Yet more failed drug trials in systemic lupus erythematosus (SLE). The primary end point was not met in two phase III, randomized, placebo-controlled, double-blind, multicentre trials of epratuzumab for moderately to severely active SLE. In EMBODY™ 1 (n = 786) and EMBODY™ 2 (n = 788), treatment response rates at 48 weeks, measured using the BILAG-based combined lupus assessment (BICLA) composite end point, were no better in patients with SLE who received the anti-CD22 monoclonal antibody in addition to standard therapy than those who received placebo in addition to standard therapy.
References
Clowse, M. E. B. et al. Efficacy and safety of epratuzumab in moderately to severely active systemic lupus erythematosus: results from the phase 3, randomized, double-blind, placebo-controlled trials, EMBODY™ 1 and EMBODY™ 2. Arthritis Rheumatol. http://dx.doi.org/10.1002/art.39856 (2016)
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Onuora, S. Epratuzumab not effective in phase III trials. Nat Rev Rheumatol 12, 622 (2016). https://doi.org/10.1038/nrrheum.2016.165
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DOI: https://doi.org/10.1038/nrrheum.2016.165
