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Epratuzumab, placebo had similar improvements in patients with SLE
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Patients with moderately to severely active systemic lupus erythematosus who were treated with epratuzumab plus standard therapy did not show improvements in response rates compared with patients who received placebo plus standard therapy, according to results.
In the EMBODY 1 and EMBODY 2 studies, researchers randomly assigned 793 and 791 patients, respectively, with a diagnosis of moderately to severely active systemic lupus erythematosus (SLE) to receive placebo, epratuzumab 600 mg every week or epratuzumab 1200 mg every other week. All patients were receiving standard therapy, including mandatory corticosteroids, according to researchers. Researchers considered responder rate at week 48, according to the British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA) composite endpoint, as the primary endpoint.
Results showed a similar proportion of patients across treatment groups had improvements in disease activity as measured by BICLA response rates. However, researchers noted no significant differences in the proportion of responders between patients who received placebo plus standard therapy and patients who received epratuzumab plus standard therapy. Although researchers found a trend toward improvement in epratuzumab-treated patients over placebo at several time points, the results were not consistent between the two studies with EMBODY 1 showing a generally greater response in the epratuzumab 1200-mg group and EMBODY 2 showing a greater response in the epratuzumab 600-mg groups. According to results, researchers did not identify new safety signals. – by Casey Tingle
Disclosures: Clowse is a consultant for UCB Pharma. Please see the full study for a list of all other authors’ relevant financial disclosures.
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