The Lupus Foundation of America recently created the Collective Data Analysis Initiative (LFA CDAI) to improve clinical trials for lupus, in an effort to speed the development of new lupus therapies.
The purpose of clinical trials is to determine whether a new therapy improves the disease activity over the current therapy. Unfortunately, because each lupus case is unique, the typical clinical trial structure does not work for lupus studies. Additionally, as these treatments vary, so do the amounts of steroids that lupus patients take for their standard-of-care treatments.
Typical clinical trials involve subjects who take the investigational drug or a placebo. This may conceal the efficiency of possible new treatments, which is challenging for the study results.
This is why the LFA created the CDAI -- to redesign lupus clinical trials so that more progress can be made to benefit patients. The most recent analysis of the initiative, available in the European Journal of Rheumatology, searched for systematic differences among six lupus clinical trials, which may reveal incorrect conclusions.
“Treatment with the immunosuppressant MMF was associated with the highest level of improvement,” Paola Daly, Lupus Foundation's senior manager of outcomes and health, said. “However, those who received MMF had more steroids and were sicker at the beginning of the trial than those who received the other treatments.”
The study detected differences in immunosuppressants, as well.
“Individuals who did not have any immunosuppressants had the least amount of flares, while those who had the MMF treatment had the highest frequency of flares,” Daly said. “This was true even when looking at moderate and severe flares and whether or not the participants started the trial with moderate or severe lupus.”
Steroids also impacted the patients.
“Individuals who received treatment with the immunosuppressant IVC had more steroids at the beginning of the trial compared to those who took MMF,” Daly said. “Even so, treatment with IVC and MMF improved disease activity at approximately the same rate, and both treatments were associated with a similar frequency of flares. Individuals who received MMF treatment had less severe flares than those who received IVC.”