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RF-The METOP Study: Further Evidence for the Use of Subcutaneous Methotrexate in Psoriasis
FR-Estudio METOP: nuevas evidencias sobre el uso del metotrexato subcutáneo en psoriasis
D. Morgado-Carrasco, X. Fustà-Novell, J. Riera-Monroig, J.M. Mascaró Galy
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Dermatology Department, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain
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A well-defined neoplastic proliferation was observed in the superficial dermis, in contact with the epidermis. It was made up of squamous cells, some with vacuolization, with foci of keratinization and corneal microcysts. Note the ulcerated epidermis and dilated vessels in the tumor periphery (arrows).</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "B. Lozano-Masdemont, I.M. de Lara Simón, L. González López" "autores" => array:3 [ 0 => array:2 [ "nombre" => "B." "apellidos" => "Lozano-Masdemont" ] 1 => array:2 [ "nombre" => "I.M. de" "apellidos" => "Lara Simón" ] 2 => array:2 [ "nombre" => "L. 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Morgado-Carrasco, X. Fustà-Novell, J. Riera-Monroig, J.M. Mascaró Galy" "autores" => array:4 [ 0 => array:2 [ "nombre" => "D." "apellidos" => "Morgado-Carrasco" ] 1 => array:2 [ "nombre" => "X." "apellidos" => "Fustà-Novell" ] 2 => array:2 [ "nombre" => "J." "apellidos" => "Riera-Monroig" ] 3 => array:4 [ "nombre" => "J.M." "apellidos" => "Mascaró Galy" "email" => array:1 [ 0 => "josemanuel.mascaro@gmail.com" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Dermatology Department, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "FR-Estudio METOP: nuevas evidencias sobre el uso del metotrexato subcutáneo en psoriasis" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Methotrexate (MTX) has been a first-line treatment for psoriasis for half a century. However, little high-quality scientific evidence and few well-designed clinical trials have yet been performed to support its efficacy. A recent meta-analysis showed a 75% reduction in the baseline Psoriasis Area Severity Index (PASI75) at 12 to 16 weeks in 45% of patients, and side effects that required drug withdrawal in 6.9%.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> A clinical trial of briakinumab versus MTX found that only 23.9% of patients receiving MTX achieved a PASI75 at 52 weeks, and that 72% (118/163) discontinued the drug due to lack of efficacy (95/163), side effects (9/163), or other reasons.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Regarding the route of administration, some studies in rheumatoid arthritis suggest greater efficacy of methotrexate when given by subcutaneous injection (MTXSC).<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Warren et al.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> recently published the results of the European METOP study, a multicenter randomized, double-blind clinical trial of MTXSC versus placebo in patients with moderate to severe plaque psoriasis (PASI<span class="elsevierStyleHsp" style=""></span>≥<span class="elsevierStyleHsp" style=""></span>10). During the first 16 weeks, patients received placebo (n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>29) or MTXSC (n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>91) at a dose of 17.5<span class="elsevierStyleHsp" style=""></span>mg/week, increasing to 22.5<span class="elsevierStyleHsp" style=""></span>mg/week depending on the clinical response at week 8. Subsequently, all patients received MTXSC up to week 52. At week 16, 41% of the MTXSC group and 10% of the placebo group achieved PASI75 (relative risk: 3.93; 95% confidence interval, 1.31-11.81; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.0026). At week 52, 45% (n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>41) of patients had achieved a PASI75, and 28% a PASI90. MTXSC was well tolerated, with no reports of death, serious infections, or major cardiovascular events. Of the patients who received the drug for 52 weeks, 3% (n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>3) presented gastrointestinal intolerance requiring treatment discontinuation. Biopsies were performed on 27 patients prior to treatment and during week 16, observing a marked reduction in interleukin 17 and interferon-γ mRNA levels in those individuals with MTXSC who achieved a PASI75.</p><p id="par0015" class="elsevierStylePara elsevierViewall">These results after 12 to 16 weeks of treatment with MTXSC are similar to those observed previously with oral MTX,<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> with a PASI75 of around 40%. However, at week 52, the subcutaneous route appears to be considerably superior, with a PASI75 of 45% compared to 23% with oral MTX in previous studies, and a lower rate of treatment interruption.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Furthermore, a PASI75 of 27% was achieved at 8 weeks in the METOP study compared with only 20% in a clinical trial with oral MTX.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> This would suggest a more rapid clinical response with MTXSC. That study also supported the use of a higher starting dose of MTXSC, as has recently been proposed.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Although MTX does not show the efficacy of the latest-generation biologic agents, it does have an appreciable response rate, a good safety profile, and lower cost. The subcutaneous route would appear to have advantages over oral MTX and could be considered as first-line therapy in psoriasis, although high-quality clinical trials comparing the efficacy of oral vs subcutaneous MTX are still required in this disease.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "PalabrasClave" => array:1 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec908582" "palabras" => array:4 [ 0 => "Methotrexate" 1 => "Subcutaneous" 2 => "Psoriasis" 3 => "Metop" ] ] ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Morgado-Carrasco D, Fustà-Novell X, Riera Monroig J, Mascaró Galy JM. RF-The METOP Study: Further Evidence for the Use of Subcutaneous Methotrexate in Psoriasis. Actas Dermosifiliogr. 2017;108:865–866.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Safety and efficacy of methotrexate in psoriasis: A meta-analysis of published trials" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "J. West" 1 => "S. Ogston" 2 => "J. 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| 2020 Abril | 22 | 19 | 41 |
| 2020 Marzo | 21 | 16 | 37 |
| 2020 Febrero | 3 | 0 | 3 |
| 2019 Diciembre | 2 | 0 | 2 |
| 2019 Septiembre | 4 | 0 | 4 |
| 2019 Junio | 2 | 0 | 2 |
| 2019 Marzo | 2 | 0 | 2 |
| 2019 Febrero | 2 | 0 | 2 |
| 2019 Enero | 1 | 0 | 1 |
| 2018 Diciembre | 3 | 0 | 3 |
| 2018 Noviembre | 1 | 0 | 1 |
| 2018 Octubre | 11 | 0 | 11 |
| 2018 Septiembre | 6 | 0 | 6 |
| 2018 Marzo | 0 | 1 | 1 |
| 2018 Febrero | 20 | 4 | 24 |
| 2018 Enero | 33 | 12 | 45 |
| 2017 Diciembre | 41 | 14 | 55 |
| 2017 Noviembre | 64 | 39 | 103 |
| 2017 Octubre | 2 | 16 | 18 |
| 2017 Septiembre | 4 | 14 | 18 |
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