Belimumab available in Spain for active lupus nephritis
The Ministry of Health, through the Interministerial Commission on Drug Prices, has approved the financing in Spain of belimumabregistered by GSK under the name Benlysta, as a treatment for active lupus nephritis. This is a new indication that will benefit patients living with systemic lupus erythematosus (SLE) who develop this complication. According to national data, around 30% of people suffer from active lupus nephritis and 40% according to global data.
Thus, it is estimated that up to 10% of patients with lupus nephritis (LN) treated with standard therapy develop end-stage kidney disease. This figure reaches 20% globally. This complication can lead to the need for dialysis or a kidney transplant. Therefore, it is necessary to modify the course of the disease in time to control the consequences in the short and long term.
It is estimated that up to 10% of patients with lupus nephritis (LN) treated with standard therapy develop ESRD.
The arrival of belimumab for LN patients in Spain comes after the European Medicines Agency (EMA) authorized it in April 2021. The EMA was based on the results of the Bliss-NL study and unmet medical needs of this patient population. This is a phase III trial designed to evaluate the safety and efficacy of IV belimumab in adults with active lupus nephritis. “The most outstanding result of the study is that adding belimumab to standard lupus nephritis induction treatment provides an improvement in therapeutic efficacy, in terms of a significantly greater renal response”, explained the researcher in charge of the Rheumatology and Immune-mediated Diseases Group of the Galicia Sur Health Research Institute, the Dr. José María Pego.
“Therefore, indicating belimumab after diagnosis would imply better outcomes for the patient. at least in a medium term of two years. Everything suggests that the association of belimumab to the initial treatment should translate into a better long-term prognosis”, added the expert.
For her part, the main researcher of the Lupus Unit of the Vall d’Hebrón Hospital in Barcelona, the Dr. Josefina Corteshas highlighted that the new therapeutic option could also act on other complications of lupus. “Due to its mechanism of action, belimumab could modulate the course of the disease, mainly by preventing the number of renal flares, renal damage, and simultaneously acting on non-renal manifestations of SLE.“, has said.
According to Dr. Ávila, the multidisciplinary approach to patients with LN is essential to be able to carry out a global management that avoids duplication in treatment.
This is an added advantage. In other words, conventional treatment has unsatisfactory remission rates, and an initial ‘multitarget’ treatment will bring more benefits in the long term. Given the different affections that patients with lupus present, which affect various organs and systems of the organism, the doctor of the Nephrology service of the Doctor Peset Hospital in Valencia, Anna Avila, has asserted that the multidisciplinary approach in these patients is essential to be able to carry out global management that avoids duplication in treatment, which can occur when each specialist focuses on their field in isolation.
“Given the evident lack of therapies in lupus, even greater in lupus nephritis, which constitutes a clear unmet need, the arrival of drugs that show positive results in clinical trials is great news”has settled Dr. Pego.