S3 – Guidelines on the treatment of psoriasis vulgaris Update 2011

Nast, Alexander; Boehncke, Wolf‐Henning; Mrowietz, Ulrich; Ockenfels, Hans-Michael; Philipp, Sandra; Reich, Kristian; Rosenbach, Thomas; Sammain, Adel; Schlaeger, Martin; Sebastian, Michael; Sterry, Wolfram; Streit, Volker; Augustin, Matthias; Erdmann, R.; Klaus, Joachim; Koza, Joachim; Müller, Siegrid; Orzechowski, Hans‐Dieter; Rosumeck, Stefanie; Schmid-Ott, ­Gerhard; Weberschock, Tobias; Rzany, Berthold

doi:10.1111/j.1610-0379.2011.07680.supp.x

Cited by 82 publications

(187 citation statements)

References 245 publications

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“…8,15 The lower direct costs of conventional treatments such as MTX, CSA or fumaric acid esters justify the initial treatment with these agents, although they are less efficacious during the induction period than the biologics infliximab, ustekinumab and adalimumab. The effectiveness of interventions may differ between clinical trials and routine care.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of systemic treatments for moderate‐to‐severe psoriasis: meta‐analysis of randomized controlled trials

et al. 2014

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Section: Discussionmentioning

confidence: 99%

“…15 For articles published thereafter (and all studies on alefacept), we systematically searched Medline, Medline in Process, Embase and the Cochrane Library from 1 January 2009 (from inception for alefacept) to 18 October 2012. An example search strategy for Medline via OvidSP is summarized in File S1 (see Supporting Information).…”

Section: Literature Searchmentioning

confidence: 99%

Efficacy and safety of systemic treatments for moderate‐to‐severe psoriasis: meta‐analysis of randomized controlled trials

et al. 2014

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“…As one of the conventional and comparatively cheap therapy options, methotrexate (MTX) is recommended as first line therapy by the "german guideline on treatment of psoriasis vulgaris" for the (induction) therapy of moderate to severe psoriasis vulgaris in adults (Nast 2011).…”

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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“…salicylic acid oil 2-10 % with triamcinolone acetonide 0.1 % NRF 11.134.) [7,14]. Further examples are listed in Table 4.…”

Section: Psoriasis -Indication For Compounded Formulationsmentioning

confidence: 99%

Magistral formulations and pruritus therapy – What is established, what is confirmed, what is new?

Staubach¹,

Metz

2013

J Deutsche Derma Gesell

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SummaryPruritus is a common symptom encountered by many different specialties. One must clinically differentiate between pruritus associated with skin disease or inflammation and pruritus with normal skin. Searching for possible underlying diseases is indispensable, because pruritus can be very chronic and has multiple pathogenetic mechanisms. Therapy -especially topical therapy -is difficult and often not successful. Very often systemic treatment has to be combined with topical approaches, considering both the active ingredients and appropriate vehicles. There are still open therapeutic gaps in the pharmaceutical product market, which can partially be resolved by using standard prescriptions for formulations. Due to the new pharmacy practice order, standardized compounded formulations should be given preference, since individual formulations often do not pass the plausibility check of the compounding pharmacist. Also the use of cosmetic ingredients (by example, commercial cold creams) is no longer permitted, since only ingredients with pharmaceutical quality can be used in compounding. We will show -based on practical cases -different therapeutic options for treatment with standardized magistral formulations from the NRF (New German Pharmacopoeia for compounded medications). Systemic and topical therapeutic agents complement each other in their efficacy. Causal and symptomatic therapies result in the most diverse therapeutic options since pruritus has so many causes. In many scenarios, novel therapeutic approaches or special vehicles require magistral formulas [4,5]. The new Pharmacy Practice Act requires a plausibility check of each prescription since 2012, so that frequently individual formulations are scrutinized, so that therapeutic alternatives in the form of magistral formulas are very welcome. We will present only established magistral formulas of the NRF that have already undergone a plausibility check [6,7]. Petra

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S3 – Guidelines on the treatment of psoriasis vulgaris Update 2011

Cited by 82 publications

References 245 publications

Efficacy and safety of systemic treatments for moderate‐to‐severe psoriasis: meta‐analysis of randomized controlled trials

Efficacy and safety of systemic treatments for moderate‐to‐severe psoriasis: meta‐analysis of randomized controlled trials

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

Magistral formulations and pruritus therapy – What is established, what is confirmed, what is new?

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