The effect of folic acid supplementation on the pharmacokinetics and pharmacodynamics of oral methotrexate during the remission-induction period of treatment for moderate-to-severe plaque psoriasis

Chládek, Jaroslav; Šimková, M; Vaněčková, J.; Hroch, Miloš; Chládková, Jiřina; Martı́nková, Jiřina; Vávrová, Jaroslava; Beránek, M.

doi:10.1007/s00228-007-0442-x

Cited by 65 publications

(65 citation statements)

References 22 publications

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“…Thus, high concentrations of intracellular folates may result in a decrease in MTX polyglutamation (37,38). In patients with psoriasis, use of folic acid 20 mg per week concomitantly with MTX resulted in lower RBC MTXGlu n concentrations compared with those found in patients taking MTX alone, although the difference did not reach statistical significance (39). While we observed a trend toward lower RBC MTXGlu 1 concentrations with higher RBC folate levels, this reached statistical significance in the multivariate analysis only.…”

Section: Discussioncontrasting

confidence: 67%

Determinants of red blood cell methotrexate polyglutamate concentrations in rheumatoid arthritis patients receiving long‐term methotrexate treatment

Stamp¹,

O’Donnell²,

Chapman³

et al. 2009

Arthritis & Rheumatism

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Section: Discussioncontrasting

confidence: 67%

Determinants of red blood cell methotrexate polyglutamate concentrations in rheumatoid arthritis patients receiving long‐term methotrexate treatment

Stamp¹,

O’Donnell²,

Chapman³

et al. 2009

Arthritis & Rheumatism

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“…Combination of folic acid demonstrably reduces this risk. A study in Psoriasis patients showed, that a dose of 20mg folic acid per week tended to decrease the efficacy of MTX (Chládek 2008). However, a study in rheumatoid arthritis showed that, administration of 5mg folic acid per week successfully reduced the hepatotoxicity without loss of efficacy (Morgan 1994).…”

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

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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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“…Apitherapy was available and inexpensive therapy in contrast with other therapeutic agents (23)(24)(25), but bee venom cost $5 only for each patient during the whole period of study. No recurrence of psoriatic lesions was detected during the follow-up observation period (6 months), and this was in agreement with Hegazi et al (10).…”

Section: Discussionmentioning

confidence: 99%

Efficacy of the apitherapy in the treatment of recalcitrant localized plaque psoriasis and evaluation of tumor necrosis factor-alpha (TNF-α) serum level: A double-blind randomized clinical trial

Eltaher

Mohammed

Younes

et al. 2014

Journal of Dermatological Treatment

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The effect of folic acid supplementation on the pharmacokinetics and pharmacodynamics of oral methotrexate during the remission-induction period of treatment for moderate-to-severe plaque psoriasis

Cited by 65 publications

References 22 publications

Determinants of red blood cell methotrexate polyglutamate concentrations in rheumatoid arthritis patients receiving long‐term methotrexate treatment

Determinants of red blood cell methotrexate polyglutamate concentrations in rheumatoid arthritis patients receiving long‐term methotrexate treatment

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

Efficacy of the apitherapy in the treatment of recalcitrant localized plaque psoriasis and evaluation of tumor necrosis factor-alpha (TNF-α) serum level: A double-blind randomized clinical trial

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