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ABSTRACT
Introduction: Lupus nephritis (LN) is associated with significant morbidity and mortality. Current treatment outcomes remain suboptimal. No disease modifying medications are licensed for the treatment of LN. Voclosporin, a novel calcineurin inhibitor, has been investigated as induction therapy in LN in combination with myocophenolate mofetil (MMF) and a glucocorticoid (GC). Two phase II trials of voclosporin were the first trials of a potential treatment of active LN that met their primary endpoints.
Areas covered: This article reviews the pharmacology of voclosporin and the efficacy and safety data from the two existing phase II trials. In the phase IIb randomized controlled trial AURA-LV, voclosporin was shown to be superior to placebo, when used in combination with MMF (1–2 g/day) and GC, in achieving remission in active LN.
Expert opinion: While the positive outcome of existing trials is promising, further data confirming its efficacy and evaluating its safety are required. A phase III trial is currently recruiting. Importantly, the positive results were achieved despite a novel and rapid GC taper regime, suggesting that rapid taper of GC may be a viable treatment option in active LN which merits further investigation.
Declaration of interest
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Referee disclosures
One referee declares that they have coauthored an Aurion abstract and was consulted in the design of the phase II AURA-LV trial.