WASHINGTON, D.C.—Several studies were presented during a late-breaking abstract session here at the 2012 ACR/ARHP Annual Meeting, held November 9–14. Turn to page 37 for some highlights from the session.
Reducing Dose of Etanercept Effective in Reducing RA Flares in Select Patients
Ronald F. van Vollenhoven, MD, PhD, professor and chief of the unit for clinical therapy research, inflammatory diseases and chief of the clinical trials unit in the department of rheumatology at the Karolinska Institute in Stockholm, Sweden, presented results of the Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) trial. The randomized, double-blind, multicenter study was undertaken to assess the effect of discontinuing or reducing the dose of etanercept (ETN) in patients with rheumatoid arthritis (RA) being treated with combination ETN and methotrexate (MTX)
The study included 73 patients with RA treated with ETN (50 mg weekly) plus MTX (stable dose, 7.5–25 mg/week) and who had maintained low disease activity/remission as measured by Disease Activity Score (DAS) 28 <3.2 for at least 11 months. To be eligible for the study, patients also had to be at least 18 years old with no prior treatment with non–antitumor necrosis factor (TNF) biologic agents or no prior attempt to discontinue ETN due to stable disease. Patients were randomly assigned to continued therapy with the same dose of ETN (50 mg weekly; n=23), a reduced dose of ETN (25 mg/weekly; n=27), or placebo (n=23) while continuing with MTX.
The primary endpoint of the study was the proportion of nonfailures at 48 weeks between patients treated with ETN (50 mg/week) versus placebo. Failure was defined as DAS28 >3.2 and an increase in DAS28 >0.6 or disease progression. A comparison of nonfailure and DAS28 outcomes for all three groups was also made.
Overall, the results showed that patients who maintained the full ETN dose (50 mg) and the reduced dose (25 mg) had response better than the placebo group. The study found that the proportion of nonfailures at 48 weeks was 52% for patients who continued on ETN (50 mg/week) versus 13% for those on placebo, with an odds ratio (OR) of 7.2 (95% CI, 1.7–29.8; P=0.007). The proportion of nonfailures for patients who continued on the reduced ETN (25 mg/week) dose was 44% versus 13% for placebo, with an OR of 4.2 (95% CI, 1.0–17.0) (P=0.044).
Although ETN at 25 mg/week is not yet an approved dose of ETN, Dr. van Vollenhoven said that the findings of the study suggest that it may be worthwhile for rheumatologists to try the reduced 25 mg/week dose of ETN in their patients to maintain low disease activity. He said the risk of doing this seems small given that the study also showed that patients who had a flare at the reduced dose and were treated again at the higher dose were able to regain low disease activity.
