Abstract
Purpose :
DUPIXENT (dupilumab) is a subcutaneous (SQ) injection for the treatment of uncontrolled moderate-to-severe eczema as well as atopic dermatitis. Atopic Blepharo-Keratoconjunctivitis (ABKC) is a serious allergic eye condition with the potential to impair vision due to prolonged inflammation of the ocular surface. Diagnosing and treating ABKC is clinically challenging owing to the limited therapeutic options. Additionally, ABKC imposes a significant burden on the patient's quality of life. This study investigates the efficacy of dupilumab in the treatment of signs and symptoms of ABKC.
Methods :
A multi-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy, safety, and tolerability study enrolled 20 subjects with ABKC. Subjects were randomized in a 2:1 ratio of dupilumab:placebo. This study consists of seven office visits over a period of approximately 126 days (18 weeks-Phase I), with the option to continue to an additional four visits, open label over a period of approximately 112 days (16 weeks- Extension Phase). Following initial loading dose, future dosing was 300 mg SQ injection. Trained personnel administered the initial injection while the second injection of dupilumab or placebo and all future injections were either self-administered by the patient or administered by a caregiver under the observation of qualified staff. During those 7 office visits for phase I and 4 additional visits for extension phase, subjects were evaluated and had external photos taken and answered symptom related questions. In between visits subjects filled out a paper diary daily at home.
Results :
This is an interim analysis. There have been over 2,500 hundred treatment days, approximately 2/3 drug and 1/3 placebo. No treatment emergent adverse events to date. Significant symptomatic improvement has been seen in participants by the sixth visit, as illustrated in figure 1.
Conclusions :
This interim analysis of dupilumab for the treatment of ABKC as a new indication of treatment. There are no significant safety concerns to date. Some subjects have shown clinically meaningful improvement. Unmasking and the open-label phase of the study are expected in 2024.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.