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

[Guest guest]

ls of the Rheumatic Diseases 2009;68:25-32

--------------------------------------------------------------------------------

CLINICAL AND EPIDEMIOLOGICAL RESEARCH

Risk of serious infections during rituximab, abatacept and anakinra

treatments for rheumatoid arthritis: meta-analyses of randomised

placebo-controlled trials

C Salliot , M Dougados , L Gossec

René-Descartes University, Medicine Faculty; AP-HP, Cochin Hospital,

Rheumatology B Department, Paris, France

Background: Tumour necrosis factor blockers in rheumatoid arthritis

are known to increase the risk of serious infections defined as

life-threatening, requiring hospitalisation or intravenous

antibiotics. Recently, new biological agents have become available.

Their safety is an important issue.

Purpose: To assess if biological agents, ie rituximab, abatacept and

anakinra increase the risk of serious infections in patients with

rheumatoid arthritis in published randomised controlled trials.

Data source: A systematic review of the literature using PUBMED,

EMBASE, Cochrane library and abstracts databases (American College of

Rheumatology and European League Against Rheumatism 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 biological agent and

placebo. Pooled odds ratios (ORs) were calculated, using the

Mantel–Haenszel method with a continuity correction.

Data synthesis: Twelve randomised controlled trials with data

concerning serious infections were analysed (three for rituximab, five

for abatacept and four 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 to 70.91) and 3.40 (95% CI, 1.11 to 10.46)

respectively).

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

in the risk of serious infections during rituximab or abatacept

treatments in patients with rheumatoid arthritis; 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.

http://ard.bmj.com/cgi/content/abstract/68/1/25?etoc

Not an MD