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NKF 2020: New Lupus Tx; Staying on Spironolactone, and More

<ѻý class="mpt-content-deck">— Research highlights from the National Kidney Foundation virtual meeting
MedpageToday

Research highlights at the virtual National Kidney Foundation (NKF) Spring Clinical Meeting included the latest advancements in the field of chronic kidney disease (CKD), such as an oral CKD-related pruritus treatment, the effect of sacubitril/valsartan (Entresto) on kidney decline in heart failure, and differences between phosphate binders.

Below are a few more noteworthy studies from the NKF meeting that was supposed to take place in New Orleans, but went virtual because of the COVID-19 pandemic.

Novel Immunosuppressant for Lupus Nephritis

Almost double the amount of people with active lupus nephritis saw a renal response when voclosporin treatment was added to mycophenolate and a low-dose steroid regimen versus standard of care, according to results from the .

Meeting its primary endpoints, 40.8% of those on the immunosuppressant voclosporin achieved a full renal response -- defined as a UPCR of 0.5 mg/mg or less, and eGFR of 60 mL/min or more, or no confirmed decrease from baseline in eGFR of over 20%, presence of sustained, low dose steroids, and no administration of rescue medication -- versus only 22.5% of those receiving standard of care treatment (OR 2.65 95% CI, P<0.001) after 52 weeks, reported Keisha Gibson, MD, MPH, of the University of North Carolina School of Medicine in Chapel Hill, and colleagues.

Significantly more patients on voclosporin also achieved a renal response after only 24 weeks versus those on standard of care (32.4% vs 19.7%, OR 2.23, 95% CI 1.34-3.72, P=0.002). And more patients on voclosporin also achieved a partial renal response after 24 and 52 weeks.

A total of 357 patients were included in the trial. The participants received either 23.7 mg twice a day of the novel high potency calcineurin inhibitor voclosporin added to 2 g/day of mycophenolate plus rapidly tapered low dose oral steroids, considered the standard of care.

Voclosporin was also deemed safe, with no unexpected safety signals and a similar serious adverse event rate to the control (20.8% vs 21.3%).

Based on these findings, the developer Aurinia Pharmaceuticals announced plans to file for during the first half of 2020.

Patiromer Support

In the of nearly 300 patients with resistant hypertension and CKD, adding the hyperkalemia drug patiromer (Veltassa) helped significantly more patients remain on spironolactone (CaroSpir, Aldactone) treatment.

"Spironolactone is effective at reducing blood pressure in patients with uncontrolled resistant hypertension; however, the use of spironolactone in patients with CKD can be restricted by hyperkalemia," explained Rajiv Agarwal, MBBS, of Indiana University School of Medicine in Indianapolis, and colleagues in a poster.

Among patients under age 65, 90% on patiromer were able to remain on spironolactone at week 12 versus only 68% of those on placebo. Similar outcomes were noted in patients 65 and older, with about 84% on patiromer remaining on treatment versus 65% on placebo.

Patiromer also allowed patients to tolerate a higher dosage of spironolactone versus placebo. After starting at 25 mg once a day of spironolactone, patients under age 65 averaged a higher cumulative spironolactone dose of 332 mg more after 12 weeks, while those 65 and older averaged 398 mg more of cumulative spironolactone with concomitant patiromer.

Heart Risk Prevention

Apabetalone -- a novel bromodomain and extraterminal protein inhibitor -- helped reduce major adverse cardiovascular event (MACE) risk in people with type 2 diabetes and CKD, according to the .

There was a 52% reduced MACE occurrence -- including cardiovascular death, non-fatal MI, or stroke -- in patients with CKD on apabetalone versus placebo (12.9% vs 25%, hazard ratio 0.48, 95% CI 0.26-0.89, P=0.02), reported Kamyar Kalantar-Zadeh, MD, of the University of California Irvine School of Medicine, and colleagues.

Interestingly, apabetalone did not show this same cardiovascular protection in patients without CKD when compared with placebo (11.3% vs 12.7%, HR 0.89, 95% CI 0.70-1.14, P=0.38). These findings in non-CKD patients were reported at the 2019 American Heart Association meeting.

Nearly 2,500 patients with type 2 diabetes, and a recent experience of acute coronary syndrome, at high risk for a recurrent cardiovascular event were included in the study.

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    Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.

Disclosures

The AURORA study was supported by Aurinia Pharmaceuticals.

The AMBER study was supported by Relypsa Inc, a Vifor Pharma Company.

The BETonMACE trial was supported by Resverlogix.

Primary Source

National Kidney Foundation

Gibson K, et al "AURORA Phase 3 Trial Demonstrates Voclosporin Statistical Superiority Over Standard of Care in Lupus Nephritis (LN)" NKF 2020; Abstract #407.

Secondary Source

National Kidney Foundation

Agarwal R, et al "Patiromer vs Placebo to Enable Spironolactone in Patients with Resistant Hypertension and CKD According to Patient Age (AMBER Trial)" NKF 2020; Abstract #401.

Additional Source

National Kidney Foundation

Kalantar-Zadeh K, et al "Apabetalone reduces Cardiovascular Events in Patients with Chronic Kidney Disease, Type 2 Diabetes, and Recent Acute Coronary Syndrome: A BETonMACE trial report" NKF 2020; Abstract #408.