In SLE, Monoclonal Antibody Can Improve Disease Activity

Omalizumab can safely improve systemic lupus erythematosus (SLE) disease activity, according to a new study.

Previous studies have shown autoreactive IgE antibodies are connected to the biological mechanisms of SLE. 

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Researchers of a new study sought to evaluate omalizumab—a monoclonal antibody binding IgE—to determine whether it may influence SLE activity by reducing type I IFN production via blocking plasmacytoid dendritic cells and basophil activation.

The researchers randomly assigned 15 participants with a SLE Disease Activity Index 2000 greater than 4 and elevated autoreactive IgE antibodies to either omalizumab or placebo for 16 weeks, followed by 16‐week open label treatment and 4‐week washout period.

The SLE Disease Activity Index 2000, British Isles Lupus Assessment Group index, and Physician Global Assessment were recorded at each visit, as was Type I interferon (IFN) induced gene signature.

Compared with the placebo treatment, omalizumab was well tolerated with no allergic reactions. A majority of observed adverse events were mild.

SLE Disease Activity Index 2000 scores improved at 16 weeks for participants in the omalizumab group, as well as during the open label phase among those who initially received placebo.

There was no worsening in either British Isles Lupus Assessment Group index scores or Physician Global Assessment.

Omalizumab also reduced IFN gene signature, more notably among participants with high baseline IFN signature.

“Omalizumab is well tolerated in SLE and associated with improvement in disease activity,” the researchers concluded. “Larger randomized clinical trials will be needed to assess efficacy of omalizumab in patients with SLE.”

—Colleen Murphy

Reference:

Hasni S, Gupta S, Davis M, et al. Safety and tolerability of omalizumab, a randomized clinical trial of humanized anti‐IgE monoclonal antibody in systemic lupus erythematosus (STOP LUPUS) [published online December 29, 2018]. Arthritis Rheumatol. https://doi.org/10.1002/art.40828.