In rheumatoid arthritis, a treat-to-target approach aims for remission or low disease activity within the first 3 months. However, investigators noted that improvements continued to increase throughout the 52-week period.
A significant amount of patients with rheumatoid arthritis (RA) were able to achieve low disease activity (LDA) or remission after 12 weeks of etanercept (ETN) treatment, which continued to increase up to week 52, according to a study published in Springer.1
ADEQUATE, a prospective, multicenter, non-interventional study, analyzed 824 patients with RA receiving ETN who achieved treat-to-target goals by weeks 12 and 24 and maintenance through week 52. Remission was defined as a Disease Activity Score-28 (DAS28) < 2.6 and LDA was defined as DAS28 ≤ 3.2. Data was collected at baseline and every 3 months for 1 year. Eligible patients exhibited moderate-to-severe active RA, had inadequate response to disease-modifying antirheumatic drugs (DMARDs), and were ETN-naïve. Secondary endpoints determined the incidence of adverse events (AEs) and patient-reported outcomes (PROs), which assessed depression, fatigue, and pain.
“For patients with RA, the treat-to-target concept suggests a goal of remission within the first 3 months of treatment, after which time treatment should be adjusted if the target is not reached,” investigators explained. “In patients who are unlikely to achieve remission, eg, those with long-standing disease who failed previous therapies, LDA can be an acceptable alternative target to remission.”
Over half of patients observed (57%) completed the study, with the main reasons for discontinuation being AEs and efficacy issues. Most participants were female (72%), median disease duration was 5.5 years, and mean age was 59 years.
At week 12, 24% (194/794)of patients were in remission, which increased to 31% (203/664) at week 24. This trend continued through week 36 (173/561) and week 52 (37%, 187/502). For those who did not achieve remission in the first 12 weeks, 19% were in remission at week 24 and 52% were able to maintain their treatment goal through week 52.
A total of 39% (313/794) of patients achieved LDA at week 12 and 45% (300/664) at week 24. This increased to 54% (273/502) at week 52. Of patients who achieved their goal at week 12 and week 24, a significant amount were able to maintain it through week 52 (45% and 59%, respectively).
Reductions in concomitant glucocorticoids were seen among the patient population, decreasing from 86% at baseline to 65% at week 52. Investigators noted improvements in PROs even for those who were unable to achieve treat-to-target goals. Fatigue and depression decreased through week 52, with the most significant reductions seen in the first 12 weeks.
No new safety signals were observed, however, half of patients (49%) experienced at least 1 AE during the study and serious adverse events (SAEs) were observed in 11% of patients. The most common AEs were administration-site reactions (28%), infections (12%), and musculoskeletal and connective tissue disorders (10%).
As nearly half (42%) of patients receiving ETN discontinued treatment or had missing documentation, there is a potential risk of bias. Observational studies are also inherently subject to the possibility of selection bias. No long-term conclusions could be made due to the duration of the study. Lastly, almost half of patients were receiving concomitant MTX, which may have influenced response rates.
“Our results show that decision-making regarding continuation or switching of therapy is complex. Optimal treatment decisions should always take into account patient preferences,” investigators stated. “While the treat-to-target approach has proven clinical benefits, some patients may benefit from prolonged treatment with ETN beyond 12 weeks before considering switching treatment.”
Feist E, Baraliakos X, Behrens F, et al. Effectiveness of Etanercept in Rheumatoid Arthritis: Real-World Data from the German Non-interventional Study ADEQUATE with Focus on Treat-to-Target and Patient-Reported Outcomes [published online ahead of print, 2022 Feb 3]. Rheumatol Ther. 2022;10.1007/s40744-021-00418-5. doi:10.1007/s40744-021-00418-5