[The off-label-prescription of TNF-alpha blocking agents for spondyloarthropathies in the context of recent statement by a German federal court].
With the TNF alpha-blocking agents for the first time a very efficient and probably disease-modifying treatment for the spondyloarthropathies, especially ankylosing spondylitis and psoriatic arthritis, has become available. Because these drugs have not yet been approved for this indication in the European Community they are regarded as off-label-therapy in Germany. It is the purpose of this article to discuss a recently released statement by a German federal court whether the herein formulated conditions for the prescription of off-label therapies is met for TNF-blocker treatment for this indication.
Sieper
J
J
Rheumatologie der Medizinischen Klinik I, Universitätsklinkum Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany.
D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D011307:Drug Prescriptions; D015507:Drugs, Investigational / Q000009:adverse effects / Q000627:therapeutic use*; D000068800:Etanercept; D005858:Germany; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use; D000069285:Infliximab; D009313:National Health Programs / Q000331:legislation & jurisprudence; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D015507:Drugs, Investigational; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068800:Etanercept