There are many good reasons to adopt the BILAG Index for clinic trials, but perhaps the most important is its ability to capture degrees of change that cannot be captured by global score systems. The BILAG Index reflects real life more accurately by asking the physician to record whether the patient has improved, gotten worse, or stayed the same, making it better suited to clinical trial use.
Another boost, Gordon Hamilton of ADS-Limathon in Sheffield, U.K., built upon Dr. Viner’s original BILAG Index software to develop a highly sophisticated computer program. The new software can record a large amount of demographic information, a BILAG activity index, a SLICC damage index, the SF36 (which has been widely used to capture the patients’ assessment of their own disease), a wide range of laboratory results, and the various drug treatments the patients are receiving. It also has graphing capacity. Caroline Gordon, MBBS, senior lecturer and consultant in rheumatology at the University of Birmingham, has worked to smooth the original BILAG Index’s rough edges and ensure that the computer program reflects these improvements.
The BILAG Index has proven very useful in long-term observational studies.10,11 It has also demonstrated its utility in a double-blind, controlled trial of 90 patients that compared prednisolone and azathioprine versus prednisolone and ciclosporin in lupus flares.12 The key to an accurate BILAG score is only scoring a clinical feature if you are certain it is due to lupus. One ‘glitch’ that has emerged is the tendency in some organs/systems in the classic BILAG Index to allow an improvement in a grade A feature to become a C on the next assessment a month later, which then remains the same and can score a B at the third assessment – giving the false impression of an extra flare. The new BILAG 2004 makes this jump unlikely to occur, firmly establishing the more natural progression from grade A to B to C.
An updated version – BILAG 2004 – has been published and is being tested in large studies.10 The revised index removed the vasculitis section, placing individual clinical features more appropriately within the other organs or systems. It now incorporates sections on gastrointestinal disease and has an ophthalmology section, both missing from the original. Furthermore, some items, which were damage items, have been removed. A software version of the new index will be available soon.
Dr. Isenberg, ARC Diamond Jubilee professor of rheumatology at the University College London, would like to thank the other current members of BILAG, particularly Drs. Bacon and Snaith, who provided constructive criticism.
