Systemic sclerosis (SSc) is a rare autoimmune disease that causes atypical growth of connective tissues and can affect the musculoskeletal system, heart, lungs, kidneys, skin, and other organs. Interstitial lung disease (ILD) is the leading cause of death in SSc, affecting as many as half of people living with the disease.1,2
With limited treatment options available for SSc-ILD, this Orphan Drug Designation reflects the need for further research and the potential for belimumab to address a critical need for people living with this debilitating condition. GSK continues to follow the science to explore how belimumab may be able to address an unmet need in B-cell-driven autoimmune diseases.
The
Benlysta (belimumab) is a B-lymphocyte stimulator (BLyS) specific inhibitor that binds to soluble BLyS, which is found to be increased in patients with systemic autoimmune diseases like systemic lupus erythematosus (SLE) and lupus nephritis (LN).3 A fully human monoclonal antibody, Benlysta inhibits the prolonged survival of B cells induced by increased BLyS, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. The
Please see the US Prescribing Information for BENLYSTA. About SSc-ILD
Research indicates that elevated BLyS and autoreactive B cells play a central role in the pathogenesis of SSc, a rare autoimmune disease affecting 2.3-10 people per million.4,5 SSc is characterised by microvascular damage, dysregulation of immunity and progressive fibrosis in multiple organs.2,6 ILD is a common and serious complication, marked by inflammation and scar tissue build-up in the lungs. ILD is observed in as many as half of SSc patients and is a significant contributor to patients' disease burden and mortality.1 There is a recognised need for additional effective, well-tolerated, disease-modifying treatment options for SSc-ILD.2 About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company. Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2021, GSK's Q4 Results for 2022 and any impacts of the COVID-19 pandemic. References
1 Vonk MC, Smith V, Sfikakis PP, Cutolo M, Del
2 Fischer A, Patel NM, Volkmann ER. Interstitial Lung Disease in Systemic Sclerosis: Focus on Early Detection and Intervention. Open Access Rheumatol. 2019
3 Parodis I, Zickert A, Sundelin B, et alEvaluation of B lymphocyte stimulator and a proliferation inducing ligand as candidate biomarkers in lupus nephritis based on clinical and histopathological outcome following induction therapy Lupus Science & Medicine 2015;2:e000061. doi: 10.1136/lupus-2014-000061. 4 Thoreau, B., Chaigne, B., & Mouthon, L. (2022). Role of B-Cell in the Pathogenesis of Systemic Sclerosis. Frontiers in immunology, 13, 933468. https://doi.org/10.3389/fimmu.2022.933468.
5 Ghosh, S. K., Bandyopadhyay, D., Saha, I., & Barua, J. K. (2012). Mucocutaneous and demographic features of systemic sclerosis: a profile of 46 patients from eastern
6 Truchetet ME, Brembilla NC, Chizzolini C. Current Concepts on the Pathogenesis of Systemic Sclerosis. Clin Rev Allergy Immunol. 2021
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