Rates of, and risk factors for, severe infections in patients with systemic autoimmune diseases receiving biological agents off-label View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2011-07-11

AUTHORS

Cándido Díaz-Lagares, Roberto Pérez-Alvarez, Francisco J García-Hernández, María M Ayala-Gutiérrez, José Luis Callejas, Agustín Martínez-Berriotxoa, Javier Rascón, Luis Caminal-Montero, Albert Selva-O'Callaghan, Joaquim Oristrell, Carmen Hidalgo, Ricardo Gómez-de-la-Torre, Luis Sáez, Jesús Canora-Lebrato, María-Teresa Camps, Norberto Ortego-Centeno, María-Jesús Castillo-Palma, Manuel Ramos-Casals

ABSTRACT

INTRODUCTION: The purpose of this observational study was to analyze the rates, characteristics and associated risk factors of severe infections in patients with systemic autoimmune diseases (SAD) who were treated off-label with biological agents in daily practice. METHODS: The BIOGEAS registry is an ongoing Spanish prospective cohort study investigating the long-term safety and efficacy of the off-label use of biological agents in adult patients with severe, refractory SAD. Severe infections were defined according to previous studies as those that required intravenous treatment or that led to hospitalization or death. Patients contributed person-years of follow-up for the period in which they were treated with biological agents. RESULTS: A total of 344 patients with SAD treated with biological agents off-label were included in the Registry until July 2010. The first biological therapies included rituximab in 264 (77%) patients, infliximab in 37 (11%), etanercept in 21 (6%), adalimumab in 19 (5%), and 'other' agents in 3 (1%). Forty-five severe infections occurred in 37 patients after a mean follow-up of 26.76 months. These infections resulted in four deaths. The crude rate of severe infections was 90.9 events/1000 person-years (112.5 for rituximab, 76.9 for infliximab, 66.9 for adalimumab and 30.5 for etanercept respectively). In patients treated with more than two courses of rituximab, the crude rate of severe infection was 226.4 events/1000 person-years. A pathogen was identified in 24 (53%) severe infections. The most common sites of severe infection were the lower respiratory tract (39%), bacteremia/sepsis (20%) and the urinary tract (16%). There were no significant differences relating to gender, SAD, agent, other previous therapies, number of previous immunosuppressive agents received or other therapies administered concomitantly. Cox regression analysis showed that age (P = 0.015) was independently associated with an increased risk of severe infection. Survival curves showed a lower survival rate in patients with severe infections (log-rank and Breslow tests < 0.001). CONCLUSIONS: The rates of severe infections in SAD patients with severe, refractory disease treated depended on the biological agent used, with the highest rates being observed for rituximab and the lowest for etanercept. The rate of infection was especially high in patients receiving three or more courses of rituximab. In patients with severe infections, survival was significantly reduced. Older age was the only significant predictive factor of severe infection. More... »

PAGES

r112-r112

Journal

TITLE

Arthritis Research & Therapy

ISSUE

4

VOLUME

13

Author Affiliations

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/ar3397

DOI

http://dx.doi.org/10.1186/ar3397

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1012217984

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/21745378


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