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. 2023 Nov-Dec;68(6):669-673.
doi: 10.4103/ijd.ijd_551_23. Epub 2024 Jan 9.

Efficacy and Safety of Methotrexate in Psoriasis Vulgaris Long-Term Treatment: A Real-World Observation Study

Dagmar Wilsmann-Theis  1 , Rhena Funk  1 , Rotraut Mössner  2 , Thomas Bieber  1 , Jörg Wenzel  1
Affiliations

Efficacy and Safety of Methotrexate in Psoriasis Vulgaris Long-Term Treatment: A Real-World Observation Study

Dagmar Wilsmann-Theis et al. Indian J Dermatol. 2023 Nov-Dec.

Abstract

Background: Methotrexate (MTX) in the therapy of psoriasis vulgaris (PV) is a well and long-established treatment option.

Aims: To assess the long-term experience of individual patients in the real world with regard to the efficacy and safety of MTX in PV therapy.

Patients and methods: In a retrospective study, MTX as a weekly used monotherapy in PV was examined. Clinical data including the Psoriasis Area Severity Index (PASI), prevalence of psoriatic-arthritis (PsA), Investigator Global Assessment (IGA), laboratory parameters, occurrence of adverse events (AEs), dosing of MTX and characteristics of patients treated for at least 24 months were collected.

Results: A total of 55 patients with 247 patient-years under MTX therapy were included. The mean PASI reduction was 51.2% with a significant (P < 0.001) improvement in the skin condition in the first 6 months of treatment, remaining stable thereafter. The mean MTX dose increased from 11.8 ± 3.7 mg to 12.9 ± 3.8 mg in the first year of therapy, with a constant mean dose in the following years. In 247 patient-years, no serious AE was documented. Gastrointestinal side effects or fatigue were commonly detected. The liver parameter alanine aminotransferase/ glutamate-pyruvate transaminase (ALT/GPT) (baseline 35.8 ± 22.0 U/L) increased after 3 years of therapy (42.0 ± 22.4 U/L; P = 0.013) without clinical significance.

Conclusion: In this patient collective, MTX in low doses was effective and safe in long-term therapy. The improved skin condition was steady and reached by an unvarying dose. New data showed a better efficacy of MTX in higher doses; however, additional data must be collected on the long-term efficacy and safety of MTX with a higher dose regime.

Keywords: Long-term treatment; methotrexate; psoriasis therapy.

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Conflict of interest statement

D. Wilsmann-Theis has been advisor and/or received speakers’ honoraria or travel expense reimbursements and/or received grants and/or participated in clinical trials of the companies AbbVie, Almirall, Amgen, Beiersdorf, Biogen, Boehringer Ingelheim Pharma, Celgene, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Lilly, Medac, Merck Sharp and Dohme Corp., Novartis, Pfizer, UCB Pharma, and VBL. R. Funk has no conflicts of interest to declare. R. Mössner has been an advisor and/or received speakers’ honoraria and/or received grants and/or participated in clinical trials of the following companies: Abbott/Abbvie, Allmirall, Biogen IDEC GmbH, Böhringer-Ingelheim, Bristol Myers Squibb, Celgene, Essex Pharma GmbH, Janssen-Cilag GmbH, Leo Pharma GmbH, Lilly, Merck Serono GmbH, MSD SHARP and DOHME GmbH, Novartis Pharma GmbH, Pfizer GmbH and UCB. T. Bieber has no conflict of interest relevant to this work. J.Wenzel has been an advisor and/or received speakers’ honoraria and/or received grants and/or participated in clinical trials of the following companies: GSK, Novartis, Medac, Merck/Serono, Roche, Actelion, Pfizer, Spirig, ArrayBio, Biogen.

Figures

Figure 1
Figure 1
(a + b): Efficacy of long-term low-dose methotrexate. Error bar chart representing mean ± 1 standard error of PASI (a) and IGA (b) data. The mean dose is shown in Figure 1a in interval timeframes
Figure 2
Figure 2
(a + b): Reasons for discontinuation of MTX therapy and distribution of adverse events. (a)*None >1.4 mg/dL (b) *Other reasons (*thrombocytopaenia, leukopaenia, feared teratogenicity, discontinued by another physician, respiratory complaints); AE = Adverse events; GPT = Glutamate-pyruvate transaminase; GIT = Gastrointestinal
See this image and copyright information in PMC

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