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Enbrel With Methotrexate: Drug Combination Improves Rheumatoid Arthritis

Study Shows Significant Benefits Combining Enbrel With Methotrexate


Updated May 25, 2006

This article is part of the Arthritis Archives.

Dateline: February 2, 1999

Study: Enbrel With Methotrexate

Results from a study sponsored by Immunex Corp., the makers of Enbrel (etanercept), indicate that there is a significant benefit derived from combining Enbrel and methotrexate for treatment of rheumatoid arthritis.

The purpose of the study was to determine whether significant improvement could be provoked in patients who had persistent rheumatoid arthritis although on methotrexate therapy, if etanercept were added to their treatment plan. Eighty nine patients (75 women and 14 men) ranging in age from 26 to 71 years old were involved in the 24- week, double-blind trial. The patients had active rheumatoid arthritis for an average span of 13 years and had undergone at least 6 months of methotrexate therapy.

During the 4 weeks preceding the trial, the patients received 10 to 25 mg. methotrexate per week, either orally or by injection. To begin the trial, researchers randomly assigned 59 patients to receive 25 mg. etanercept and 30 patients to receive placebo by subcutaneous injection twice a week, while continuing their methotrexate treatment.

Criteria set by the The American College of Rheumatology was used to assess clinical response. The results showed:

  • 71% of patients receiving both etanercept and methotrexate had a 20% improvement in symptoms, as did 27% of those receiving placebo along with methotrexate.
  • 39% of patients receiving both etanercept and methotrexate had a 50% improvement in symptoms, as did only 3% receiving placebo along with methotrexate.
  • 15% of patients receiving both etanercept and methotrexate had a 70% improvement in symptoms (classified as a major clinical response), not observed in those receiving placebo and methotrexate.

    Adverse Effects

    Mild injection site reactions were the only adverse effect associated with etanercept. Gastrointestinal side effects, hematologic effects, and headaches were not increased by etanercept.

    The study concluded that in patients with persistently active rheumatoid arthritis, the combination of etanercept and methotrexate was safe, well-tolerated, and provided a significant response beyond what methotrexate produced alone. It was concluded that patients who have had an inadequate response to methotrexate at doses of 20-25 mg./week are the best candidates for etanercept. The study is being extended to determine if the effectiveness of etanercept diminishes and whether its ability to block inflammation also alters a patient's ability to fight infection and disease.

    Related Resources

  • Enbrel (etanercept)
  • Methotrexate
  • Rheumatoid Arthritis
  • Sources: A Trial Of Etanercept, a Recombinant Tumor Necrosis Factor:Fc Fusion Protein, in Patients with Rheumatoid Arthritis Receiving Methotrexate, New England Journal of Medicine, January 28,1999; Drug Duo Treats Persistent Arthritis, Intelihealth 1/28/99; Adding Etanercept To Methotrexate Improves RA, Reuters, 1/28/99; Arthritis Drug Combo Helps Patients, UPI, 1/27/99; US Study Finds New Drug Helps Arthritis Sufferers, Reuters, 1/27/99
    First published: 02/02/1999

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