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Main project information

Project Team

The Academic Medical Centre of the University of Amsterdam

(prof. R. Gyulai, drs. A. van Huizen, prof. L. Iversen, dr. S. Menting, dr. M. Middelkamp, prof. P. Spuls and prof. R. Warren)

The Academic Medical Centre of the University of Amsterdam, with SPIN's support, is realising two projects about methotrexate's dosing : one on psoriasis and one on atopic dermatitis.

SPIN MTX dosing consensus survey in Psoriasis

You can find below the summary about MTX dosing in Psoriasis.

Context & Objectives

Context : The effectiveness and safety of methotrexate (MTX) in chronic plaque psoriasis is acknowledged in international guidelines and studies from around the world. Since this drug has been used for years, there is a large amount of experience. MTX was FDA approved before dose ranging studies were performed, and a clear dose regimen is lacking. Starting doses for example, are in practice varying from 5 – 22.5 mg/week (see also Gyulai et al. 2015, JEADV, Current practice of methotrexate use for psoriasis: results of a worldwide survey among dermatologist and Menting et al. 2016, Acta Derm Venereol, A Systematic Review of the Use of Test-dose, Start-dose, Dosing Scheme, Dose Adjustments, Maximum Dose and Folic Acid Supplementation). The current variability in prescribed treatment regimens might contribute to discontinuation of treatment with MTX due to ineffectiveness or adverse events. MTX is available worldwide and is relatively affordable. Therefore, optimizing MTX therapy with a more uniform dosing regimen may have a huge impact on the global improvement of chronic plaque psoriasis therapy and beyond.

Objectives : The aim of this eDelphi study is to achieve international consensus on various statements on MTX dosing regimens for psoriasis, and to provide initial recommendations on the dosing regimen in daily practice. Furthermore, the aim of the study is to formulate future research topics.

Method

The investigators send out an eDelphi survey with proposals involving the dosing regimen of MTX in patients with psoriasis we would like to reach consensus on. The proposals are drafted by the working group (prof. R. Gyulai, drs. A. van Huizen, prof. L. Iversen, dr. S. Menting, dr. M. Middelkamp, prof. P. Spuls and prof. R. Warren) and based on a systematic review of the literature and guidelines. The survey will run over three rounds.

In the first round of the survey, comments and proposals for consensus can be added by the participants, preferably supported by evidence or references (e.g. RCT’s, national guidelines, treatment goals). If no consensus is met on certain proposals, the working group will adjust them according to the most frequently send comments by the participants. In the second round, participants are able to view the distribution of the scores per proposal of the first round.

All participants will vote on every proposal using a 9 point scale where 1-3 is disagree, 4-6 neither agree nor disagree and 7-9 agree. For participants who feel unable to fill in a 1-9 score, the option ‘unable to score’ can be selected. Consensus is defined as less than 15% scores 1 to 3 (disagree) in the survey. For the conference meeting if no consensus is reached, consensus is defined as less than 30% scores 1 to 3 (disagree).


Status as of April 2021

For Psoriasis we sent out three survey rounds and achieved consensus on 17 out of 22 proposals. We will discuss the further steps of the five remaining proposals of dosing regimen with the working group.

Outcome

N/A yet.

SPIN MTX dosing consensus survey in Atopic Dermatitis (AD)

You can find below the summary about MTX dosing in Atopic Dermatitis.

Context & Objectives

Context : Methotrexate (MTX) has been shown to be a safe and effective off-label treatment for atopic dermatitis (AD) and is acknowledged as such in international guidelines. However, the use of MTX may carry a risk of severe side-effects, including gastro-intestinal disorders, pulmonary fibrosis and hepatotoxicity. In order to optimize the treatment of AD, it is helpful to obtain a good balance between MTX tolerance and effectiveness. Because the safety and effectiveness of medication is often dose-dependent, it is therefore important to prescribe an informed dosage. It is currently impossible to make scientifically sound choices between the different MTX dosing regimens, due to lack of high level evidence. When prescribing off-label, it is even more important to base your choice on the most comprehensive evidence. With knowledge of the optimal dosing regimen, patients will be treated more effectively and have a lower risk of side effects. Because the drug is very affordable and is widely available around the world, optimization of use can improve care in many patients.

Objectives : The aim of this eDelphi study is to achieve international consensus on various statements on MTX dosing regimens for AD, and to provide initial recommendations on the dosing regimen in daily practice. Furthermore, the aim of the study is to formulate future research topics.

Method

The investigators send out an eDelphi survey with proposals for the dosing of MTX in patients with AD we would like to reach consensus on. The proposals are drafted by the working group (dr. H. Brandling-Bennett, A. Caron, BSc, dr. A. Drucker, prof. C. Flohr, dr. L. Gerbens, drs. A. van Huizen, prof. A. Irvine, dr. M. Middelkamp-Hup, drs. A. Musters, prof. K. Peris, prof. P. Spuls, dr. C. Vestergaard) and based on a systematic review of the literature and guidelines. The survey will run over three rounds.

In the first round of the survey, comments and proposals for consensus can be added by the participants, preferably supported by evidence or references (e.g. RCT’s, national guidelines, treatment goals). If no consensus is met on certain proposals, the working group will adjust the proposals according to the most frequently send comments by the participants. In the second round, participants are able to view the distribution of the scores per proposal of the first round.

All participants will vote on every proposal using a 9 point scale where 1-3 is disagree, 4-6 neither agree nor disagree and 7-9 agree. For participants who feel unable to fill in a 1-9 score, the option ‘unable to score’ can be selected. Consensus is defined as at least 70% of the participants scoring a proposal as “agree” (score 7 to 9) and less than 15% scoring it as “disagree” (score 1 to 3).

Status as of April 2021

For Atopic Dermatitis we are planning to send out the first eDelphi survey round in May/June 2021.

Outcome

N/A yet