Lupus treatment has had such a difficult improvement trajectory that I’m posting this despite its technical challenges….
The monoclonal antibody ustekinumab (Stelara) showed sustained clinical benefits for systemic lupus erythematosus (SLE) through 1 year and may offer a new therapeutic option, according to a researcher here.
At week 24, the SLE Responder Index-4 (SRI4) response rate was achieved by 61.7% of patients randomized to receive ustekinumab compared with 33.3% of those given placebo, a difference of 29% (P=0.0057), reported Ronald van Vollenhoven, MD, of the Amsterdam Rheumatology and Immunology Center in the Netherlands, at the American College of Rheumatology annual meeting.
Ustekinumab inhibits the interleukin (IL)-12/23 pathways, both of which have been implicated in the incompletely understood pathogenesis of SLE. This monoclonal antibody has been approved for use in psoriasis, psoriatic arthritis, and Crohn’s disease.
The last agent to be approved for use in SLE was belimumab (Benlysta) in 2011, and that was the first drug to be approved in half a century. “Drug development has been very bittersweet in lupus,” said Susan Manzi, MD, who is co-director of the Lupus Center of Excellence, Allegheny Health Network, in Pittsburgh. “But ustekinumab looks like a promising treatment,” she told MedPage Today.
The number of patients who experienced a 30% or more improvement over baseline on the physician global assessment was 67.9% at week 24 and rose slightly to 75% at 1 year, while the percentages with an improvement of 50% or more in the number of joints with pain and inflammation remained at 86.5% at both time points. A more pronounced improvement was seen on the Cutaneous Lupus Erythematosus Disease Area and Severity Index, with improvements of 50% or more being seen in 53.1% at week 24 and in 68.6% at 1 year.
More than 60% of patients had sustained responses at 1 year, “and that’s good news,” Manzi commented. “What you don’t want to see is that they get better but then lose the response at 1 year,” she said in an interview.