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

Siegfried Wassenberg, Rolf Rau, Thilo Klopsch, Anja Plenske, Jürgen Jobst, Pascal Klaus, Thomas Meng, Peter-Andreas Löschmann, Siegfried Wassenberg, Rolf Rau, Thilo Klopsch, Anja Plenske, Jürgen Jobst, Pascal Klaus, Thomas Meng, Peter-Andreas Löschmann

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.

Keywords: Auto-injector; IL-6, IL-6Rα; Patient preference; Pen, Prefilled syringe; Rheumatoid arthritis; Sarilumab.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Patient disposition
Fig. 3
Fig. 3
Mean mTSS during the course of the study for different subpopulations: A RA and B PsA
Fig. 4
Fig. 4
Mean annualized radiographic progression in mTSS, ES, and JSN before and during ETN treatment in patients with A RA and B PsA with historic, baseline, and first follow-up X-rays, and cumulative probability plots of progression in patients with C RA and D PsA with historic, baseline, and first follow-up X-rays
Fig. 5
Fig. 5
Percentage of patients with historic, baseline, and first follow-up X-rays with radiographic non-progression: A RA and B PsA
Fig. 6
Fig. 6
Mean DAS28 during phase 1 and phase 2: A RA and B PsA; and the level of disease activity as measured by DAS28: C RA and D PsA
Fig. 7
Fig. 7
FFbH scores reported by patients with A RA and B PsA; proportion of patients reporting “no problems” by EQ-5D dimension: C RA and D PsA; pain VAS scores reported by patients with E RA and F PsA

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