Journal of Clinical and Experimental Ophthalmology
Open Access

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

5^th International Conference on Clinical & Experimental Ophthalmology

August 04-06, 2015 Valencia, Spain

Rola N Hamam

Scientific Tracks Abstracts: J Clin Exp Ophthalmol

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 vialsstored at 4°C and the efficacy and
safety of intravitreal adalimumab (IVA) for treatment of active noninfectious uveitis.
Methods: Adalimumab refrigerated in plasticvials 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 fibrosarcoma 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 noncomparative interventional case series, eyes with active noninfectious 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.

Biography :

Rola N Hamam is an Assistant Professor of Ophthalmology at the American University of Beirut. She is the Director of the residency training program and the medical retina
fellowship training program. She received her BS degree in Biology from the American University of Beirut in 1998 and her MD in 2002. She completed her residency in
Ophthalmology at the same institution then had fellowship training at Harvard University in Boston at the Beetham Eye Institute, the Massachusetts Eye and Ear Infirmary,
and the Massachusetts Eye Research and Surgery Institution with Doctor C Stephen Foster until 2008. She returned to her home country and joined her Alma matter in
2009 to start the first uveitis specialty referral clinic in the country at the American University of Beirut. She is a member of several national and international societies. She
has organized and lectured on ocular immunology and uveitis in many national and international conferences and scientific meetings. She is involved in multiple research
projects on ocular inflammatory and infectious disease and she continues to contribute scientific publications in the field.