HUMIRA (adalimumab) has been recommended by The National Institute for Health and Clinical Excellence (NICE) as one of the treatment options for adults with severe active ankylosing spondylitis (AS).[i] This is the first time that NICE has reviewed anti-TNF (anti-tumour necrosis factor) therapies for AS. Today's decision is also the third positive opinion from NICE for adalimumab for rheumatological conditions, having been recommended for the treatment of active and progressive psoriatic arthritis and moderate-to-severe active rheumatoid arthritis in 2007.[ii],[iii]
Until recently, treatment for AS has been limited to non-steroidal anti-inflammatory drugs (NSAIDs) and physiotherapy. The availability of anti-TNFs, such as adalimumab, which works by blocking tumour necrosis factor alpha - known to cause inflammation, marks an important advance in the treatment of adults with severe active AS who have had an inadequate response to conventional therapy.[iv]
"Today's recommendations by NICE mark an important step forward for the management of patients with ankylosing spondylitis," commented Dr Bruce Kirkham, Consultant Rheumatologist, Guy's Hospital, London, "People living with AS will welcome today's recommendation. The use of the anti-TNF class of treatments significantly improves the quality of life of those receiving them."
AS is a chronic and progressive auto-immune disorder, which affects approximately 1 in 200 men and 1 in 500 women in Britain.[v] The disease primarily affects the spine with symptoms including inflammatory back pain, stiffness, painful ligaments and tendons. In its most severe form, AS can result in complete spinal fusion, leading to severe functional limitation and deformity over time.
Today's announcement by NICE underscores the clinical value of the use of adalimumab as an effective option if the following criteria are fulfilled:1
-- The patient's disease satisfies the modified New York criteria for diagnosis of ankylosing spondylitis.
-- There is confirmation of sustained active spinal disease, demonstrated by:
- a score of at least 4 units on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and
- at least 4 cm on the 0 to 10 cm spinal pain visual analogue scale (VAS).
These should both be demonstrated on two occasions at least 12 weeks apart without any change of treatment.
-- Conventional treatment with two or more non-steroidal anti-inflammatory drugs taken sequentially at maximum tolerated or recommended dosage for 4 weeks has failed to control symptoms.
Amongst the data submitted to NICE were the results of a double-blind placebo-controlled clinical study involving 315 adults with severe active AS.[vi] The study assessed the safety and efficacy of treatment with adalimumab and concluded that adalimumab was well-tolerated during the 24-week study period and was associated with a significant and sustained reduction in the signs and
symptoms of active AS.6
Primary Care Trusts have a statutory duty to fund NICE technology appraisals within three months of publication. Further information on the NICE guidance can be found at nice.uk
About AS
The course of AS is variable, but the majority of patients have continuous disease activity with episodes of acute pain, known as 'flare ups', against a background of persistent symptoms. There is a need for joint replacement surgery in some patients. In its most severe form, AS can result in complete spinal fusion, which can cause severe functional limitation and the potential for deformity over time. Disease damage is progressive and irreversible and in later life there is an increased risk of spinal fracture and/or mortality due to cardiac valvular disease, amyloidosis and fractures.
Although symptoms can occur at any stage of life, onset of AS is typically in the late teenage years and twenties.5 AS is nearly three times as common in men as it is in women, and men are also more likely to develop severe spinal disease.5 About a third of people with AS may be unable to work altogether, with a further 15 per cent reporting some changes to their working lives.1
The prevalence of AS is unknown, although according to the British Society for Rheumatology (BSR) guidelines it has been estimated to range from 0.05 per cent to 0.23 per cent. Population figures for England and Wales, in 2004, suggest that there are approximately 2,300 new cases each year.1
The disease is associated with other inflammatory diseases of the skin, eyes and intestines including psoriasis, ulcerative colitis and Crohn's disease. Although the exact cause of the disease remains unknown, certain genetic, immune, and environmental factors may be involved.
About HUMIRA® (adalimumab)7[vii]
Adalimumab is an anti-tumour necrosis factor (anti-TNF) therapy. It is a human-sequence antibody, which functions to neutralise the biological function of tumour necrosis factor alpha (TNF-?±) and mediate cell inflammation. The consequence of this action is efficacy against a number of auto-immune diseases of the skin, joints and intestines. Adalimumab is licensed in the UK to treat the following five immunological conditions:
Ankylosing Spondylitis7
Adalimumab is indicated for the treatment of adults with severe active AS who have had an inadequate response to conventional therapy.
Rheumatoid Arthritis7
Adalimumab in combination with methotrexate (MTX) 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 MTX has been inadequate.
- the treatment of severe, active and progressive RA in adults not previously treated with MTX.
Adalimumab has been shown to reduce the rate of joint damage in RA as measured by X-ray and improve physical function, when given in combination with MTX.7 Adalimumab can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.7
Psoriatic Arthritis7
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.
Psoriasis7
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 (psoralen and long-wave ultraviolet radiation).
Crohn's Disease7
Adalimumab is indicated for treatment of severe, active Crohn's disease (CD), 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.
Dosing
Adalimumab is administered as a subcutaneous injection either as a pre-filled pen or pre-filled syringe. For the AS, RA and PsA indications, adalimumab is usually administered as 40mg every other week as a single dose.7 For CD the recommended dosing is 80mg at week 0 followed by 40mg at week 2 and 40 mg every other week thereafter.7 For psoriasis the recommended dosing is an initial dose of 80mg, followed by 40 mg given every other week starting one week after the initial dose.7
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. Patients should also be evaluated for non-melanoma skin cancer prior to and during treatment. Other precautions also exist. Please refer to the Summary of Product Characteristics for full information on adalimumab.
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.
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References
[i]. National Institute for Clinical Excellence. Adalimumab, etanercept and infliximab for ankylosing spondylitis - Guidance. May 2008 nice.uk
[ii]. National Institute for Clinical Excellence. Adalimumab for the treatment of moderate-to severepsoriatic arthritis - Guidance. August 2007 nice.uk
[iii]. National Institute for Clinical Excellence. Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis - Guidance. October 2007. nice.uk
[iv]. McVeigh C.M, Cairns A.P. Diagnosis and management of ankylosing spondylitis, BMJ 2006;333:581-5
[v]. Rogers F.J. The National Ankylosing Spondylitis Society, Guidebook for Patients, A Positive Response to Ankylosing Spondylitis, NASS, June 2004; 3
[vi]. Van der Heijde et al, Efficacy and Safety of Adalimumab in Patients With Ankylosing Spondylitis
Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis & Rheumatism 2006; 54:7:2136-2146
[vii]. Electronics Medicines Compendium HUMIRA (adalimumab) Summary of Product Characteristics emc.medicines.uk/
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