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Spain approves funding for belimumab for active lupus nephritis

The Ministry of Health, through the Interministerial Commission on Drug Prices, has approved the financing in Spain of belimumab (Benlysta) as a treatment for active lupus nephritis. 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”, assures José María Pego, researcher in charge of the Rheumatology and Immune-mediated Diseases Group of the Galicia Sur Health Research Institute.

This incorporation is a new indication that, as detailed GSK, will benefit patients living with Systemic Lupus Erythematosus (SLE) who develop this complication —about 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.

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, points out that “The multidisciplinary approach in these patients is essential to be able to carry out a global management that avoids duplication in treatment.which can happen when each specialist focuses on their field in isolation”.

Belimumab will benefit patients living with Systemic Lupus Erythematosus who develop this complication

For this reason, for Ávila, the inclusion of belimumab entails “an increase in the therapeutic options available to these patients from the beginning of the treatment of the disease”, which allows progress in the objective of “preventing patients from having nephritis active lupus, prevent it from progressing and, ultimately, avoid kidney failure and the need for dialysis or kidney transplant”.

Based on this reflection, the experts indicate that “it is necessary to modify the course of the disease in time to control the short and long term consequences“.

Better therapeutic efficacy

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 Pego, the most outstanding result of this study “is that adding belimumab 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, this researcher explains that “indicating belimumab 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 belimumab to the initial treatment should result in a better long-term prognosis”.

“Adding belimumab 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

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 acting simultaneously on the non-renal manifestations of SLE”, concludes Cortes.


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