Many of the patients with oral lichen planus (OLP) either fail to achieve complete remission or experience frequent relapses with conventional topical corticosteroid therapy, which is currently the mainstay of treatment. Long-term corticosteroid use is limited by local and systemic adverse effects, and many patients develop steroid resistance or intolerance. To overcome these limitations, combination therapy with agents having complementary mechanisms may improve therapeutic outcomes, reduce steroid requirements, and minimize associated adverse effects. Tofacitinib, a Janus kinase (JAK1/JAK3) inhibitor, modulates the JAK-STAT signaling pathway, thereby reducing inflammatory cytokine production involved in OLP pathogenesis. Preliminary case series and pilot trials have shown promising results with tofacitinib in OLP. However, to date, no randomized controlled trial has evaluated the efficacy and safety of add-on oral tofacitinib with standard topical steroid therapy in OLP. Hence, investigators considered tofacitinib to be a candidate drug for add-on therapy due to its anti-inflammatory and immunomodulatory properties. Adding tofacitinib to ongoing topical triamcinolone therapy may increase the response rate, reduce adverse drug reactions by lowering steroid dose requirements, or achieve a quicker therapeutic effect. Therefore, the present randomized controlled trial has been planned to evaluate the efficacy and safety of oral tofacitinib as an add-on therapy in patients with OLP.
Patients aged ≥18 of either sex with the clinical diagnosis of oral lichen planus.
Patients with a PGA score of ≥3 (moderate and severe oral LP).
Patients who are willing to give informed written consent.
Treatment with a systemic corticosteroid within the last 4 weeks.
Patients on immunosuppressive agents such as azathioprine, cyclosporine, and others within one month of recruitment.
Patients with a clinical history and any lesion distribution suspicious of a lichenoid drug eruption, and patients with other skin diseases.
Past or current history of any malignancy, including moderate to severe dysplasia of the oral mucosa on oral biopsy.
Parallel
Tofacitinib 5 mg BID and Triamcinolone ointment
DrugPatients in the test group will get tofacitinib 5mg capsules twice daily as an add on to triamcinolone ointment
Placebo and Triamcinolone ointment
DrugPatients in the control group will receive identical looking capsules as placebo with triamcinolone ointment
Change in oral mucosal disease severity score from baseline
The change in oral mucosal disease severity score (maximum 106) will be evaluated using oral mucosal disease severity score questionnaire. Each item of the questionnaire yields a score of 0 to 106. A higher score depicts severe disease.
Pain by Pain Visual Analogue Scale (VAS) score
Change in Pain Visual Analogue Scale (VAS) score after treatment with triamcinolone ointment and capsule tofacitinib vs. triamcinolone ointment and capsule placebo at baseline, 4 weeks, and 12 weeks. The VAS consists of a 10 cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Interpretation of the scores:0 = No pain, 2= Mild, 4 = Nagging, 6 = Miserable, 8 = intense, 10 = worst
Severity by Physician global assessment of disease (PGA) Score
Compare the proportion of patients achieving a reduction of Physician Global Assessment of Disease (PGA) score of 0 or a 2-grade reduction (minimum initial PGA 3) after treatment with triamcinolone ointment and capsule tofacitinib vs. triamcinolone ointment and capsule placebo at baseline, 4 weeks, and 12 weeks by using a 6-point disease severity scoring system. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe).
Quality of life by using oral health-related quality of life score (ORAL HEALTH IMPACT PROFILE - 14 )
Change in the oral health-related quality of life from baseline after 4 and 12 weeks. designed to assess patients' perception of the impact of oral disorders on their quality of life (QoL). The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. The domain scores can range from 0 to 8. Higher OHIP-14 scores indicate worse OHRQoL, and lower scores indicate better OHRQol
serum IL 6 level
Change in serum IL-6 after treatment with ointment triamcinolone and capsule tofacitinib vs. ointment triamcinolone and capsule placebo. The levels of salivary and serum IL-6 were significantly higher among patients with OLP than among healthy control participants
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