Omalizumab Safe and Effective in SLE Patients

Researchers recently tested the effects of omalizumab in patients with systemic lupus erythematosus (SLE) and had positive initial results. 

Researchers predicted that omalizumab, a monoclonal antibody (mAb) binding immunoglobulin E (IgE), could be beneficial for SLE patients by decreasing the production of type 1 interferon (IFN) through blocking plasmacytoid dendritic cells and basophil activation, they explained. 

The study included 15 SLE patients with a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) of > 4 and elevated autoreactive IgE antibodies. Patients were randomized to receive omalizumab or placebo for 16 weeks; a 16-week open label treatment and four-week washout period followed. Researchers assessed patients’ SLEDAI 2K, British Isles Lupus Assessment Group index (BILAG 2004), and Physician Global Assessment (PGA) at every visit. 

By the end of the study, no allergic reactions had occurred in either group; the majority of adverse events were mild. Compared to the placebo group, the omalizumab group showed improved SLEDAI 2K scores at week 16 (P = 0.038) and during the open-label phase in the initial placebo patients (P = 0.020). BILAG scores and PGA did not get worse during the study. Researchers observed a trend in decreased IFN gene signature in omalizumab patients (P = 0.11); IFN gene signature was measured with quantitative polymerase chain reaction. 

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

Measuring Disease Damage and Its Severity in Childhood-Onset Systemic Lupus Erythematosus  

Real-world safety and efficacy of omalizumab in patients with severe allergic asthma: A long-term post-marketing study in Japan 

Endotypes of severe allergic asthma patients who clinically benefit from anti‐IgE therapy 

Fatigue in systemic lupus erythematosus and other autoimmune skin diseases

Source: Arthritis & Rheumatology