REVIEW - Kineret (anakinra) for RA

[Guest guest]

Cochrane Database Syst Rev. 2009 Jan 21;(1):CD005121.

Anakinra for rheumatoid arthritis.

Mertens M, Singh JA.

University of Minnesota, 596 Grand Ave., Apt 1, Saint , Minnesota

55102, USA.

BACKGROUND: In the past decade, a novel class of therapies directed

against specific cytokines implicated in the disease process of

rheumatoid arthritis (RA), called the 'Biologics' have greatly

improved and expanded treatment for RA. Anakinra is an interleukin-1

receptor antagonist that is currently FDA-approved for moderate-severe

RA that has been unresponsive to initial disease-modifying

anti-rheumatic drugs (DMARD) therapy.

OBJECTIVES: To evaluate the clinical effectiveness and safety of

anakinra in adult patients with rheumatoid arthritis.

SEARCH STRATEGY: We searched the following electronic databases: the

Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane

Library Issue 1, 2008), MEDLINE (1950 to Week 4 2008) , EMBASE (1980

to Week 5 2008), CINAHL (1982 to November 2007) and reference lists of

articles.

SELECTION CRITERIA: Randomized controlled trials comparing anakinra

alone or in combination with DMARDs or biologics to placebo or other

DMARDs or biologics in patients >18 years old with rheumatoid

arthritis.

DATA COLLECTION AND ANALYSIS: Two review authors independently

assessed trial quality and extracted data. We contacted study authors

for additional information.

MAIN RESULTS: Five trials involving 2876 patients, 781 randomized to

placebo and 2065 to anakinra, were included. There was a significant

improvement in number of participants achieving ACR20 (38% versus 23%)

who were treated with anakinra 50 to 150 mg daily versus placebo after

24 weeks. This 15% increase in patients achieving ACR20 with anakinra

versus placebo is felt to be a clinically meaningful, though modest,

outcome. Other efficacy data - including ACR50 (18% versus 7%), ACR70

(7% versus 2%), HAQ, visual analog score (VAS), Larsen radiographic

scores, and change in erythrocyte sedimentation rate (ESR) - all

demonstrated significant improvement with anakinra 50 to 150 mg daily

versus placebo as well. There were no statistically significant

differences noted in most safety outcomes with treatment with anakinra

versus placebo - including number of withdrawals, deaths, adverse

events (total and serious), and infections (total and serious).

Injection site reactions were significantly increased, occurring in

1235/1729 (71%) versus 204/729 (28%) of patients treated with anakinra

versus placebo, respectively. The incidence of serious infections was

clinically higher, but not statistically different, in the anakinra

(25/1366 patients, 1.8%) versus placebo group (3/534 patients, 0.6%).

AUTHORS' CONCLUSIONS: Anakinra is a relatively safe and modestly

efficacious biologic therapy for rheumatoid arthritis. Although head

to head comparison trials have not been carried out, the amount of

improvement is notably less when compared to studies using other

biologic therapies. More studies are needed to evaluate safety and

efficacy, especially in comparison to other therapies, and adverse

event data for the long-term use of Anakinra has yet to be assessed.

PMID: 19160248

http://www.ncbi.nlm.nih.gov/pubmed/19160248

Not an MD