Evaluation of oral rebamipide as a potential therapy for Sjögren syndrome-related dry eye and mouth

Abstract

Background: Efficacy and safety of orally administered rebamipide was assessed in treating dry eye disease (DED) and xerostomia in Sjögren syndrome (SS) patients. Methods: Patients of SS with bilateral DED and xerostomia were offered a choice between either oral rebamipide (100 mg BID) with topical 0.5% carboxymethylcellulose (CMC) (R + CMC group) or CMC alone (CMC group), for 3 months, in a quasi-experimental study. Outcome measures were tear-film break-up time (TBUT) and xerostomia symptoms (XS), Schirmer's test (ST), Lissamine green staining grade (LGSG) and goblet cell density (GCD), Saxon salivary secretion test (SSST), and Ocular Surface Disease Index (OSDI). Results: Twenty patients were enrolled in each group. Those who preferred oral rebamipide had worse ST (P = 0.04), LGSG (P = 0.04), SSST (P = 0.006), and GCD (P = 0.009). At 1, 2, and 3 months, the mean increase in TBUT were, respectively, 3.4, 2.9, and 3.45 s in R + CMC, higher than CMC (P < 0.001). Improvement in ST was significantly higher in R + CMC (from 6.75 ± 0.43 to 12.6 ± 1.23 mm) than CMC (P < 0.001). The improvement in OSDI, LGSG, and XS was higher in R + CMC group (all P < 0.001), while that in SSTT (P = 0.6) and GCD (P = 0.7) was similar. No serious adverse events were seen. Conclusion: The dry eye and mouth showed improvement with oral rebamipide, proving its dual therapeutic action in SS.