Results of a new study assessing the efficacy of combination treatment with Enbrel (etanercept) and methotrexate in rheumatoid arthritis (RA) patients, showed 80% of patients experienced no disease progression over one year, compared with Enbrel or methotrexate alone.
One-year results of TEMPO, (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes), were presented by Amgen and Wyeth Pharmaceuticals at a satellite symposium during the European League Against Rheumatism meeting in Lisbon, Portugal.
Eighty percent of patients treated with combination therapy experienced no radiographic progression through one year, compared to 68 percent of patients treated with Enbrel alone and 57 percent of patients treated with methotrexate.
The multi-center, double-blind, Phase 3 study randomized 682 patients with RA for a period of one year to receive Enbrel (25 mg twice weekly) plus methotrexate (mean dose of 17 mg once weekly), Enbrel (25 mg twice weekly) plus placebo capsules once weekly, or methotrexate (mean dose of 17 mg once weekly) plus placebo injections twice weekly.
Both combination therapy and Enbrel monotherapy provided significant inhibition of joint damage (-0.5 mean change and 0.5 mean change from baseline in total Sharp score, respectively), compared with methotrexate alone (2.8 mean change in total Sharp score). A Sharp score is an X-ray measurement of changes in total joint damage as assessed by bone erosions and joint space narrowing.
“The radiographic data in this study demonstrate that Enbrel in combination or alone had a more significant impact on the progression of structural damage in RA versus methotrexate alone,” said Dr. Désirée van der Heijde, professor of rheumatology, University of Maastricht in the Netherlands. “In fact, the combination of Enbrel and methotrexate provided some of best radiographic responses noted to date. This is especially important considering the characteristics of RA as a chronic, progressively disabling disease.”
Other responses were evaluated by 20 percent, 50 percent and 70 percent ACR score improvements in the signs and symptoms of RA (known as ACR20, ACR50 and ACR70 scores).
After 52 weeks of treatment, an ACR20 score was achieved by 85 percent of patients treated with the Enbrel and methotrexate combination, 76 percent of patients treated with Enbrel alone and 75 percent of patients treated with methotrexate.
Sixty-nine percent of patients on combination therapy reached an ACR50 score at one year, versus 48 percent and 43 percent with Enbrel alone and methotrexate respectively. ACR70 scores were 43 percent, 24 percent and 19 percent with the Enbrel combination, Enbrel alone, and methotrexate respectively.
“This study shows that Enbrel, either in combination with methotrexate or alone, provided patients not only symptomatic relief but significant inhibition of joint damage,” said Dr. Beth Seidenberg, Amgen senior vice president of development.
Adverse events were similar to those reported in previous clinical trials of Enbrel in patients with RA.
Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. If left untreated or improperly treated, RA can produce serious destruction of one or more joints, which frequently leads to permanent disability, significantly impacting quality of life.