6533b7dbfe1ef96bd1271663
RESEARCH PRODUCT
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.
F AtzeniP Sarzi PuttiniC BotsiosA CarlettoP CiprianiEg FavalliE FratiV FoschiS GaspariniA GiardinaE GremeseF IannoneM SebastianiT ZiglioliD BiasiC FerriM GaleazziRoberto GerliR GiacomelliR GorlaM GovoniG LapadulaA MarchesoniF SalaffiL PunziG TrioloG Ferraccioli On Behalf Of Giseasubject
Malerheumatoid arthritisArthritisReceptors Tumor Necrosis FactorEtanerceptEtanerceptArthritis RheumatoidAdalimumab; Adult; Aged; Antibodies Monoclonal; Antibodies Monoclonal Humanized; Antirheumatic Agents; Arthritis Rheumatoid; Etanercept; Female; Humans; Immunoglobulin G; Incidence; Infection; Infliximab; Male; Middle Aged; Receptors Tumor Necrosis Factor; Registries; Tumor Necrosis FactorsRheumatoidadalimumabMonoclonalReceptorsImmunology and AllergyRegistriesinfectionsHumanizedAnti-TNF agents; GISEA register; Infections; Predictive factorsIncidence (epidemiology)IncidenceAntibodies MonoclonalAnti-TNF agentsMiddle AgedRheumatoid arthritisAntirheumatic AgentsCohortTumor Necrosis FactorsFemaleInfectionPredictive factorsmedicine.druganti-TNF; serious infections; rheumatoid arthritisAdultmedicine.medical_specialtyanti-TNF therapy; infections; rheumatoid arthritis; adalimumab; etanercept; infliximabanti-TNF therapyserious infectionsImmunologyInfections rheumatoid arthritis anti-TNF therapyAntibodies Monoclonal HumanizedInfectionsAntibodiesInternal medicinemedicineAdalimumabHumansAgedGISEA registerbusiness.industryArthritisAdalimumabanti-TNFGISEA register; Infections; Anti-TNF agents; Predictive factors; Adalimumab; Adult; Aged; Antibodies Monoclonal; Antibodies Monoclonal Humanized; Antirheumatic Agents; Arthritis Rheumatoid; Etanercept; Female; Humans; Immunoglobulin G; Incidence; Infection; Infliximab; Male; Middle Aged; Receptors Tumor Necrosis Factor; Registries; Tumor Necrosis Factorsmedicine.diseaseInfliximabInfliximabConcomitantImmunoglobulin GImmunologyTumor Necrosis Factor InhibitorsbusinessTumor Necrosis Factorinfliximabetanerceptdescription
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±13.4years; mean disease duration 9.0±8.3years) enrolled in the GISEA register, who had been treated for at least 6months 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 9years 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 12months 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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2012-01-01 |