[Recommendations on therapy using interleukin-1beta-blocking agents]

In Germany, the only available interleukin-1beta (IL-1beta) blocking agent is anakinra (ANR) (as of August 2009) which is given subcutaneously at a dosage of 100 mg/day (adults) and 1-2 mg/kg body weight/day (maximum 100 mg/day) (children), respectively. Based on published data and clinical experience the German Society of Rheumatology (Deutsche Gesellschaft für Rheumatologie) recommends the following indications for ANR: (1) Rheumatoid arthritis, if treatment with two DMARDs (one of the two being methotrexate, MTX) for at least 6 months has failed. (2) Adult-onset and juvenile-onset Still's disease (systemic juvenile idiopathic arthritis) in the case of insufficient response to glucocorticoids or inadequate long-term dosage, as well as failure of a conventional DMARD, usually MTX. For both indications the treatment should be supervised and documented by a rheumatologist or paediatric rheumatologist. Cryopyrin-associated periodic syndromes (CAPS) are recommended as an additional treatment option for IL-1 blocking therapy. The efficacy of the fusion protein rilonacept (RIC) and the monoclonal antibody canakinumab in the treatment of CAPS has been proven by randomized, placebo-controlled trials. In the US, RIL was recently approved by the FDA for the treatment of CAPS under the "Orphan Drug Status".