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.