Last updated on November 2017

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)


Brief description of study

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)

Detailed Study Description

Systemic lupus erythematosus (SLE) is a chronic, debilitating autoimmune disease that is characterized by the presence of autoreactive B cells and elevated levels of autoantibodies, which directly damage the body’s cells and tissues. SLE can affect multiple organ systems simultaneously or sequentially, and follows an unpredictable clinical course where periods of relatively stable disease are followed by flares and/or periods of active disease that can ultimately lead to irreversible damage to tissues and organ systems.

Baricitinib is an orally available, selective Janus kinase (JAK) inhibitor with excellent potency and selectivity for JAK1 and JAK2 and less potency for JAK3 or Tyrosine kinase 2 (TYK2; Fridman et al. 2010). This activity profile suggests that baricitinib may inhibit cytokines implicated in SLE such as type I interferon (IFN; JAK1/TYK2), type II IFN-γ, interleukin (IL)-6 (JAK1/JAK2/TYK2), and IL-23 (JAK2/TYK2) as well as other cytokines that may have a role in SLE, including granulocyte-macrophage colony stimulating factor (JAK2/JAK2) and IL-12 (JAK2/TYK2). The potential impact of baricitinib on the IFN pathway is highly relevant to SLE, as clinical and preclinical studies have established that this pathway is involved in the pathogenesis of SLE.

Clinical studies have established that baricitinib is effective in autoimmune/autoinflammatory diseases involving the joints, skin, and kidneys. Baricitinib was effective at reducing swollen and tender joints in patients with rheumatoid arthritis (RA; I4V-MC-JADA [Phase 2] and I4V-MC-JADW and I4V-MC-JADX [Phase 3]), was effective at reducing disease severity in patients with moderate to severe plaque psoriasis (Menter et al. 2014), and was effective at reducing the urinary albumin-to-creatinine ratio (UACR) in patients with diabetic kidney disease (Tuttle et al. 2015). The mechanism of action, combined with demonstration of clinical benefit in inflammatory diseases involving joints, skin and kidneys, provides the rationale for evaluating baricitinib in SLE.

Clinical Study Identifier: TX9059

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Diana Del Valle

New Horizon Research Center
Miami, FL USA
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