Wyeth Pharmaceuticals

New Data Demonstrates Joint Damage is Inhibited With Wyeth's Biologic Enbrel(R) Plus Methotrexate in Patients With Early Active Rheumatoid Arthritis

    Maidenhead, England (ots/PRNewswire) -

    - Study Results Provide Further Evidence That Early Treatment of Rheumatoid Arthritis With Enbrel(R) Plus Methotrexate in Moderate to Severe Patients can Stop the Disease From Progressing, and Helps Patients Return to More Normal and Productive Lives

    Data presented today show that 80% of patients with early active rheumatoid arthritis achieved radiographic remission (or non-progression defined as a change in TSS is less than or equal to 0.5) at one year when treated with Enbrel (etanercept) and methotrexate, compared to 59% when treated with methotrexate alone(1). COMET* (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) is the first major trial to use remission as its primary endpoint in patients with early active rheumatoid arthritis treated with a biologic. Data from the landmark COMET study were presented today at the European League Against Rheumatism (EULAR) Annual Meeting in Paris.

    The COMET trial also showed that 50% of patients taking this Enbrel combination achieved clinical remission (DAS28<2.6), and nearly 55% achieved functional remission (HAQ <0.5), compared to 28% and 39% respectively when treated by methotrexate alone(1).

    "Until recently, we did not know whether remission was a realistic or even achievable goal", said Professor Paul Emery, lead COMET trial investigator and Professor of Rheumatology, University of Leeds, UK. "We now have results which show that not only is clinical remission achievable in a significant number of patients, but radiographic and functional remission are also achievable. These exciting results lead to the next therapeutic step in aiming for multiple measures of remission as our treatment goal, no longer just one. Given that these levels of remission have not previously been seen and represent the optimal goal, these results will lead to the need for treatment of RA with an anti-TNF treatment option such as etanercept at the earliest appropriate opportunity to halt disease progression."

    Enbrel's ability to achieve remission in many of the patients treated, irrespective of how it is measured, provides real-life benefits for the patient by stopping the disease from progressing whilst at the same time helping them to continue normal day-to-day functioning. Further data from the COMET trial show that the number of lost work days in patients treated with the Enbrel combination was approximately half that of patients receiving methotrexate alone(2).

    No differences were observed in rates of serious infections or malignancies among patients in the Enbrel plus methotrexate group compared with the methotrexate-only group.

    The economic data from another study called DART** were also presented at the EULAR Annual Meeting(3), complementing the results from the COMET study. DART trial investigator Professor Robert Moots, Professor of Rheumatology, University of Liverpool, United Kingdom commented: "The DART study confirms that whilst all of the TNF inhibitors are highly effective in reducing disease activity in RA, in normal clinical usage there may be a need to increase the dose of infliximab and adalimumab, but not etanercept, to maintain this beneficial effect. Similarly, the COMET results also demonstrate Enbrel's value by enabling more patients to stay at work than those taking methotrexate alone. In conclusion, these results, coupled with previous studies, demonstrate that Enbrel can not only protect joints from further damage but also permit optimisation of the long-term management of patients with RA, due to a predictable dosing and hence more predictable cost."

    To access further media information relating to this press release, additional information on Enbrel and future media announcements, please log on to the media centre at http://www.wyeth.eu.

    Notes to editors

    About ENBREL(4)

    ENBREL is a fully human soluble tumour necrosis factor (TNF) receptor antagonist. ENBREL was first approved in 1998 for moderate to severe 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

    *COMET study details:

    This study was designed to compare the clinical efficacy and safety of ENBREL and methotrexate combination therapy with methotrexate alone in patients with early active rheumatoid arthritis. Patients in this study had disease duration of less than or equal to 2 years, had not previously received methotrexate, and had active disease based on DAS28 (more than or equal to 3.2) and elevation of erythrocyte sedimentation rate (more than or equal to 28 mm/hr) or C-reactive protein levels (more than or equal to 20 mg/L). Patients were randomised to receive either ENBREL plus methotrexate (n = 274) or methotrexate alone (n = 268). Primary efficacy endpoints were:

    1) The radiographic change at week 52 from baseline assessed by using an X-ray measurement of changes in joint damage, the modified Total Sharp Score (mTSS). Radiographic remission was assessed with the TSS, with non-progression defined as a change in TSS less than or equal to 0.5. Patients receiving Enbrel with methotrexate experienced significantly less progression of joint damage with a 0.27 unit mean change from baseline at one year in TSS, compared with a 2.44 unit mean change in those treated with methotrexate alone which translates into nine times less joint damage with the Enbrel combination versus methotrexate alone (1).

    2) The proportion of patients achieving clinical remission, as measured by disease activity score (DAS28 less than 2.6). DAS28 is a measure of joint swelling and tenderness (based on 28 joints), as well as overall disease activity measured by a global health assessment and an objective marker of inflammation (erythrocyte sedimentation rate). DAS28 is a validated tool used in clinical trials.

    Other endpoints included low disease activity (DAS28 less than or equal to 3.2), radiographic non-progression (mTSS less than or equal to 0.5), and the number of patients achieving functional remission as measured by Health Assessment Questionnaire (HAQ). This double-blind, randomised, multicenter study consists of two 12-month periods. The data presented at EULAR is from the first 12-month period (52 weeks).

    **DART study details:

    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 is greater than or equal to 12 month 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 is greater than or equal to 12 months 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.

@@start.t1@@                 Dosing Patterns and Clinical and Economic Outcomes at Year 1
                                                         Etanercept        Adalimumab         Infliximab
      ----------------------------------------------------------------------
                    DAS 28 (0-10)                      3.3                  3.4                 3.7
            EULAR Good Response (%)                46                    47                  31
            ATA Dose Escalation (%)                <1                    8(i)                29(i)
        ATA or DMARD intensification              7                  16(ii)              36(ii)
                            (%)
      ATA or Steroid Intensification            6                  15(ii)              32(ii)
                            (%)
              Inpatient Visit Rate                0.29 (-47)      0.22 (-38)        0.93 (41)
          (% change from baseline)
              Outpatient visit rate                5.4 (17)         6.3 (29)          8.0 (54)
          (% change from baseline)
                Total cost of care        EUR 19,775      EUR 23,253*      EUR 20,348
      ----------------------------------------------------------------------
      *p<0.05; (i)p<0.001; (ii)p<0.01@@end@@

    About WYETH:

    Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.

    Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

    References

    (1) Abstract OP-0008 from the European League Against Rheumatism (EULAR) congress, 12 June 2008. Emery P. et al. Clinical Remission, Radiographic Non-Progression, And Normalized Function With The Combination Of Etanercept And Methotrexate In The Treatment Of Early Active Rheumatoid Arthritis: 1-Year Results Of The COMET Trial

    (2) Abstract OP-0096 from the European League Against Rheumatism (EULAR) congress, 12 June 2008. Anis. A. et al. Work-Related Outcomes In Early Active Rheumatoid Arthritis: Results From The COMET Trial

    (3) Abstract FRI0139 from the European League Against Rheumatism (EULAR) congress, 13 June 2008. Moots, R. et al. Dose Escalation Accounts For Differences In Cost Of Care In 739 Patients With Rheumatoid Arthritis (RA) Treated With Anti-TNF Agents (ATAs): Results From The DART Study

    (4) Enbrel EMEA SPC (eMC last accessed 25/05/08)

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