Patients treated with lifitegrast ophthalmic solution 5.0% achieved higher odds of simultaneous improvement in clinical signs and symptoms than placebo-treated patients, according to a study published in JAMA Ophthalmology. This study appears to confirm the drug’s ability to treat moderate to severe dry eye disease (DED).
Researchers conducted a post hoc responder analysis to explore the heterogeneity across different subgroups of DED, and to identify which participants following lifitegrast treatment were most likely to achieve clinically meaningful benefit. The analysis used data from the 12-week phase 3 OPUS-2 and OPUS-3 (clinicaltrials.gov identifier: NCT02284516) studies, which had previously demonstrated the efficacy of lifitegrast in DED.
The researchers stratified pooled data into 4 subgroups based on severity of interior corneal staining score (ICSS; <1.5 vs >1.5) and eye dryness score (EDS; <60 or >60) at baseline. Data were collected from December 2012 to October 2015, and post hoc analysis was performed from April 2020 to July 2021. Intervention included twice-daily lifitegrast or placebo for 84 days.
The main outcome measures included the proportion of participants with clinically meaningful improvement in signs and symptoms, and a composite response for a given sign and symptom endpoint pair at day 84. The researchers defined “clinically meaningful improvement” as at least 30% improvement in symptoms and either at least a 1-point improvement in ICSS or at least a 3-point improvement in total corneal staining score (TCSS). The analysis included 1429 total participants, with 716 in the placebo group and 713 in the lifitegrast group.
The study found that responder and composite responder rates favored lifitegrast vs placebo for the overall pooled population. The subgroup with ICSS of greater than 1.5 and EDS of at least 60 at baseline for the composite analysis demonstrated a 1.70- to 2.11-fold higher odds of achieving clinically meaningful improvement with lifitegrast across all sign and symptom end point pairs (P <.001).
The analysis of data of participants from masked clinical trials was a study strength. Additionally, the reduction threshold for symptoms of 30% or greater as a definition of clinically meaningful response is in line with similar studies as well as regulatory agencies.
The post hoc nature of the analyses and lack of efficacy data beyond 3 months are study limitations. Also, all reported P values were not adjusted for multiplicity, and the researchers recommend future evaluation of the role of other baseline factors, such as type of DED, tear breakup time, and tear osmolarity.
Disclosure: Multiple study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. This study was supported by Novartis Pharma AG. Please see the original reference for a full list of authors’ disclosures.
Holland E, Jackson M, Donnenfeld E, et al. Efficacy of lifitegrast ophthalmic solution, 5.0%, in patients with moderate to severe dry eye disease: a post hoc analysis of 2 randomized clinical trials. JAMA Ophthalmol. Published online October 7, 2021. doi:10.1001/jamaophthalmol.2021.3943