To optimize the treatment of Systemic Lupus Erythematosus (SLE), Europe has taken a critically important step: a new, simpler way of administering the drug Saphnelo has been approved.
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease. In SLE, the body’s immune system pathologically attacks its own healthy tissues and organs. This autoimmune process causes a persistent inflammatory reaction, pain, severe fatigue, and damage to multiple organs (e.g., skin, kidneys, joints). Since SLE is currently incurable, the therapeutic goal is primarily to alleviate symptoms and prevent flares.
Saphnelo (active substance: anifrolumab) is a new-generation medication. It controls lupus activity by the selective blockade of the Type I interferon receptor. This receptor plays a crucial role in the pathological overactivation of the immune system characteristic of SLE. By blocking this receptor, anifrolumab reduces the autoimmune response and prevents damage to healthy tissues.
From Infusion to Injection:
Previously, Saphnelo was administered via intravenous infusion, which required a visit to a medical facility once a month and a procedure lasting about 30 minutes. Now, the relevant committee of the European Medicines Agency (EMA), the CHMP, has approved the administration of the medication as a subcutaneous injection. This is a pivotal change because patients are now given the opportunity to receive the drug via a subcutaneous injection, which significantly simplifies the therapy process and increases its accessibility.
This change is primarily based on data from the large-scale, Phase III TULIP-2 clinical trial. The study involved 362 adult participants with active SLE, who were randomly assigned to groups. Over one year, they were prescribed either Saphnelo or a placebo.
The study confirmed the significant efficacy of Saphnelo: a reduction in SLE disease activity was observed in 47.8% of patients treated with the drug, compared to the placebo group (31.5%). Notably, patients were able to reduce their dose of glucocorticoids, and skin manifestations improved. Regarding safety, the most common side effects recorded were upper respiratory tract infections and herpes zoster.
The new method of administering Saphnelo significantly simplifies treatment and increases accessibility by reducing the necessity of visits to infusion centers. This progress directly improves the quality of life for people with lupus, fundamentally changing the approach to disease management.
Source: NEJM
