Document Detail


Lack of adverse effect of anti-tumor necrosis factor-α biologics in treatment of rheumatoid arthritis: 5 years follow-up.
MedLine Citation:
PMID:  22709496     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Rheumatoid arthritis (RA) is a chronic, systemic inflammatory disorder affecting synovial joints and many other organs. Most patients seen in clinical settings have a progressive chronic disease, with radiographic damage, frequent work disability, incremental functional declines and increased mortality rates. The introduction of the biological drugs in treatment of RA has played an important role in prevention of destructive effects of the disease but may have serious adverse effects due to their powerful inhibition of the immune system.
OBJECTIVES: To study the adverse effects (ADEs) of three different tumor necrosis factor α inhibitor (TNFi) drugs (infliximab, adalimumab and etanercept) in RA patients for 5 years in the south-west area of Saudi Arabia.
METHODS: Two groups of RA patients were included in this study: The first group included 112 patients, representing the biologics group. These patients received biological therapy plus disease modifying anti-rheumatic drugs (DMARDs): 56 patients received infliximab (IFX), 36 patients received adalimumab (ADL) and 20 patients received etanercept (ETN). The second group also included 112 patients, representing the control group: RA patients treated only with the traditional DMARDs. ADEs were classified into mild and severe.
RESULTS: The mild ADEs which had been recorded during 5 years of follow-up in patients receiving TNFi, were onycholysis (1.8%), positive tuberculin test (1.8%) and small vessel vasculitis (1.8%). Statistically, there were insignificant differences in the mild ADEs except for upper respiratory tract infection that was significantly higher in the control group. Severe ADEs included pneumonia (1.8%) and solid tumor (1.8%) and there were no significant differences between the biologics and control groups. Also there were no significant statistical differences for the ADEs, mild or severe, between the three biologics, infliximab, adalimumab and etanercept. Occurrence of ADEs did not correlate to methotrexate dose, steroid dose or rheumatoid factor positivity.
CONCLUSIONS: Our results indicate that the use of TNFi therapy appeared to be as safe as traditional DMARDs in treatment of rheumatoid arthritis patients and long-term follow-up with careful examination is essential to pick up any abnormal ADEs.
Authors:
Ahmed M Dewedar; Medhat A Shalaby; Sulaiman Al-Homaid; Ahmed M Mahfouz; Osama A Shams; Ahmed Fathy
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Publication Detail:
Type:  Journal Article     Date:  2012-02-13
Journal Detail:
Title:  International journal of rheumatic diseases     Volume:  15     ISSN:  1756-185X     ISO Abbreviation:  Int J Rheum Dis     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-06-19     Completed Date:  2012-10-23     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  101474930     Medline TA:  Int J Rheum Dis     Country:  England    
Other Details:
Languages:  eng     Pagination:  330-5     Citation Subset:  IM    
Copyright Information:
© 2012 The Authors International Journal of Rheumatic Diseases © 2012 Asia Pacific League of Associations for Rheumatology and Blackwell Publishing Asia Pty Ltd.
Affiliation:
Department of Rheumatology, Suez Canal University, Ismailia, Egypt. ahmeddewedar@yahoo.co.uk
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MeSH Terms
Descriptor/Qualifier:
Adult
Analysis of Variance
Antibodies, Monoclonal / adverse effects,  therapeutic use*
Antibodies, Monoclonal, Humanized / adverse effects,  therapeutic use*
Antirheumatic Agents / adverse effects,  therapeutic use*
Arthritis, Rheumatoid / drug therapy*,  immunology
Biological Agents / adverse effects,  therapeutic use*
Case-Control Studies
Chi-Square Distribution
Drug Therapy, Combination
Female
Follow-Up Studies
Humans
Immunoglobulin G / adverse effects,  therapeutic use*
Male
Middle Aged
Receptors, Tumor Necrosis Factor / therapeutic use*
Risk Assessment
Risk Factors
Saudi Arabia
Time Factors
Treatment Outcome
Tumor Necrosis Factor-alpha / antagonists & inhibitors*,  metabolism
Young Adult
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Antibodies, Monoclonal, Humanized; 0/Antirheumatic Agents; 0/Biological Agents; 0/Immunoglobulin G; 0/Receptors, Tumor Necrosis Factor; 0/Tumor Necrosis Factor-alpha; 0/infliximab; 185243-69-0/TNFR-Fc fusion protein; FYS6T7F842/adalimumab

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