Early Combination Of Enbrel(R) (etanercept) And Methotrexate Halts Radiographic Progression In 90% Of Patients During Second Year Of The COMET Study

Main Category: Arthritis / Rheumatology
Article Date: 16 Jun 2009 - 1:00 PDT

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New data presented this week during the European League Against Rheumatism (EULAR) Annual Meeting in Copenhagen demonstrated that sustained combination therapy (etanercept and methotrexate) was consistently superior to continuous methotrexate monotherapy in providing clinical remission and radiographic non-progression over two years in patients with early active rheumatoid arthritis.1 These new data add to the body of evidence supporting the benefits of early intervention with a biologic treatment in patients with rheumatoid arthritis.

The new data from the COMET (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) study show the percentage of patients in clinical remission after two years was significantly greater in the continued combination therapy (EM/EM) and delayed combination therapy groups (M/EM), than in the continued methotrexate monotherapy group (M/M) - 57% and 58% vs 35% (p<0.01) respectively1. Radiographic non-progression was achieved by a significantly greater percentage in the EM/EM group (90% p<0.001) compared with the continued methotrexate monotherapy group (68% M/M)1. The continued combination therapy patients (EM/EM) achieving clinical remission over the two year period experienced an almost two-fold improvement in quality of life as measured using the Health Assessment Questionnaire (HAQ).

Professor Paul Emery, lead COMET trial investigator and Professor of Rheumatology, University of Leeds, UK, said: "These study results indicated that when treating moderate-to-severe RA with etanercept, clinical remission is achievable and, as such, should be a primary treatment goal. These data highlight the importance of treating early with etanercept which can help stop progressive joint damage and provide the opportunity to maintain quality of life."

The two year data also show that a combination therapy of etanercept and methotrexate continues to be well tolerated with no new safety signals and no new differences in the rates of serious adverse events1.

The COMET study was the first major study designed to use clinical remission (DAS28<2.6) as an endpoint.

RA is a progressive disease in which symptoms and evidence of joint destruction may become increasingly worse over time. This may lead to irreversible joint damage, work disability and functional decline. RA has a significant impact on the quality of life of both those people with RA and their family/carer3.

Notes

The COMET study

The COMET study (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) is a 24 month, randomized, double blind, two period study to evaluate the efficacy and safety of the combination of etanercept and methotrexate and methotrexate alone in subjects with early rheumatoid arthritis.

The study compared the clinical efficacy and safety of etanercept and methotrexate combination therapy with methotrexate alone, in patients with early active rheumatoid arthritis1. After one year, the original combination group either continued combination (EM/EM; n=111) or received etanercept monotherapy (EM/E; n=111); the original methotrexate monotherapy group either received combination (M/EM; n=90) or continued monotherapy (M/M; n=99).

About Enbrel2

ENBREL is a fully human soluble tumour necrosis factor (TNF) receptor antagonist. ENBREL was first approved in the UK in 2000 for moderate to severe rheumatoid arthritis and has since been used in nearly 500,000 patients worldwide across indications.

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.

References

1. Emery P. et al. Clinical remission and inhibition of radiographic progression with combination ENBREL-methotrexate therapy versus monotherapy in active, early rheumatoid arthritis: 2-year results from the COMET trial. Abstract OP-0149 from the European League Against Rheumatism (EULAR) Annual European Congress, 10-13 June 2009.

2. Enbrel® Summary of Product Characteristics, Wyeth Pharmaceuticals, www.medicines.org.uk

3. NICE Clinical Guideline 79. Rheumatoid Arthritis: The Management of Rheumatoid Arthritis in Adults. February 2009

Source
Wyeth