PMID: 15230300Jul 3, 2004Paper

Clinical trial design in systemic lupus erythematosus: lessons learned and future directions

Lupus
V Strand

Abstract

Designing successful randomized controlled trials (RCTs) in systemic lupus erythematosus (SLE) poses many challenges. It remains difficult to correlate alterations in biologic markers with clinical outcome, especially when signs and symptoms are intermittent and broadly variable between patients. Disease activity indices were not designed specifically as outcome measures in RCTs, as they were developed in the context of longitudinal observational studies. Although all disease activity indices have been validated against each other and demonstrated to show change, organ system manifestations are variably weighted; fatigue and autoantibody titers are scored in some and not in others. Due to the variability of the underlying disease course an assessment of disease activity may most accurately be portrayed as change over time, such as an area under the curve analysis. Another lesson learned is that 'responder indices' proposed in the absence of prospective validation in RCTs do not function well. The argument can always be made that any response criteria will work if the treatment is effective; but without the precedent of a product specifically approved for use in SLE, this is hard to prove. The ACR/Systemic Lupus International Co...Continue Reading

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Citations

Oct 17, 2012·Psychiatry and Clinical Neurosciences·Hung-Chieh Wu ChangLi-Ren Chang
Sep 4, 2010·Annals of Indian Academy of Neurology·Afshin Borhani Haghighi, Shahab Ghasem Haza
Jul 23, 2014·Nature Reviews. Rheumatology·Kate FranklynEric F Morand
Aug 9, 2012·Expert Opinion on Biological Therapy·Alberta Y Hoi, Geoffrey O Littlejohn
May 14, 2009·Current Medical Research and Opinion·Kenneth Kalunian, Joan T Merrill
Aug 29, 2009·Arthritis and Rheumatism·Mandana NikpourDafna D Gladman
Feb 24, 2007·Autoimmunity Reviews·Vibeke Strand
Oct 19, 2007·The Cochrane Database of Systematic Reviews·D CrosbieS Thomas
Mar 10, 2021·The Cochrane Database of Systematic Reviews·Cora W HannonCathy Bennett

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