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Seguimiento a largo plazo" ] ] "contieneResumen" => array:2 [ "en" => true "es" => true ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2417 "Ancho" => 1675 "Tamanyo" => 250761 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Evolution of fibrosis measured by non-invasive methods in patients with an SVR.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Ester Badia Aranda, Cristina Fernández Marcos, Aida Puebla Maestu, Visitación Gozalo Marín, Raquel Vinuesa Campo, Sara Calvo Simal, Judith Gómez Camarero" "autores" => array:7 [ 0 => array:2 [ "nombre" => "Ester" "apellidos" => "Badia Aranda" ] 1 => array:2 [ "nombre" => "Cristina" "apellidos" => "Fernández Marcos" ] 2 => array:2 [ "nombre" => "Aida" "apellidos" => "Puebla Maestu" ] 3 => array:2 [ "nombre" => "Visitación" "apellidos" => "Gozalo Marín" ] 4 => array:2 [ "nombre" => "Raquel" "apellidos" => "Vinuesa Campo" ] 5 => array:2 [ "nombre" => "Sara" "apellidos" => "Calvo Simal" ] 6 => array:2 [ "nombre" => "Judith" "apellidos" => "Gómez Camarero" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S0210570522000644" "doi" => "10.1016/j.gastrohep.2022.02.002" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0210570522000644?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2444382422001870?idApp=UINPBA00004N" "url" => "/24443824/0000004500000010/v2_202301300801/S2444382422001870/v2_202301300801/en/main.assets" ] "en" => array:12 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Scientific letter</span>" "titulo" => "A high adalimumab induction dosing regimen achieves clinical and endoscopic remission in super-refractory ulcerative colitis" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "780" "paginaFinal" => "781" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Alexandra Ruiz-Cerulla, Lorena Rodríguez-Alonso, Francisco Rodríguez-Moranta, Jordi Guardiola" "autores" => array:4 [ 0 => array:4 [ "nombre" => "Alexandra" "apellidos" => "Ruiz-Cerulla" "email" => array:1 [ 0 => "aruizcerulla@bellvitgehospital.cat" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "Lorena" "apellidos" => "Rodríguez-Alonso" ] 2 => array:2 [ "nombre" => "Francisco" "apellidos" => "Rodríguez-Moranta" ] 3 => array:2 [ "nombre" => "Jordi" "apellidos" => "Guardiola" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Department of Gastroenterology, Hospital Universitari de Bellvitge-IDIBELL, L’Hospitalet de Llobregat, Barcelona, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Una pauta de inducción con dosis altas de adalimumab consigue la remisión clínica y endoscópica en colitis ulcerosa superrefractaria" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In the following, we report our experience with a high adalimumab (ADA) induction dosing regimen in the context of a super-refractory ulcerative colitis (UC) patient. A 40-year-old female was diagnosed with left-sided UC in 2006 and remained in remission with aminosalicylates. In 2014, she presented with a severe flare with pancolitis progression and a steroid-refractory course. Rescue with ciclosporin obtained a partial response and infliximab (IFX) plus azathioprine (AZA) was administered with a favorable clinical response. However, IFX intensification proved necessary and few months later, secondary loss of response (LOR) was observed. The patient was subsequently included in a pivotal randomized clinical trial evaluating tofacitinib, but, after worsening symptoms, IFX was reintroduced. Three years later, secondary LOR was observed again despite optimal drug levels. Vedolizumab plus AZA was initiated with a poor response. In October 2018, the patient was admitted to hospital for a new severe flare. The patient rejected colectomy so intravenous steroid therapy and a high ADA induction dosing regimen (160<span class="elsevierStyleHsp" style=""></span>mg at week 0, 80<span class="elsevierStyleHsp" style=""></span>mg at week 1 and week 2, followed by 80<span class="elsevierStyleHsp" style=""></span>mg every two weeks) was initiated. Clinical response was achieved at week 4. Clinical, biological, and endoscopic free-steroid remission was achieved at week 16 and maintained through to week 52. At this point ADA levels were 44<span class="elsevierStyleHsp" style=""></span>mg/L and anti-drug antibodies were absent.</p><p id="par0010" class="elsevierStylePara elsevierViewall">In the context of an anti-tumor necrosis factor (anti-TNF) pharmacodynamic failure, a change in mechanism of action is generally recommended. In this case, after vedolizumab and tofacitinib had failed, no other effective medical options were available, so we decided to try high doses of a second anti-TNF treatment.