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Expert view: Ustekinumab for SLE?

Development of treatments for systemic lupus erythematosus (SLE) has been challenging.

Many components of the immune system have been identified as targets for novel therapies, but the majority of the clinical trials have failed. However, many trials are ongoing and some of them have reported promising preliminary results.

The most hopeful results come from a recent Phase II clinical trial of ustekinumab, a monoclonal antibody towards interleukin-12 (IL-12) and IL-23, published in The Lancet.1 The drug is already approved and used for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease. Because IL-12 and IL-23 have also been implicated in SLE, a Phase II trial was designed aiming at assessing the efficacy and safety of ustekinumab in patients with moderately to severely active SLE despite standard of care therapy.

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The study was carried out at 44 private practices and academic centres in Argentina, Australia, Germany, Hungary, Mexico, Poland, Spain, Taiwan, and the USA. A total of 102 patients were randomised to receive ustekinumab (n=60) or placebo (n=42). Eligible adults were aged 18–75 years, weighed at least 35 kg, and had a diagnosis of SLE at least three months before the first administration of study drug. A significantly higher proportion of patients achieved the primary efficacy endpoint in the ustekinumab arm (62%) compared with the placebo arm (33%) (P=0.006) at week 24 from baseline, and the drug was generally well tolerated. Infections were the most common adverse event, with similar rates in the two arms.

These observations support further development of ustekinumab as a new therapy for SLE, and results from Phase III trials are awaited.


  1. van Vollenhoven R et al. Efficacy and safety of ustekinumab, an IL-12 and IL-23 inhibitor, in patients with active systemic lupus erythematosus: results of a multicentre, double-blind, phase 2, randomised, controlled study. Lancet 2018;392:1330-9.