Case and Research Letter
Use of Antihistamines During Omalizumab Therapy in Chronic Urticaria in the Routine Clinical Practice. A 48-Patient Observational Trial
El empleo de antihistamínicos durante el tratamiento con omalizumab en la urticaria crónica en práctica clínica real. Estudio observacional de 48 pacientes
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Estudio observacional de 48 pacientes" "tienePdf" => "es" "tieneTextoCompleto" => "es" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "636" "paginaFinal" => "638" ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Use of Antihistamines During Omalizumab Therapy in Chronic Urticaria in the Routine Clinical Practice. A 48-Patient Observational Trial" ] ] "contieneTextoCompleto" => array:1 [ "es" => true ] "contienePdf" => array:1 [ "es" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figura 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 781 "Ancho" => 2333 "Tamanyo" => 115402 ] ] "descripcion" => array:1 [ "es" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Refleja el número absoluto de pacientes (eje vertical) que consume cada una de las dosis de AH (eje transversal) según el mes de tratamiento estudiado y se clasifican en función de la actividad de la urticaria (representado mediante segmentos de colores en las columnas de cada gráfica) considerándose una UC controlada si el UAS7 es de 0-6, una urticaria leve si el UAS7 se encuentra entre 7-15, moderada si el UAS7 es 16-27 y severa si encontramos un UAS7 entre 28-42. En esta gráfica solo se incluyeron a los pacientes con diagnóstico de UC espontánea. Se observa que cuanto mayor es el tiempo de tratamiento con el biológico, mayor es el control de la actividad de la enfermedad, y menor es el consumo de AH.</p> <p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">AH: antihistamínicos; UC: urticaria crónica; UAS7: <span class="elsevierStyleItalic">Urticaria Activity Score</span> por siete días.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "M. Menéndez-Sánchez, E. Pérez-Fernández, J.L. López-Estebaranz, E. Gómez-de la Fuente" "autores" => array:4 [ 0 => array:2 [ "nombre" => "M." "apellidos" => "Menéndez-Sánchez" ] 1 => array:2 [ "nombre" => "E." "apellidos" => "Pérez-Fernández" ] 2 => array:2 [ "nombre" => "J.L." "apellidos" => "López-Estebaranz" ] 3 => array:2 [ "nombre" => "E." "apellidos" => "Gómez-de la Fuente" ] ] ] ] ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0001731024001455?idApp=UINPBA000044" "url" => "/00017310/0000011500000006/v1_202406021150/S0001731024001455/v1_202406021150/es/main.assets" ] "asociados" => array:1 [ 0 => array:18 [ "pii" => "S0001731024001455" "issn" => "00017310" "doi" => "10.1016/j.ad.2023.08.015" "estado" => "S300" "fechaPublicacion" => "2024-06-01" "aid" => "3857" "copyright" => "AEDV" "documento" => "simple-article" "crossmark" => 1 "subdocumento" => "crp" "cita" => "Actas Dermosifiliogr. 2024;115:636-8" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:1 [ "total" => 0 ] "es" => array:11 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">CARTA CIENTÍFICO-CLÍNICA</span>" "titulo" => "El empleo de antihistamínicos durante el tratamiento con omalizumab en la urticaria crónica en práctica clínica real. Estudio observacional de 48 pacientes" "tienePdf" => "es" "tieneTextoCompleto" => "es" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "636" "paginaFinal" => "638" ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Use of Antihistamines During Omalizumab Therapy in Chronic Urticaria in the Routine Clinical Practice. A 48-Patient Observational Trial" ] ] "contieneTextoCompleto" => array:1 [ "es" => true ] "contienePdf" => array:1 [ "es" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figura 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 781 "Ancho" => 2333 "Tamanyo" => 115402 ] ] "descripcion" => array:1 [ "es" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Refleja el número absoluto de pacientes (eje vertical) que consume cada una de las dosis de AH (eje transversal) según el mes de tratamiento estudiado y se clasifican en función de la actividad de la urticaria (representado mediante segmentos de colores en las columnas de cada gráfica) considerándose una UC controlada si el UAS7 es de 0-6, una urticaria leve si el UAS7 se encuentra entre 7-15, moderada si el UAS7 es 16-27 y severa si encontramos un UAS7 entre 28-42. En esta gráfica solo se incluyeron a los pacientes con diagnóstico de UC espontánea. Se observa que cuanto mayor es el tiempo de tratamiento con el biológico, mayor es el control de la actividad de la enfermedad, y menor es el consumo de AH.</p> <p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">AH: antihistamínicos; UC: urticaria crónica; UAS7: <span class="elsevierStyleItalic">Urticaria Activity Score</span> por siete días.