Anvisa approves therapy for moderate to severe forms of Systemic Lupus Erythematosus (SLE), a disease that affects between 150,000 and 300,000 people in Brazil
The National Health Surveillance Agency (Anvisa) approved last Monday (5th), Saphnelo® (antifrolumab), which is a novel drug for the treatment of adult patients with moderate to severe, autoantibody-positive Systemic Lupus Erythematosus (SLE) in addition to standard therapy.
Of inflammatory, autoimmune and chronic origin, it is estimated that it affects between 150 and 300 thousand patients in Brazil.1.
Namely, lupus occurs when the patient’s immune system attacks their organs and tissues. There is no cure, but the symptoms can be controlledtwo.
Already approved in the United States and Europe, the drug has proven safety and efficacy based on a clinical development program that includes two phase III studies (TULIP-1 and TULIP-2) disclosed in the New England Journal of Medicine and not The Lancet Rheumatologyand a phase II study (MUSE).
In these studies, it was observed that a greater number of patients treated with Sapnelo® (anifrolumab) therefore had a significant reduction in overall disease activity in different organ systems, including skin, joints, and haematological response, in addition to achieving a sustained reduction through Week 52 in corticosteroid use when compared to placebo, with both groups receiving standard therapy2-5.
What is the new treatment available for Systemic Lupus Erythematosus (SLE)
The therapy is a monoclonal antibody capable of blocking proteins of the Interferon type I group (IFN-1).
This mechanism of action is unprecedented, and this is the first regulatory approval of a biological treatment in years for the treatment of SLE.
IFN-1 therefore plays a key role in the pathophysiology of lupus – increased rates of IFN-1 signaling are associated with high rates of disease activity and severity.2.5.
More than 50% of patients with SLE develop permanent organ damage from the disease or its treatment, which worsens symptoms and increases the risk of death.6.
“Aware of the unmet needs of patients, we sought an innovation that could improve their quality of life in living with the disease. For this, it is important to reduce the activity of the disease as well as the use of high doses of corticosteroids”, says the medical director of AstraZeneca Brasil, Dr. Marina Belhaus. “There is an expectation from the medical profession for a new therapeutic option to treat SLE”, she adds.
Lupus can manifest heterogeneously.
Among the most common manifestations are skin lesions, joint pain and swelling, organ damage, weight loss, loss of appetite, weakness and hypertension.
Although there are records of disease manifestations at different ages, it is more frequent between 20 and 45 years old, and most of them are women.
Of unknown origin, lupus has genetic, hormonal and socio-environmental factors involved.6.
The most common adverse reactions that occurred with patients taking this drug in the three clinical studies included upper respiratory tract infection, bronchitis, infusion-related reactions, cough and herpes zoster1.7.
1. The landscape of systemic lupus erythematosus in Brazil: An expert panel review and recommendations, Jul/2021
2. Product Package Insert. Saphnelo® (anifrolumab): ANVISA.
3. Morand E, et al. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020;382(3):211-221.
4. Furie R, et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomized, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208-e219.
5. Furie R, et al. Anifrolumab, an Anti–Interferon-α Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus.
6. Brazilian Society of Rheumatology. Systemic Lupus Erythematosus (SLE). Available in: Link. Access 08/22/2022.
7. Morand E, et al. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020;382(3):211-221.
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