Cargando…
Real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study
INTRODUCTION: An understanding of real-world predictors of abatacept retention is limited. We analysed retention rates and predictors of abatacept retention in biologic-naïve and biologic-failure patients in a 12-month interim analysis of the 2-yearAbataCepTIn rOutiNe clinical practice (ACTION) stud...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5761291/ https://www.ncbi.nlm.nih.gov/pubmed/29435360 http://dx.doi.org/10.1136/rmdopen-2017-000538 |
_version_ | 1783291541856452608 |
---|---|
author | Alten, Rieke Mariette, Xavier Lorenz, Hanns-Martin Galeazzi, Mauro Cantagrel, Alain Nüßlein, Hubert G Chartier, Melanie Elbez, Yedid Rauch, Christiane Le Bars, Manuela |
author_facet | Alten, Rieke Mariette, Xavier Lorenz, Hanns-Martin Galeazzi, Mauro Cantagrel, Alain Nüßlein, Hubert G Chartier, Melanie Elbez, Yedid Rauch, Christiane Le Bars, Manuela |
author_sort | Alten, Rieke |
collection | PubMed |
description | INTRODUCTION: An understanding of real-world predictors of abatacept retention is limited. We analysed retention rates and predictors of abatacept retention in biologic-naïve and biologic-failure patients in a 12-month interim analysis of the 2-yearAbataCepTIn rOutiNe clinical practice (ACTION) study. METHODS: ACTION was an international, observational study of patients with moderate-to-severe rheumatoid arthritis (RA) who initiated intravenous abatacept. In this 12-month interim analysis, crude abatacept retention rates, predictors of retention and European League Against Rheumatism (EULAR) response were evaluated in both biologic-naïve and biologic-failure patients. Retention by rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) status was also assessed, in patients with or without baseline radiographic erosions, and by body mass index (BMI). RESULTS: Overall, 2350/2364 enrolled patients were evaluable (674 biologic naїve; 1676 biologic failure). Baseline characteristics were largely similar in biologic-naïve and biologic-failure groups. Crude retention rates (95% CI) at 12 months were significantly higher in biologic-naїve (78.1%(74.7% to 81.2%)) versus biologic-failure patients (69.9%(67.6% to 72.1%); P<0.001). RF/anti-CCP double positivity predicted higher retention in both patient groups, and remained associated with higher retention in patients with erosive disease. BMI did not impact abatacept retention in either patient group, irrespective of RF/anti-CCP serostatus. Good/moderate EULAR response rate at 12 months was numerically higher in biologic-naїve (83.8%) versus biologic-failure (73.3%) patients. There were no new safety signals. CONCLUSION: High levels of intravenous abatacept retention in clinical practice were confirmed, particularly in biologic-naïve patients, including in those with poor RA prognostic factors. Retention was unaffected by BMI, regardless of RF/anti-CCP serostatus. TRIAL REGISTRATION NUMBER: NCT02109666; retrospectively registered 8 April 2014. |
format | Online Article Text |
id | pubmed-5761291 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-57612912018-02-12 Real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study Alten, Rieke Mariette, Xavier Lorenz, Hanns-Martin Galeazzi, Mauro Cantagrel, Alain Nüßlein, Hubert G Chartier, Melanie Elbez, Yedid Rauch, Christiane Le Bars, Manuela RMD Open Rheumatoid Arthritis INTRODUCTION: An understanding of real-world predictors of abatacept retention is limited. We analysed retention rates and predictors of abatacept retention in biologic-naïve and biologic-failure patients in a 12-month interim analysis of the 2-yearAbataCepTIn rOutiNe clinical practice (ACTION) study. METHODS: ACTION was an international, observational study of patients with moderate-to-severe rheumatoid arthritis (RA) who initiated intravenous abatacept. In this 12-month interim analysis, crude abatacept retention rates, predictors of retention and European League Against Rheumatism (EULAR) response were evaluated in both biologic-naïve and biologic-failure patients. Retention by rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) status was also assessed, in patients with or without baseline radiographic erosions, and by body mass index (BMI). RESULTS: Overall, 2350/2364 enrolled patients were evaluable (674 biologic naїve; 1676 biologic failure). Baseline characteristics were largely similar in biologic-naïve and biologic-failure groups. Crude retention rates (95% CI) at 12 months were significantly higher in biologic-naїve (78.1%(74.7% to 81.2%)) versus biologic-failure patients (69.9%(67.6% to 72.1%); P<0.001). RF/anti-CCP double positivity predicted higher retention in both patient groups, and remained associated with higher retention in patients with erosive disease. BMI did not impact abatacept retention in either patient group, irrespective of RF/anti-CCP serostatus. Good/moderate EULAR response rate at 12 months was numerically higher in biologic-naїve (83.8%) versus biologic-failure (73.3%) patients. There were no new safety signals. CONCLUSION: High levels of intravenous abatacept retention in clinical practice were confirmed, particularly in biologic-naïve patients, including in those with poor RA prognostic factors. Retention was unaffected by BMI, regardless of RF/anti-CCP serostatus. TRIAL REGISTRATION NUMBER: NCT02109666; retrospectively registered 8 April 2014. BMJ Publishing Group 2017-12-29 /pmc/articles/PMC5761291/ /pubmed/29435360 http://dx.doi.org/10.1136/rmdopen-2017-000538 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Rheumatoid Arthritis Alten, Rieke Mariette, Xavier Lorenz, Hanns-Martin Galeazzi, Mauro Cantagrel, Alain Nüßlein, Hubert G Chartier, Melanie Elbez, Yedid Rauch, Christiane Le Bars, Manuela Real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study |
title | Real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study |
title_full | Real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study |
title_fullStr | Real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study |
title_full_unstemmed | Real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study |
title_short | Real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study |
title_sort | real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the action observational study |
topic | Rheumatoid Arthritis |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5761291/ https://www.ncbi.nlm.nih.gov/pubmed/29435360 http://dx.doi.org/10.1136/rmdopen-2017-000538 |
work_keys_str_mv | AT altenrieke realworldpredictorsof12monthintravenousabataceptretentioninpatientswithrheumatoidarthritisintheactionobservationalstudy AT mariettexavier realworldpredictorsof12monthintravenousabataceptretentioninpatientswithrheumatoidarthritisintheactionobservationalstudy AT lorenzhannsmartin realworldpredictorsof12monthintravenousabataceptretentioninpatientswithrheumatoidarthritisintheactionobservationalstudy AT galeazzimauro realworldpredictorsof12monthintravenousabataceptretentioninpatientswithrheumatoidarthritisintheactionobservationalstudy AT cantagrelalain realworldpredictorsof12monthintravenousabataceptretentioninpatientswithrheumatoidarthritisintheactionobservationalstudy AT nußleinhubertg realworldpredictorsof12monthintravenousabataceptretentioninpatientswithrheumatoidarthritisintheactionobservationalstudy AT chartiermelanie realworldpredictorsof12monthintravenousabataceptretentioninpatientswithrheumatoidarthritisintheactionobservationalstudy AT elbezyedid realworldpredictorsof12monthintravenousabataceptretentioninpatientswithrheumatoidarthritisintheactionobservationalstudy AT rauchchristiane realworldpredictorsof12monthintravenousabataceptretentioninpatientswithrheumatoidarthritisintheactionobservationalstudy AT lebarsmanuela realworldpredictorsof12monthintravenousabataceptretentioninpatientswithrheumatoidarthritisintheactionobservationalstudy |