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

Background For rheumatoid arthritis (RA), the treat-to-target concept suggests attaining remission or at least low disease activity (LDA) after 12 weeks. Objectives This German, prospective, multicenter, non-interventional study aimed to determine the proportion of patients with RA who achieved their treat-to-target aim after 12 and 24 weeks of etanercept (ETN) treatment in a real-life setting, as opposed to patients achieving their therapeutic target at a later timepoint (week 36 or 52). Methods A total of 824 adults with a confirmed diagnosis of RA without prior ETN treatment were included. Remission and LDA were defined as DAS28 < 2.6 and DAS28 <= 3.2, respectively. Results The proportion of patients achieving remission was 24% at week 12 and 31% at week 24. The proportion of patients achieving LDA was 39% at week 12 and 45% at week 24. The proportion of patients achieving remission or LDA further increased beyond week 24 up to week 52. Improvement in pain and reduction in concomitant glucocorticoid treatment were observed. Improvements in patient-reported outcomes were also seen in patients who did not reach remission or LDA. No new safety signals were detected. Conclusions A considerable proportion of patients with RA attained the target of remission or LDA after 12 weeks of ETN treatment. Even beyond that timepoint, the proportion of patients achieving treatment targets continued to increase up to week 52. Plain Language Summary Physicians measure response to treatment of rheumatoid arthritis using a disease activity score (DAS28). People with a DAS28 of less than 2.6 have very few to no symptoms (also called remission). People with a DAS28 of 3.2 or less, called low disease activity, may experience mild symptoms. When people do not respond to treatment after 12 weeks, it is usually recommended to prescribe a different treatment. Researchers do not know how many people who do not respond after 12 weeks would respond if treatment were continued. A total of 824 German people with rheumatoid arthritis who received a drug called etanercept for up to 52 weeks took part in this study. Researchers wanted to know how many people had remission or low disease activity after 12 weeks and 24 weeks of treatment. After 12 weeks, 24 in 100 people had remission; this increased to 31 in 100 people after 24 weeks. Thirty-nine in 100 people had low disease activity after 12 weeks; this increased to 45 in 100 people after 24 weeks. The number of people with remission or low disease activity increased with longer treatment (up to 52 weeks). People needed less additional treatment with a type of drug called glucocorticoids. The people in this study experienced side effects that were similar to those reported by people who took etanercept in previous studies. The researchers concluded that a considerable proportion of people responded to treatment with etanercept after 12 weeks. This proportion increased when treatment was continued for longer than 12 weeks.