title: Serious infections during anti-TNFalpha treatment in rheumatoid arthritis patients.
abstract: The objective was to estimate the incidence of serious infections in the patients treated with anti-TNFalpha agents for rheumatoid arthritis (RA) recorded in the Lombardy Rheumatology Network (LORHEN) registry. The study inclusion criteria were met by 1064 of the 1114 patients with long-standing RA, 519 treated with infliximab, 303 with adalimumab, and 242 with etanercept; their mean age was 55.8 years and the mean duration of RA 9.4 years. Seventy-three patients (6.9%) experienced a total of 74 serious infections, an incidence rate for all treatment courses of 35.9 per 1000 patient-years (95% confidence interval [95% CI] 27.66-44.13). Most were lower respiratory tract (34.2%) or skin and soft tissue infections (20.5%). Of the 1064 patients, the 790 treated with anti-TNFalpha after March 2002 underwent screening tests for LTBI; five patients developed active tuberculosis. Three patients died of septic shock. The type of anti-TNFalpha agent did not seem to affect the incidence or site of the infections. Both univariate and multivariate analyses identified age at the start of anti-TNFalpha treatment (p=0.008), baseline erythrocyte sedimentation rate ([ESR] p=0.014), and the concomitant use of corticosteroids (p=0.029) as significant predictors of infections. There was no statistically significant difference in risk between the anti-TNFalpha agents.
authors.affiliation: UOC Day Hospital of Rheumatology, G. Pini Orthopedic Institute, University of Milan, Milan, Italy. ennio.favalli@fastwebnet.it
authors.forename: Ennio Giulio
authors.initials: EG
authors.lastname: Favalli
authors.forename: Francesca
authors.initials: F
authors.lastname: Desiati
authors.forename: Fabiola
authors.initials: F
authors.lastname: Atzeni
authors.forename: Piercarlo
authors.initials: P
authors.lastname: Sarzi-Puttini
authors.forename: Roberto
authors.initials: R
authors.lastname: Caporali
authors.forename: Francesca Bobbio
authors.initials: FB
authors.lastname: Pallavicini
authors.forename: Roberto
authors.initials: R
authors.lastname: Gorla
authors.forename: Matteo
authors.initials: M
authors.lastname: Filippini
authors.forename: Antonio
authors.initials: A
authors.lastname: Marchesoni
mesh_terms: D000068879:Adalimumab; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000367:Age Factors; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000276:immunology / Q000628:therapy*; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage; D007165:Immunosuppression Therapy; D015994:Incidence; D000069285:Infliximab; D007558:Italy; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections / Q000453:epidemiology* / Q000209:etiology / Q000276:immunology; D013902:Radiography, Thoracic; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage; D012307:Risk Factors; D012772:Shock, Septic / Q000453:epidemiology* / Q000209:etiology / Q000276:immunology; D012882:Skin Tests; D014376:Tuberculosis / Q000453:epidemiology* / Q000209:etiology / Q000276:immunology; D014409:Tumor Necrosis Factor-alpha / Q000276:immunology*
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab; D000068800:Etanercept