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Current challenges in the development of new treatments for lupus
  1. Maria Dall'Era1,
  2. Ian N Bruce2,
  3. Caroline Gordon3,
  4. Susan Manzi4,
  5. Janis McCaffrey5,
  6. Peter E Lipsky6
  1. 1 Division of Rheumatology and Russell/Engleman Rheumatology Research Center, University of California San Francisco, San Francisco, California, USA
  2. 2 Arthritis Research UK Centre for Epidemiology, Medicine and Health, The University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
  3. 3 Institute of Inflammation and Ageing, University of Birmingham, Edgbaston, Birmingham, UK
  4. 4 Lupus Center of Excellence, Allegheny Health Network, Pittsburgh, Pennsylvania, USA
  5. 5 Private Consultative Practice, West Vancouver, British Columbia, Canada
  6. 6 RILITE Research Institute, Charlottesville, Virginia, USA
  1. Correspondence to Dr Maria Dall'Era, UCSF School of Medicine, University of California San Francisco, San Francisco, CA, USA; Maria.DallEra{at}


Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a considerable impact on patients’ quality of life. Despite the plethora of clinical trials for SLE since the turn of the millennium, only one new treatment has been approved for the condition, and the overall pace of successful drug development remains slow. Nevertheless, the myriad of clinical studies has yielded insights that have informed and refined our understanding of eligibility criteria, outcome measures and trial design in SLE. In this review, we highlight the achievements of clinical trials as well as the major pitfalls that have been identified in drug development for SLE and, in doing so, identify areas where collaboration and consensus will be important to facilitate progress.

  • systemic lupus erythematosus
  • lupus nephritis
  • autoimmune diseases
  • autoantibodies

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  • Handling editor Josef S Smolen

  • Contributors Substantial contributions to the development of this publication, or revising it critically for important intellectual content: MD, INB, CG, SM, JM and PEL; final approval of the publication: MD, INB, CG, SM, JM and PEL.

  • Funding This article was funded by UCB Pharma.

  • Disclaimer The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health.

  • Competing interests INB is a National Institute for Health Research (NIHR) senior investigator and is supported by the NIHR Manchester Biomedical Research Centre. He has also received grants from Genzyme Sanofi and GSK and undertaken consultancies and speakers’ bureau for GSK, AstraZeneca, UCB Pharma, Merck Serono, Genzyme Sanofi, Eli Lilly and BMS. CG has undertaken consultancies and received honoraria from BMS, GSK, EMD Serono and UCB Pharma, related to clinical trial design and analysis. CG has also been a member of the speakers’ bureau for GSK and UCB Pharma. She has received research grant support at Sandwell and West Birmingham Hospitals NHS Trust from UCB Pharma in the past and currently, unrelated to the study of any specific drug and without any personal payments to herself. She has participated in clinical trials sponsored by UCB Pharma in the past and funded by Arthritis Research UK, with drug supplied by GSK currently. She has no financial interests in any of these companies and does not and will not benefit from the sales of any drugs manufactured or developed by them. SM has a patent portfolio that was licenced and commercialised by Exagen, Inc. She has served as a consultant or member of an advisory board for Exagen, Inc, GSK, UCB Pharma and AstraZeneca. She serves as the Chair, Board of Directors for the Lupus Foundation of America. MD, JM and PEL have no conflicts of interest to declare.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.