February 19, 2019
In Healio Rheumatology, Dr. Gregg Silverman, professor of medicine and pathology at NYU School of Medicine, provided an overview of potential lupus therapies in development. He highlighted ustekinumab (brand name Stelara®) and baricitinib (brand name Olumiant®) as two drugs that look particularly promising.
“The phase 2 extra-renal trial of baricitinib looks good; ustekinumab looks even better,” Silverman said.
Following phase 2 study results demonstrating that 4-mg doses of baricitinib were associated with significant clinical improvements among patients with SLE, the FDA granted fast track designation for the treatment of SLE in December 2018. Similarly, the phase 2 trial for ustekinumab demonstrated improved global and organ-specific SLE activity measures that were sustained through 1 year, with a safety profile consistent with the drug’s other indications.
“I’m optimistic for baricitinib because I’m really kind of a closet optimist. Ustekinumab is an unexpected success but I think it has a lot of potential,” Silverman said. He also noted promising findings from the ongoing phase 2 study of obinutuzumab (Gazyva, Genentech) for the treatment of lupus nephritis.
Looking at Stelara® in lupus is an outcome of the drug repurposing program Lupus Research Alliance had initiated to accelerate availability of new treatments by identifying viable options among drugs already approved by the FDA for other conditions. In this comprehensive analysis, Stelara® was the top of the list among biologics as offering potential benefit in treating lupus.
Our affiliate Lupus Therapeutics is currently working with the pharmaceutical company, Janssen, to help conduct a Phase 3 trial to evaluate whether their drug may offer benefit to people with lupus. Called LOTUS, the international study is being conducted in over 200 sites, 20 of which are members of Lupus Therapeutics’ Lupus Clinical Investigators Network (LuCIN).