title: Recent advances in the biologic therapy of lupus: the 10 most important areas to look for common pitfalls in clinical trials.
abstract: Systemic lupus erythematosus (SLE) is an autoimmune disease affecting different organs. The improved knowledge of the disease's pathogenesis has contributed to the emergence of immune targets and new biologic drugs directed at them. Although rheumatologists continue to use off-label biologics in SLE resistant to other immunosuppressants, only belimumab has been approved as a biological therapy since 2011.
  
  
  
  In this review, an overview is provided on: 1) the classification of the biologic drugs in clinical trials and of those under research; 2) the results of clinical trials of biologic therapy with an interpretation of pitfalls and syntheses of potential approaches to overcome these pitfalls and, 3) the commonly used disease activity metrics and composite indices for assessing response to drugs.
  
  
  
  Some drugs that have failed in previous drug trials have shown to be efficacious in the treatment of lupus in observational studies. Moreover, the post-hoc analyses of the data of negative drug trials have shown that results of the same trials could be altered with the modification of some pitfalls. For future clinical trials, the consideration of these pitfalls is crucial when designing clinical trials. This could potentially enhance the approval of novel drugs for SLE.
authors.affiliation: a Toronto Western Hospital, Centre for Prognosis Studies in the Rheumatic Diseases , University of Toronto Lupus Clinic , Toronto , Canada.
authors.forename: Jorge
authors.initials: J
authors.lastname: Medina-Rosas
authors.affiliation: a Toronto Western Hospital, Centre for Prognosis Studies in the Rheumatic Diseases , University of Toronto Lupus Clinic , Toronto , Canada.
authors.forename: Hanan
authors.initials: H
authors.lastname: Al-Rayes
authors.affiliation: a Toronto Western Hospital, Centre for Prognosis Studies in the Rheumatic Diseases , University of Toronto Lupus Clinic , Toronto , Canada.
authors.forename: Ahmed T
authors.initials: AT
authors.lastname: Moustafa
authors.affiliation: a Toronto Western Hospital, Centre for Prognosis Studies in the Rheumatic Diseases , University of Toronto Lupus Clinic , Toronto , Canada.
authors.forename: Zahi
authors.initials: Z
authors.lastname: Touma
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D001688:Biological Products / Q000627:therapeutic use*; D001691:Biological Therapy / Q000379:methods* / Q000639:trends; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D001688:Biological Products; D007166:Immunosuppressive Agents; C511911:belimumab
keywords: Systemic lupus erythematosus; biological therapy; clinical trials; immunosuppressive agents