Systemic lupus erythematosus and systemic sclerosis. (A) In a combined analysis of two prematurely discontinued randomised controlled trials (RCT) in systemic lupus erythematosus, treatment-associated changes with active treatment are large; despite low baseline (BL) scores due to high disease activity: subjects with moderate and/or severe flares (British Isles Lupus Assessment Group (BILAG)) “A” and “B” scores (inner aqua polygon). Age/gender matched normative data (outer light purple polygon) are based on the combined sample size of all subjects with available data. Despite large decrements from matched norms, treatment-associated improvements were evident with the 360 mg/m2 dose of epratuzumab (middle light blue polygon) compared with placebo (not shown), and are reflected by a large change in Short Form-6D (SF-6D) scores. (B) Baseline and treatment-associated changes at 6 months in a systemic sclerosis (SSc) trial, which failed to distinguish active (relaxin) from placebo treatment by clinical as well as Short Form-36 (SF-36) and SF-6D scores.