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"documento" => "simple-article" "crossmark" => 0 "subdocumento" => "cor" "cita" => "Reumatol Clin. 2013;9:252-3" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 2010 "formatos" => array:3 [ "EPUB" => 52 "HTML" => 1499 "PDF" => 459 ] ] "en" => array:10 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Letter to the Editor</span>" "titulo" => "Reply to: “Understanding the Immunogenicity Concept”" "tienePdf" => "en" "tieneTextoCompleto" => "en" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "252" "paginaFinal" => "253" ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Respuesta a: «Comprender el concepto de inmunogenicidad»" ] ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Alejandro Balsa, Chamaida Plasencia, Dora Pascual-Salcedo" "autores" => array:3 [ 0 => array:2 [ "nombre" => "Alejandro" "apellidos" => "Balsa" ] 1 => array:2 [ "nombre" => "Chamaida" "apellidos" => "Plasencia" ] 2 => array:2 [ "nombre" => "Dora" "apellidos" => "Pascual-Salcedo" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S1699258X13000934" "doi" => "10.1016/j.reuma.2013.03.004" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1699258X13000934?idApp=UINPBA00004M" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2173574313000798?idApp=UINPBA00004M" "url" => "/21735743/0000000900000004/v1_201307160008/S2173574313000798/v1_201307160008/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Letter to the Editor</span>" "titulo" => "Reply to Balsa et al. Relative With the Review “Understanding the Concept of Immunogenicity”" "tieneTextoCompleto" => true "saludo" => "<span class="elsevierStyleItalic">Dear Editor</span>," "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "253" "paginaFinal" => "254" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Lara Valor, Inmaculada de la Torre" "autores" => array:2 [ 0 => array:3 [ "nombre" => "Lara" "apellidos" => "Valor" "email" => array:1 [ 0 => "larissa.valor@salud.madrid.org" ] ] 1 => array:4 [ "nombre" => "Inmaculada" "apellidos" => "de la Torre" "email" => array:1 [ 0 => "inma.torre.ortega@googlemail.com" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">¿</span>" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Reumatología, Hospital General Universitario Gregorio Marañón, Madrid, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Respuesta a Balsa et al. en relación con la revisión «Entendiendo el concepto de inmunogenicidad»" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">We would like to thank Balsa et al. their interest and comments on the review “Understanding the concept of immunogenicity”,<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> in giving their opinion on the concept of immunogenicity, more specifically when applied to biological therapies in rheumatology. We would also like to thank the editor of Reumatología CLínica the opportunity to reply, which manifests the commitment of this journal in the settlement of very current controversies. With these lines we would like to mention some of the comments made.</p><p id="par0010" class="elsevierStylePara elsevierViewall">It is well known that both standardizing and validating assays in immunology, especially in the area of autoimmunity, are an extremely difficult and complex task. Therefore, determinations made over time have high inter and/or intra laboratory methodological variability which always requires consensus to establish the steps to be followed in order to standardize results and to optimize techniques in order to have an adequate sensitivity, specificity and reproducibility. In the case of the determination of immunogenicity in biological therapies, such procedures have not been well documented in the field of rheumatology. Our duty is to promote the validation and standardization of techniques and when this is not possible, the next step is to establish rules among the relevant stakeholders and build consensus.