Targeting T Cell–Mediated Inflammation: Clinical Benefits of Lifitegrast in Improving Symptoms and Signs of Dry Eye Disease

Objective To investigate the specific therapeutic effect of lifitegrast on symptoms and signs of dry eye disease (DED) patients, as well as to examine its treatment‐emergent adverse effects (TEAEs). Methods We conducted a systematic literature search in PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases from inception to August 2020. The inclusion criteria were RCTs or non‐RCTs involving DED patients treated with lifitegrast. The outcomes were eye dryness score (EDS), inferior corneal staining score (ICSS), and frequency of TEAEs. The pooled effect sizes were estimated by a random‐effects model or fixed‐effects model according to the heterogeneity results, which were calculated by the Q test and I 2 statistic. Subgroup analysis and the Galbraith plot were also performed to explore the origin of heterogeneity. Sensitivity analysis was conducted with leave‐one‐out analysis. Publication bias was assessed by funnel plots and Egger’s test if possible. Result Ten studies involving 2, 847 DED patients were included. Compared to placebo and thermal pulsation procedure (TPP), lifitegrast decreased EDS (standardized mean difference, SDM = −0.30; CI, −0.44 to 0.25; p < 0.00001) and ICSS (SDM = −0.23; CI, −0.39 to 0.07; p = 0.005) significantly in DED patients. The overall frequency of TEAEs was approximately 40.7% (CI, 30%–52.5%), and the majority of the TEAEs were mild. Sensitivity analysis indicated the robustness of the results. Publication bias was assessed only for the frequency of TEAEs due to the limited number of included studies and showed no significant bias. Conclusions Our meta‐analysis indicates that lifitegrast improves the symptoms and signs of DED compared to placebo and TPP by inhibiting the binding of LFA‐1 and ICAM‐1. Therefore, lifitegrast is more likely to be effective in patients with inflammatory etiologies. In addition, most TEAEs of lifitegrast are mild, and the frequency of TEAEs is much lower within 12 weeks and similar to that of cyclosporine, while higher than that of artificial tears.