Topical Rapamycin vs Betamethasone Dipropionate Ointment for Treating Oral Erosive Lichen Planus
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- In this placebo-controlled trial, 75 patients with oral erosive lichen planus (OELP) were randomized to receive either rapamycin 1 mg/mL solution or betamethasone 0.05% ointment twice daily for 3 months. At 3 months, clinical remission rates were lower with rapamycin than betamethasone (27.3% vs 39.4%; P = .30), as was reduction in minimal pain rates (51.6% vs 87.9%; P = .003). Overall, 55.6% of rapamycin patients experienced burning versus 7.7% of betamethasone patients, (P = .003). Rapamycin was systemically detected in 15/25 tested patients (60%) with levels above that of the immunosuppressive threshold in 2/25 (8%).
- Rapamycin, an mTOR inhibitor, has been reported to effectively treat OELP in prior case series, prompting this clinical trial. However, its efficacy was inferior to that of high-potency topical corticosteroids, it was found systemically in 60% of patients, and 8% of patients had levels surpassing those associated with an immunosuppressive threshold. High-potency topical corticosteroids remain the first-line treatment of OELP.
BACKGROUND
Although superpotent topical corticosteroids are the first-line treatment for oral erosive lichen planus (OELP), topical rapamycin was found efficient in a previous case series.
OBJECTIVES
To compare the efficacy and safety of topical rapamycin and betamethasone dipropionate ointment for OELP in a randomized, double-blind trial.
METHODS
Patients were randomized to receive treatment with betamethasone dipropionate ointment 0.05% in Orabase® or topical rapamycin solution (1 mg/mL) on lesions twice daily for 3 months, followed by 3 months of observation. The primary outcome was clinical remission after 3 months of treatment. Secondary outcomes were clinical remission after 1 and 2 months, reduced oral pain and reduced impact on food intake after 3 months, clinical recurrence after treatment withdrawal, and adverse events.
RESULTS
During a 4-year period, 76 patients were randomized and 75 received treatment (rapamycin, n = 39; betamethasone, n = 36). At 3 months, 39.4% of patients with betamethasone and 27.3% with rapamycin showed clinical remission (odds ratio 0.68, 95% CI [0.24; 1.89]; P = 0.46). Rates of remission after 1 and 2 months, reduction in pain and impact on food intake after 3 months, were higher with betamethasone than rapamycin. Recurrence of oral erosions was similar between groups. Adverse events occurred in 43.6% of patients with rapamycin (mostly burning sensation, impaired taste) and 27.8% with betamethasone (mostly oral candidiasis).
CONCLUSION
Although the study was limited by insufficient recruitment, we did not find any superiority of topical rapamycin over betamethasone dipropionate ointment for OELP. Given the rapid remission and pain improvement in the betamethasone group, it appears that superpotent topical corticosteroids should remain the first-line treatment for OELP.
Topical Rapamycin Versus Betamethasone Dipropionate Ointment for Treating Oral Erosive Lichen Planus: A Randomized, Double-Blind, Controlled Study
J Eur Acad Dermatol Venereol 2020 Mar 03;[EPub Ahead of Print], M Samimi, A Le Gouge, F Boralevi, T Passeron, F Pascal, P Bernard, S Agbo-Godeau, S Leducq, JC Fricain, L Vaillant, C FrancèsSkin Care Physicians of Costa Rica
Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574
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