Wyeth Pharmaceuticals

DART Study Results Demonstrate Dose Escalation With Enbrel(R)(etanercept) is Significantly Lower Than Other Commonly Used Anti-TNF Agents in Patients With Rheumatoid Arthritis(1)

Liverpool, England (ots/PRNewswire) - - Irrespective of Budgetary Restrictions, etanercept Dose Escalation Remains Low Suggesting etanercept Achieves Sustained Efficacy and is a Cost Effective Treatment for Rheumatoid Arthritis New pan-European data presented today at the British Society of Rheumatology's annual meeting in Liverpool demonstrate that patients treated with Enbrel(R) (etanercept) required significantly lower dose escalation than patients treated with infliximab and adalimumab in the first 12 months of therapy. The latter two anti-TNF agents (ATAs) for the treatment of rheumatoid arthritis are monoclonal antibodies while etanercept is a soluble TNF receptor. The DART* study assessed current clinical practice in the treatment of rheumatoid arthritis patients by comparing potential dose escalation in three selected ATAs and their associated costs of treatment.(1) The results of the 44 European centre study showed that the dose escalation to maintain clinical response was less than 1 per cent with etanercept compared to 8 per cent with adalimumab and 29 per cent with infliximab in the first 12 months. In those study centres where there were no restrictions to prescribing ATAs, the results showed a 2 per cent dose escalation with etanercept versus 11 per cent and 35 per cent respectively, indicating that associated cost increments were negligible with etanercept.(1) "The results of the DART study add to the body of evidence that etanercept achieves sustained efficacy without the need for dose escalation in 99 per cent of patients studied and thus demonstrates a cost effective treatment option for patients with rheumatoid arthritis over both the short and long term," said Professor Robert Moots, Professor of Rheumatology, University of Liverpool, Liverpool, United Kingdom and DART study investigator. "The current perception of biological therapy for inflammatory conditions such as rheumatoid arthritis is that it can be costly, however if the long term outlook and patient quality of life is taken into consideration, biologics such as etanercept are extremely cost effective. This is important both for physicians and patients as treatment can be maintained without the concern of rising cost increments." The minimal dose escalation observed in patients treated with etanercept may be due to its molecular structure which makes the development of neutralizing antibodies less likely than in patients treated with adalimumab and infliximab.(2,3,4,5,6) Recent studies have shown that physicians find that efficacy with some biological therapies diminishes or wears off over a period of time and hence may lead to the need for dose escalation and subsequent increased costs of treatment.(2,3,4) This may be partially due to the development of neutralizing antibodies. To assist in the analysis of current clinical practice, an investigator survey was conducted to assess restriction on dose adjustment and the preferred strategy when an inadequate clinical response was observed. Two in five investigators felt restrictions prevented them from increasing the dose or frequency of anti-TNF agents. Despite these restrictions a similar pattern of dose escalation was observed in these centres compared to the overall dose escalation results. Adding, or increasing the dose of a DMARD, was used in some countries when restrictions prohibited the dose escalation of ATAs.(1) In conclusion the DART study investigators report that the results suggest that patients receiving the monoclonal antibodies to TNF (infliximab and adalimumab), have a significantly higher rate of dose escalation than patients receiving the soluble TNF receptor etanercept, even in a restrictive budgetary environment and despite lower initial or concurrent DMARD use in etanercept patients. Notes to editors ABOUT ENBREL(7) ENBREL is a fully human soluble tumour necrosis factor (TNF) receptor antagonist. ENBREL was first approved in 1998 for moderate to rheumatoid arthritis and has since been used in nearly 500,000 patients worldwide across indications. ENBREL in the EU is approved for the following indications: Rheumatoid arthritis Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Polyarticular juvenile idiopathic arthritis Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents aged 4 to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Enbrel has not been studied in children aged less than 4 years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Ankylosing spondylitis Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA DART* Study Details:(1) The DART (Anti-TNF Drug utilization and dosing patterns Assessment: a Retrospective observational study of subjects Treated for rheumatoid arthritis) study is a retrospective observational study involving 739 patients in 44 European centres treated with monoclonal antibodies to TNF-alpha or soluble TNF-alpha receptor over a twelve month or greater period. The study was designed to assess potential dose escalation and other associated treatment costs on routine clinical practice. Eligible subjects were required to be continuously treated with prescribed anti-TNF agent (ATA) for over a twelve month or greater period and have no concurrent diagnosis of any other TNF-mediated conditions. Participating investigators completed a questionnaire on treatment strategies to overcome loss of response or failure to achieve initial response and whether there were restrictions on dose escalation. Clinical Outcomes and Drug Dosing Patterns at Year 1 Etanercept Adalimumab Infliximab DAS 28 (0-10) 3.3 3.4 3.5 EULAR Good Response (%) 46 47 31 ATA Dose-Escalation (%) <1 8* 29* ATA or DMARD Dose Escalation (%) 7 16** 36** ATA Dose-Escalation in Centers without 2 11* 35* Restrictions (%) *p is less than 0.001; **p is less than 0.01 About Wyeth: Wyeth is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of prescription drugs and over-the-counter medications. It is also a global leader in vaccines, biotechnology and animal health care. References 1. Moots R et al. Patterns of dose escalation and DMARD intensification in 739 patients with rheumatoid arthritis (RA) treated with anti-TNF agents (ATAs): Results from the DART study. Presented at the British Society of Rheumatology annual meeting, 24 April 2008, Liverpool, UK; Abstract 418 2. Bartelds GM et al. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis 2007 Jul;66(7):921-6 3. van der Laken CJ et al. Imaging and serum analysis of immune complex formation of radiolabelled infliximab and anti-infliximab in responders and non-responders to therapy for rheumatoid arthritis. Ann Rheum Dis. 2007 Feb;66(2):253-6 4. Wolbink GJ et al. Relationship between serum trough infliximab levels, pretreatment C reactive protein levels, and clinical response to infliximab treatment in patients with rheumatoid arthritis. Ann Rheum Dis. 2005 May;64(5):704-7 5. Remicade(R) (infliximab) EMEA SPC: http://www.emea.europa.eu/h umandocs/PDFs/EPAR/Remicade/H-240-PI-en.pdf. Last accessed 16 April 2008 6. Humira(R) (adalimumab) EMEA SPC. http://www.emea.europa.eu/humandocs/PDFs/EPAR/humira/H-481-PI-en.pdf. Last accessed 16 April 2008 7. Enbrel EMEA SPC. http://www.emea.europa.eu/humandocs/PDFs/EPAR/Enbrel/H-262-PI-en.pdf) Last accessed 14 April 2008 To register for further media information relating to this press release and future media announcements, please log on to the media centre at http://www.wyeth.eu. ots Originaltext: Wyeth Pharmaceuticals Im Internet recherchierbar: http://www.presseportal.ch Contact: For further information, please contact: Wyeth: Gill Markham, Communications - Europe, Middle East and Africa, Direct Tel: +44(0)1628-692536, Email: markhagl@wyeth.com; OgilvyHealthPR: Karen Crum, Direct Tel: +44(0)207-108-6411, Email: karen.crum@ohpr.com; Jodi Lewis, Direct Tel: +44(0)207-108-6086, Email: jodi.lewis@ohpr.com

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