Ustekinumab: a promising new drug for SLE?
(2018) The Lancet — Vol. 392, n° 10155, p. 1284-1286 (2018)
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- In The Lancet, Ronald van Vollenhoven and colleagues1 report a positive multicentre double-blind phase 2 randomised, placebo-controlled trial with ustekinumab, an anti-interleukin-12/23 (IL-12/23) monoclonal antibody, in 102 patients aged 18–75 years with active systemic lupus erythematosus (93 women and nine men). The design of the study is common for trials of biotherapies in patients with systemic lupus erythematosus: ustekinumab was assessed as add-on treatment to standard-of-care therapy in patients with active disease, excluding severe cases with active glomerulonephritis, systemic vasculitis, or CNS involvement. The primary endpoint, assessed at week 24, was the systemic lupus erythematosus disease activity index 2000 responder index-4 (SRI-4), a composite endpoint used in many other trials.2 The results are notable, with 37 (62%) of 60 patients in the ustekinumab group and 13 (33%) of 42 patients in the placebo group achieving an SRI-4 response (difference 28% [95% CI 10–47], p=0·006). [...]
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Costedoat-Chalumeau, N., & Houssiau, F. (2018). Ustekinumab: a promising new drug for SLE? The Lancet, 392(10155), 1284-1286. https://doi.org/10.1016/S0140-6736(18)32330-4 (Original work published 2018)