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INTRODUCTION: For chronic diseases such as axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and plaque psoriasis (PsO), treatment goals include remission or at least low disease activity (LDA) by 12 weeks. Improvements in symptoms such as pain and fatigue should also be treatment goals. METHODS: ADEQUATE was a German, prospective, non-interventional study to evaluate the proportion of patients with rheumatoid arthritis, PsA, axSpA, or PsO who, in routine clinical practice, benefit from the continuation of treatment with etanercept (ETN) beyond 12 weeks, even when their treatment goals have not yet been reached. Patient-reported outcomes (PROs) and changes in concomitant glucocorticoid use were also recorded. This article focuses on results for patients with axSpA and PsA; data for patients with PsO are described briefly. RESULTS: In total, 305, 254, and 70 patients with axSpA, PsA, and PsO, respectively, were included. Rates of remission at week 12 and week 24, respectively, were 19% and 18% for axSpA, 38% and 51% for PsA, and 7% and 19% for PsO. Rates of LDA at week 12 and week 24, respectively, were 39% and 45% for axSpA, 50% and 60% for PsA, and 34% and 51% for PsO. Extending treatment up to 52 weeks was associated with stable rates of or further increases in remission and LDA rates. Improvements in pain, fatigue, and depression (axSpA, PsA, and PsO) and reductions in concomitant glucocorticoid use (axSpA and PsA) were observed. No new safety signals were detected. CONCLUSION: These findings confirm the effectiveness and safety of ETN in routine clinical practice for several indications and highlight potential benefits of continuing ETN treatment in patients who have not reached their treatment goals after 12 weeks. Additional benefits included improvements in PROs and reduction of concomitant glucocorticoids. TRIAL REGISTRATION: ClinicalTrials.gov NCT02486302.
Axial spondyloarthritis is a disorder that causes joint pain mainly in the spine and can cause deformation of the spine. Psoriatic arthritis and plaque psoriasis are disorders that cause dry, itchy, and raised skin patches. Psoriatic arthritis also causes swollen, stiff, and painful joints. Etanercept is a treatment used to reduce the symptoms of axial spondyloarthritis, psoriatic arthritis, and plaque psoriasis. The aim of treatment is remission, or low disease activity after 12 weeks. In this study, people received etanercept for up to 52 weeks from their usual doctors in Germany. A total of 305 people with axial spondyloarthritis, 254 people with psoriatic arthritis, and 70 people with plaque psoriasis took part in the study. After 12 weeks of treatment, 19 in 100 people with axial spondyloarthritis were in remission and 39 in 100 people had low disease activity. In addition, 38 in 100 people with psoriatic arthritis were in remission and 50 in 100 people had low disease activity. Finally, 7 in 100 people with plaque psoriasis were in remission and 34 in 100 people had low disease activity. These numbers remained mostly stable until the end of the study. People also reported less pain, fatigue, and depression. Most people were able to use less glucocorticoids. The number and types of unwanted side effects were similar to those seen in other studies of etanercept in people with axial spondyloarthritis, psoriatic arthritis, or plaque psoriasis.
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INTRODUCTION: Etanercept (ETN) has been shown to slow radiographic progression of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) in clinical trials. This real-world, non-interventional study assessed radiographic progression in patients with RA or PsA treated with ETN for ≤ 36 months in outpatient care in Germany (NCT01623752). METHODS: Patients with RA or PsA attended ≤ 10 visits across two study phases (phase 1: seven visits, baseline to month 18; phase 2: three visits until month 36). Radiographs were taken at baseline (Rx1), months 12-18 (Rx2), and/or months 30-36 (Rx3). Historic radiographs (Rx0) taken 12-48 months pre-baseline were also evaluated (if available). The primary endpoint was the change in modified total Sharp score (mTSS). The erosion score (ES) and joint space narrowing score (JSN) were also evaluated. RESULTS: Overall, 1821 patients were enrolled (RA: n = 1378; PsA: n = 440). In patients with Rx1 and Rx2 (RA: n = 511; PsA: n = 167), the mean mTSS remained stable for both disease groups, and the annualized median change in mTSS was 0. In patients with Rx0, Rx1, and Rx2 (RA: n = 180; PsA: n = 47), annualized radiographic progression in mTSS, ES, and JSN was larger in the pre-ETN treatment phase than during ETN treatment in both disease groups. The percentage of patients with radiographic non-progression was higher during ETN treatment versus pre-ETN. Improvement in clinical disease activity and patient-reported outcomes was also observed. CONCLUSIONS: This was the first real-world, non-interventional study to report systematically collected radiographic data in a large cohort of patients with RA or PsA under treatment with a biologic. In patients with available radiographic data, mean radiographic progression was lower and the proportion of patients without progression was greater during ETN treatment than in the pre-ETN period.
Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are diseases in which inflammation can lead to damage in the joints. X-ray images can show whether the disease gets worse; this is called radiographic progression. Etanercept is a drug that acts on the body's immune system and can reduce inflammation in the joints. In clinical studies, radiographic progression was slower in people with RA or PsA who received etanercept compared with people who received another drug called methotrexate. In this study, we wanted to know how radiographic progression changes in people in Germany who receive etanercept as part of their routine treatment. A total of 1378 people with RA and 440 people with PsA received etanercept for up to 36 months. We observed little to no radiographic progression for most people during the study. Radiographic progression was worse before people started taking etanercept. More people had no radiographic progression while taking etanercept compared with before they started treatment. The proportion of people who responded to treatment with etanercept as measured by the number of painful joints increased throughout the study. Overall, people felt that their health improved after they started taking etanercept.This was the first large study in which we investigated how radiographic progression changes when people with RA or PsA start taking etanercept as part of their routine treatment. We observed a slowing or halting of radiographic progression in most people and an improvement in their overall health.
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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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02486302.
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.
