RESEARCH - Risk of serious infections during Rituxan, Orencia, and Kineret therapies for RA

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Ann Rheum Dis. 2008 Jan 18 [Epub ahead of print]

Risk of serious infections during rituximab, abatacept and anakinra

therapies for rheumatoid arthritis: meta-analyses of randomized

placebo-controlled trials.

Salliot C, Dougados M, Gossec L.

Rhumatologie B, Hopital Cochin, France.

BACKGROUND: Tumor Necrosis Factor alpha (TNF alpha) blockers in

rheumatoid arthritis (RA) are known to increase the risk of serious

infections defined as life-threatening, requiring hospitalization or

intravenous antibiotics. Recently, new biologic agents have become

available. Their safety is an important issue. Purpose: To assess if

biologic agents i.e. rituximab, abatacept and anakinra increase the

risk of serious infections in RA patients in published randomized

controlled trials (RCTs). DATA SOURCE: A systematic review of the

literature using PUBMED, EMBASE, Cochrane library and abstracts

databases (EULAR and ACR annual meetings) was performed up to October

2007. This search was completed with data from the Food and Drug

Administration, the European Agency for the Evaluation of Medicinal

Products and manufacturers. DATA EXTRACTION: Three fixed effect

meta-analyses were performed to compare serious infection rates

between each biologic agent and placebo. Pooled Odds Ratios (ORs) were

calculated, using the Mantel-Haenszel method with a continuity

correction. DATA SYNTHESIS: Twelve RCTs with data concerning serious

infections were analyzed (3 for rituximab, 5 for abatacept and 4 for

anakinra). They included 745 patients, 1960 patients, 2062 patients

and 2112 patients treated by rituximab, abatacept, anakinra and

placebo respectively. The overall pooled ORs did not reveal a

statistically significant increased risk of serious infection for

abatacept and rituximab; this risk was increased for high doses of

anakinra (>/=100 mg daily) versus low dose and placebo (ORs = 9.63

(95% CI, 1.31-70.91) and 3.40 (95% CI, 1.11-10.46) respectively).

CONCLUSION: These meta-analyses did not reveal a significant increase

in the risk of serious infections during rituximab or abatacept

therapies in RA patients; however, high doses of anakinra may increase

this risk, especially when patients have comorbidity factors. Large

studies must be performed to confirm this safety profile in daily

practice.

PMID: 18203761

http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve & db=PubMed & list_uids=182037\

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