Finally, the investigators suggested that the clinical SLEDAI score, rather than the overall score, is the best way to assess this drug. "Comparing the number of responders in the target population and those of the overall population it appears that there is no change. Exactly the same number of responders was recorded in the three groups in the overall population and the target population. This indicates that the commonly used inclusion criterion [SLEDAI score of 6 and above] creates a bias in the evaluation of the study results in falsely reducing the response rate and therefore statistical analysis."
ImmuPharma is developing the drug and conducted the study.