- A response from four weeks and sustained response through 33 weeks when continued on open label adalimumab from week 16. Among those patients who achieved PASI 75 (a 75 per cent reduction in disease score), at week 16, 84.4 per cent (N=490) maintained this response until 33 weeks.3
- At week 16 more patients treated with adalimumab every other week achieved PASI 75 response compared to placebo (p‹0.001).3
- 80 per cent of adalimumab patients achieved PASI 75 at 16 weeks compared to 36 per cent of methotrexate patients and 19 per cent of placebo patients.4
"The licensing of adalimumab offers a valuable new treatment option for people living with moderate-to-severe psoriasis, a very difficult and often isolating condition," said Gladys Edwards from the Psoriasis Association. "We welcome the approval of new therapies such as adalimumab that can significantly improve the quality of life of patients and expand the options available to those who are most in need of treatment."
Adalimumab is a subcutaneous injection, meaning it can be self-administered at home after suitable training. Adalimumab is available in a pre-filled pen.5
Notes
How adalimumab works
Adalimumab is a fully human monoclonal antibody that works by specifically blocking the activity of TNF. Fully human monoclonal antibodies (antibodies derived from a single cell) are essentially indistinguishable from antibodies found in the body and represent the latest advance in the evolution of monoclonal antibodies. Adalimumab binds specifically to TNF and neutralises the biological function of TNF by blocking its interaction with cell surface TNF receptors.
Clinical trials
Clinical trials have evaluated the efficacy and safety of adalimumab in a range of moderate-to-severe psoriasis patients. Two phase III randomized, controlled, multi-centre clinical trials in adult patients, REVEAL3 and CHAMPION4, were conducted by Abbott. REVEAL was a 52-week study of 1,212 patients randomized to receive adalimumab or placebo every other week for the first 15 weeks. CHAMPION was the first head-to-head study comparing a biologic medication to methotrexate, the standard systemic treatment for moderate and severe psoriasis.
More Information About Psoriasis
Psoriasis is an inflammatory skin disease that is characterised by an accelerated rate of turnover of the top layer of the skin (epidermis). Although it is a chronic progressive condition, its course may be erratic, with flare-ups and remissions.
The most common form, which affects 80 per cent of psoriasis cases, is chronic plaque psoriasis (psoriasis vulgaris), which is characterized by well-demarcated, often systematically distributed, thickened, red, scaly plaques which can crack and bleed. There is considerable variation in both the size and the number of the plaques, which can range from one or two plaques to more widespread involvement. Although the plaques can affect any part of the skin, they are typically found on the extensor surfaces of the knees and elbows, and on the scalp.1
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Adalimumab Licensed Indications5
Psoriasis
Adalimumab is indicated 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 or PUVA.
Crohn's disease
Adalimumab is indicated for treatment of severe, 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.
For induction treatment, adalimumab should be given in combination with cortiocosteroids. Adalimumab can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate.
Rheumatoid arthritis
Adalimumab in combination with methotrexate is indicated for:
- the treatment of moderate-to-severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
- the treatment of severe, active and progressive RA in adults not previously treated with methotrexate.
Adalimumab can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
Psoriatic arthritis
Adalimumab is indicated for the treatment of active and progressive psoriatic arthritis (PsA) in adults when the response to previous disease-modifying anti rheumatic drug therapy has been inadequate.
Ankylosing spondylitis
Adalimumab is indicated for the treatment of adults with severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.
Dosing
The recommended dose of adalimumab for adult patients with chronic plaque psoriasis is an initial dose of 80mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose. Please note that the dosage regime in other indications differs.
Adalimumab should not be administered in patients with active TB, opportunistic or other severe infections, moderate to severe heart failure (NYHA III/IV) or known hypersensitivity to (any of the components of) adalimumab.
Before initiation of therapy with adalimumab, all patients must be evaluated for infection, including active and latent TB. Patients must be actively and regularly monitored for infections during and for 5 months after treatment with adalimumab. Patients should also be evaluated for non-melanoma skin cancer prior to and during treatment with adalimumab. Other precautions also exist, please refer to the summary of product characteristics.
Serious, including fatal, side effects have been reported including infections/sepsis, opportunistic infections, TB, demyelinating disease, malignancies including lymphoma and skin cancers, reactivation of hepatitis B, cytopenia, worsening heart failure and anaphylaxis.
Please refer to the Summary of Product Characteristics for full information on adalimumab including contraindications, special warnings and precautions and side effect information.
References
1. National Institute for Clinical Excellence. Etanercept and efalizumumab for the treatment of adults with psoriasis. Technology appraisal guidance 103. http://www.nice.org.uk/nicemedia/pdf/TA103guidance.pdf
2. National Institute for Health and Clinical. Adalimumab for the treatment of psoriasis: Final Scope. http://www.nice.org.uk/nicemedia/pdf/Finalscope240707.pdf
3. Menter A et al. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. Acad Dermatol 2007; Published on-line: 10.1016/j.jaad.2007.09.010
4. Saurat J et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). British Journal of Dermatology 2007; Published on-line: DOI 10.1111/j.1365-2133.2007.08315.
5. Humira Summary of Product Characteristics. Abbott Laboratories Ltd. Electronics Medicines Compendium http://emc.medicines.org.uk/ January 2007.
http://www.abbott.com/
View drug information on Humira.
Abbott a HUMIRA (Adalimumab) a primit licenþã pentru tratamentul cronic plãci Psoriazis in Marea Britanie - Abbott's HUMIRA (Adalimumab) Receives License For The Treatment Of Chronic Plaque Psoriasis In The UK - articole medicale engleza - startsanatate