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Fortunately, the international scientific community has recognized the need to work together and in 2012 created the group Anti-Biopharmaceutical Immunization: prediction and analysis of clinical relevance to minimize the risk. European Union Innovative Medical Initiative (ABIRISK).<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Its main objective is the establishment of international standards, internal standards and consistent detection techniques applied to each biologic drug marketed. In the near future, establishing multicenter studies and using appropriate techniques, the determination of both the immunogenicity and drug levels will gain ground in the monitoring of patients on biological therapies.</p><p id="par0020" class="elsevierStylePara elsevierViewall">The examples mentioned by Balsa et al., to highlight the difficulties that have existed in the standardization of the detection techniques for antiphospholipid antibodies (APA) and<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3,4</span></a> anti granulocyte cytoplasmic antibodies and their application in clinical practice, are perfectly valid.However, both measurements and their interpretation are supported by international consensus groups, numerous publications and multicenter studies that have exchanged biological samples, with the aim of agreeing on detection ranges, establishing guidelines for testing and the use of calibration curves and appropriate cut points.<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3,5,6</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">In the specific case of the APL, which were described in 1983, the consensus of Sapporo, in 1999 helped to define the clinical and especially the laboratory data for the diagnosis of antiphospholipid syndrome (APS), which included the presence of lupus anticoagulant and the G and/or M anticardiolipin isotypes.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> In view of the persistent variability of APL determinations by various research groups within APS, these criteria were reviewed in the consensus of Sydney in 2005, adding B2 glycoprotein determinations to the criteria <span class="elsevierStyleSmallCaps">i</span> for laboratory diagnoses, criteria currently considered valid internationally.<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3,8–10</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">With respect to the regulated analysis of observational studies in epidemiology and the review of the literature cited by Balsa et al., both publications conclude that although the trends with respect to clinical response are clear, different studies evaluating the whole, the heterogeneity of the cohorts studied, using techniques not yet standardized and the imprecision of the assays makes the reliable correlations with clinical response to biologic therapy risky.<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11,12</span></a> Especially noteworthy is the review by Vincent et al., detailing the great variability of results regarding drug-drug immunogenicity data.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">As discussed Balsa et al., for the detection of specific antibodies traits such as isotype and affinity, the technique known as acid dissociation procedure is very helpful in immunology and has already been used to determine anti-drug antibody and is likely to be integrated in the design these techniques.<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">13–15</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Finally, as authors, we would say that the highest motivation of this review was to highlight the complexity surrounding the determination of immunogenicity that other medical specialties have previously experienced and to understand and apply these important concepts in an effective way in the area of rheumatology. The editorial entitled “Understanding the concept of immunogenicity” has achieved the most important of our goals, to increase the interest and promote discussion on this topic among readers of <span class="elsevierStyleSmallCaps">Reumatología Clínica.