New treatment strategies in rheumatoid arthritis are targeted to interfere with 
critical mediators of inflammation. Proinflammatory cytokines like IL-1 beta and 
TNFalpha play a crucial role in induction and maintenance of synovitis, pannus 
formation and bone and cartilage destruction. Within a few years, these 
morphological changes may lead to joint destruction and consecutively to 
functional impairment. Since April 2002 a recombinant human interleukin-1 
receptor antagonist (Anakinra) is available in Germany for treatment of patients 
with rheumatoid arthritis. Anakinra (Kineret(R)) is approved for therapy in 
combination with methotrexate and should be applied according to guidelines 
established by the German Rheumatology Society for the use of biologicals in 
treatment of patients with rheumatoid arthritis. The approval of anakinra as a 
new therapeutic is based on data obtained in large multicenter, 
placebo-controlled, and randomised trials in comparison to placebo. Treatment of 
Anakinra as monotherapy or in combination with methotrexate lead to significant 
improvement of signs and symptoms of disease as measured by the ACR 20 (or more) 
response and was associated with a slower radiographic progression with regard 
to joint space narrowing and development of erosions. Anakinra showed a 
favourable safety profile with injection side reactions as the predominant side 
effect that occurs in 70% of patients usually after 10-12 days of treatment and 
that are mostly mild to moderate and self-limiting. Patients with previous 
pneumonia or other risk factors for pulmonary infections such as chronic 
obstructive lung disease seem to show a slightly increased risk of developing 
infectious complications of the bronchopulmonary system while being on anakinra 
and should be monitored appropriately. Combining IL-1ra treatment with the use 
of anti-TNF agents showed an increased risk of infectious complications in 
clinical studies and is not recommended at present. Studies are currently 
assessing the use of anakinra for treatment of other rheumatic diseases like 
psoriatic arthritis, juvenile arthritis or spondylarthropathy.