The safety of Kineret in high-risk patients with active RA

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Arthritis Rheum. 2004 Jun;50(6):1752-60.

The safety of anakinra in high-risk patients with active rheumatoid

arthritis: six-month observations of patients with comorbid conditions.

Schiff MH, DiVittorio G, Tesser J, Fleischmann R, Schechtman J, Hartman

S, Liu T, Solinger AM.

Denver Arthritis Clinic, Colorado 80230, USA.

crendon@...

OBJECTIVE: To determine in a placebo-controlled, double-blind trial the

safety profile of daily anakinra (Kineret) use in patients with active

rheumatoid arthritis (RA) and concurrent comorbid conditions. METHODS:

In 169 centers in 9 countries, 1,414 patients with active RA were

randomly assigned to receive either anakinra (100 mg) or placebo

treatment (4:1 anakinra-to-placebo allocation ratio), with study drug

administered by daily subcutaneous injection for 6 months. The current

post hoc analysis assessed baseline comorbid conditions, and patients

were considered at high risk for the occurrence of adverse events if

they had a history of at least one of the following: cardiovascular

event, pulmonary event, central nervous system-related event, infection,

diabetes, malignancy, or renal impairment. Within each treatment group

(anakinra or placebo), incidence rates were summarized for serious

adverse events, infectious events, and serious infectious events in

high-risk patients and compared with these incidence rates in patients

without comorbid conditions. RESULTS: The majority of patients in the

trial had one or more comorbid conditions. In these high-risk patients,

there were no differences in the incidence of serious adverse events or

infectious events between treatment groups. The incidence of serious

infectious events with anakinra use was similar between high-risk

patients (2.5%) and the entire study population (2.1%) and was not

attributable to any single comorbidity.

CONCLUSION: Results of the analysis of adverse events in patients with

active RA and coexisting comorbidities suggest that the favorable safety

profile of anakinra is maintained in a high-risk patient population.

PMID: 15188350

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