</p><p id="par0015" class="elsevierStylePara elsevierViewall">ADA has been shown to be effective in UC both in clinical trials and in “real life” experience. The efficacy of ADA in UC refractory to IFX has been extensively evaluated, although it is likely to prove less effective than in naïve patients. Specifically, primary non response to the first anti-TNF and low drug levels during induction have been identified as predictors of non-response to ADA as a second anti-TNF.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Early measurement of drug concentration and early intervention in patients with low serum concentrations may improve both the rate and the duration of response. Recently, a “real-life” retrospective cohort showed that anti-TNF-naïve patients had significantly better long-term outcomes. In this study, the rate of ADA dose escalation was 17.6% for anti-TNF-naïve patients and 55.2% for anti-TNF-experienced patients. ADA dose escalation enabled the recovery of response in nearly half of the patients.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Additionally, the benefits of ADA as a second anti-TNF can be maximized by the adjustment of concomitant therapies, close therapeutic drug monitoring (TDM) and the optimization of ADA dosing after LOR. Ungar et al. recently demonstrated that immunogenicity can be reversed in patients with LOR developing anti-adalimumab antibodies (AAA) by intensification to weekly dosing and/or by the addition of immunomodulator therapy.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> In our case, early or post-induction drug levels were not available. Early TDM during induction to achieve adequate drug levels could potentially overcome the effect of the inflammatory burden of active disease and, in our opinion, is a reasonable strategy.</p><p id="par0020" class="elsevierStylePara elsevierViewall">A recent phase 3, double-blind, randomized, multicenter study (SERENE-UC) evaluated higher vs. standard ADA dosing regimens for induction and maintenance therapy in adult patients with moderately to severely active UC.<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4,5</span></a> The results of this study failed to demonstrate significant differences in clinical remission between patients who were treated with either a high-dose or a standard-dose of adalimumab. However, this study largely contained bio-naïve UC patients (87%), so it is likely that these results cannot be extrapolated to patients with prior anti-TNF failure. Further, the SERENE-UC study did not include patients with severe UC flare like our patient. Also, we don’t know if conventional dosage would have achieved similar results. In severe acute UC, anti-TNF clearance is accelerated due to high serum and mucosal TNF levels, low albumin, and intestinal losses. For these reasons, it is conceivable than better results could be achieved with a high dose and/or an accelerated induction therapy. Whether concomitant steroids add any benefit in this setting is unknown.</p><p id="par0025" class="elsevierStylePara elsevierViewall">In our opinion, high-dose induction of adalimumab may still be an option to consider in selected patients after IFX failure. More data are needed to assess the optimal dosing regimen of a second anti-TNF drug.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Authors’ contributions</span><p id="par0030" class="elsevierStylePara elsevierViewall">A.R.C.: patient recruitment, data collection, literature review, writing up of the first draft of the paper, revision of the manuscript; L.R.A.: data collection, literature review, revision of the manuscript; F.R.M.: literature review, revision of the manuscript; J.G.: literature review, revision of the manuscript.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Data availability statement</span><p id="par0035" class="elsevierStylePara elsevierViewall">Data cannot be shared for ethical/privacy reasons. Data available on request. The data underlying this short report cannot be shared publicly in order to protect the privacy of the individual. The data will be shared on reasonable request to the corresponding author.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Funding</span><p id="par0040" class="elsevierStylePara elsevierViewall">No specific funding has been received. Data have been generated as part of our routine work at our hospital.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Conflicts of interest</span><p id="par0045" class="elsevierStylePara elsevierViewall">Alexandra Ruiz-Cerulla has served as a speaker for Takeda.