Comparison Between Oral Methotrexate and Tofacitinib in the Treatment Of Chronic Plaque Psoriasis
Main Article Content
Abstract
Background: Chronic plaque psoriasis is a systemic immune-mediated inflammatory disease requiring effective systemic therapy in patients with moderate-to-severe disease or inadequate response to topical treatment. Methotrexate remains widely used because of affordability and availability, while tofacitinib offers targeted oral Janus kinase inhibition with potential efficacy in plaque psoriasis. Objective: To compare the efficacy and short-term safety of oral tofacitinib and oral methotrexate in patients with chronic plaque psoriasis. Methods: This randomized controlled trial was conducted at the Department of Dermatology, Lahore General Hospital, Lahore, from February 2025 to June 2025. Seventy-five patients aged 18–70 years with chronic plaque psoriasis of at least 6 months’ duration, PASI score ≥10 or body surface area involvement ≥10%, and inadequate response to topical therapy were included. Group A received oral tofacitinib 5 mg twice daily, while Group B received oral methotrexate once weekly, starting at 10 mg and titrated according to response and tolerance. Patients were followed for 12 weeks. The primary outcome was PASI-75 achievement at week 12. Results: Tofacitinib was given to 38 patients and methotrexate to 37 patients. Mean PASI decreased from 18.6 ± 4.4 to 4.9 ± 3.1 with tofacitinib and from 18.2 ± 4.6 to 6.7 ± 3.7 with methotrexate. Mean percentage PASI reduction was higher with tofacitinib than methotrexate. PASI-75 was achieved by 23 patients (60.5%) receiving tofacitinib and 16 patients (43.2%) receiving methotrexate. Any adverse event occurred in 10 patients (26.3%) in the tofacitinib group and 12 patients (32.4%) in the methotrexate group. Conclusion: Both oral tofacitinib and methotrexate improved PASI score over 12 weeks. Tofacitinib produced greater mean PASI reduction and numerically higher PASI-75 response, although categorical response superiority was not statistically confirmed. Both drugs were generally tolerated during short-term follow-up.
Article Details
Issue
Section

This work is licensed under a Creative Commons Attribution 4.0 International License.
How to Cite
References
1. World Health Organization. Global report on psoriasis. Geneva: World Health Organization; 2016.
2. Armstrong AW, Read C. Pathophysiology, clinical presentation, and treatment of psoriasis: a review. JAMA. 2020;323(19):1945–60.
3. Greb JE, Goldminz AM, Elder JT, Lebwohl MG, Gladman DD, Wu JJ, et al. Psoriasis. Nat Rev Dis Primers. 2016;2:16082.
4. Rendon A, Schäkel K. Psoriasis pathogenesis and treatment. Int J Mol Sci. 2019;20(6):1475.
5. Menter A, Gelfand JM, Connor C, Armstrong AW, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445–86.
6. Raaby L, Zachariae C, Østensen M, Heickendorff L, Thielsen P, Grønbæk H, et al. Methotrexate use and monitoring in patients with psoriasis: a consensus report based on a Danish expert meeting. Acta Derm Venereol. 2017;97(4):426–32.
7. Zhang JZ, Tsai TF, Lee MG, Zheng M, Wang G, Jin H, et al. The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: a phase 3, randomized, double-blind, placebo-controlled study. J Dermatol Sci. 2017;88(1):36–45.
8. Valenzuela F, Korman NJ, Bissonnette R, Bakos N, Tsai TF, Harper MK, et al. Tofacitinib in patients with moderate-to-severe chronic plaque psoriasis: long-term safety and efficacy in an open-label extension study. Br J Dermatol. 2018;179(4):853–62.
9. Papp KA, Menter MA, Abe M, Elewski B, Feldman SR, Gottlieb AB, et al. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015;173(4):949–61.
