Rola N Hamam
American University of Beirut
Lebanon
Title: The efficacy of adalimumab stored in plastic vials at four degrees celsius and the effect of intravitreal adalimumab on the treatment of active non-infectious ocular inflammation
Biography
Biography: Rola N Hamam
Abstract
Objective: To prove that small amounts of adalimumab may be stored in plastic syringes for intravitreal use in active non infectious uveitis. Also report the favourable results of intravitreal adalimumab for the treatment of active uveitis. Efficacy of adalimumab stored in plastic vials at 4° C and a pilot study on the clinical effect of intravitreal adalimumab on active non infectious uveitis
Purpose: Evaluate the efficacy of adalimumab repackaged into plastic polypropylene vials stored at 4° C and the efficacy and safety of intravitreal adalimumab (IVA) for treatment of active non infectious uveitis.
Methods: Adalimumab refrigerated in plastic vials at 4° C for 5 weeks were used to neutralize the cytotoxic effect of recombinant human tumour necrosis factor alpha (rh-TNF-α) on mouse fibro sarcoma cell line (L929 cells). Cell survival was assessed after treatment with effective dose of rhTNF-α and with the different concentrations of adalimumab (0.1, 1, 10 μg/ml) stored in plastic using RTCA xCELLigence system. The inhibitory response of adalimumab was measured at one hour interval for up to 48 hours at weeks 1 and 5. In a prospective non comparative interventional case series, eyes with active non infectious uveitis were injected with 1.5 mg IVA at 0, 2 then every 4 weeks for total of 6 months. Change in VA, grade of inflammation (cells, haze and leakage on FA) and central retinal thickness (CRT) were recorded.
Results: Adalimumab (1, 10 μg/ml) stored for 5 weeks in plastic vials was able to neutralize the cytotoxic effect of rhTNF-α with 100% L929 cell survival. 7 patients (13 eyes) were treated with IVA. 6 or 7 patients (12 or 13 eyes) completed 6 month treatment. 1 patient (1 eye) failed treatment with worsening VA and inflammation and was taken out of the study at visit 5. Median logMar at baseline was 0.243 (IQR=0.855) it improved to 0.049 (IQR=0.398) at 6 months. 7/12 eyes had improvement of ≥2 ETDRS lines at 6 months. At baseline, 3/13 eyes had AC cells grade ≥1, 10/13 eyes had vit haze grade ≥1. At 6 months, 0/12 eyes had AC grade or vit haze ≥1. Median CRT at baseline was 317 (IQR=199) it improved to 277 (IQR=107.25) at 6 months. At baseline, 8/13 eyes had macular edema 5 of which resolved at 6 months. Median FA score at baseline was 14 (IQR=7.5) it improved to 4 (IQR=4.75) at 6 months. Using Wilcoxon Signed Rank test, the decrease in logMar, CRT and FA score at 6 months compared to baseline was significant (p=0.003, 0.021, 0.002 respectively). No side effects were detected, stratifying the data to include one eye per patient revealed similar results.
Conclusions: Adilamumab stored in plastic vials retained its efficacy after five weeks of storage at 4° C at concentration as low as 1 μg/ml. Furthermore, IVA was safe in this pilot study was effective in improving the VA in 7/12 eyes resolving macular edema in 5/8 eyes and decreasing AC cells, vit haze and FA score in 12 eyes while 1 patient (1 eye) failed treatment.