Article
作者: Sené, Thomas ; Domont, Fanny ; Saadoun, David ; Toutee, Adelaide ; Desbois, Anne Claire ; Chiambaretta, Frederic ; Resche-Rigon, Matthieu ; Biard, Lucie ; Clavel, Gaelle ; Leclercq, Mathilde ; Maalouf, Georgina ; Rogier, Thomas ; Vautier, Mathieu ; Bron, Alain ; Cacoub, Patrice ; Girszyn, Nicolas ; Stanescu-Segall, Dinu ; Hie, Miguel ; Pugnet, Gregory ; Ribeiro, Emmanuel ; Desseaux, Kristell ; Héron, Emmanuel ; Seve, Pascal ; Raked, Nabil ; Andre, Marc ; Vieira, Matheus ; Terrada, Celine ; Bodaghi, Bahram ; Ghembaza, Amine ; Soler, Vincent ; Gueudry, Julie ; Touhami, Sarah ; Moulana, Asma ; Abad, Sebastien ; Trad, Salim ; Bielefeld, Philip ; Titah, Salah Mohamed Cherif ; Kodjikian, Laurent ; Massamba, Nathalie
OBJECTIVE:To evaluate the efficacy and safety of adalimumab, anakinra, and tocilizumab in patients with active and refractory non-infectious uveitis (NIU).
DESIGN:Multicenter, Bayesian, randomized controlled trial.
SUBJECTS:A total of 112 patients with active, noninfectious, nonanterior uveitis across 27 French centers were enrolled.
METHODS:Participants were randomly assigned (1:1:1) to receive either subcutaneous adalimumab (n=44; initial dose 80 mg, followed by 40 mg every other week), anakinra (n=18; 100 mg daily), or tocilizumab (n=50; 162 mg weekly) for a 16-week treatment period.
MAIN OUTCOME MEASURES:The primary endpoint was a reduction of at least two steps on the Miami 9-step scale for vitreous haze with a corticosteroid dose of 0.1 mg/kg/day or less at week 16.
RESULTS:During interim analyses, anakinra was shown to be ineffective, and this arm was stopped prematurely. By week 16, the primary outcome was achieved in 7/44 (16%) and 7/50 (14%) patients in the adalimumab and tocilizumab groups, respectively (mean difference -2.0%; 95% Credible interval, CrI -16.8% to +12.3%). Absence of macular edema and retinal vasculitis was seen in 54% and 56%, and 59% and 57%, respectively (mean differences -2.0% [95% CrI, -14% to +26%] and 2.0% [95% CrI, -31% to +15%]). A prednisone taper to ≤0.1 mg/kg/day at week 16 was reached by 59% and 74% of patients, respectively (mean difference -15%; 95% CrI, -4% to +32%). Mild-to-moderate adverse events occurred in 43% (adalimumab) and 54% (tocilizumab).
CONCLUSIONS:Adalimumab and tocilizumab show comparable efficacy in active, refractory NIU, whereas anakinra was ineffective.
TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02929251.