medwireNews: A post-hoc subgroup analysis of the EMBODY trials suggests that systemic lupus erythematosus (SLE) patients who have associated Sjögren’s syndrome may derive clinical benefit from the CD22-targeted B-cell inhibitor epratuzumab.
Previously reported analyses from the EMBODY 1 and 2 trials suggested that 48 weeks of treatment with the CD22-targeted B-cell inhibitor did not significantly improve disease activity relative to placebo in patients with moderate-to-severe SLE, say Jacques-Eric Gottenberg (Strasbourg University Hospital, France) and co-investigators.
However, they note that epratuzumab “did demonstrate B-cell-specific immunological activity” in these studies, and that the drug showed promise in a phase I/II Sjögren’s syndrome trial, leading them to hypothesize that epratuzumab may have clinical efficacy in SLE patients with associated Sjögren’s syndrome.
Gottenberg and team found that among the 112 trial participants with SLE-associated Sjögren’s syndrome, those who were treated with epratuzumab 600 mg weekly or 1200 mg every other week experienced a significantly greater British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response at week 16 compared with placebo-treated patients, and the response was maintained at the 48-week follow-up.
By contrast, for the 1329 SLE patients without Sjögren’s syndrome, there was no significant difference in BICLA response rates at these timepoints between patients receiving epratuzumab 1200 mg versus those given placebo. A significantly higher proportion of patients receiving epratuzumab 600 mg versus placebo experienced a BICLA response at week 16, but this difference was not statistically significant at 48 weeks.
The team observed a comparable 30–40% reduction in B cells among patients from both subgroups, but the reduction occurred more rapidly in those with Sjögren’s syndrome. Therefore, B cells from patients with SLE-associated Sjögren’s syndrome may “respond more quickly to epratuzumab treatment” compared with B cells from those with SLE alone, observe the researchers.
Gottenberg and colleagues say their findings suggest that “epratuzumab may have clinical benefits in certain subsets of SLE patients and so stratification of SLE patients may be appropriate,” but caution that the post-hoc analysis was limited by the small number of patients with Sjögren’s syndrome.
And they conclude in Arthritis & Rheumatology: “The efficacy and safety of epratuzumab in a larger patient population with [Sjögren’s syndrome]-specific outcome measures now needs to be assessed to determine if epratuzumab would be helpful for treating patients with Sjögren’s syndrome.”
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