Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA).

ABSTRACT

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.