The Ministry of Health, through the Interministerial Commission on Drug Prices, has approved the financing in Spain from Benlysta (belimumab) as a treatment for active lupus nephritis. This is a new indication that, as detailed GSKwill benefit patients living with Systemic Lupus Erythematosus (SLE) who develop this complication —around 30 percent according to national data and 40 percent according to global data—.
Experts estimate that up to 10 percent of patients with lupus nephritis (LN) treated with standard therapy develop end-stage kidney disease (ERT) at the national level, a figure that reaches 20 percent globally. This, they indicate from GSK, can lead to the need to undergo dialysis or a kidney transplant. For this reason, “it is necessary to modify the course of the disease in time to control the consequences in the short and long term,” says the company.
The arrival of this drug in Spanish territory occurs after authorization from the European Medicines Agency (EMA) in April 2021, who based it on the results of the BLISS-LN study And in the unmet medical needs of this patient population.
It is estimated that up to 10% of Spanish patients with lupus nephritis treated with standard therapy develop ERT at the national level
As pointed out by GKS, the study achieved its main objective by demonstrating that “a statistically significant greater number of adult patients with active LN achieved a Major Renal Efficacy Response at two years.”
For José María Pego, researcher in charge of the Rheumatology and Immune-mediated Diseases Group of the Galicia Sur Health Research Institute, he stresses that the most outstanding result of this study “is that adding Benlysta to the standard induction treatment for lupus nephritis provides an improvement in therapeutic efficacy, in terms of a significantly greater renal response”.
For this reason, Pego explains that “indicating Benlysta after the diagnosis of lupus nephritis, in its induction treatment, would imply better patient outcomesat least, in a medium term of two years”.
“Everything suggests -he adds- that the association of Benlysta to the initial treatment should result in a better long-term prognosis”.
“Adding Benlysta to standard lupus nephritis induction treatment provides an improvement in therapeutic efficacy”
Jose Maria Pegoresearcher in charge of the Rheumatology and Immune-mediated Diseases Group of the Galicia Sur Health Research Institute
About other complications of lupus
For her part, Josefina Cortés, principal investigator of the Lupus Unit of the Vall d’Hebrón Hospital in Barcelona, highlights that the new therapeutic option it is an added advantage since “conventional treatment has unsatisfactory rates of remission, and treatment multitargetinitial t will bring more benefits in the long run”. Likewise, Cortés indicates that this therapy could also act on other complications of the lupus.
The study showed that a greater number of adult patients with active LN achieved a Major Renal Efficacy Response at two years
“Because of its mechanism of action, Benlysta could modulate the course of the disease, mainly by preventing the number of renal flares, renal damage and acting simultaneously on the non-renal manifestations of SLE”.
Given the different effects that patients with lupus present, which affect various organs and systems of the body, Ana Ávila, from the Nephrology service of the Doctor Peset Hospital in Valencia, also points out that “the multidisciplinary approach in these patients is essential to be able to perform global management that avoids duplication in treatment, which can occur when each specialist focuses on their field in isolation”. In this line, Pego considers that given the “obvious lack of therapies in lupus, even greater in lupus nephritis, the arrival of drugs that show positive results in clinical trials is great news”.