Methotrexate for Psoriasis in Weekly Oral Doses Without Any Adjunctive Therapy

Nyfors, A; Brodthagen, H

doi:10.1159/000252574

Cited by 40 publications

(33 citation statements)

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“…During recent years the therapeutic armamentarium has been considerably increased, in particular after the introduction of MTX and later photochemotherapy. Several studies have shown that from 60 to 70% of psoriasis patients present improvement when treated with MTX [8,15], and that complete clearing is obtained by photochemotherapy in 95 to 98% of patients [12,19], It is a common feature of the more recent methods of treatment that possible late side-effects cannot be predicted yet. Therefore, it would be desirable to augment therapeutic possibilities.…”

Section: Discussionmentioning

confidence: 99%

Treatment of Psoriasis vulgaris with a New Retinoic Acid Derivative Ro 10-9359

Dahl¹,

Møllenbach²,

Reymann³

1977

Dermatology

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The retinoic acid derivative Ro 10-9359, given orally in maximum daily doses of 100 mg to 15 patients with psoriasis vulgaris, led to clearing of the lesions in 8 patients. The average period of treatment was 9 weeks. In 14 patients side-effects were observed, the most important being palmo-plantar desquamation, shivering, thirst and diffuse hair loss. In 2 patients scaling led to withdrawal. In 6 patients abnormal alkaline phosphatase and glutamic-aspartatic transaminase values, partly transient, developed (glutamic-aspartatic transaminase, p < 0.01).

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Section: Discussionmentioning

confidence: 99%

Treatment of Psoriasis vulgaris with a New Retinoic Acid Derivative Ro 10-9359

Dahl¹,

Møllenbach²,

Reymann³

1977

Dermatology

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“…Yet some authors have reported that these side effects can occur independently of the dose or length of therapy [351,355,357,358]. In general the risk of liver fibrosis or cirrhosis occurring with a cumulative dosage of 1 -1.5 g is very low.…”

Section: Undesirable Drug Interactions / Safetymentioning

confidence: 99%

S3 – Guidelines on the treatment of psoriasis vulgaris Update 2011

Nast

Boehncke

Mrowietz

et al. 2011

J Deutsche Derma Gesell

155

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“…31 patients and a lesion reduction of at least 50% in 1/5, i.e. 10 of 50 MTX treated patients (Nyfors 1970). Another small study showed an improvement of skin lesions of at least 75% in 77% of 25 MTX treated patients (Weinstein 1971).…”

Section: Introductionmentioning

confidence: 98%

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

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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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Methotrexate for Psoriasis in Weekly Oral Doses Without Any Adjunctive Therapy

Cited by 40 publications

References 0 publications

Treatment of Psoriasis vulgaris with a New Retinoic Acid Derivative Ro 10-9359

Treatment of Psoriasis vulgaris with a New Retinoic Acid Derivative Ro 10-9359

S3 – Guidelines on the treatment of psoriasis vulgaris Update 2011

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

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