New data presented yesterday at the annual congress of the European League Against Rheumatism (EULAR) in Barcelona show that patients with rheumatoid arthritis (RA) treated with HUMIRA® (adalimumab) in combination with methotrexate (MTX) stayed in work longer, had fewer absences and reported greater improvements in work performance. [1], [2], [3]
The results from three separate studies are encouraging following the recent "I want to work??¦" survey - produced by the UK's National Rheumatoid Arthritis Society which revealed that one in three people with RA in the UK lose their jobs after developing the disease and a "staggering" 86% of respondents with the disease experienced or expected barriers to staying in their job.4 Thus, treatments that enable people with RA to remain in work will have considerable benefits to individuals struggling to live with RA, helping them to retain their financial independence, and contribute to wider society - currently a key priority for the UK government. [4]
Data from one study examining the effect of combination therapy on work performance demonstrated that RA treatment with adalimumab + MTX halves the number of missed workdays for both paid workers and homemakers compared to standard treatment (MTX alone).1 The second study - PRevention of Work Disability (PROWD) - investigated the effect that adalimumab therapy can have on work stability and job loss in patients with early RA. This was the first prospective placebo-controlled anti-TNF study to investigate this endpoint. Although the changes in all cause job loss and imminent job loss did not reach significance between weeks 16 and 56, PROWD showed that significantly more patients taking methotrexate (MTX) alone reported job loss and/or imminent job loss between weeks 0 and 56 compared with those treated with a combination of adalimumab and MTX.2
"While the long-term efficacy, safety and convenience of adalimumab has been widely established, the studies demonstrate early treatment with adalimumab plus MTX reduces joint damage, slowing progress of disease and disability, which keeps RA patients at work and working longer, " said Paul Emery, M.D., Professor of Rheumatology, Head of the Academic Unit of Musculoskeletal Medicine at the University of Leeds and lead investigator of the PROWD study.
A further study showed that patients taking adalimumab were significantly more likely to work longer periods and continue working compared to patients taking a DMARD (disease modifying anti-rheumatic drug). Additionally, patients taking adalimumab were more likely to achieve disease remission. [5]
In the UK, over half a million people have RA [6], [7], [8] which accounted for 9.4 million lost working days, equivalent to ??833m in lost production in 1999/2000. [9] Each year, the total cost of RA (health costs and lost working days) is estimated at ??3.8 - ??4.75bn. [10]
Study Highlights:
-- PROWD is a multi-centre, randomised 56-week controlled trial that examined the effect of HUMIRA plus MTX versus MTX alone on job loss due to all causes and imminent job loss in 148 early RA patients. Although the changes in all cause job loss did not reach significance between weeks 16 and 56, results showed that significantly more patients on placebo plus MTX (n=29) reported job loss compared to patients taking HUMIRA plus MTX (n=14) during the entire period of 56 weeks (40% vs. 29%). The investigators concluded that HUMIRA plus MTX reduced RA-related job loss and work time lost in patients with early RA more than MTX alone.
-- DE032 is an economic companion study to PREMIER, a two-year, double-blind controlled study that compared the effectiveness of HUMIRA, MTX and the combination of the two drugs in treating early RA. The DE032 study compared HUMIRA plus MTX (n=219) to MTX alone (n=214) on patient-reported measures of work performance in both paid workers and homemakers. Results showed that after two years paid workers and homemakers taking MTX alone missed significantly more work days than patients taking HUMIRA plus MTX (26 vs. 15 and 14 vs. 7, respectively). In addition, patients on HUMIRA plus MTX were 21% more likely to have a positive change in work status (gain employment or stay employed) compared to patients on MTX alone at the end of two years.
-- DE033, an open label DMARD registry controlled study, examined the long-term impact on time remaining at work and likelihood of stopping work over 24 months for RA patients on HUMIRA versus those on a DMARD. Multivariate regression analyses controlled for the baseline characteristic differences between the two populations while comparing the outcomes. Over the two-year period, patients working at study enrollment in the HUMIRA group worked more than seven months longer and were 36% less likely to stop working than the patients in the DMARD registry.
About RA
Up to 600,000 people in the UK suffer from RA.6,7,8 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 MTX, is indicated for:
-- The treatment of moderate to severe active rheumatoid arthritis (RA) in adults (aged 18 and over) when the response to disease-modifying anti-rheumatic drugs (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.
-- Sctive and progressive psoriatic arthritis (PsA) when the response to previous disease-modifying anti-rheumatic drug 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. The recommended dosing in CD is 80mg adaliumuab 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. [11]
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, device and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries. abbott
References
[1] van Vollenhoven - Effect Of Adalimumab Combination Therapy On Work Performance: Results From A Companion Study To Premier . Abstract presented at European League Against Rheumatism, June 2007
[2] Bejarano - Adalimumab Plus Methotrexate Improves Work Stability and Reduces Job Loss in Early Rheumatoid Arthritis (RA): Results of the PRevention Of Work Disability (PROWD) Study. Abstract presented at European League Against Rheumatism, June 2007
[3] Halpern - Impact Of Adalimumab On Rheumatoid Arthritis (RA) Outcomes: Comparison Of An Open-Label Extension Study And A Registry-Based Control Group. Abstract presented at European League Against Rheumatism, June 2007.
[4] I Want to Work. Employment and rheumatoid arthritis. A national survey. National Rheumatoid Arthritis Society, May 2007
[5] Keystone - Inhibition Of Radiographic Progression In Patients With Long-Standing Rheumatoid Arthritis Treated With Adalimumab Plus Methotrexate For 5 Years. Abstract presented at European League Against Rheumatism, June 2007.
[6] Funding anti-TNF Therapies for Severe Resistant Rheumatoid Arthritis. Birmingham University 2004
[7] Simpson C et al. The Patient's journey: rheumatoid arthritis. BMJ 2005; 331;887-889
[8] Government Actuary's Department. UK Base Population Estimates for mid-2003
Please click here accessed April 2007
[9] Arthritis: the big picture. Arthritis Research Campaign May 2002
[10] Pugner KM, Scott DL, Holmeds JW, Hieke K. The costs of Rheumatoid Arthritis: an international long-term view. Semin. Arthritis Rheum. 2000, 29: 305-320
[11] Electronics Medicines Compendium Humira (adalimumab) Summary of Product characteristics emc.medicines.uk/
View drug information on Humira.
Комментариев нет:
Отправить комментарий