This new protocol is characterised by the use of a very much lower dosage of oral corticoids (prednisone), which to date have been administered in high doses. The results show that the new treatment protocol drawn up by the BioCruces researchers at least equals standard treatment, obtaining an earlier response, at the same time notably reducing the adverse effects linked to glucocorticoids.
As Doctor Guillermo Ruiz-Irastorza, in charge of the Autoimmune Diseases Group at the BioCruces Health Research Institute, explained “lupus nephritis (inflammation of the kidney due to systemic lupus erythematosus) affects 35% to 40% of patients with lupus, an autoimmune disease especially affecting young women; in fact, it is the most serious frequent organ condition. To date, treatment has been based on the combination of immunosuppressant drugs with prednisone in high doses – in general one milligram per kilo of weight per day, i.e. 50 or 60 milligrams daily”.
The doctor pointed out “the great impact of oral glucocorticoids on irreversible organ damage, particularly osteonecrosis (destruction of the bone), fractures due to osteoporosis, cataracts and cardiovascular disease. Nevertheless, the morbidity linked with the use of prednisone has to date been accepted as the inevitable price to pay for achieving remission of the renal disease”.
Equal efficacy in less time and with less toxicity
The BioCruces Autoimmune Diseases Group research compared a group of patients with lupus nephritis from the Autoimmune Diseases Unit at the Internal Medicine Service of the Cruces University Hospital with a second control group made up of past patients treated with high dosages of prednisone and cyclophosphamide, The former who had been treated with prednisone in average dosages (in no case greater than 30 milligrams/day) at a rapidly decreasing rate and combined with pulses of methylprednisolone, cyclophosphamide and hydroxychloroquine.
“With the new protocol a more rapid and longer-lasting response from the patients was observed, with a complete remission of 100% in individuals receiving average doses of prednisone, compared to 70% in those treated with high dosages. It is worth underlining that the difference in the accumulated dosage of prednisone between both groups was 60%”, underlined the researcher.
Also, the BioCruces researchers observed “a significantly lower rate of adverse effects amongst the treated group with lower doses of corticoids, with a total absence amongst these patients of avascular necrosis, osteoporotic fractures and Cushingoid stigmas (such as obesity, ‘moon face’ or stretch marks). Concretely, toxicity attributable to corticoids was detected in 67% of patients treated with the standard protocol (high doses of prednisone), while amongst those treated with average doses of prednisone undesired effects were only observed in 7%”.
Doctor Guillermo Ruiz-Irastorza highlighted that “this treatment regimen with average doses of prednisone is at least equal in effectiveness in the treatment for lupus nephritis to the traditional treatment involving high doses of corticoids. Moreover, the new protocol shows minimum associated toxicity. Thus, this research opens the door to the use of lower dosages of prednisone in the treatment for lupus nephritis and other serious systemic lupus erythematosus disorders”.
Ruiz-Irastorza G., Danza A., Perales I., Villar I., Garcia M, Delgado S., Khamashta M. Prednisone in lupus nephritis: How much is enough? 2014. Autoimmun Rev. Feb;13(2):206-14. doi: 10.1016/j.autrev.2013.10.013