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Abbott's Humira(R) (Adalimumab) Recommended By NICE For The Treatment Of Rheumatoid Arthritis, UK

 25 Oct 2007

As edited by

The National Institute for Health and Clinical Excellence (NICE) recommended Humira (adalimumab) as an option for the treatment of adults with rheumatoid arthritis (RA). It is the second positive opinion for adalimumab for rheumatological conditions in as many months, having been recommended by NICE for the treatment of psoriatic arthritis in August of this year.[1]

Adalimumab, licensed in the UK since 2003, is indicated for the treatment of active RA in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Today's announcement by NICE underscores the clinical value of the use of adalimumab as an effective option for the management of adults who have both:

- Active rheumatoid arthritis as measured by disease activity score (DAS28) greater than 5.1 confirmed on at least two occasions, 1 month apart.

- Undergone trials of two DMARDs, including methotrexate (unless contraindicated). A trial of a DMARD is defined as being normally of 6 months, with 2 months at standard dose, unless significant toxicity has limited the dose or duration of treatment.

Primary Care Trusts have a statutory duty to fund NICE technology appraisals within three months of publication.

"The recommendation of adalimumab in NICE's guidance is an important milestone for clinicians and patients alike," noted Dr Bruce Kirkham, Consultant Rheumatologist, Guy's & St Thomas' NHS Foundation Trust, London. "The efficacy of treatments such as adalimumab has long been recognised, and NICE's recommendation acknowledges this efficacy, while confirming both the clinical and economic rationale for their use."

RA is a chronic and progressive disabling condition characterised by inflammation of the synovial tissue of the joints. It causes tenderness and stiffness of joints leading to progressive destruction, and other symptoms such as pain and fatigue. It affects approximately 400,000 people in England and Wales. Of these, approximately 15% have severe disease.[2]

"People living with rheumatoid arthritis will welcome today's recommendation from NICE," commented Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society. "In order to effectively manage RA, it is crucial that those of us with the disease have access to the right treatment at the right time. NICE's decision means there are more options - and fewer barriers - to people with RA having access to treatments that work."

Article adapted by from original press release.

About RA

Up to 600,000 people in the UK suffer from RA.[3],[4],[5] Unlike osteoarthritis, the most common form of arthritis, RA is an inflammatory disease of the joints, which can result in eventual destruction of the joints' interior and the surrounding bone, leading to disability. The joints most commonly affected during the beginning of the disease are the smaller joints of the fingers, feet and wrists. The elbows, knees, ankles and hips can be affected, but less often. Although there is no cure for RA, people continue to seek treatments that not only alleviate the pain and inflammation but also slow disease progression, thereby inhibiting the joint damage that can hinder patients from performing daily activities.

About HUMIRA® (adalimumab)

Adalimumab, in combination with methotrexate (MTX), is indicated for:

- The treatment of moderate to severe active RA in adults (aged 18 and over) when the response to DMARDs including MTX has been inadequate.

- The treatment of severe, active and progressive RA in adults not previously treated with MTX.

Adalimumab is also indicated for the treatment of adults with:

- Severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.

- Active and progressive psoriatic arthritis (PsA) when the response to previous DMARD therapy has been inadequate.

- 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 the RA, AS and PsA indications, adalimumab is usually administered as 40mg every other week as a single dose via subcutaneous injection using a pre-filled pen. The recommended dosing in CD is 80mg adalimumab at week 0 followed by 40mg at week 2 and 40 mg every other week thereafter.

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. Adalimumab can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.

Please refer to the Summary of Product Characteristics for full information on adalimumab including contraindications, special warnings and precautions and side effect information.[6]

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.


[1]. National Institute for Clinical Excellence. Adalimumab for the treatment of moderate-to-severe psoriatic arthritis - Guidance. August 2007 .

[2]. National Institute for Clinical Excellence. Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis. Guidance October 2007. .

[3].Funding anti-TNF Therapies for Severe Resistant Rheumatoid Arthritis. Birmingham University 2004

[4]. Simpson C et al. The Patient's journey: rheumatoid arthritis. BMJ 2005; 331;887-889

[5]. Government Actuary's Department. UK Base Population Estimates for mid-2003 accessed April 2007

[6]. Electronics Medicines Compendium Humira (adalimumab) Summary of Product characteristics

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