William A. Wegener, Willem Koetse, Caroline Gordon, Xavier Mariette, Simon J. Bowman, Valérie Devauchelle-Pensec, Hendrika Bootsma, Anthony Shock, Sabine Bongardt, Catrinel Galateanu, David M. Goldenberg, Marga Oortgiesen, Jacques-Eric Gottenberg, Guy Meno-Tetang, Thomas Dörner, Gordana Kosutic, Holger Bartz
EMBODY 1 (NCT01262365) and EMBODY 2 (NCT01261793) investigated the efficacy and safety of epratuzumab, a CD22-targeted humanized monoclonal IgG1 antibody, in patients with systemic lupus erythematosus (SLE). The studies showed no significant difference from placebo in primary or secondary clinical outcome measures, but did demonstrate B-cell-specific immunological activity.
Efficacy and safety of epratuzumab were compared between two patient subpopulations randomized in EMBODY 1 & 2: SLE patients with a diagnosis of associated Sjögren's syndrome (aSjS) and without aSjS (non-aSjS patients). BILAG total score, BICLA clinical response to treatment, biological markers (including B cells, IgG, IgM, and IgA), and safety were assessed.
1584 patients were randomized in EMBODY 1 and EMBODY 2; 113 patients were anti-SS-A positive, and had a diagnosis of aSjS, and 1375 patients (86.8%) had no diagnosis of aSjS (918 patients were randomized to epratuzumab and 457 to placebo). For aSjS, but not non-aSjS patients, a higher proportion of epratuzumab patients achieved a BICLA response and a reduction from baseline in BILAG total score. B-cell reduction was faster in aSjS patients. The sensitivity of B cells to epratuzumab as measured by mean concentration producing 50% of the maximum B-cell count depletion was lower for aSjS patients (9.47 μg/ml) vs the EMBODY total population (87.1 μg/ml). No difference in the frequency of adverse events from placebo was reported.
Patients with SLE and aSjS treated with epratuzumab showed improvements in SLE disease activity, which was associated with bioactivity, such as decreases in B cells and IgM.
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