Ghent University Academic Bibliography

Advanced

74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis

Isabelle Delabaye and Filip De Keyser UGent (2010) ARTHRITIS RESEARCH & THERAPY. 12(3).
abstract
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.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
TUMOR-NECROSIS-FACTOR, PLACEBO-CONTROLLED TRIAL, DOUBLE-BLIND, PHASE-III, FACTOR THERAPY, ANTI-TNF ANTIBODY, HEART-FAILURE, LYMPHOMA, METHOTREXATE, RISK
journal title
ARTHRITIS RESEARCH & THERAPY
Arthritis Res. Ther.
volume
12
issue
3
article number
R121
pages
12 pages
Web of Science type
Article
Web of Science id
000280227900066
ISSN
1478-6362
DOI
10.1186/ar3058
language
English
UGent publication?
yes
classification
A1
additional info
publication for the REMITRACT study group
copyright statement
I have retained and own the full copyright for this publication
id
1095705
handle
http://hdl.handle.net/1854/LU-1095705
date created
2011-01-07 13:49:23
date last changed
2016-12-21 15:42:39
@article{1095705,
  abstract     = {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.},
  articleno    = {R121},
  author       = {Delabaye, Isabelle and De Keyser, Filip},
  issn         = {1478-6362},
  journal      = {ARTHRITIS RESEARCH \& THERAPY},
  keyword      = {TUMOR-NECROSIS-FACTOR,PLACEBO-CONTROLLED TRIAL,DOUBLE-BLIND,PHASE-III,FACTOR THERAPY,ANTI-TNF ANTIBODY,HEART-FAILURE,LYMPHOMA,METHOTREXATE,RISK},
  language     = {eng},
  number       = {3},
  pages        = {12},
  title        = {74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis},
  url          = {http://dx.doi.org/10.1186/ar3058},
  volume       = {12},
  year         = {2010},
}

Chicago
Delabaye, Isabelle, and Filip De Keyser. 2010. “74-week Follow-up of Safety of Infliximab in Patients with Refractory Rheumatoid Arthritis.” Arthritis Research & Therapy 12 (3).
APA
Delabaye, I., & De Keyser, F. (2010). 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis. ARTHRITIS RESEARCH & THERAPY, 12(3).
Vancouver
1.
Delabaye I, De Keyser F. 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis. ARTHRITIS RESEARCH & THERAPY. 2010;12(3).
MLA
Delabaye, Isabelle, and Filip De Keyser. “74-week Follow-up of Safety of Infliximab in Patients with Refractory Rheumatoid Arthritis.” ARTHRITIS RESEARCH & THERAPY 12.3 (2010): n. pag. Print.