Wallace D; Strand V; Furie R; Petri M; Kalunian K; Pike M; Kelley L; Gordon C
The BILAG-Based Composite Lupus Assessment (BICLA) is a composite index that was originally derived by expert consensus of disease activity indices . It was employed as the primary endpoint in the EMBLEM (Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease) trial of epratuzumab in lupus (moderate-to-severe SLE disease activity), where it appeared to discriminate well between standard of care and epratuzumab added to standard of care, at least in some doses tested.
BICLA response is defined as (1) at least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (eg, all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D); (2) no new BILAG A or more than one new BILAG B scores; (3) no worsening of total SLEDAI score from baseline; (4) no significant deterioration (≤10%) in physicians global assessment and (5) no treatment failure (initiation of non-protocol treatment).
Wallace DJ, Strand V, Furie R, et al. Evaluation of Treatment Success in Systemic Lupus Erythematosus Clinical Trials: Development of the British Isles Lupus Assessment Group-based Composite Lupus Assessment Endpoint. Presented at: ACR 2011: Poster 2265
Wallace DJ, Kalunian K, Petri MA, Strand V, Houssiau FA, Pike M, Kilgallen B, Bongardt S, Barry A, Kelley L, Gordon C. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis. 2014 Jan;73(1):183-90 (Full text article)