• Jorge Medina-Rosas, Hanan Al-Rayes, Ahmed T Moustafa, and Zahi Touma.
• a Toronto Western Hospital, Centre for Prognosis Studies in the Rheumatic Diseases , University of Toronto Lupus Clinic , Toronto , Canada.
• Expert Opin Biol Ther. 2016 Oct 1; 16 (10): 1225-38.

IntroductionSystemic 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.Areas CoveredIn 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.Expert OpinionSome 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.

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