Evaluation of Glucocorticoids Plus Rituximab in Patients With Newly-Diagnosed or Relapsing IgA Vasculitis

Summary

Systemic vasculitis are inflammatory diseases of the blood vessels, responsible for systemic manifestations. Among the systemic vasculitis affecting small blood vessels, IgA vasculitis (IgAV) is one of the most common forms and mainly affects the skin, joints, kidneys and gastrointestinal tract. Kidney and gastrointestinal damage can be serious, causing complications and life-threatening sequelae, especially in adults. The treatment of adult-onset IgAV is still a matter of debate. Glucocorticoids have been the standard of care for inducing remission for years in severe forms of IgAV. However, not all patients achieve remission and may experience disease flares associated with increased morbidity and mortality. In addition, the cumulative side effects of glucocorticoids are also major causes of long-term adverse events and death.Rituximab (RTX), an anti-CD20 monoclonal antibody, has been shown to be spectacularly effective in inducing remission in d 'other small vascular vessels, in particular ANCA-associated vasculitis and cryoglobulinemic vasculitis, with an acceptable safety profile. Recently, a multicenter observational study suggested that RTX was an effective and safe therapeutic option for treating relapsed and / or refractory adult IgAV. Overall, RTX may be an effective and safe therapeutic approach in adult IgAVs, justifying the need for a prospective randomized controlled trial evaluating Rituximab as an induction of remission for adult IgAV.

Timeline

Start

2022-03-11

Primary completion

2026-01-13

Completion

2026-01-13

Publications

• Results Gardner-Medwin JM, Dolezalova P, Cummins C, Southwood TR. Incidence of Henoch-Schonlein purpura, Kawasaki disease, and rare vasculitides in children of different ethnic origins. Lancet. 2002 Oct 19;360(9341):1197-202. doi: 10.1016/S0140-6736(02)11279-7.
• Results Audemard-Verger A, Terrier B, Dechartres A, Chanal J, Amoura Z, Le Gouellec N, Cacoub P, Jourde-Chiche N, Urbanski G, Augusto JF, Moulis G, Raffray L, Deroux A, Hummel A, Lioger B, Catroux M, Faguer S, Goutte J, Martis N, Maurier F, Riviere E, Sanges S, Baldolli A, Costedoat-Chalumeau N, Roriz M, Puechal X, Andre M, Lavigne C, Bienvenu B, Mekinian A, Zagdoun E, Girard C, Berezne A, Guillevin L, Thervet E, Pillebout E; French Vasculitis Study Group. Characteristics and Management of IgA Vasculitis (Henoch-Schonlein) in Adults: Data From 260 Patients Included in a French Multicenter Retrospective Survey. Arthritis Rheumatol. 2017 Sep;69(9):1862-1870. doi: 10.1002/art.40178.

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Indications