Effect of lifitegrast on eye dryness scores and inferior corneal staining scores in patients with moderate to severe dry eye disease: an ad hoc analysis of the OPUS-2 and OPUS-3 clinical trials
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First Author: E.Donnenfeld USA
Co Author(s): R. Piccolo D. Hubatsch S. Barabino
Lifitegrast ophthalmic solution 5.0% is a novel, potent, selective anti-inflammatory small molecule antagonist of lymphocyte function associated antigen-1 developed to reduce inflammation in dry eye disease (DED). Results from the OPUS-2 and OPUS-3 trials proved that lifitegrast improves signs and symptoms in DED patients compared to placebo. Here, an ad hoc analysis was performed to further determine the effect of lifitegrast on eye dryness scores (EDS) and inferior corneal staining scores (ICSS), by stratifying patients based on their severity of DED.
Published data from OPUS-2/-3 showed the benefit of lifitegrast in patients with DED. An ad hoc analysis was performed on the pooled OPUS-2/-3 patient population to identify a subgroup that would have a clinically meaningful improvement in signs (ICSS), in symptoms (EDS), and in both ICSS and EDS simultaneously.
The cohort of patients in the OPUS-2/-3 trials were defined by a history of artificial tears use, EDS ≥40, ICSS ≥0.5, and total corneal staining score (TCSS) ≥2. Randomization was based on the patients’ signs and symptoms captured as ICSS (≤1.5/>1.5) and EDS (<60/≥60), respectively. For the responder analysis, the patients were analyzed according to the 4 subgroups defined by these stratifications: ICSS ≤1.5/EDS <60; ICSS ≤1.5/EDS ≥60; ICSS >1.5/EDS <60; and ICSS >1.5/EDS ≥60 (latter representing moderate-to-severe DED).
1429 patients (lifitegrast/placebo, 713/716) were included in this pooled subgroup analysis. Patients across subgroups showed improvement in signs and symptoms with lifitegrast vs. placebo (ICSS ≤1.5/EDS <60: 14.3% vs. 18.6%, OR: 0.73 [95% CI: 0.23, 2.32], P=0.5915; ICSS ≤1.5/EDS ≥60: 22.2% vs. 11.3%, OR: 2.24 [95% CI: 0.84, 6.02], P=0.1021; ICSS >1.5/EDS <60: 36.4% vs. 30.4%, OR: 1.31 [95% CI: 0.87, 1.97], P=0.1999); however, the greatest improvement was seen in the moderate-to-severe DED (ICSS >1.5/EDS ≥60) subgroup, where 41.6% of patients showed improvement in signs and symptoms with lifitegrast vs. 27.5% with placebo (OR: 1.88 [95% CI: 1.40, 2.53]; P<0.0001).
This ad hoc subgroup analysis from the OPUS-2/-3 trials concluded that the subpopulation of patients with a greater severity of DED signs (ICSS >1.5) and symptoms (EDS ≥60) demonstrated a more pronounced treatment effect with lifitegrast. Patients who received greatest benefit from lifitegrast were those with moderate-to-severe DED (ICSS >1.5 and EDS ≥60), where artificial tears use had not been sufficient.
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