Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus

Summary

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.

Timeline

Start

2025-10-10

Primary completion

2027-01-01

Completion

2027-06-01

Publications

• Results Sandhu S, Klein BA, Al-Hadlaq M, Chirravur P, Bajonaid A, Xu Y, Intini R, Hussein M, Vacharotayangul P, Sroussi H, Treister N, Sonis S. Oral lichen planus: comparative efficacy and treatment costs-a systematic review. BMC Oral Health. 2022 May 6;22(1):161. doi: 10.1186/s12903-022-02168-4.
• Results Kulkarni S, Durham H, Glover L, Ather O, Phillips V, Nemes S, Cousens L, Blomgran P, Ambery P. Metabolic adverse events associated with systemic corticosteroid therapy-a systematic review and meta-analysis. BMJ Open. 2022 Dec 22;12(12):e061476. doi: 10.1136/bmjopen-2022-061476.
• Results Rotaru D, Chisnoiu R, Picos AM, Picos A, Chisnoiu A. Treatment trends in oral lichen planus and oral lichenoid lesions (Review). Exp Ther Med. 2020 Dec;20(6):198. doi: 10.3892/etm.2020.9328. Epub 2020 Oct 14.
• Results Qing M, Yang D, Shang Q, Peng J, Deng J, Lu J, Li J, Dan H, Zhou Y, Xu H, Chen Q. CD8+ tissue-resident memory T cells induce oral lichen planus erosion via cytokine network. Elife. 2023 Aug 9;12:e83981. doi: 10.7554/eLife.83981.
• Results Alrashdan MS, Cirillo N, McCullough M. Oral lichen planus: a literature review and update. Arch Dermatol Res. 2016 Oct;308(8):539-51. doi: 10.1007/s00403-016-1667-2. Epub 2016 Jun 27.
• Results Katta R. Lichen planus. Am Fam Physician. 2000 Jun 1;61(11):3319-24, 3327-8.

Drugs

Indications