Wednesday, 17 Oct 2018

You are here

Baricitinib Effective in SLE Trial

Dan Wallace and colleagues report in Lancet the results of a phase II study of the selective baricitinib, an oral selective Janus kinase (JAK1 and JAK2) inhibitor, in patients with systemic lupus erythematosus (SLE), demonstrating the efficacy and safety of JAK1/2 inhibition with baricitinib as a new potential oral therapy for SLE.

This randomised, placebo-controlled, 24-week trial enrolled 314 active (with skin or joint involvement), ANA+ or dsDNA+ SLE patients from in 11 countries to receive daily baricitinib 2 mg, or baricitinib 4 mg, or placebo. The primary endpoint was the proportion of patients achieving resolution of arthritis or rash at week 24, as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K).

At week 24, an SLEDAI-2K arthritis or rash response was seen in 67% of baricitinib 4 mg, 58% of baricitinib 2 mg and 53% of placebo patients (4mg vs PBO; p=0·0414).  The SRI-4 response was also significant for the Bari 4 mg cohort only.

Adverse events were similar between groups and similar to that seen with baricitinib in the rheumatoid arthritis trials. Serious adverse events were reported in ten (10%) patients receiving baricitinib 4 mg, 11 (10%) receiving baricitinib 2 mg, and five (5%) receiving placebo; no deaths were reported. Serious infections were reported in six (6%) patients with baricitinib 4 mg, two (2%) with baricitinib 2 mg, and one (1%) with placebo.

This trial demonstrates the potential use of higher dose baricitinib therapy in uncontrolled SLE patients. Further studies must be done before JAK inhibition could be used to treat problematic lupus not controlled on standard or approved therapies. 

The author has no conflicts of interest to disclose related to this subject

Rheumatologists' Comments

The patients haven't had good response to DMARDs or they are naaive? How about increased risk of thrombosis with JAK inhibitors in SLE especially with positive anti phospholipid serology?

More Like This

Teenage Obesity Increases Lupus Risk

Analysis of the Black Women's Health Study shows that obesity as a teenager may be associated with increased risk of systemic lupus erythematous (SLE) in adulthood.

The relationship between obesity and SLE risk is unclear. Past studies have predominantly assessed white women, while black women have higher prevalence of both obesity and SLE.

SLE-Scleroderma Overlap Outcomes

Overlap of autoimmune disorders represents a significant diagnostic and management challenge to the rheumatologist. A novel cohort analysis of overlap between systemic sclerosis (SSc) and systemic lupus erythematous (SLE) suggests such patients tend to be younger, more frequently have PAH, but less cutaneous manifestations of SSc.

Excess Mortality in CTD or Systemic Vasculitis Patients

The Norwegian connective tissue disease (CTD) and systemic vasculitis (PSV) registry (NOSVAR) studied patient outcomes over a 15 year period and found overall mortality to be higher in the CTD compared to the PSV group.

Mortality Improves in Lupus ESRD

The past two decades have seen a significant decline in mortality among patients with lupus nephritis, U.S. registry data indicated.

Ustekinumab May be Effective in Lupus

Ronald F van Vollenhoven and colleagues have reported in Lancet that ustekinumab (UST), an interleukin-12 and -23 inhibitor, when added to usual therapy in systemic lupus erythematosus (SLE) patients, was shown to be superior to placebo at improving clinical efficacy and laboratory parameters after 6 months of therapy.