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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 Joint-Pain-Forum.com
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
www.Joint-Pain-Forum.com 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.
References:
[1]. National Institute for Clinical
Excellence. Adalimumab for the treatment of moderate-to-severe psoriatic
arthritis - Guidance. August 2007 http://www.nice.org.uk .
[2]. National Institute for
Clinical Excellence. Adalimumab, etanercept and infliximab for the treatment of
rheumatoid arthritis. Guidance October 2007. http://www.nice.org.uk .
[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 http://emc.medicines.org.uk/
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