Treatment of Psoriasis with Folic Acid Antagonists

Edmundson, Walter F.

doi:10.1001/archderm.1958.01560080060010

Cited by 137 publications

(57 citation statements)

References 2 publications

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“…53 MTX remains the most widely used systemic agent for the treatment of psoriasis since its introduction 40 years ago and is a logical first choice of systemic agent, because it is the most costeffective systemic psoriasis agent with the longest safety follow-up data. 143 In studies of oral MTX given at doses of 15 to 20 mg weekly for patients with moderate to severe plaque psoriasis, approximately 50% to 60% of patients achieved a PASI-75 response whereas up to 30% experienced adverse effects, including gastrointestinal side effects, hepatotoxicity, bonemarrow suppression, acute pneumonitis, and pulmonary fibrosis that necessitated discontinuation of therapy. 144 The coadministration of folic acid is important to help ameliorate the hematologic and hepatic side effects of MTX.…”

Section: J Am Acad Dermatolmentioning

confidence: 99%

Guidelines of care for the management of psoriasis and psoriatic arthritis

Menter

Korman

Elmets

et al. 2011

Journal of the American Academy of Dermatology

395

123

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Section: J Am Acad Dermatolmentioning

confidence: 99%

Guidelines of care for the management of psoriasis and psoriatic arthritis

Menter

Korman

Elmets

et al. 2011

Journal of the American Academy of Dermatology

395

123

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“…In contrast to the world-wide clinical experience with MTX, it has been used for the treatment of psoriasis for over 50 years (Edmundson 1958, Smith 2000, the evidence for its efficacy in psoriasis is limited.…”

Section: Introductionmentioning

confidence: 99%

An intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis (METOP): a 52 week, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Warren

Mrowietz

Kiedrowski³

et al. 2017

The Lancet

102

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Background: We report the study of an intensified dosing schedule of subcutaneous methotrexate (MTX) in patients with moderate-tosevere psoriasis. Methods: In this prospective, double-blind, multicentre phase 3 study (METOP) eligible patients were 18 years or older with a diagnosis of chronic plaque psoriasis at least 6 months before baseline, had a psoriasis area and severity index (PASI) of 10 or more or 10% or greater body-surface area involvement or a dermatology life quality index (DLQI) of 10 or more and were naïve to treatment with MTX. Participants were randomly assigned 3:1 by computer-generated random sequence integrated in the electronic data capture system to receive either MTX at a starting dose of 17.5 mg/week or placebo for the first 16 weeks, followed by openlabel MTX treatment of all patients up to 52 weeks (MTX/MTX and PLC/MTX groups, respectively). Dose escalation to 22.5 mg/week was allowed after 8 weeks of MTX therapy if patients failed to achieve an at least 50% improvement of their baseline PASI (PASI50); blinding was maintained by a corresponding volume increase of placebo injections. Treatment was combined with folic acid 5 mg/week. The primary efficacy endpoint was the proportion of patients achieving a PASI75 response at week 16 analysed by intention to treat with non-responder imputation. This study is registered with the European Medicines Agency, EudraCT number 2012-002716-10. Findings: Between February 2013 and May 2015 120 patients were randomly assigned to receive subcutaneous MTX (n=91) or placebo (n=29). The primary endpoint was met; the PASI75 response rate at week 16 was 41% (n=37) in the MTX group compared to 10% (n=3) in the placebo group [p=0.0026; effect size 30.3% (95% CI 15.3-45.3) MTX vs placebo]. Subcutaneous MTX was generally well tolerated; no cases of serious infections, malignancies, major adverse cardiovascular events or deaths were noted. Serious adverse events were observed in 3 patients started on MTX during the 52-week study period. Interpretation: The study documents a favourable 52-week benefit-risk profile of subcutaneous MTX in psoriasis. The route of administration and the intensified dosing schedule should be considered when using MTX in patients with psoriasis. Role of the funding source (see also below)The study was an investigator-initiated trial supported by a grant from Medac to K.R. Manuscript 2 SummaryBackground: We report the study of an intensified dosing schedule of subcutaneous methotrexate (MTX) in patients with moderate-to-severe psoriasis.

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“…All rights reserved. L. Puig treatment of psoriasis was published in 1958, 1 and the first guidelines on its use in dermatology appeared in 1972. 2 Until quite recently, however, there was relatively little evidence to support the use of MTX in the treatment of psoriasis.…”

Section: Introductionmentioning

confidence: 99%

Methotrexate: New Therapeutic Approaches

Puig

2014

Actas Dermo-Sifiliográficas (English Edition)

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Although the first study on the efficacy of methotrexate in the treatment of psoriasis was reported in 1958, scientific evidence for this indication has been scant until quite recently. We now have new data on the pharmacokinetics and mechanism of action of methotrexate and new subcutaneous formulations that have improved the bioavailability, efficacy, and ease of administration of the drug. The results of recent clinical trials comparing methotrexate with several biologic agents have shown it to be the first-line therapy among the classic systemic treatments for psoriasis. Moreover, the incremental cost-effectiveness ratio for subcutaneous methotrexate has been shown to be superior to that of ciclosporin, adalimumab, and infliximab. Metotrexato: novedades terapéuticasResumen Pese a que el primer estudio sobre la eficacia de metotrexato en el tratamiento de la psoriasis se remonta a 1958, hasta no hace mucho ha sido escasa la evidencia científica disponible sobre su uso en esta indicación.Disponemos de nuevos datos acerca de la farmacocinética y el mecanismo de acción del metotrexato, así como de nuevas presentaciones por vía subcutánea que mejoran la biodisponibilidad, la eficacia y la conveniencia de la administración de este fármaco. La reciente publicación de ensayos clínicos comparativos con diversos biológicos permite considerar al metotrexato como el estándar terapéutico dentro de los tratamientos sistémicos clásicos de la psoriasis, con un cociente coste-eficacia incremental favorable al metotrexato subcutáneo si se compara con ciclosporina, adalimumab o infliximab.

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Treatment of Psoriasis with Folic Acid Antagonists

Cited by 137 publications

References 2 publications

Guidelines of care for the management of psoriasis and psoriatic arthritis

Guidelines of care for the management of psoriasis and psoriatic arthritis

An intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis (METOP): a 52 week, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Methotrexate: New Therapeutic Approaches

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