Further development of ustekinumab supported in SLE
medwireNews: The interleukin (IL)-12/23 inhibitor ustekinumab may be a promising new treatment option for systemic lupus erythematosus (SLE), phase II trial results suggest.
“There is clearly an unmet medical need in the treatment of patients with systemic lupus erythematosus,” said Ronald van Vollenhoven (Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, the Netherlands), who presented the findings at the 2017 ACR/ARHP Annual Meeting in San Diego, California, USA.
Although the pathophysiology of SLE is not completely understood, “both IL-12 and Il-23 have to some extent been implicated” in the disease mechanisms, he added, noting that ustekinumab is currently approved for the treatment of psoriatic arthritis, plaque psoriasis, and Crohn’s disease.
In their phase II trial, the investigators randomly assigned patients with active, seropositive SLE to receive 6 mg/kg intravenous ustekinumab followed by subcutaneous injections of ustekinumab 90 mg every 8 weeks or matched placebo in addition to standard care.
At the 24-week follow-up, 60% of 60 patients receiving ustekinumab achieved an SLE Responder Index (SRI)-4 response, compared with 31% of 42 patients in the placebo group, a significant difference.
Participants in the ustekinumab group also had significantly greater improvements in SLE Disease Activity Index 2000 (SLEDAI-2K) scores from baseline to week 24 than those receiving placebo, with mean reductions of 4.4 versus 3.8 points, and patients in the active treatment group had an 89% lower risk for SLE flares during the study period.
In all, 78.3% of patients receiving ustekinumab and 66.7% of those given placebo experienced treatment-emergent adverse events (TEAEs) over approximately 24 weeks of follow-up, and serious TEAEs occurred in a corresponding 8.3% and 9.5% of patients.
Van Vollenhoven noted that there were no deaths in this “relatively short trial,” and that the observed safety profile was “consistent with what is known about ustekinumab” from extensive studies in other indications.
And he concluded: “This phase II trial indicates that ustekinumab has the potential to be a new treatment in SLE with a novel mechanism of action.”
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