PURPOSE: Lifitegrast ophthalmic solution, 5.0%, is an anti-inflammatory agent indicated for treatment of the signs and symptoms of dry eye disease (DED). This post hoc analysis used phase 3 pivotal data to evaluate patterns of response to treatment with lifitegrast in patients with DED.

METHODS: This was an exploratory analysis of data from two 12-week, randomized, placebo-controlled clinical trials: OPUS-2 (NCT01743729) and OPUS-3 (NCT02284516). Cluster analysis was performed using pooled data (lifitegrast treatment arm) to identify homogenous populations of patient response types based on percent change from baseline in eye dryness score (EDS; as evaluated on a VAS 0-100 scale) at Days 14, 42, and 84. Patients with Sjögren’s syndrome or incomplete data were excluded from the analysis.

RESULTS: The analysis population included 638 patients who received lifitegrast. Mean (SD) age was 58.4 (14.1) years; most patients were female (77.4%) and White (80.1%). In the overall analysis population, mean (SD) EDS score at baseline was 69.4 (16.9). The cluster analysis identified 5 patterns of response to lifitegrast. The 5 patient subgroups were (1) early sustained responders with at least 60% EDS reduction at all time points (n=113; 17.7%); (2) steady responders with at least 20%, at least 40%, and at least 60% reduction at Days 14, 42, and 85 (n=113; 17.7%); (3) Day 84 response of at least 60% (n=127; 19.9%); (4) Day 84 response of 30% to 60% (n=119; 18.7%); and (5) Day 84 response of less than 30% (n=166; 26.0%). There were significant differences in mean symptom scores across the 5 patient subgroups (P<0.001), with numerically lower mean symptom scores for eye pain burning stinging foreign body sensation and photophobia at days 14 42 and 84 in the patients demonstrating an early sustained response.>

CONCLUSION: After 12 weeks of treatment with lifitegrast, most patients (353 of 638, 55.3%) had at least 60% reduction in their EDS. The group with rapid and sustained EDS reductions by week 2 tended to have lower symptom scores than the other subgroups across the treatment period, suggesting that early treatment may be beneficial for maximal response. Further studies to corroborate these findings are warranted.