The work of a clinician-scientist often feels like two steps forward, one step back. Just ask Professor Eric Morand, Head of the School of Clinical Sciences at Monash University.
Professor Morand, an international expert in lupus (Systemic Lupus Erythematosus, [SLE]), published Feb. 25 in The Lancet results of a phase 3 trial of baricitinib for patients with SLE, involving patients globally including at Monash Health. Baricitinib is commonly used for the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata.
A considerable body of evidence supported the role of pathways targeted by baricitinib in the pathogenesis of lupus, including a phase 2 study, which showed daily oral baricitinib was superior to placebo in improving SLE activity—particularly resolving rash and joint manifestations.
The current study was positive, but a negative companion study means that the benefit of baricitinib for the treatment of patients with moderately to severe active SLE is unclear. The development program for baricitinib in SLE has therefore been discontinued.
While disappointing, Professor Morand said, “In many ways, this has sent us back to the drawing board, but all results help us know where to go from here.”
“We are determined to find effective treatments for all autoimmune diseases, including SLE, because people who have these diseases experience significant challenges to quality of life, and in many cases, shortened life expectancy. It is not acceptable.”
To this end, Professor Morand led a recently reported Phase 2 trial of a different drug—deucvravicitinib—that shows promise, and Phase 3 trials are planned.
“As lupus is a disease where no two patients are alike, measurement of treatment effects is complex and complicated. Monash is leading a global project to generate new and better validated clinical trial measures and continues the quest for relief for patients,” Professor Morand said.
Eric F Morand et al, Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I), The Lancet (2023). DOI: 10.1016/S0140-6736(22)02607-1
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