Epratuzumab Benefits Lupus Patients with Associated Sjögren’s Syndrome

Treatment with epratuzumab, a B-cell targeting antibody, improves clinical outcomes of systemic lupus erythematosus (SLE) in patients with associated Sjögren’s syndrome, research shows.

But the post hoc analysis of the Phase 3 EMBODY trials suggests that the treatment fails in those with SLE alone. A post hoc analysis is one that was not specified before the data was obtained.

While the results support a faster response in SLE-Sjögren’s syndrome patients, future studies are required to assess its efficacy in patients with primary Sjögren’s syndrome.

The study, “Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients with Associated Sjögren’s Syndrome: Post-hoc Analyses from the EMBODY Trials,” appeared in the journal Arthritis & Rheumatology.

The EMBODY 1 (NCT01262365) and EMBODY 2 (NCT01261793) Phase 3 trials were designed to assess the efficacy of epratuzumab — which targets the B-cell-specific protein, CD22 — in treating SLE patients.

While the trials failed to achieve its primary endpoints, researchers observed that epratuzumab treatment reduced B-cell numbers and activity in the blood.

In the trials, a subset of SLE patients had secondary Sjögren’s syndrome, which had developed due to the primary autoimmune disease, SLE.

Because B-cells also play a role in Sjögren’s syndrome, researchers aimed to determine if epratuzumab worked better in patients with both conditions. They compared the treatment’s safety and efficacy in SLE patients with or without Sjögren’s syndrome.

While adding the therapy to standard care had no effect in patients without Sjögren’s syndrome, as seen in prior analysis, the team found that patients with a diagnosis of secondary Sjögren’s syndrome had better SLE-specific clinical outcomes by the end of the study than those on placebo.

While treatment with epratuzumab led to a similar reduction in B-cell numbers, the results suggest that SLE patients with associated Sjögren’s syndrome respond faster to epratuzumab.

“These data suggest that epratuzumab may have clinical benefits in certain subsets of SLE patients and so stratification of SLE patients may be appropriate,” researchers wrote. “Further trials examining the effectiveness of epratuzumab in primary Sjögren’s would be required to confirm the effectiveness of epratuzumab in this population.”