Randomized Trial Comparing Efficacy of Adalimumab, Anakinra and Tocilizumab in Non-infectious Refractory Uveitis

Summary

RUBI, is the first prospective randomized, head to head study, comparing Adalimumab to either anakinra, or tocilizumab in refractory Non Infectious Uveitis (NIU). There is no firm evidence or randomized controlled trials directly addressing the best biologic agent in severe and refractory NIU. NIU can cause devastating visual loss and up to 20% of legal blindness. Corticosteroids and immunosuppressants failed to demonstrate sustainable remission over 70 % of refractory/relapsing severe uveitis. The incidence of blindness in NIU has been dramatically reduced in the recent years with the use of biologics, raising the question of whether these compounds should be used earlier in the treatment of severe non infectious uveitis. Contrasting with immunosuppressors, biotherapies act rapidly and are highly effective in steroid's sparing thus preventing occurrence of cataract and/or glaucoma. Despite a strong rationale, these compounds are not yet approved in uveitis, which guarantees the innovative nature of this study that aims selecting or dropping any arm when evidence of efficacy already exists.

Timeline

Start

2017-06-29

Primary completion

2021-10-29

Completion

2022-01-29

Publications

• Saadoun D, Ghembaza A, Touhami S, Girszyn N, Bielefeld P, Seve P, Pugnet G, Andre M, Leclercq M, Rogier T, Ribeiro E, Hie M, Clavel G, Abad S, Stanescu-Segall D, Toutee A, Gueudry J, Bron A, Kodjikian L, Soler V, Chiambaretta F, Sene T, Titah SMC, Heron E, Moulana A, Trad S, Terrada C, Massamba N, Raked N, Resche-Rigon M, Domont F, Desbois AC, Maalouf G, Vautier M, Cacoub P, Desseaux K, Vieira M, Biard L, Bodaghi B. Adalimumab, Anakinra, and Tocilizumab in Patients With Noninfectious Uveitis: A Multicenter Randomized Controlled Trial. Am J Ophthalmol. 2026 May;285:202-212. doi: 10.1016/j.ajo.2026.01.037. Epub 2026 Feb 3.

Drugs

Indications