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Spotlight on Etanercept in Rheumatoid Arthritis, Psoriatic Arthritis and Juvenile Rheumatoid Arthritis

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Abstract

Etanercept (Enbrel®2) is a subcutaneously administered biological response modifier that binds and inactivates tumour necrosis factor-α, a proinflammatory cytokine.

In patients with early active rheumatoid arthritis, etanercept 25mg twice weekly was associated with a more rapid improvement in disease activity and a significantly greater cumulative response than methotrexate over 12 months of treatment in a randomised, double-blind trial. In addition, etanercept recipients showed a slower rate of radiographic progression and a more rapid improvement in quality of life than methotrexate recipients. The efficacy of etanercept was maintained at 3 years’ follow-up.

Etanercept was also significantly better than placebo at reducing disease activity in patients who had an inadequate response to previous treatment with disease-modifying antirheumatic drugs (DMARDs) in several well controlled trials. At study end (after 3 or 6 months’ treatment), the percentage of patients achieving an American College of Rheumatology 20% (ACR20) response with etanercept (25mg or 16 mg/m2 twice weekly) was 59–75% as monotherapy and 71 % in combination with methotrexate; corresponding placebo response rates were 11–14% and 27%, respectively. Response has been maintained in patients who continued treatment for up to 5 years.

In patients with psoriatic arthritis, etanercept 25mg twice weekly significantly reduced disease activity and improved skin lesions in two double-blind, placebo-controlled, 12- to 24-week trials. In the 24-week study, ACR20 response rates (50 vs 13%), psoriatic arthritis response rates (70 vs 23%) and the median improvement in skin lesions (33 vs 0%) were significantly greater in etanercept than in placebo recipients.

In patients with polyarticular-course juvenile rheumatoid arthritis, etanercept resulted in improvements in all measures of disease activity and was significantly more effective than placebo at reducing disease flare. Eighty percent of patients receiving etanercept achieved a ≥30% reduction in disease activity over 7 months of treatment, and this was maintained for up to 2 years in a trial extension.

Etanercept was generally well tolerated in children and adults in clinical trials; the most commonly occurring adverse effects included injection site reactions, infection, headache, rhinitis and dizziness.

In conclusion, etanercept has emerged as an important new treatment option in inflammatory arthritis. Etanercept provides rapid and sustained improvements in disease activity in patients with early and DMARD-refractory rheumatoid arthritis and has been shown to inhibit radiographic progression in those with early disease. Well controlled studies have also demonstrated the efficacy of etanercept in patients with psoriatic arthritis or polyarticular-course juvenile rheumatoid arthritis.

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Acknowledgments

The full text article in Drugs 2002; 62 (17): 2493–2537 was reviewed by: A. Eigler, Medizinische Klinik Innenstadt, Klinikum der Ludwig-Maximilians-Universität, Munich, Germany; R. Fleischmann, Radiant Research-Dallas, Dallas, Texas, USA; G. Jones, Department of Rheumatology, Menzies Centre for Population Health Research, Hobart, Australia; D. Lovell, Pediatric Rheumatology, Children’s Hosptial Medical Center, Cincinnati, Ohio, USA; N.J. McGriff-Lee, Philadelphia College of Pharmacy, University of the Sciences in Philadelphia, Phildaelphia, Pennsylvania, USA; L.W. Moreland, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA; D.L. Scott, Department of Rheumatology, King’s Healthcare (Dulwich), London, England; W. Taylor, Department of Medicine, Wellington School of Medicine, Wellington, New Zealand.

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  1. Adis International Limited, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland 10, New Zealand

    Christine R. Culy & Gillian M. Keating

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  1. Christine R. Culy
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  2. Gillian M. Keating
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Correspondence to Gillian M. Keating.

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This Spotlight is derived from abstract and summary text of an Adis Drug Evaluation originally published in full in Drugs 2002; 62 (17): 2493–2537

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Culy, C.R., Keating, G.M. Spotlight on Etanercept in Rheumatoid Arthritis, Psoriatic Arthritis and Juvenile Rheumatoid Arthritis. BioDrugs 17, 139–145 (2003). https://doi.org/10.2165/00063030-200317020-00006

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