RESEARCH - Efficacy, safety, and drug survival of Kineret (anakinra) in RA patients in clinical practice

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ls of the Rheumatic Diseases 2006;65:760-762;

doi:10.1136/ard.2004.033662

© 2006 by BMJ Publishing Group Ltd & European League Against Rheumatism

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EXTENDED REPORT

Observational study on efficacy, safety, and drug survival of anakinra in

rheumatoid arthritis patients in clinical practice

A A den Broeder1, E de Jong1, M J A M Franssen1, M E C Jeurissen1, M

Flendrie2 and F H J van den Hoogen1,2

1 Sint Maartenskliniek, Nijmegen, Netherlands

2 University Medical Centre Nijmegen, Nijmegen, Netherlands

Background: The efficacy and safety of anakinra, a recombinant human

interleukin 1 (IL1) receptor antagonist used in rheumatoid arthritis, has

been documented in five randomised controlled studies. However, long term

post-marketing efficacy data are lacking.

Objective: To evaluate the efficacy, safety, and drug survival of anakinra

in clinical practice.

Methods: All patients with rheumatoid arthritis who started anakinra in six

hospitals between May 2002 and February 2004 were included in a two year

prospective, in part retrospective, cohort study. Efficacy was assessed

using the 28 joint disease activity score (DAS28) and the EULAR response

criteria. Safety was evaluated using the common toxicity criteria. Drug

survival and prognostic factors were analysed using Kaplan-Meier and

proportional hazard analyses.

Results: After three months, 55% of the patients (n = 146) showed a response

(43% moderate, 12% good). A subset of patients continuing anakinra after 18

months had a sustained clinical response compared with patients who switched

to other disease modifying antirheumatic drug treatment (DAS28 improvement,

2.46 v 1.79). Drug survival was 78%, 54%, and 14% after three, six, and 24

months, respectively. The reason for discontinuation was lack of efficacy in

78% and adverse events in 22%. Except for higher drug survival in women

(odds ratio = 0.51, 95% confidence interval, 0.27 to 0.97), no prognostic

factors were found. Adverse events were reported 206 times in 111 patients,

the most common being injection site reactions (36%). Serious adverse events

occurred in 12% of the patients, with one classified as related.

Conclusions: The short term efficacy and safety profile of anakinra are

comparable to those found in randomised clinical studies. However, the drug

survival of anakinra after two years is low, mostly because of lack of

efficacy.

http://ard.bmjjournals.com/cgi/content/abstract/65/6/760

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