Topical Cyclosporine in Oral Lichen Planus—A Series of 21 Open-Label, Biphasic, Single-Patient Observations

Abstract

Topical cyclosporine (CSA) has been reported as an alternative treatment in steroid-refractory oral lichen planus (OLP), but evidence is limited and conflicting. An N-of-1 trial setting could be appropriate to evaluate interindividual differences in treatment response. We studied a series of 21 open-label, biphasic single-patient observations. Patients (15 women, 6 men) with OLP recalcitrant to topical steroids received four weeks of CSA mouth rinse (200 mg/twice daily) followed by four weeks of drug withdrawal. Pain (visual analogue scale (VAS) score), disease extent (physicians’ global assessment (PGA) score) and quality of life (Dermatology Life Quality Index (DLQI) score,) were assessed at baseline (T0), after four weeks of treatment (T1) and after another four weeks without treatment (T2). Median age was 58 years (interquartile range/IQR = 52–67) and median disease duration was 18 months (IQR = 12–44). Median baseline VAS score decreased significantly at T1 (p = 0.0003) and increased at T2 (p = 0.032) (T0 = 5 (IQR = 3–6.5); T1 = 2 (IQR = 0.5–3.4); T2 = 3 (IQR = 2–4.8)). Similarly, median baseline PGA score decreased significantly at T1 (p = 0.001) and increased at T2 (p = 0.007) (T0 = 2 (IQR = 1.3–2.5); T1 = 1 (IQR = 1–2); T2 = 2 (IQR = 1–2)). Median baseline DLQI score also decreased significantly at T1 (p =.027) but did not change at T2 (p = 0.5) (T0 = 2.5 (IQR = 1–5.8); T1 = 1 (IQR = 0–3); T2 = 1 (IQR = 1–4)). CSA responders (n = 16) had significantly higher median baseline VAS scores (5.2 (IQR = 5–6.5)) than nonresponders (n =5) (2 (IQR = 2–3.5) (p = 0.02). In our study, pain, disease extent and quality of life of patients with OLP improved significantly during therapy with low-dose CSA mouth rinse and exacerbated after drug withdrawal. Remarkably, patients with high initial VAS scores seemed to profit most.

A systematic review of the efficacy and safety of topical cyclosporine in dermatology

“…A case series by Monshi et al, 2021 24 assessed the efficacy of Cyc‐A mouthwash, 100 mg/ml bid, in the treatment of 21 patients with oral lichen planus (OLP) for 4 weeks. Evaluation was performed with measurement tools such as visual analog scales (VAS), physician's global assessment (PGA), and dermatology life quality index (DLQI).…”

An improved scoring system for monitoring oral lichen planus: A preliminary clinical study

“…At present, there was no gold standard for evaluating the improvement of OLP. The REU system and PGA were used as the comparative scales in this study (Monshi et al, 2021, Ormond et al, 2018, 2020). NRS and OHIP‐14 evaluated the severity of the disease from the subjective of the patient (Park et al, 2012).…”

“…Then the physicians will objectively repeat the above operation. During the first visit and 4 follow-up visits, the patients were scored for the REU system, numerical rating scale (NRS) (Chainani-Wu et al, 2008;Williamson & Hoggart, 2005), Oral Health Impact Profile-14 (OHIP-14) (Slade, 1997), physician global assessment (PGA) (Monshi et al, 2021;Ormond et al, 2018Ormond et al, , 2020 at the same time. At present, there was no gold standard for evaluating the improvement of OLP.…”

Prolonged mucosal topical application of cyclosporin A for severe stomatitis of paraneoplastic pemphigus

“…The efficacy of topical CSA has been reported in other bullous diseases and oral lichen planus. 4,5 This case demonstrated that topical CSA application can also be a useful and welltolerable treatment option for PNP stomatitis, although the shrinkage of the underlying lymphoma and R-CHOP may have affected the stomatitis. Further research is needed to clarify the efficacy of CSA topical application for PNP stomatitis.…”