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Ronald F van Vollenhoven and colleagues have reported in Lancet that ustekinumab (UST), an interleukin-12 and -23 inhibitor, when added to usual therapy in systemic lupus erythematosus (SLE) patients, was shown to be superior to placebo at improving clinical efficacy and laboratory parameters after 6 months of therapy.
The study was a double-blind, phase 2, randomised, controlled trial of UST vs. PBO in ANA positive, adult SLE patients with moderate-to-severe disease activity.
Patients were randomly assigned (3:2) to the UST or PBO and were stratified according to skin biopsy, nephritis, baseline medications and SLEDAI-2K scores.
Patients received weight-based initial intravenous infusions followed by subcutaneous injections of UST 90 mg every 8 weeks or placebo parenterally as well. The primary endpoint was a SLEDAI-2K responder index-4 (SRI-4) response at week 24.
Of the 166 patients screened, 102 were randomly assigned to UST (n=60) or PBO (n=42). The week 24 SRI-4 response rates were:
- UST - 62%
- PBO - 33% (p=0·006)
Adverse events were similar between groups (78% vs 67%) as were infections (45%] vs 50%). There were no deaths or opportunistic infections.
These data are encouraging for larger phase III trials studying UST in active SLE patients to proceed.
The study was funed by Janssen Research & Development, LLC.