About 4 out of 10 patients already within 2 years of the diagnosis of systemic lupus erythematosus (SLE) suffer from kidney complications related to the disease, but they realize it when it is too late because the kidney suffers in silence. No symptoms or signs of the disease that comes to light with a urine test. For these patients, precision medicine is available in Italy: belimumab, a monoclonal antibody developed by Gsk, whose clinical data show a high profile of efficacy and safety and which the specialist can use based on the characteristics and needs of the patient. Belimumab, with this new indication – reads a note from GSK – is confirmed as a real revolution in the treatment of SLE: in addition to being the first drug to become available for this pathology after 50 years of substantial absence of specific therapies for lupus, today it also represents the first monoclonal that can be administered in case of lupus nephritis.
It is the progenitor of a new class of drugs, the BLyS-specific inhibitors – recalls the company – It is administered via slow intravenous infusion or subcutaneous formulation and is produced throughout the world in the Gsk plant in Parma, a world center of excellence for production of antivirals and monoclonal antibodies, which also produces sotrovimab for the treatment of Sars-CoV-2 disease. The new indication for treatment with belimumab for lupus nephritis – details the note – stems from a series of studies and in particular from the results of the Bliss-Ln study (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis). The clinical trial, the longest and largest Phase III study in active lupus nephritis, involved 448 adult patients and showed that, over 2 years, belimumab added to standard therapy increased rates of positive renal response to therapies and helped prevent worsening of kidney disease in patients with active lupus nephritis compared with standard care alone.
“Lupus glomerulonephritis is the most widespread and serious form of renal involvement of the disease, present in over 40% of patients – says Stefano Bianchi, president of the Italian Society of Nephrology (Sin) – In half of them it can have serious consequences and be the cause of renal insufficiency, with possible evolution towards dialysis or even transplantation. Recognizing this condition as soon as possible is essential to arrive at targeted nephroprotective treatments, in the interest of the patient”. As if that weren’t enough, it must be said that this condition is often silent from a subjective point of view and therefore must always be sought, right from the moment of diagnosis of SLE. “For this reason it is necessary that rheumatologist and nephrologist – underlines Gian Domenico Sebastiani, president of the Italian Society of Rheumatology (SIR) – manage the patient with SLE together and that this taking charge takes place as far as possible in centers of excellence, which follow numerous patients and they have the experience and knowledge to better manage treatment opportunities and access to innovation, represented by drugs such as belimumab”.
“Belimumab, with the indication for lupus nephritis, represents today an important novelty for patients – declares Barbara Grassi, medical director of GSK – Offering answers to the unmet needs of patients, as occurs for kidney disease linked to SLE, is the primary goal of our research. Belimumab has demonstrated in real life how important it can be to ensure targeted and early treatment for this disease in order to prevent or slow organ damage. We will continue to strive to offer innovative responses to patients, with a opening for the future in the area of nephrology, where there are important unmet demands from patients and their families”.
The availability of a drug specifically designed for patients with lupus nephritis, which has already demonstrated a valid safety and tolerability profile in its use for SLE – the note underlines – represents an important step forward for both specialists and patients. And it can prove to be an important opportunity for those suffering from the disease and their caregivers.
“The availability of biological drugs for the treatment of lupus and in particular for lupus nephritis makes multidisciplinary management and care for patients even more fundamental – concludes Rosa Pelissero, president of the Les Group – who have the right to early treatment of the pathology and a precise diagnosis of the involvement of the organism in order to then be able to have the most appropriate treatment.This is a fundamental request that lupus patients and their families make to health and scientific institutions: treatment in centers of excellence, where rheumatologist and nephrologist work together and with other specialists, it represents the most effective way for optimal management of the disease”.
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