The safety of anakinra in high-risk patients with active rheumatoid arthritis: six-month observations of patients with comorbid conditions

Arthritis Rheum. 2004 Jun;50(6):1752-60. doi: 10.1002/art.20277.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antirheumatic Agents / adverse effects*
  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / epidemiology*
  • Cardiovascular Diseases / epidemiology
  • Comorbidity
  • Female
  • Humans
  • Incidence
  • Infections / epidemiology
  • Interleukin 1 Receptor Antagonist Protein
  • Kidney Diseases / epidemiology
  • Lung Diseases / epidemiology
  • Male
  • Middle Aged
  • Risk Factors
  • Sialoglycoproteins / adverse effects*


  • Antirheumatic Agents
  • IL1RN protein, human
  • Interleukin 1 Receptor Antagonist Protein
  • Sialoglycoproteins