Cargando…
74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis
INTRODUCTION: The objective was to describe the prevalence, types, and predictors of adverse events (AEs) in rheumatoid arthritis (RA) patients treated with infliximab and methotrexate in a daily clinical setting. METHODS: This was a prospective, multi-center, open-label, 74-week observational study...
Autores principales: | , |
---|---|
Formato: | Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2010
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2911915/ https://www.ncbi.nlm.nih.gov/pubmed/20569501 http://dx.doi.org/10.1186/ar3058 |
_version_ | 1782184538445709312 |
---|---|
author | Delabaye, Isabelle De Keyser, Filip |
author_facet | Delabaye, Isabelle De Keyser, Filip |
author_sort | Delabaye, Isabelle |
collection | PubMed |
description | INTRODUCTION: The objective was to describe the prevalence, types, and predictors of adverse events (AEs) in rheumatoid arthritis (RA) patients treated with infliximab and methotrexate in a daily clinical setting. METHODS: This was a prospective, multi-center, open-label, 74-week observational study in patients with active RA despite treatment with methotrexate and at least one other disease-modifying anti-rheumatic drug. Patients were treated with 3 mg/kg infliximab at weeks 0, 2, and 6 and then every 8 weeks. At weeks 0, 6, 26, 50, and 74, patients answered a health assessment questionnaire, a swollen joint count was made, and adverse events (AEs) occurring during the previous period were registered. RESULTS: Five hundred and seventy-five patients were treated with infliximab, of which 346 were still on infliximab at the study end, 158 discontinued treatment, and 71 were lost to follow-up. Reasons for discontinuation included safety (n = 74), elective reasons (n = 43), and inefficacy (n = 41). Infusion reactions (n = 33) and infections (n = 20) were the most common AEs causing discontinuation and the most common AEs overall. There were four cases of tuberculosis, all of which occurred in patients negative at screening. Total AEs, serious AEs, and infusion reactions as well as discontinuations for AEs were most frequent during the first 26 weeks. Higher age was a predictor of serious adverse events (SAEs), infection, and discontinuation due to an SAE, but odds ratios were close to one. CONCLUSIONS: AEs and discontinuations due to AEs occur most frequently during the first half year of infliximab treatment in refractory RA patients. The main reasons for discontinuing treatment are infections and infusion reactions. Tuberculosis and other infections remain an important concern in these patients. |
format | Text |
id | pubmed-2911915 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-29119152010-07-29 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis Delabaye, Isabelle De Keyser, Filip Arthritis Res Ther Research Article INTRODUCTION: The objective was to describe the prevalence, types, and predictors of adverse events (AEs) in rheumatoid arthritis (RA) patients treated with infliximab and methotrexate in a daily clinical setting. METHODS: This was a prospective, multi-center, open-label, 74-week observational study in patients with active RA despite treatment with methotrexate and at least one other disease-modifying anti-rheumatic drug. Patients were treated with 3 mg/kg infliximab at weeks 0, 2, and 6 and then every 8 weeks. At weeks 0, 6, 26, 50, and 74, patients answered a health assessment questionnaire, a swollen joint count was made, and adverse events (AEs) occurring during the previous period were registered. RESULTS: Five hundred and seventy-five patients were treated with infliximab, of which 346 were still on infliximab at the study end, 158 discontinued treatment, and 71 were lost to follow-up. Reasons for discontinuation included safety (n = 74), elective reasons (n = 43), and inefficacy (n = 41). Infusion reactions (n = 33) and infections (n = 20) were the most common AEs causing discontinuation and the most common AEs overall. There were four cases of tuberculosis, all of which occurred in patients negative at screening. Total AEs, serious AEs, and infusion reactions as well as discontinuations for AEs were most frequent during the first 26 weeks. Higher age was a predictor of serious adverse events (SAEs), infection, and discontinuation due to an SAE, but odds ratios were close to one. CONCLUSIONS: AEs and discontinuations due to AEs occur most frequently during the first half year of infliximab treatment in refractory RA patients. The main reasons for discontinuing treatment are infections and infusion reactions. Tuberculosis and other infections remain an important concern in these patients. BioMed Central 2010 2010-06-22 /pmc/articles/PMC2911915/ /pubmed/20569501 http://dx.doi.org/10.1186/ar3058 Text en Copyright ©2010 Delabaye and De Keyser; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Delabaye, Isabelle De Keyser, Filip 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis |
title | 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis |
title_full | 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis |
title_fullStr | 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis |
title_full_unstemmed | 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis |
title_short | 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis |
title_sort | 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2911915/ https://www.ncbi.nlm.nih.gov/pubmed/20569501 http://dx.doi.org/10.1186/ar3058 |
work_keys_str_mv | AT delabayeisabelle 74weekfollowupofsafetyofinfliximabinpatientswithrefractoryrheumatoidarthritis AT dekeyserfilip 74weekfollowupofsafetyofinfliximabinpatientswithrefractoryrheumatoidarthritis |