Aurinia Pharmaceuticals Inc. announced the 2023 updated recommendations from The European Alliance of Associations for Rheumatology (EULAR) for the management of systemic lupus erythematosus (SLE) based on emerging new evidence, including a new treatment paradigm for lupus nephritis (LN). The new recommendations suggest that in addition to traditional anchor drugs, therapies including LUPKYNIS® (voclosporin) should be considered for any active class of lupus nephritis. In most cases, patients should continue the therapy they were initially treated with for at least three years following treatment response, including voclosporin, as the guidelines cited the stable estimated glomerular filtration rate (eGFR, an important measurement of kidney function) observed with voclosporin over 3 years.

Importantly, the recommendations suggest that 5 mg/day should serve as the highest acceptable maintenance dose of steroids in SLE or LN (pre previous recommendations suggested achieving =7.5 mg/day by three to six months of LN treatment). This recommendation was based on the significantly lower glucocorticoid doses used in recent randomized clinical trials, including the AURORA clinical studies of voclosporin. The recommendations highlight the profound repercussions of delaying diagnosis, thus recommending vigilant monitoring for new organ damage, especially lupus nephritis, at every visit (at least yearly).

The recommendations were based on the understanding that LN is a severe disease by nature and is associated with worse rates of mortality and morbidity. LN causes nephron loss over time that can lead to chronic kidney disease and end-stage renal disease. Given the consistently low rates of complete response at one to two years of treatment observed in the control arms of LN clinical trials (i.e., 20-30%), the option for additional therapy upfront should be considered.

Since recently approved therapies are indicated for all adult patients with active LN, it was deemed reasonable that they be considered as a first-line option. The recommendations noted that the final decision for the treatment of active LN should depend on the individual patient characteristics, such as histological class, baseline eGFR, proteinuria, presence of extrarenal manifestations, comorbidities, risk for toxicity, access to drugs and cost issues, and patient preferences. Voclosporin was well tolerated with no new or worsening safety signals in the extension study.

Clinical efficacy over three years of treatment was maintained, as observed by maintenance of urine protein creatinine ratio (UPCR) reductions, sustained CRR and preserved kidney function, suggesting a positive benefit-risk profile for voclosporin in LN patients. These results were achieved with most patients in both groups (>75%) maintaining glucocorticoid tapering throughout the study and receiving doses of 2.5 mg/day at the end of the extension study. AURORA 2 results were published in Arthritis & Rheumatology, the official peer-reviewed journal of the American College of Rheumatology.