Definition of Improvement
Among outcome instruments used in clinical trials, the British Isles Lupus Assessment Group index (BILAG) is based on an intention-to-treat approach according to an extensive series of criteria to classify a patient’s SLE manifestations arising from different organ systems (see Table 1, p. 36). The BILAG score was used as the primary outcome measure in the unsuccessful trials of Genentech’s rituximab and Bristol-Myers Squibb’s abatacept in lupus, and is currently being used as the primary outcome measure in an ongoing trial of EMD Serono’s atacicept (TACI-Ig).
Explore This IssueAugust 2010
During the meeting, representatives of all three companies described their efforts to compensate for the BILAG’s limitations, including rigorous physician training programs, the use of adjudication panels to review scores to ensure the authenticity of any changes, and the use of simple questionnaires to allow more subjective measures. In the abatacept trial, the physicians’ subjective reports suggested that the drug was working, even though the BILAG scores and related analyses found no evidence of benefit. Other drug trials presented at the meeting also showed significant differences between physician opinions and BILAG outcomes, which reinforced the prevailing view that the BILAG index is not sufficiently sensitive to detect benefit from the new treatments. Particularly problematic may be the use of BILAG B events as outcome measures of lupus flares.