Document Detail

Long-term anti-TNF therapy and the risk of serious infections in a cohort of patients with rheumatoid arthritis: comparison of adalimumab, etanercept and infliximab in the GISEA registry.
MedLine Citation:
PMID:  22796281     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate the risk of serious infections (SIs) in RA patients receiving anti-TNF therapy on the basis of the data included in the GISEA register.
METHODS: The study involved 2769 adult patients with long-standing RA (mean age 53.2±13.4 years; mean disease duration 9.0±8.3 years) enrolled in the GISEA register, who had been treated for at least 6 months with TNF inhibitors or had discontinued therapy due to SI: 837 (30%) treated with infliximab (IFN), 802 (29%) with adalimumab (ADA), and 1130 (41%) with etanercept (ETN).
RESULTS: 176 patients had experienced at least one of the 226 Sis during the 9 years of treatment with an anti-TNF agent, an overall incidence of 31.8/1000 patient-years (95% CI 25.2-38.3): 23.7/1000 patient-years (95% CI 13.1-34.2) on ADA; 12.8/1000 patient-years (95% CI 6.3-19.4) on ETN and 65.1/1000 patient-years (95% CI 48.4-81.8) on IFN. The risk was higher in the first than in the second year of treatment, but this difference was not statistically significant (p=0.08) (38.9% of the SIs were recorded in the first 12 months of treatment). The risk of SI was significantly different among the three treatment groups (p<0.0001). Multivariate models confirmed that the use of steroids (p<0.046), concomitant DMARD treatment during anti-TNF therapy (p=0.004), advanced age at the start of anti-TNF treatment (p<0.0001), and the use of IFN or ADA rather than ETN (respectively p<0.0001 and p=0.023) were strong and statistically significant predictors of infection.
CONCLUSIONS: Anti-TNF therapy is associated with a small but significant risk of SI that is associated with the concomitant use of steroids, advanced age at the start of anti-TNF treatment, and the type of anti-TNF agent.
Fabiola Atzeni; Piercarlo Sarzi-Puttini; Costantino Botsios; Antonio Carletto; Paola Cipriani; Ennio Giulio Favalli; Elena Frati; Valentina Foschi; Stefania Gasparini; AnnaRita Giardina; Elisa Gremese; Florenzo Iannone; Marco Sebastiani; Tamara Ziglioli; Domenico Biasi; Clodoveo Ferri; Mauro Galeazzi; Roberto Gerli; Roberto Giacomelli; Roberto Gorla; Marcello Govoni; Giovanni Lapadula; Antonio Marchesoni; Fausto Salaffi; Leonardo Punzi; Giovanni Triolo; Gianfranco Ferraccioli
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2012-07-13
Journal Detail:
Title:  Autoimmunity reviews     Volume:  12     ISSN:  1873-0183     ISO Abbreviation:  Autoimmun Rev     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-27     Completed Date:  2013-05-02     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  101128967     Medline TA:  Autoimmun Rev     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  225-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Elsevier B.V. All rights reserved.
Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
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MeSH Terms
Antibodies, Monoclonal / adverse effects,  therapeutic use*
Antibodies, Monoclonal, Humanized / adverse effects,  therapeutic use
Antirheumatic Agents / adverse effects,  therapeutic use*
Arthritis, Rheumatoid / complications*,  drug therapy*
Immunoglobulin G / adverse effects,  therapeutic use
Infection / chemically induced,  complications*,  epidemiology
Middle Aged
Receptors, Tumor Necrosis Factor / therapeutic use
Tumor Necrosis Factors / antagonists & inhibitors*
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Antibodies, Monoclonal, Humanized; 0/Antirheumatic Agents; 0/Immunoglobulin G; 0/Receptors, Tumor Necrosis Factor; 0/Tumor Necrosis Factors; 0/infliximab; 185243-69-0/TNFR-Fc fusion protein; FYS6T7F842/adalimumab

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