Background Etanercept has been widely used as an effective treatment for patients with rheumatoid arthritis (RA). It is essential to acquire long-term efficacy and safety data in daily clinical practice.
Objectives To ascertain the long-term efficacy and safety of etanercept treatment for RA.
Methods From December 2004-December 2011, 560 consecutive patients have been included in the Dutch etanercept for RA (ETRA) cohort at the Jan van Breemen Research Institute. For the purpose of this analysis only patients who started with etanercept treatment and had at least one follow-up visit were included, leaving 493 patients.
Results The mean age was 53 years (SD:13), and 400 (81%) were female. At baseline, the median disease duration was 6.9 (IQR:2.6-15.9) years, 339 (70%) were rheumatoid factor positive, 305 (64%) had erosive disease, 176 (36%) used methotrexate, 194 (39%) used prednisolone, and 84 (17%) a DMARD other than MTX. Patients had used a mean of 2.8 (1.3) DMARDs, and 124 (38%) had used another biological prior to inclusion in the ETRA cohort. The median follow-up for the total cohort was 1 year (16 weeks-3 years), 28 weeks (16-52 weeks) for the drop-outs, and 2 years (40 weeks-3.5 years) for those remaining on etanercept treatment. A total of 288 (58%) patients remained on drug during the follow up period, and 205 (42%) had discontinued etanercept treatment earlier. Drop-out occurred mostly (95 patients, 46% of drop-outs) due to inefficacy (<1.2 reduction in DAS28) or adverse events (34 (17%) patients). In addition, 44 (21%) patients were lost to follow-up or withdrew consent, and 5 (2%) patients died while on etanercept treatment (two malignancies, one sepsis, one lung fibrosis and one while waiting for lung transplantation). A total of 424 (86%) patients reported adverse events during etanercept treatment, and 93 (19%) patients reported serious adverse events, with infections (40 patients, 43%) as the most frequent cause. The mean DAS28 dropped significantly from 5.0 (1.3) at baseline to 3.4 (1.4) at 16 weeks. This improvement was sustained, and increased further over 4 years (see table 1). The percentage of EULAR good responders was high, with 163 (39%) good responders after 16 weeks (and another 156 (37%) moderate responders), and rose steadily after (table 1). The median HAQ improved from 1.25 (0.75-1.75) to 0.88 (0.38-1.38) at 16 weeks of treatment, and remained stable thereafter (table 1).
Conclusions The initial good response on etanercept persisted for the duration of follow-up. The decrease in DAS28 continued (albeit more slowly) for the entire 4 years, and the percentage of EULAR good responders steadily increased over the 4 years. The majority of drop-outs occurred early in the cohort. Over time, a satisfactory response both in EULAR response and DAS28 was sustained during further follow-up for 4 years.
Disclosure of Interest I. Visman: None Declared, A. Jamnitski: None Declared, C. van Dongen: None Declared, A. Voskuyl: None Declared, M. Nurmohamed Grant/Research support from: The Jan van Breemen Research Institute has received Educational grants from Pfizer, Consultant for: BMS, MSD, Roche, Abbott, Pfizer and UCB, Speakers Bureau: BMS, MSD, Roche, Abbott, Pfizer and UCB
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