Adalimumab, Anakinra, and Tocilizumab in Patients With Noninfectious Uveitis: A Multicenter Randomized Controlled Trial.
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Saadoun David, Ghembaza Amine, Touhami Sarah, Girszyn Nicolas, Bielefeld Philip, Seve Pascal, Pugnet Gregory, Andre Marc, Leclercq Mathilde, Rogier Thomas, Ribeiro Emmanuel, Hie Miguel, Clavel Gaelle, Abad Sebastien, Stanescu-Segall Dinu, Toutee Adelaide, Gueudry Julie, Bron Alain, Kodjikian Laurent, Soler Vincent, Chiambaretta Frederic, Sené Thomas, Titah Salah Mohamed Cherif, Héron Emmanuel, Moulana Asma, Trad Salim, Terrada Celine, Massamba Nathalie, Raked Nabil, Resche-Rigon Matthieu, Domont Fanny, Desbois Anne Claire, Maalouf Georgina, Vautier Mathieu, Cacoub Patrice, Desseaux Kristell, Vieira Matheus, Biard Lucie, Bodaghi Bahram
Аннотация
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 end point was a reduction of at least 2 steps on the Miami 9-step scale for vitreous haze with a corticosteroid dose of 0.1 mg/kg/d 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 of 44 (16%) and 7 of 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 in 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/d 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.