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Rola N Hamam, Rachid Istambouli, Ahmad M. Mansour, Maamoun Abdul Fattah, Carl-Joe Mehanna, Julien Torbey, Nasrine Anais El Salloukh, Haytham I. Salti, Souha Allam, Alaa Bou Ghannam; Intravitreal Adalimumab for Noninfectious Uveitis: Clinical Trial Preliminary Data. Invest. Ophthalmol. Vis. Sci. 2019;60(9):3518.
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© ARVO (1962-2015); The Authors (2016-present)
Subcutaneous (SC) Adalimumab is FDA-approved for the treatment of noninfectious intermediate, posterior and panuveitis, but poses the risk for serious systemic side effects. To avoid them, intravitreal (IV) administration of this drug offers an interesting alternative, which has not been sufficiently studied to date. This is an open-label randomized clinical trial that aims to compare the efficacy and safety of IV Adalimumab to that of SC Adalimumab.
13 patients(25 eyes), out of a total target of 32, with active noninfectious posterior or panuveitis have been enrolled and 9 completed the study so far. Patients are equally randomized to receive SC Adalimumab(80 mg at time 0, then 40 mg on week 1, then 40 mg every other week) or IV injections of the drug(1.5 mg/0.03 mL at time 0, on week 2, then every 4 weeks) for 26 weeks. Full ophthalmologic examination and Fluorescein Angiography (FA) are performed, and Central Retinal Thickness (CRT) is determined by Optical Coherence Tomography for all patients at baseline, weekly for the first 2 weeks, then monthly. Each FA is graded according to a standard scoring system. For the current small sample, baseline, mid- and end-study results of the main outcomes are compared using Mann-Whitney and Fischer’s exact test.
The mean Best Corrected Visual Acuity (BCVA) in the IV group (n=8) at baseline, mid- and end-study was not statistically different from that of the SC group (n=10), as well as the mean gain of ETDRS letters(10 vs 12,p=0.7).There was also no statistically significant difference between the 2 groups in the proportion of patients with anterior chamber or vitreous activity, FA scores, or total decrease in CRT and FA scores(Table 1).CRT was higher at baseline in the SC group(370 ± 33) than in the IV group(261±19, p=0.003), but it became comparable in the 2 arms on further follow-up. 1 patient in the SC group developed a urinary tract infection, and 2 patients developed an upper respiratory tract infection. No adverse events where reported in the IV group.
The preliminary results of our study suggest that IV Adalimumab may be as effective as SC Adalimumab in the treatment of noninfectious uveitis, while potentially sparing its systemic side effects.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
Main outcomes (mean±SEM for continuous variables) at baseline, 14 weeks and 26 weeks. ETDRS=Early Treatment Diabetic Retinopathy Study; dBCVA=Total change in BCVA; dCRT=Total change in CRT.
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