Observational study on efficacy, safety and drug- survival of anakinra in RA patients in clinical practice

November 20, 2005

1: Ann Rheum Dis. 2005 Nov 3; [Epub ahead of print]

Observational study on efficacy, safety and drug- survival of

anakinra in RA patients in clinical practice.

den Broeder AA, de Jong E, Franssen MJ, Jeurissen ME, Flendrie M, van

den Hoogen FH.

Sint Maartenskliniek, Netherlands.

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

IL-1 receptor antagonist used in rheumatoid arthritis (RA), has been

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

post- marketing efficacy data are lacking. METHODS: All RA patients

that 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 Disease Activity Score

28 (DAS28) and EULAR response criteria. Safety was evaluated using

the Common Toxicity Criteria. Drug-survival and prognostic factors

were analyzed using Kaplan-Meier and proportional Hazard

analyses. RESULTS: After three months, 55% of the patients (n=146)

showed response (43% moderate and 12% good response). A subset of

patients that continued anakinra after eighteen months showed

sustained clinical response compared to patients who switched to

other DMARD therapy (DAS28 improvement 2.46 vs 1.79). Drug-survival

was 78%, 54% and 14% after three, six and twenty-four months

respectively. Reason for discontinuation was lack of efficacy in 78%

and adverse events in 22%. Except for higher drug-survival in woman

(OR 0.51, CI 0.27 - 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 randomized clinical studies. However, the drug-

survival of anakinra after two years is low, mostly due to lack of

efficacy.

PMID: 16269431 [PubMed - as supplied by publisher]

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