RESEARCH - Infections in patients with RA treated with biologic agents

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Arthritis Rheum. 2005 Nov;52(11):3403-12.

Infections in patients with rheumatoid arthritis treated with biologic

agents.

Listing J, Strangfeld A, Kary S, Rau R, von Hinueber U, Stoyanova-Scholz M,

Gromnica-Ihle E, Antoni C, Herzer P, Kekow J, Schneider M, Zink A.

German Rheumatism Research Centre, Schumannstrasse 21/22, D-10117 Berlin,

Germany. Listing@...

OBJECTIVE: To estimate the incidence rates of serious and nonserious

infections in patients with rheumatoid arthritis (RA) who start treatment

with a biologic agent, and to compare these rates with those in patients

with RA who receive conventional treatment. METHODS: Patients enrolled in

the German biologics register between May 2001 and September 2003 were

included. Treating rheumatologists assessed adverse events and serious

adverse events. All adverse events and serious adverse events experienced

within 12 months after study entry were analyzed. Propensity score methods

were applied to estimate which part of a rate increase was likely to be

attributable to differences in patient characteristics. RESULTS: Data were

available for 512 patients receiving etanercept, 346 patients receiving

infliximab, 70 patients receiving anakinra, and 601 control patients treated

with disease-modifying antirheumatic drugs. The total number of adverse

events per 100 patient-years was 22.6 (95% confidence interval [95% CI]

18.7-27.2) among patients receiving etanercept, 28.3 (95% CI 23.1-34.7)

among patients receiving infliximab, and 6.8 (95% CI 5.0-9.4) among controls

(P < 0.0001). Significant differences in the rate of serious adverse events

were also observed. For patients receiving etanercept, those receiving

infliximab, and controls, the total numbers of serious adverse events per

100 patient-years were 6.4 (95% CI 4.5-9.1), 6.2 (95% CI 4.0-9.5), and 2.3

(95% CI 1.3-3.9), respectively (P = 0.0016). After adjusting for differences

in the case patient mix, the relative risks of serious adverse events were

2.2 (95% CI 0.9-5.4) for patients receiving etanercept and 2.1 (95% CI

0.8-5.5) for patients receiving infliximab, compared with controls.

CONCLUSION: Patients treated with biologic agents have a higher a priori

risk of infection. However, our data suggest that this risk is increased by

treatment with tumor necrosis factor inhibitors.

PMID: 16255017

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=16255017 & itool=iconabstr & query_hl=1

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