Patients with lupus nephritis were effectively treated in a protocol designed to avoid the use of maintenance oral steroids, according to recent study results.
Using a steroid-avoiding “rituxilup” protocol, researchers in London reported the outcomes of 50 patients (median age, 45 years; 39 women) with active lupus nephritis who received two doses of rituximab (1 g) and methylprednisolone (500 mg) on days 1 and 15 and maintenance treatment of mycophenolate mofetil. Patients on maintenance steroids or with life-threatening systemic lupus erythematosus (SLE) or those who required dialysis were excluded from the study.
Serum creatinine no greater than 15% above baseline defined renal remission. Complete remission (CR) was defined as a urine protein-to-creatinine ratio (PCR) of less than 50 mg/mmol. Partial remission (PR) occurred if PCR was less than 300 mg/mmol but non-nephrotic and more than a 50% reduction from baseline.
Of 49 evaluable patients, 45 achieved CR or PR at a median of 37 weeks. Thirty-six patients reached CR (median time, 36 weeks) while persistent PR was achieved by nine others (median, 32 weeks). CR was achieved by 26 patients and PR by 17 patients by week 52.
At a median of 65.1 weeks from remission, 11 patients experienced 12 relapses. Six patients had systemic flares, most mild. Two of the 45 responders required more than 2 weeks of oral steroids.
Nine patients required inpatient care after an adverse event, and two patients died.
“Our data suggest that the use of the rituxilup regimen … namely rituximab, in conjunction with two relatively low doses of methylprednisolone, combined with maintenance mycophenolate mofetil, allows effective treatment of class III or IV or V lupus nephritis without the use of oral steroids,” researcher Liz Lightstone, PhD, FRCP, reader and honorary consultant physician, Imperial College London, told Healio.com. “This is a step change in the approach to treatment and now needs to be ratified as effective by being subjected to clinical trial.”
Disclosure: See the full study for a complete list of relevant financial disclosures.