Division of di Rheumatology, University of Pavia, IRCCS Policlinico S. Matteo Foundation, Pavia, Italy.
Clin Exp Rheumatol. 2011 May-Jun;29(3 Suppl 66):S42-62. Epub 2011 Jul 26.
The advent of biological agents has provided further opportunities to treat resistant or relapsing rheumatic diseases, with robust data for rheumatoid arthritis and spondyloarthritis coming from randomised controlled trials. However there are data also on other rare inflammatory rheumatic diseases even if the evidence available may be heterogeneous and/or controversial. Another challenging scenario is represented by diseases that are not uncommon, but that may present with multiple manifestations and prove resistant to conventional therapies, thus requiring the use of biological agents. To assist physicians in making correct therapeutic choices in such cases, the Italian Society for Rheumatology (SIR) has developed specific recommendations for the use of biological agents in rare disease or for the off-label use of such agents in refractory inflammatory disorders.
生物制剂的出现为治疗耐药或复发的风湿性疾病提供了更多机会，随机对照试验为类风湿关节炎和脊柱关节炎提供了有力的数据。然而，其他罕见的炎症性风湿性疾病也有数据，尽管现有证据可能存在异质性和/或争议。另一个具有挑战性的情况是，有些疾病并不罕见，但可能表现出多种症状，且对常规治疗有抗药性，因此需要使用生物制剂。为了帮助医生在这种情况下做出正确的治疗选择，意大利风湿病学会（SIR）制定了在罕见疾病中使用生物制剂或在难治性炎症性疾病中使用此类制剂的特定建议。
