title: [Off-label therapy of rheumatoid arthritis and spondyloarthritis].
abstract: For rheumatoid arthritis (RA) and diseases of the spondyloarthritis group (SpA) a large number of approved medications are available. Nevertheless, in Germany even for these diseases several off-label risks exist for the rheumatologist prescribing antirheumatic drugs which have recently led to a series of recourses or threats of recourse. In RA as well as SpA first of all biologicals are the target of recourse imposed mainly by health insurances. In RA monotherapy (when labeled only in combination with methotrexate), combination with leflunomide (instead of methotrexate) and dose deviations are the most important causes. In SpA TNF inhibitors are labeled only for the definite diagnosis of ankylosing spondylitis (AS) and psoriatic arthritis (PsA) leaving aside patients with severe peripheral spondyloarthritis including enthesitis which does not exactly meet the diagnostic criteria of AS and PsA. The same applies to early AS not fulfilling the 1984 New York criteria which still lacks labeled use of TNF inhibitors. In these cases, however, based on successful randomized controlled trials and changed diagnostic criteria a label extension is expected in the near future. Until then it seems suitable to apply for permission for this treatment from insurers in each case.
authors.affiliation: Rheumatologisches Praxiszentrum, München, Deutschland. klaus.krueger@med.uni-muenchen.de
authors.forename: K
authors.initials: K
authors.lastname: Krüger
authors.forename: J
authors.initials: J
authors.lastname: Sieper
mesh_terms: D018501:Antirheumatic Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000191:economics; D001688:Biological Products / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D016527:Drug Costs / Q000331:legislation & jurisprudence; D004359:Drug Therapy, Combination / Q000191:economics; D005858:Germany; D006801:Humans; D007356:Insurance, Pharmaceutical Services / Q000191:economics* / Q000331:legislation & jurisprudence*; D007555:Isoxazoles / Q000191:economics / Q000627:therapeutic use; D000077339:Leflunomide; D008727:Methotrexate / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D009313:National Health Programs / Q000191:economics*; D056687:Off-Label Use / Q000191:economics* / Q000331:legislation & jurisprudence*; D012051:Reimbursement Mechanisms / Q000191:economics / Q000331:legislation & jurisprudence; D025241:Spondylarthritis / Q000188:drug therapy* / Q000191:economics; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000009:adverse effects / Q000037:antagonists & inhibitors / Q000191:economics
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products; D007555:Isoxazoles; D014409:Tumor Necrosis Factor-alpha; D000077339:Leflunomide; D008727:Methotrexate