Making progress for lupus
Jane E. Salmon, MD, director of the Lupus and APS Center of Excellence and codirector of the Mary Kirkland Center for Lupus Research at the Hospital for Special Surgery in New York, who was not involved in the research, said in an email that she is “cautiously optimistic, because in SLE, successful phase 2 trials too often are followed by unsuccessful phase 3 trials.”
Courtesy Hospital for Special Surgery
Dr. Jane E. Salmon
Blocking the production of type 1 interferon by pDCs implicated in SLE pathogenesis has the theoretical advantage of preserving type 1 interferon critical to protection from viruses, she noted. Herpes infections were reported among patients who received litifilimab, but rates were not increased, compared with placebo.
Diversity is an important priority in further research, Dr. Salmon said.
Daniel J. Wallace, MD, of Cedars-Sinai Medical Center in Los Angeles, similarly pointed out in an editorial that accompanied the SLE phase 2 trial that while Black patients make up one-third of the U.S. population with lupus, only about 10% of study participants whose race and ethnicity was reported were Black). (Race was not reported by sites in Europe.)
Dr. Daniel J. Wallace
The results of the LILAC trials “encourage further exploration of interventions that affect upstream lupus inflammatory pathways in the innate immune system in lupus,” Dr. Wallace wrote. He noted that lupus has “lagged behind its rheumatic cousins,” such as rheumatoid arthritis and vasculitis, in drug development.
Developing endpoints and study designs for SLE trials has been challenging, at least partly because it is a multisystem disease, Dr. Furie said. “But we’re making progress.”
Anifrolumab, a type 1 interferon receptor monoclonal antibody that was approved for SLE in July 2021, “may have a broader effect on type 1 interferons,” he noted, while litifilimab “may have a broader effect on proinflammatory cytokines, at least those expressed by pDCs.”
Biogen, the sponsor of the LILAC trial, is currently enrolling patients in phase 3 studies – TOPAZ-1 and TOPAZ-2 – to evaluate litifilimab in SLE over a 52-week period. The company also plans to start a pivotal study of the drug in CLE later this year, according to a press release.
Six coauthors are employees of Biogen; five, including Dr. Furie, reported serving as a consultant to the company; one served on a data and safety monitoring board for Biogen; and Dr. Salmon owns stock in the company.
A version of this article first appeared on Medscape.com.