Systemic lupus erythematosus (SLE) is the most common type of Lupus, which is an autoimmune disease. Autoimmune disorders are not so rare, which are characterized by the immune system attacking own body tissues, affecting the vital organs. SLE can affect brain, lungs and kidneys along with joints, skin and blood vessels. The Lupus Foundation of America describes it as ‘difficult to diagnose, hard to live with, and a challenge to treat’. There have been very few treatment options for SLE that include management with Corticosteroids such as prednisone. The approval of Belimumab in 2011 was a new development in this disease segment. However, the need for a drug that can inhibit type I interferons has been the compelling necessity. Aptly so, AstraZeneca’s Anifrolumab (Saphnelo) has the properties that dampen excessive type I interferons. It is found to be effective in both adults and children. The recent FDA approval of Saphnelo is largely significant for this reason and has been considered as an important milestone in the management of Lupus.
Anifrolumab (Saphnelo) approval backed by clinical research outcomes
The US FDA approval for Saphnelo was based on three clinical trials. The data was evaluated from two TULIP trials and a MUSE trial. The TULIP-1 and TULIP-2 are Phase III trials, whereas the MUSE trial was a Phase II trial. This drug is the first to be approved in ten years for SLE treatment. As per the clinical data, Saphnelo clearly demonstrated reduction in overall disease activity along with reducing the need for oral corticosteroids. As per the company’s press release, the three clinical trials are randomized, double-blinded and placebo controlled trials. The participants had moderate to severe SLE. Patients being treated with the standard of care therapy, indicating the addition of Anifrolumab led to better outcomes. This drug can become a potential treatment option for lupus nephritis, cutaneous lupus erythematosus and myositis in the future. It is now being pursued by AstraZeneca. Saphnelo is also now under review for approval in European Union and Japan.
How can patients with SLE benefit from Saphnelo?
Patients who are diagnosed with Systemic lupus erythematosus have very limited treatment options. The standard care is often limited to symptomatic relief and may not aid in recovery. Moreover, the risk of damage to vital organs like liver, kidney and brain by the autoimmune disease cannot be averted through the standard therapy alone. Apart from that, sustained and excessive usage of corticosteroids is only harmful due to their well-known side effects. Rheumatologists can now recommend Anifrolumab for patients with SLE. It certainly has the promise of reducing the risk of severe organ damage and need for sustained use of corticosteroids. It is packaged as 300mg/2mL single-dose vial. The benefits from standard therapy can be enhanced by adding a new drug with proven clinical outcomes. More data in this area is anticipated and may positively point towards the improvement in disease recovery and quality of life.
