Treatment with epratuzumab produced clinically meaningful and sustained improvements in systemic lupus erythematosus.
Strand V, Petri M, Kalunian K, et al. Epratuzumab for patients with moderate to severe flaring SLE: health-related quality of life outcomes and corticosteroid use in the randomized controlled ALLEVIATE trials and extension study SL0006. Rheumatology. (2013) doi: 10.1093/rheumatology/ket378. First published online
Epratuzumab, a novel medication aimed at curbing B-cell activation, appears to produce sustained improvement in quality of life (QOL) while reducing the need for corticosteroids in patients with moderate to severe flaring systemic lupus erythematosus (SLE), according to pooled analysis of two international clinical trials.
The drug, a humanized monoclonal antibody designed to modulate proliferation and trafficking of B-cells, has shown therapeutic potential in previous studies.
A total of 90 SLE patients (mostly white women, median age 38) were enrolled in two randomized, placebo-controlled ALLEVIATE trials of epratuzumab. Both trials ended prematurely after about a year and a half due to interruptions in drug supply.
Epratuzumab yielded clinically meaningful and sustained improvements in physician and patient global assessments and health-related QOL compared with placebo at 12 weeks, and led to a reduction in corticosteroid dose by 24 weeks.
Data came from patients followed for at least six months who had received varying cycles of epratuzumab infusions. All the patients werealso on oral or IV steroids.
A group of 29 ALLEVIATE patients continued in a long-term safety extension study (SL0006), with interim analysis at a median of 120 weeks. Improvements were maintained for around two years.
Positive safety and efficacy data for epratuzumab in the ALLEVIATE trials were reported at the 2013 American College of Rheumatology meeting in San Diego. In addition, Dr. Strand and another team of coauthors reported similar improvements in health-related QOL among patients in the open-label extension of the smaller, shorter-term randomized trial called EMBLEM.