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Francisco Rodríguez-Moranta has served as a speaker for Abbvie, Takeda, Pfizer, Jansen, and MSD and has served as an advisor for Abbvie, Jansen, MSD, and Pfizer.</p><p id="par0055" class="elsevierStylePara elsevierViewall">Lorena Rodríguez-Alonso has served as a speaker for Takeda, Pfizer and MSD and has served as an advisor for Abbvie.</p><p id="par0060" class="elsevierStylePara elsevierViewall">Jordi Guardiola has served as a speaker and consultant or has received research or education funding from MSD, Abbvie, Kern, Pfizer, Takeda, Janssen, Ferring, Roche and General Electric.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:5 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Authors’ contributions" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Data availability statement" ] 2 => array:2 [ "identificador" => "sec0015" "titulo" => "Funding" ] 3 => array:2 [ "identificador" => "sec0020" "titulo" => "Conflicts of interest" ] 4 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "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" => "Prior response to infliximab and early serum drug concentrations predict effects of adalimumab in ulcerative colitis" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "F. Baert" 1 => "N. Vande Casteele" 2 => "S. Tops" 3 => "M. Noman" 4 => "G. Van Assche" 5 => "P. Rutgeerts" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1111/apt.12968" "Revista" => array:6 [ "tituloSerie" => "Aliment Pharmacol Ther." "fecha" => "2014" "volumen" => "40" "paginaInicial" => "1324" "paginaFinal" => "1332" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/25277873" "web" => "Medline" ] ] ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0010" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Adalimumab maintenance treatment in ulcerative colitis: outcomes by prior anti-TNF use and efficacy of dose escalation" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "C. Taxonera" 1 => "E. Iglesias" 2 => "M. Munoz" 3 => "M. Calvo" 4 => "M. Barreiro-de Acosta" 5 => "D. Busquets" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1007/s10620-016-4398-5" "Revista" => array:7 [ "tituloSerie" => "Dig Dis Sci." "fecha" => "2017" "volumen" => "62" "paginaInicial" => "481" "paginaFinal" => "490" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/27995400" "web" => "Medline" ] ] "itemHostRev" => array:3 [ "pii" => "S0140673612610228" "estado" => "S300" "issn" => "01406736" ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0015" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Addition of an immunomodulator can reverse antibody formation and loss of response in patients treated with adalimumab" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "B. Ungar" 1 => "U. Kopylov" 2 => "T. Engel" 3 => "M. Yavzori" 4 => "E. Fudim" 5 => "O. Picard" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1111/apt.13862" "Revista" => array:6 [ "tituloSerie" => "Aliment Pharmacol Ther." "fecha" => "2017" "volumen" => "45" "paginaInicial" => "276" "paginaFinal" => "282" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/27862102" "web" => "Medline" ] ] ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib0020" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Panés J, Colombel JF, D’Haens GR, Schreiber S, Panaccione R, Peyrin-Biroulet L, et al. High versus standard adalimumab induction dosing regimens in patients with moderately to severely active ulcerative colitis: results from the SERENE-UC induction study. Oral presentation: Paradigms shifts in IBD treatment. UEG week; 2019 Oct 19-23; Barcelona, Spain. Unit Eur Gastroenterol J. 2019; 7 Suppl. 8." ] ] ] 4 => array:3 [ "identificador" => "bib0025" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Colombel JF, Panés J, D’Haens G, Schreiber S, Panaccione R, Peyrin-Biroulet L, et al. OP01 Higher vs. standard adalimumab maintenance regimens in patients with moderately to severely a ctive ulcerative colitis: Results from the SERENEUC maintenance study. Oral presentations: Scientific Session 1: Hot debates in IBD. Congress of ECCO; 2020 Feb 12-15: Vienna, Austria. J Cronhs Colitis. 2020; 14 Suppl. 1:S001." ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/24443824/0000004500000010/v2_202301300801/S2444382422001936/v2_202301300801/en/main.assets" "Apartado" => array:4 [ "identificador" => "77930" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Scientific letter" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/24443824/0000004500000010/v2_202301300801/S2444382422001936/v2_202301300801/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2444382422001936?idApp=UINPBA00004N" ]
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