Cargando…

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

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 out...

Descripción completa

Detalles Bibliográficos
Autores principales: Wassenberg, Siegfried, Rau, Rolf, Klopsch, Thilo, Plenske, Anja, Jobst, Jürgen, Klaus, Pascal, Meng, Thomas, Löschmann, Peter-Andreas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9931988/
https://www.ncbi.nlm.nih.gov/pubmed/36251174
http://dx.doi.org/10.1007/s40744-022-00491-4
_version_ 1784889350489636864
author Wassenberg, Siegfried
Rau, Rolf
Klopsch, Thilo
Plenske, Anja
Jobst, Jürgen
Klaus, Pascal
Meng, Thomas
Löschmann, Peter-Andreas
author_facet Wassenberg, Siegfried
Rau, Rolf
Klopsch, Thilo
Plenske, Anja
Jobst, Jürgen
Klaus, Pascal
Meng, Thomas
Löschmann, Peter-Andreas
author_sort Wassenberg, Siegfried
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40744-022-00491-4.
format Online
Article
Text
id pubmed-9931988
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Springer Healthcare
record_format MEDLINE/PubMed
spelling pubmed-99319882023-02-17 Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA) Wassenberg, Siegfried Rau, Rolf Klopsch, Thilo Plenske, Anja Jobst, Jürgen Klaus, Pascal Meng, Thomas Löschmann, Peter-Andreas Rheumatol Ther Original Research 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40744-022-00491-4. Springer Healthcare 2022-10-17 /pmc/articles/PMC9931988/ /pubmed/36251174 http://dx.doi.org/10.1007/s40744-022-00491-4 Text en © The Author(s) 2022, corrected publication 2023 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Wassenberg, Siegfried
Rau, Rolf
Klopsch, Thilo
Plenske, Anja
Jobst, Jürgen
Klaus, Pascal
Meng, Thomas
Löschmann, Peter-Andreas
Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA)
title Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA)
title_full Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA)
title_fullStr Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA)
title_full_unstemmed Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA)
title_short Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA)
title_sort etanercept is effective and halts radiographic progression in rheumatoid arthritis and psoriatic arthritis: final results from a german non-interventional study (prera)
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9931988/
https://www.ncbi.nlm.nih.gov/pubmed/36251174
http://dx.doi.org/10.1007/s40744-022-00491-4
work_keys_str_mv AT wassenbergsiegfried etanerceptiseffectiveandhaltsradiographicprogressioninrheumatoidarthritisandpsoriaticarthritisfinalresultsfromagermannoninterventionalstudyprera
AT raurolf etanerceptiseffectiveandhaltsradiographicprogressioninrheumatoidarthritisandpsoriaticarthritisfinalresultsfromagermannoninterventionalstudyprera
AT klopschthilo etanerceptiseffectiveandhaltsradiographicprogressioninrheumatoidarthritisandpsoriaticarthritisfinalresultsfromagermannoninterventionalstudyprera
AT plenskeanja etanerceptiseffectiveandhaltsradiographicprogressioninrheumatoidarthritisandpsoriaticarthritisfinalresultsfromagermannoninterventionalstudyprera
AT jobstjurgen etanerceptiseffectiveandhaltsradiographicprogressioninrheumatoidarthritisandpsoriaticarthritisfinalresultsfromagermannoninterventionalstudyprera
AT klauspascal etanerceptiseffectiveandhaltsradiographicprogressioninrheumatoidarthritisandpsoriaticarthritisfinalresultsfromagermannoninterventionalstudyprera
AT mengthomas etanerceptiseffectiveandhaltsradiographicprogressioninrheumatoidarthritisandpsoriaticarthritisfinalresultsfromagermannoninterventionalstudyprera
AT loschmannpeterandreas etanerceptiseffectiveandhaltsradiographicprogressioninrheumatoidarthritisandpsoriaticarthritisfinalresultsfromagermannoninterventionalstudyprera