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Safety and Tolerability of Omalizumab, A Randomized Clinical Trial of Humanized anti-IgE Monoclonal Antibody in Systemic Lupus Erythematosus (STOP LUPUS)

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Hasni S1, Gupta S1, Davis M1, Poncio E1, Temesgen-Oyelakin Y1, Joyal E1, Fike A1, Manna Z1, Auh S2, Shi Y1, Chan D1, Carlucci P1, Biehl A3, Dema B1,4, Charles N1,4, Balow JE2, Waldman M2, Siegel RM1, Kaplan MJ1, Rivera J1. Arthritis Rheumatol. 2018 Dec 29. doi: 10.1002/art.40828. [Epub ahead of print]


Author information 1 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Bethesda, MD. 2 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, Bethesda, MD. 3 Clinical Center, NIH, Bethesda, MD. 4 Centre de Recherche sur l'Inflammation, INSERM UMR1149, CNRS ERL8252, Université Paris Diderot, Sorbonne Paris Cité, Faculté de Médecine site Bichat, Laboratoire d'Excellence Inflamex, DHU FIRE, 16 rue Henri Huchard, 75018, Paris, France.

Abstract BACKGROUND: Autoreactive IgE antibodies have been implicated in the pathogenesis systemic lupus erythematosus (SLE). We hypothesized that omalizumab, a monoclonal antibody (mAb) binding IgE, may improve SLE activity by reducing type I IFN production by hampering plasmacytoid dendritic cells and basophil activation. This study assessed the safety, tolerability, and clinical efficacy of omalizumab in mild to moderate SLE.

METHODS: Fifteen subjects with SLE and a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) of > 4 and elevated autoreactive IgE antibodies were randomized to receive omalizumab or placebo (2:1) for 16 weeks, followed by 16-week open label treatment and 4-week washout period. SLEDAI 2K, British Isles Lupus Assessment Group index (BILAG 2004) and Physician Global Assessment (PGA) were recorded at each visit. Type I interferon (IFN) induced gene signature was determined using quantitative PCR.

RESULTS: Omalizumab was well tolerated with no allergic reactions, and mostly mild adverse events comparable to placebo treatment. SLEDAI 2K scores improved in the omalizumab group at week 16 (p=0.038), as well as during the open label phase in subjects initially receiving placebo (p=0.020). No worsening in BILAG scores or PGA were detected. Omalizumab led to a trend towards reduction in IFN gene signature in subjects treated with omalizumab (p=0.11), especially in subjects with high baseline IFN signature (p=0.052).

CONCLUSION: Omalizumab is well tolerated in SLE and associated with improvement in disease activity. Larger randomized clinical trials will be needed to assess efficacy of omalizumab in patients with SLE.