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
- PMID: 22830389
- DOI: 10.1111/j.1365-2230.2012.04440.x
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
Abstract
Background: Methotrexate (MTX) is the 'gold-standard' drug for the treatment of severe psoriasis. In the absence of any consensus on an optimum dose of MTX for psoriasis, there is wide variation in prescribing patterns between dermatologists, resulting in variable or delayed therapeutic effects.
Aim: To identify the most effective fixed single weekly dose of oral MTX with acceptable side-effects in the treatment of severe plaque-type psoriasis.
Methods: This was a prospective, randomized, double-blind, parallel-group, dose-ranging study, which enrolled 60 patients of both genders (aged 18-62 years) with severe chronic plaque-type psoriasis. Patients were randomly assigned to one of two groups: group A was treated with MTX 10 mg once weekly, and group B was treated with 25 mg MTX once weekly. The main outcome measure was change in Psoriasis Area and Severity Index (PASI) between the two groups from baseline to 12 weeks.
Results: Of the 60 patients, 51 (85%) completed the 12-week study. At the end of the study, 24 patients (92.3%) in the MTX 25 mg group had achieved a 75% reduction in PASI (PASI 75) from baseline, compared with 18 patients (72%) in the MTX 10 mg group (P>0.05). Mean time in weeks to achieve PASI 75 was significantly shorter in the MTX 25mg group (7.92±1.91) than in the MTX 10mg group (9.47±2.29) (P<0.05). In addition, 20 patients (69%) in the MTX 25mg group achieved 100% reduction in PASI compared with 9 patients (30%) in the MTX 10mg group within 12weeks of the study period (P<0.01). Adverse effects were generally mild, and were noted in 43.1% of the 51 patients who completed the study, with no significant difference in frequency between the two groups, although they were less severe in the 10mg group.
Conclusions: MTX 25mg is an effective dose as monotherapy for the treatment of severe psoriasis, whereas the 10mg dose is slow to act and less effective, but has a less severe side-effect profile.
© The Author(s). CED © 2012 British Association of Dermatologists.
Similar articles
-
Efficacy and safety of infliximab vs. methotrexate in patients with moderate-to-severe plaque psoriasis: results of an open-label, active-controlled, randomized trial (RESTORE1).Br J Dermatol. 2011 Nov;165(5):1109-17. doi: 10.1111/j.1365-2133.2011.10615.x. Br J Dermatol. 2011. PMID: 21910713 Clinical Trial.
-
A pilot study of pharmacokinetically guided dosing of oral methotrexate in the initial phase of psoriasis treatment.J Eur Acad Dermatol Venereol. 2008 Jan;22(1):19-24. doi: 10.1111/j.1468-3083.2007.02264.x. Epub 2007 Nov 19. J Eur Acad Dermatol Venereol. 2008. PMID: 18031504 Clinical Trial.
-
Folic acid supplementation during treatment of psoriasis with methotrexate: a randomized, double-blind, placebo-controlled trial.Br J Dermatol. 2006 Jun;154(6):1169-74. doi: 10.1111/j.1365-2133.2006.07289.x. Br J Dermatol. 2006. PMID: 16704650 Clinical Trial.
-
A retrospective review of methotrexate-induced hepatotoxicity among patients with psoriasis in a tertiary dermatology center in Malaysia.Int J Dermatol. 2013 Jan;52(1):102-5. doi: 10.1111/j.1365-4632.2011.05436.x. Int J Dermatol. 2013. PMID: 23278617 Review.
-
Folate supplementation reduces the side effects of methotrexate therapy for psoriasis.Expert Opin Drug Saf. 2014 Aug;13(8):1015-21. doi: 10.1517/14740338.2014.933805. Epub 2014 Jun 27. Expert Opin Drug Saf. 2014. PMID: 24972718 Review.
Cited by
-
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD011535. doi: 10.1002/14651858.CD011535.pub6. Cochrane Database Syst Rev. 2023. PMID: 37436070 Free PMC article. Review.
-
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.Cochrane Database Syst Rev. 2022 May 23;5(5):CD011535. doi: 10.1002/14651858.CD011535.pub5. Cochrane Database Syst Rev. 2022. Update in: Cochrane Database Syst Rev. 2023 Jul 12;7:CD011535. doi: 10.1002/14651858.CD011535.pub6. PMID: 35603936 Free PMC article. Updated.
-
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.Cochrane Database Syst Rev. 2020 Jan 9;1(1):CD011535. doi: 10.1002/14651858.CD011535.pub3. Cochrane Database Syst Rev. 2020. Update in: Cochrane Database Syst Rev. 2021 Apr 19;4:CD011535. doi: 10.1002/14651858.CD011535.pub4. PMID: 31917873 Free PMC article. Updated.
-
Real-World Experience of Methotrexate in the Treatment of Skin Diseases: an Italian Delphi Consensus.Dermatol Ther (Heidelb). 2023 Jun;13(6):1219-1241. doi: 10.1007/s13555-023-00930-2. Epub 2023 May 21. Dermatol Ther (Heidelb). 2023. PMID: 37210684 Free PMC article.
-
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.Cochrane Database Syst Rev. 2025 Aug 6;8(8):CD011535. doi: 10.1002/14651858.CD011535.pub7. Cochrane Database Syst Rev. 2025. PMID: 40767824
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Medical