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AURORA Trial Voclosporin — SCE Rheumatology MCQ

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HardSLE & Antiphospholipid SyndromeAURORA Trial VoclosporinSCE Rheumatology

A landmark double-blind phase 3 trial enrolled adults with biopsy-proven class III, IV or V lupus nephritis. Participants received voclosporin 23.7 mg twice daily or placebo, together with mycophenolate mofetil and rapidly tapered low-dose glucocorticoids. At week 52, complete renal response was achieved by approximately 41% and 23% of participants, respectively. Which trial was this?

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Correct answer: DAURORA 1

AURORA 1 was the pivotal 52-week phase 3 trial of voclosporin 23.7 mg twice daily added to mycophenolate mofetil and rapidly tapered glucocorticoids. Complete renal response occurred in 40.8% of the voclosporin group versus 22.5% with background therapy alone. The phase, dose and week-52 endpoint distinguish it from AURA-LV, the preceding phase 2 dose-ranging trial whose primary endpoint was at week 24. AURORA 2 was the two-year continuation of AURORA 1, giving up to three years of total follow-up. BLISS-LN evaluated belimumab, while NOBILITY evaluated obinutuzumab. The current UK SmPC bases the clinical efficacy description of voclosporin on AURORA 1 and indicates its use with mycophenolate mofetil in active class III, IV or V lupus nephritis.

Reference: Lupkynis 7.9 mg soft capsules, Summary of Product Characteristics, sections 4.1 and 5.1: Phase 3 AURORA 1, revised 4 November 2025. https://www.medicines.org.uk/emc/product/14381/smpc