June 8, 2021
The annual European Congress of Rheumatology (EULAR 2021) brought much good news of potential new treatments for systemic lupus erythematosus (SLE). Following are highlights:
Rituximab Plus Belimumab
Taking belimumab after rituximab may help lupus according to data from the BEAT-LUPUS trial presented at the 2021 EULAR Virtual Congress by the trial lead investigator Prof. Michael Ehrenstein.
The addition of belimumab after rituximab significantly decreased antibody levels versus rituximab alone. The combination also lengthened the amount of time before flare-ups were seen with no increase in adverse events or risk of infection seen with rituximab by itself.
Results of a Phase 2b trial showed that the investigational agent iberdomide had beneficial effects on skin manifestations of people with SLE. Evaluated by the standardized measurement tool called Cutaneous Lupus Area and Severity Index Activity Score (CLASI-A), the effects were more pronounced in patients who also had cutaneous lupus erythematosus.
Iberdomide is being developed by Bristol Myers Squibb as a potential novel treatment for SLE.
A new analysis presented at EULAR of the TULIP Phase 3 clinical trials showed that the investigational drug anifrolumab was associated with improvements in both skin rash and arthritis across three different disease measures each, compared to placebo, in patients with moderate to severe systemic lupus erythematosus (SLE). Anifrolumab is being developed by AstraZeneca as a potential treatment for SLE.
AstraZeneca reports that its application for anifrolumab in SLE is under review by regulatory authorities in the US, EU and Japan, with decisions anticipated in the second half of 2021.
The benefit for patients with lupus nephritis treated with voclosporin were maintained at two years according to results presented at EULAR. This was the first presentation of data from the extension by one year of the original Phase 3 AURORA 1 trial.
Voclosporin was already approved by the U.S. Food and Drug Administration based on data taken from a combined analysis of two positive pivotal trials —AURORA Phase 3 study and the AURA-LV Phase 2 study. Results from more than 500 lupus nephritis patients showed that those who had been treated with voclosporin in combination with standard therapy of mycophenolate mofetil and low-dose steroids had better and faster response rates than those who received the standard therapy alone.