Small Study Shows Treating Lupus Nephritis with Lower Doses of Prednisone Works

A small study conducted in Spain found that a lower dose of the oral corticosteroid prednisone worked as well with less side effects than the current standard dosage.   Researchers at the BioCruces Health Research Institute reported in a paper published in Autoimmunity Reviews that half or less than half the usual prednisone dose produced either complete or partial remission of lupus nephritis in most patients with few or no side effects.

Ruiz-Irastorza G, Danza A, Perales I, et al. Prednisone in lupus nephritis: How much is enough? (2014) Autoimmun Rev. Feb;13(2):206-14. doi: 10.1016/j.autrev.2013.10.013

Spanish researchers say lupus nephritis (LN) can be safely and effectively treated using a much lower dose of oral corticosteroids than the current standard – in less time and with less toxicity.

LN is typically treated with a combination of immunosuppressants and high-dose prednisone (50-60 mg a day). But the cost of remission over time at that dose is often bone loss, osteonecrosis, cataracts, and cardiovascular disease.

However, researchers at the BioCruces Health Research Institute in Spain report that half or even less than half that amount of prednisone produced complete or partial remission in a majority of patients in as quickly as six months, with few or no side effects.

The new regimen, which they call the “Cruces Protocol,” consists of starting doses of 15-30 mg/day given with pulses of methyl-prednisolone, hydroxychloroquine, and cyclophosphamide, rapidly tapering the prednisone to a maintenance dose of 2.5-5 mg/day within 16 weeks, and maintaining azathioprine and/or mycophenolate mofetil for up to two years.

They have tested this protocol among 15 LN patients and compared the results to retrospective data for a control group of 30 patients treated with an NIH-based regimen (high-dose prednisone and monthly pulses of cyclophosphamide, followed by maintenance doses of azathioprine and/or mycophenolate mofetil for at least two years.)

Most of the patients were white women in their mid to late 30s.

Among the protocol cohort, 80% reached full or partial remission at six months and 87% within a year. This is superior to the results in the historic controls taking the high-dose regimen: 47% and 63%, respectively.

All LN patients in the Cruces cohort eventually reached remission during at least two years of follow-up, compared with 70% of the control group. Two cohort patients and 14 of the high-dose patients eventually relapsed.

Only one cohort patient experienced glucocorticoid-related toxicity as against 20 of the high-dose patients, among who there were 3 osteoporotic fractures and 7 cases of osteonecrosis over a period of 138 months.