Use of Lifitegrast may reduce reliance on Artificial Tears in dry eye disease

Over the counter (OTC) artificial tears (ATs) are considered the first-line treatment in patients with DED. Due to the easy accessibility and immediate symptomatic relief provided by ATs, most patients initially self-manage their DED. As their symptoms become more pronounced, patients become more reliant on use of ATs. Even though OTC ATs can provide temporary symptomatic relief, they do not address the underlying disease mechanisms and provide negligible impact on disease intervention.

Disrupting the vicious cycle of inflammation on the ocular surface is hypothesized to be important in managing DED and preventing its progression. Besides ATs, current treatments include topical ophthalmic corticosteroids, which have been shown to rapidly improve both signs and symptoms in patients with DED, together with immunomodulators and non-steroidal anti-inflammatory drugs. However, frequent use of corticosteroids has safety concerns.

Lifitegrast 5.0% is a small molecule integrin competitive antagonist that inhibits T-cell–mediated inflammation by blocking lymphocyte function-associated antigen 1/intercellular adhesion molecule-1 binding, resulting in a decreased ocular inflammatory cycle.

The efficacy and safety of lifitegrast 5.0% in improving the signs and symptoms of DED is well established in clinical trials. The long-term safety of lifitegrast in patients with DED was demonstrated in SONATA (Safety Of a 5.0% coNcentrATion of lifitegrAst ophthalmic solution).

The aim of this report by Nichols et al was to evaluate whether treatment with lifitegrast can provide sustained symptomatic relief such that patients become less reliant on the overall use and frequency of ATs. Patient data from SONATA and the RWE chart review study have been analyzed separately.

Two independent analyses were performed using the data from the 1-year, randomized, multicenter, Phase 3 SONATA trial and a noninterventional, real-world evidence (RWE) study conducted in patients with DED who were treated with lifitegrast in the United States and Canada. In SONATA, patients who had used ATs in the lifitegrast and placebo groups were included. The RWE study reviewed patients' electronic medical records, prescribing patterns, and practices of physicians throughout the survey. These data were then used to compare the proportion of patients using ATs in the 6-month pre-index period versus the 12-month post-index period

Of 293 patients (lifitegrast, n=195; placebo, n=98) from SONATA, 107 (lifitegrast, n=64; placebo, n=43) used ATs during the on-therapy period while 186 (lifitegrast, n=131; placebo, n=55) did not. Of those not using ATs, the proportion of patients in the lifitegrast group at any time was higher (~67%) versus placebo (~56% ); this was the case at all study time-points (Days 90, 180, 270, and 360).

The RWE study included 600 patient charts (US, n=550; Canada, n=50); 75.5% (n=453) reported AT use. There was ~40% decrease in the proportion of patients using ATs as adjunct DED therapy to lifitegrast in the post-index period (n=273) versus those in the pre-index period (n=453).

The results from the SONATA and RWE chart review studies showed a consistent decreased use of OTC ATs as a rescue therapy following lifitegrast treatment in patients with DED. In the SONATA trial, a higher proportion of patients reported not using ATs in the lifitegrast group compared with placebo (67.2% vs 56.1%) during the 1-year period.22 In the RWE chart review study, the proportion of patients using ATs was reported to be 40.2% lower during the 12-month postindex period following lifitegrast treatment compared with the pre-index period.

In the SONATA trial, the proportion of patients using ATs gradually decreased from Day 270–360 in those who were treated with lifitegrast; patients on placebo showed no decline. These data show that lifitegrast, apart from addressing the inflammation, also provides sustained relief of symptoms, which can help to reduce the reliance/dependence on ATs for temporary short-term symptomatic relief.

In the RWE chart review study, there was a reduction in the proportion of patients who were using lid hygiene and topical corticosteroids. Following lifitegrast treatment, the proportion of patients using lid hygiene was reduced by 43.8%compared with the pre-index period. This is important since lid hygiene has been considered the first-line therapy in patients with meibomian gland dysfunction and blepharitis. Lid hygiene is inconvenient and time-consuming, hence, a decline in its usage may also help reduce treatment burden in patients with DED. Moreover, there was an ~80% reduction in the use of topical corticosteroids in the post-index period compared with pre-index, reducing the risk of adverse events (AEs) from steroids.

Frequent use of ATs may indicate inadequate symptom control. For temporary relief from ocular discomfort while working in front of a screen, wearing contact lenses, or travelling, the use of ATs is convenient and more easily accessible compared with prescription therapy, and should continue to have a key role in management. However, ATs cannot be considered as the only resolutive treatment since they do not address the underlying inflammation.

Findings from this short analysis suggest that following treatment with lifitegrast in patients with DED there is a gradual reduction in the use of ATs, indicating improved symptomatic relief and hence, a reduction in the dependency of ATs.

Source: Nichols et al; Clinical Ophthalmology 2022:16

https://doi.org/10.2147/OPTH.S347496