</span></p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Valor L, De la Torre I. Respuesta a Balsa et al. en relación con la revisión «Entendiendo el concepto de inmunogenicidad». Reumatol. Clin. 2013. <span class="elsevierStyleInterRef" id="intr0005" href="doi:10.1016/j.reumae.2013.03.009">http://dx.doi.org/10.1016/j.reumae.2013.03.009</span>.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:15 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Understanding the immunogenicity concept" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "L. 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Year/Month | Html | Total | |
---|---|---|---|
2024 November | 9 | 15 | 24 |
2024 October | 28 | 35 | 63 |
2024 September | 30 | 18 | 48 |
2024 August | 43 | 34 | 77 |
2024 July | 25 | 21 | 46 |
2024 June | 28 | 30 | 58 |
2024 May | 33 | 22 | 55 |
2024 April | 26 | 20 | 46 |
2024 March | 35 | 26 | 61 |
2024 February | 28 | 22 | 50 |
2024 January | 29 | 18 | 47 |
2023 December | 22 | 20 | 42 |
2023 November | 31 | 19 | 50 |
2023 October | 20 | 30 | 50 |
2023 September | 52 | 31 | 83 |
2023 August | 22 | 15 | 37 |
2023 July | 21 | 32 | 53 |
2023 June | 32 | 47 | 79 |
2023 May | 27 | 25 | 52 |
2023 April | 18 | 10 | 28 |
2023 March | 30 | 24 | 54 |
2023 February | 18 | 28 | 46 |
2023 January | 31 | 21 | 52 |
2022 December | 36 | 55 | 91 |
2022 November | 40 | 37 | 77 |
2022 October | 30 | 29 | 59 |
2022 September | 28 | 30 | 58 |
2022 August | 22 | 37 | 59 |
2022 July | 29 | 46 | 75 |
2022 June | 24 | 35 | 59 |
2022 May | 30 | 34 | 64 |
2022 April | 31 | 43 | 74 |
2022 March | 33 | 38 | 71 |
2022 February | 30 | 25 | 55 |
2022 January | 19 | 31 | 50 |
2021 December | 27 | 35 | 62 |
2021 November | 34 | 36 | 70 |
2021 October | 34 | 49 | 83 |
2021 September | 27 | 36 | 63 |
2021 August | 16 | 40 | 56 |
2021 July | 11 | 34 | 45 |
2021 June | 28 | 45 | 73 |
2021 May | 36 | 25 | 61 |
2021 April | 69 | 59 | 128 |
2021 March | 62 | 27 | 89 |
2021 February | 19 | 18 | 37 |
2021 January | 12 | 18 | 30 |
2020 December | 21 | 21 | 42 |
2020 November | 18 | 12 | 30 |
2020 October | 10 | 6 | 16 |
2020 September | 29 | 21 | 50 |
2020 August | 15 | 18 | 33 |
2020 July | 16 | 11 | 27 |
2020 June | 23 | 13 | 36 |
2020 May | 28 | 12 | 40 |
2020 April | 21 | 13 | 34 |
2020 March | 14 | 11 | 25 |
2020 February | 1 | 0 | 1 |
2019 April | 2 | 0 | 2 |
2019 January | 1 | 0 | 1 |
2018 May | 3 | 0 | 3 |
2018 April | 66 | 8 | 74 |
2018 March | 38 | 5 | 43 |
2018 February | 58 | 3 | 61 |
2018 January | 22 | 8 | 30 |
2017 December | 53 | 5 | 58 |
2017 November | 24 | 4 | 28 |
2017 October | 32 | 4 | 36 |
2017 September | 19 | 2 | 21 |
2017 August | 19 | 6 | 25 |
2017 July | 22 | 7 | 29 |
2017 June | 32 | 15 | 47 |
2017 May | 36 | 10 | 46 |
2017 April | 24 | 3 | 27 |
2017 March | 33 | 9 | 42 |
2017 February | 14 | 4 | 18 |
2017 January | 27 | 7 | 34 |
2016 December | 63 | 12 | 75 |
2016 November | 32 | 3 | 35 |
2016 October | 44 | 8 | 52 |
2016 September | 52 | 9 | 61 |
2016 August | 45 | 9 | 54 |
2016 July | 25 | 0 | 25 |
2016 June | 0 | 18 | 18 |
2016 May | 0 | 26 | 26 |
2016 January | 2 | 0 | 2 |
2015 December | 2 | 0 | 2 |
2015 October | 1 | 16 | 17 |
2015 September | 1 | 0 | 1 |
2015 August | 1 | 0 | 1 |
2015 July | 10 | 5 | 15 |
2015 June | 13 | 9 | 22 |
2015 May | 24 | 16 | 40 |
2015 April | 15 | 11 | 26 |
2015 March | 16 | 5 | 21 |
2015 February | 12 | 14 | 26 |
2015 January | 16 | 11 | 27 |
2014 December | 19 | 15 | 34 |
2014 November | 16 | 20 | 36 |
2014 October | 17 | 30 | 47 |
2014 September | 15 | 25 | 40 |
2014 August | 24 | 19 | 43 |
2014 July | 25 | 25 | 50 |
2014 June | 28 | 23 | 51 |
2014 May | 23 | 37 | 60 |
2014 April | 38 | 10 | 48 |
2014 March | 30 | 15 | 45 |
2014 February | 29 | 21 | 50 |
2014 January | 26 | 11 | 37 |
2013 December | 16 | 9 | 25 |
2013 November | 18 | 9 | 27 |
2013 October | 37 | 9 | 46 |
2013 September | 24 | 16 | 40 |
2013 August | 51 | 23 | 74 |
2013 July | 18 | 11 | 29 |