In a “game changing” study, UK clinicians have shown that lupus nephritis can be successfully treated without oral steroids by using the immunosuppreant rituximab.
The breakthrough may allow patients with lupus to avoid the significant morbidity and premature mortality associated with long term steroid treatment, the researchers say.
And by avoiding steroids, patients will avoid the cosmetic changes that cause poor adherence to therapy and also forego the onerous monitoring and prophylaxis requiremenrts of steroid treatment, according to the study authors from Imperial College London
In a prospective observational study published in the Annals of Rheumatic Diseases 50 patients with lupus nephritis were treated with two doses of rituximab (1g) and methyl prednisolone (500 mg) on days 1 and 15, and given maintenance treatment of mycophenolate mofetil.
Overall, 72% of patients (36) achieved complete biochemical remission after a median time of 36 weeks. Remission was defined as urine protein : creatinine ratio (PCR)<50 mg/mmol. A further 18% (9) patients achieved persistent partial remission after a median time of 32 weeks.
Eleven patients had relapses after a median time of 65 weeks from remission and six patients had systemic flares. Only two of the 45 patients who responded required more than two weeks of oral steroids.
The study authors said their results showed that a steroid-sparing regimen was well tolerated and the results compared favourably with those achieved by patients treated with steroids.
“This study marks a step change in the approach to the treatment of lups nephritis. For the first time in 60 years, it has suggested that oral steroids can be safely avoided in the treatment of lupus nephritis without apparent reduction in efficacy or increase in relapse rates, at least up to three years of follow-up,” they concluded.
An accompanying editorial said the trial was potentially “game changing” but further studies were needed to address questions such as the renal relapse rate (21% after a median time of 65 weeks).