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.
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.
Authors: Lars Klareskog; Désirée van der Heijde; Julien P de Jager; Andrew Gough; Joachim Kalden; Michel Malaise; Emilio Martín Mola; Karel Pavelka; Jacques Sany; Lucas Settas; Joseph Wajdula; Ronald Pedersen; Saeed Fatenejad; Marie Sanda Journal: Lancet Date: 2004-02-28 Impact factor: 79.321
Authors: Y P M Goekoop-Ruiterman; J K de Vries-Bouwstra; C F Allaart; D van Zeben; P J S M Kerstens; J M W Hazes; A H Zwinderman; H K Ronday; K H Han; M L Westedt; A H Gerards; J H L M van Groenendael; W F Lems; M V van Krugten; F C Breedveld; B A C Dijkmans Journal: Arthritis Rheum Date: 2005-11
Authors: Désirée van der Heijde; Lars Klareskog; Vicente Rodriguez-Valverde; Catalin Codreanu; Horatiu Bolosiu; Jose Melo-Gomes; Jesus Tornero-Molina; Joseph Wajdula; Ronald Pedersen; Saeed Fatenejad Journal: Arthritis Rheum Date: 2006-04
Authors: Philip J Mease; Alan J Kivitz; Francis X Burch; Evan L Siegel; Stanley B Cohen; Peter Ory; David Salonen; Joel Rubenstein; John T Sharp; Wayne Tsuji Journal: Arthritis Rheum Date: 2004-07
Authors: Paul Emery; Ferdinand C Breedveld; Stephen Hall; Patrick Durez; David J Chang; Deborah Robertson; Amitabh Singh; Ronald D Pedersen; Andrew S Koenig; Bruce Freundlich Journal: Lancet Date: 2008-07-16 Impact factor: 79.321
Authors: A K Brown; P G Conaghan; Z Karim; M A Quinn; K Ikeda; C G Peterfy; E Hensor; R J Wakefield; P J O'Connor; P Emery Journal: Arthritis Rheum Date: 2008-10