Title: Voclosporin with immunosuppressive therapies for treating lupus nephritis [ID3962]
Funder: Department of Health and Social Care

Abstract: Systemic lupus erythematosus (SLE) is a chronic autoimmune condition that causes inflammation in the body's tissues. The manifestations of SLE vary greatly between people and can affect the whole body including the skin, joints, internal organs and serous membranes. _x000D_ _x000D_ In some people with SLE, the body’s immune system targets kidney cells, particularly the filtering units called glomeruli, resulting in inflammation. This complication is called lupus nephritis. Lupus nephritis is divided into classes (I to VI), based on glomerular pathology, following a kidney biopsy[1]. Common signs and symptoms of lupus nephritis include blood or foam in urine, swelling in extremities, and high blood pressure. Untreated lupus nephritis can permanently damage kidney structures[2]. People with lupus nephritis are at increased risk of developing end-stage renal disease[3], which will need dialysis or kidney transplantation[4]. Lupus nephritis has an increased mortality risk compared with SLE without lupus nephritis[3]._x000D_ _x000D_ There are currently around 60,000 people with SLE in England and Wales and around 3,000 people are diagnosed with SLE each year[5]. Around 40% to 60% of people with SLE develop lupus nephritis[6],[7]. Compared with people who are described as white, the prevalence of lupus nephritis is around 4, 18 and 19 times higher, respectively, among those with Indo-Asian, Afro-Caribbean and Chinese family backgrounds[8]. Lupus nephritis is also more prevalent in women than in men[8]._x000D_ _x000D_ There is no cure for lupus nephritis. The aim of current treatments for lupus nephritis is to preserve renal function, prevent disease flares, improve quality of life, and improve survival[6]. Recommended initial treatment is mycophenolate with corticosteroids or cyclophosphamide with corticosteroids[6]. A calcineurin inhibitor (especially tacrolimus) can be added to mycophenolate plus corticosteroids, particularly in people with nephrotic-range proteinuria[6]. If the disease responds to initial treatment, maintenance treatment with mycophenolate or azathioprine in combination with corticosteroids is recommended[6]. Rituximab may be considered for treating people whose disease is relapsed or refractory to other treatments[6]_x000D_ _x000D_ References_x000D_ 1 Weening, J.J et al. (2004) The Classification of Glomerulonephritis in Systemic Lupus Erythematosus Revisited. J Am Soc Nephrol 15:241-250_x000D_ 2 Lupus Foundation of America. What is lupus nephritis? Accessed March 2022._x000D_ 3 Hanly J G, O’Keefe, A G, Su L, Urowitz M R, Romero-Diaz J (2016) The frequency and outcome of lupus nephritis: results from an international inception cohort study. Rheumatology 55:252-262._x000D_ 4 Bertsias GK, Tektonidou M, Amoura Z, Aringer M, Bajema I, Berden JHM, et al. (2012) Joint European League Against Rheumatism and European Renal Association–European Dialysis and Transplant Association (EULAR/ERA-EDTA) recommendations for the management of adult and paediatric lupus nephritis. Annals of the Rheumatic Diseases 71(11):1771._x000D_ 5 Rees F, Doherty M, Grainge M et al. (2016) The incidence and prevalence of systemic lupus erythematosus in the UK, 1999-2012. Ann Rheum Dis 75:13641._x000D_ 6 Fanouriakis A, Kostopoulou M, Cheema K et al. (2020) 2019 Update of the Joint European League Against Rheumatism and European Renal Association–European Dialysis and Transplant Association (EULAR/ERA–EDTA) recommendations for the management of lupus nephritis. Annals of the Rheumatic Diseases 79:713-723._x000D_ 7 Saxena R, Mahajan T and Mohan C. (2011). Lupus nephritis: current update. Arthritis research & therapy 13(5):240_x000D_ 8 Patel M, Clarke AM, Bruce IN and Symmons DPM, The prevalence and incidence of biopsy-proven lupus nephritis in the UK: Evidence of an ethnic gradient. Arthritis & Rheumatism 54(9):2963-2969.

Lay abstract: To appraise the clinical and cost effectiveness of voclosporin with immunosuppressive therapies within its marketing authorisation for treating lupus nephritis.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: INFLAMMATORY AND IMMUNE SYSTEM;RENAL AND UROGENITAL