Anifrolumab safe, effective in refractory SLE

Use of anifrolumab improves symptoms and induces remission in patients with refractory systemic lupus erythematosus (SLE), with an acceptable safety profile, a study has shown. 

This retrospective study was conducted in nine SLE referral centres participating in a compassionate use program for the use of ANI in 26 patients with active SLE in whom all available treatments failed, were not tolerated, or were contraindicated. 

The investigators recorded the overall and organ-specific disease activity, flares, daily glucocorticoid (GC) dose, and adverse events at baseline and at 1, 3, 6, 9, and 12 months of treatment. 

The Systemic Lupus Erythematosus Disease Activity Index 2000 (p=0.01), Systemic Lupus Erythematosus–Disease Activity Score (p=0.01), and physician global assessment (p=0.001) significantly decreased at 4 weeks, and this trend persisted over time. 

A significant reduction was also observed in Cutaneous Lupus Erythematosus Disease Area and Severity Index-activity (p<0.001) and in tender (p=0.03) and swollen (p=0.02) joint counts. 

Of the patients, 33 percent achieved remission and 46 percent were in Lupus Low Disease Activity State (LLDAS) at 3-month follow-up. At 6 months, 50 percent achieved remission and 80 percent were in LLDAS. In addition, there was a significant decrease in mean GC daily dose starting from week 4 (p=0.04). 

With regard to safety, four cases of disease flares (three mild-to-moderate and one severe) occurred. In addition, four out of 20 patients with at least 24 weeks of follow-up (20 percent) showed no response to treatment.