10. Abe M, Nishigori C, Torii H, Ihn H, Ito K, Nagaoka M, et al. Tofacitinib for the treatment of moderate to severe chronic plaque psoriasis in Japanese patients: subgroup analyses from a randomized, placebo-controlled phase 3 trial. J Dermatol. 2017;44(11):1228–37.
11. Bissonnette R, Iversen L, Sofen H, Griffiths CEM, Foley P, Romiti R, et al. Tofacitinib withdrawal and retreatment in moderate-to-severe chronic plaque psoriasis: a randomized controlled trial. Br J Dermatol. 2015;172(5):1395–406.
12. Khondker L. Efficacy and safety of tofacitinib vs methotrexate in patients with moderate to severe plaque psoriasis. J Enam Med Coll. 2021;11(2):108–19.
13. Dogra S, Krishna V, Kanwar AJ. Efficacy and safety of systemic methotrexate in two fixed doses of 10 mg or 25 mg orally once weekly in adult patients with severe plaque-type psoriasis: a prospective, randomized, double-blind, dose-ranging study. Clin Exp Dermatol. 2012;37(7):729–34.
14. Saurat JH, Stingl G, Dubertret L, Papp K, Langley RG, Ortonne JP, et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab versus methotrexate versus placebo in patients with psoriasis. Br J Dermatol. 2008;158(3):558–66.
15. Tournier A, Beauchet A, Fite C, Dupin N, Paul C, Lahfa M, et al. Methotrexate efficacy and tolerance in plaque psoriasis: a prospective real-life multicentre study. Ann Dermatol Venereol. 2019;146(8-9):575–82.
16. Khawaja AR, Bokhari SM, Tariq R, Waqas A, Zaman R, Fatima N, et al. Disease severity, quality of life, and psychiatric morbidity in patients with psoriasis with reference to sociodemographic, lifestyle, and clinical variables. Indian J Dermatol. 2015;60(6):595–602.
17. Fredriksson T, Pettersson U. Severe psoriasis: oral therapy with a new retinoid. Dermatologica. 1978;157(4):238–44.
18. Bożek A, Reich A. The reliability of three psoriasis assessment tools: psoriasis area and severity index, body surface area and physician global assessment. Adv Clin Exp Med. 2017;26(5):851–6.
19. Agarwal P, Sahu S. Determination of hand and palm area as a ratio of body surface area in Indian population. Indian J Plast Surg. 2010;43(1):49–53.
20. Bachelez H, van de Kerkhof PCM, Strohal R, Kubanov A, Valenzuela F, Lee JH, et al. Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomized non-inferiority trial. Lancet. 2015;386(9993):552–61.
21. Papp KA, Menter MA, Abe M, Elewski B, Feldman SR, Gottlieb AB, et al. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of moderate-to-severe chronic plaque psoriasis: long-term efficacy and safety. J Am Acad Dermatol. 2016;74(5):841–50.
22. Tian F, Chen Z, Xu T. Efficacy and safety of tofacitinib for the treatment of chronic plaque psoriasis: a systematic review and meta-analysis. J Int Med Res. 2019;47(6):2342–50.
23. Menting SP, Dekker PM, Limpens J, Hooft L, Spuls PI. Methotrexate dosing regimen for plaque-type psoriasis: a systematic review of the use of test-dose, start-dose, dosing scheme, dose adjustments, maximum dose and folic acid supplementation. Acta Derm Venereol. 2016;96(1):23–8.
24. Heydendael VMR, Spuls PI, Opmeer BC, de Borgie CAJM, Reitsma JB, Goldschmidt WFM, et al. Methotrexate versus cyclosporine in moderate-to-severe chronic plaque psoriasis. N Engl J Med. 2003;349(7):658–65.
25. Tareen A, Asghar S, Rajar UDM, Khan HY, Bhatti D, Asad M. Efficacy of methotrexate in the treatment of plaque psoriasis in a local population. J Pak Assoc Dermatol. 2023;33(3):997–1003.