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Omalizumab Linked to Improved Disease Activity in SLE
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Omalizumab is well tolerated and associated with improved disease activity in patients with systematic lupus erythematosus, according to data published in Arthritis & Rheumatology.
“Omalizumab is approved by the [FDA] for the treatment of asthma and chronic idiopathic urticaria, effectively depletes circulating IgE and decreases basophil activation,” Sarfaraz Hasni, MD, of the NIH National Institute of Arthritis and Musculoskeletal and Skin Diseases, and colleagues wrote. “We hypothesized that depleting IgE autoantibodies with omalizumab in those SLE subjects with elevated autoreactive IgEs would hamper type I [interferon] production and reduce autoantibodies, possibly by reducing basophil and [plasmacytoid dendritic cell] activation, and could potentially reduce disease activity.”
To evaluate the safety, tolerability, and clinical efficacy of omalizumab (Xolair; Genentech, Novartis) in cases of mild to moderate SLE, Hasni and colleagues conducted a study in three phases. First, 15 participants with SLE and Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) of greater than 4 were randomized 2-to-1 to receive either omalizumab or placebo for 16 weeks. In the second, open-label phase, all participants were treated with subcutaneous omalizumab for an additional 16 weeks. Finally, the patients were followed off study drug for a washout period of 4 weeks.
The subcutaneous treatments were administered as a 600 mg loading dose, followed by 300 mg every 4 weeks. The researchers recorded SLEDAI 2K, British Isles Lupus Assessment Group index (BILAG 2004) and Physician Global Assessment (PGA) at each visit. In addition, Hasni and colleagues determined type I interferon–induced gene signature using quantitative polymerase chain reaction.
According to the researchers, omalizumab was well-tolerated among the participants, with no allergic reactions and mostly mild adverse events compared with placebo. SLEDAI 2K scores improved among patients in the omalizumab group at week 16 (P = .038) and during the open label phase in participants who originally received placebo (P = .02). In addition, the researchers noted no worsening in BILAG scores or PGA. According to Hasni and colleagues, omalizumab reduced interferon gene signatures in patients treated with the medication (P = .11), particularly in those with a high baseline interferon signature (P = .052).
“The use of omalizumab — if proven by subsequent large scale studies — in SLE will be a better alternative for the treatment of SLE,” Hasni told Healio Rheumatology. “The potential advantage is a side effect profile better than currently used immunosuppressive drugs and a convenient once a month subcutaneous injection. The IgE autoantibodies are shown to be present in up to 70% of patients with SLE, hence omalizumab use may be applicable to a large subset of SLE patients.” – by Jason Laday
Disclosure: Hasni reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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