Objectives: To assess, in a randomised controlled trial (RCT) and in clinical practice, an association of time to remission and baseline disease activity with both induction of remission and sustained remission in etanercept-treated patients with rheumatoid arthritis (RA).
Methods: Data from an RCT (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes [TEMPO]; n=682) and an observational registry (Rheumatoid Arthritis DMARD Intervention and Utilization Study [RADIUS II]; n=4341) were used to evaluate disease activity (Clinical Disease Activity Index [CDAI] score) over time in patients initiating etanercept (monotherapy or with methotrexate). CDAI remission (CDAI≤2.8) and sustained remission (≥6 months) were determined through year 3 by treatment group, study, time to remission, and disease severity.
Results: Patients from TEMPO and RADIUS II who received etanercept monotherapy showed similar CDAI remission rates (39% and 35%, respectively, at 3 years). Among patients who received etanercept with methotrexate, remission rates were 54% and 36%, respectively. Remission occurred more rapidly in TEMPO than RADIUS II perhaps from differences in compliance, patient populations, or sequence of combination therapy initiation. Generally, more patients with lower baseline CDAI scores achieved remission than those with higher scores. Continued remission appeared more likely in patients achieving remission earlier in the course of their therapy (0-6 months).
Conclusions: Remission by year 3 in etanercept-treated (with and without methotrexate) patients with RA occurred in ≥35% of patients in both an RCT (TEMPO) and a clinical practice setting (RADIUS II), and more frequently in those with lower baseline disease severity. Patients with lower RA disease activity were more likely to reach remission. Continued remission may be more likely in patients who achieved remission earlier.