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "M. Menéndez-Sánchez, E. Pérez-Fernández, J.L. López-Estebaranz, E. Gómez-de la Fuente" "autores" => array:4 [ 0 => array:2 [ "nombre" => "M." "apellidos" => "Menéndez-Sánchez" ] 1 => array:2 [ "nombre" => "E." "apellidos" => "Pérez-Fernández" ] 2 => array:2 [ "nombre" => "J.L." "apellidos" => "López-Estebaranz" ] 3 => array:2 [ "nombre" => "E." "apellidos" => "Gómez-de la Fuente" ] ] ] ] ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0001731024001455?idApp=UINPBA000044" "url" => "/00017310/0000011500000006/v1_202406021150/S0001731024001455/v1_202406021150/es/main.assets" ] ] "en" => array:15 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Case and Research Letter</span>" "titulo" => " Use of Antihistamines During Omalizumab Therapy in Chronic Urticaria in the Routine Clinical Practice. A 48-Patient Observational Trial" "tieneTextoCompleto" => true "saludo" => "<span class="elsevierStyleItalic">To the Editor,</span>" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "T636" "paginaFinal" => "T638" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "M. Menéndez-Sánchez, E. Pérez-Fernández, J.L. López-Estebaranz, E. Gómez-de la Fuente" "autores" => array:4 [ 0 => array:4 [ "nombre" => "M." "apellidos" => "Menéndez-Sánchez" "email" => array:1 [ 0 => "martamenendez03@gmail.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "E." "apellidos" => "Pérez-Fernández" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "J.L." "apellidos" => "López-Estebaranz" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 3 => array:3 [ "nombre" => "E." "apellidos" => "Gómez-de la Fuente" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Unidad de Investigación, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "El empleo de antihistamínicos durante el tratamiento con omalizumab en la urticaria crónica en práctica clínica real. Estudio observacional de 48 pacientes" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 783 "Ancho" => 2333 "Tamanyo" => 131026 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Shows the absolute number of patients (vertical axis) consuming each dose of AH (transverse axis) according to the month of treatment studied. Patients are classified based on urticaria activity (represented by colored segments in the columns of each graph), considering controlled CU if UAS7 is 0-6, mild urticaria if between 7 and 15, moderate if between 16 and 27, and severe if between 28 and 42. Only patients diagnosed with spontaneous CU were included in this graph. It becomes obvious that longer biologic regimens of treatment are associated with better disease control, and a lower consumption of AH.</p> <p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">AH, antihistamines; CU, chronic urticaria; UAS7, Urticaria Activity Score over 7 days.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Current guidelines recommend omalizumab as the second-line therapy for chronic urticaria (CU) after failed high-dose antihistamines (AH) (3 or 4 times the standard dose).<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">1</span></a> However, it has not been defined whether these AH should be maintained while on omalizumab, what the optimal dosage of AH is, and whether they offer any real benefits to the patient.</p><p id="par0010" class="elsevierStylePara elsevierViewall">The aim of this study was to analyze the use of AH before, 3 and 6 months after starting omalizumab, and evaluate the differences between prescribed and consumed AH. Therefore, we conducted a single-center, retrospective, observational study with a cohort of 48 adult patients diagnosed with CU who had been on omalizumab for, at least, 6 months.</p><p id="par0015" class="elsevierStylePara elsevierViewall">To determine drug use by the patients, we consulted the dispensation of these drugs in the electronic prescription system of the Community of Madrid, Spain. Patients were classified based on urticaria activity using the Urticaria Activity Score over 7 days (UAS7) the Urticarial Control Test (UCT), and according to the AH doses. The chi-square test and the Mann-Whitney U test were used to analyze the study variables. Furthermore, the McNemar symmetry test was used to compare prescribed and consumed AH figures. The software used was the IBM Statistical Package for the Social Sciences (SPSS).</p><p id="par0020" class="elsevierStylePara elsevierViewall">A total of 32 out of the 48 patients included in this study (66.7%) were women and the mean age was 49 years. A total of 23% of the patients showed autoimmune comorbidities (with hypothyroidism being prominent) and 33% stigmata of atopic constitution. Patients with spontaneous CU (66% overall), inducible urticaria (IU) (11% overall), and those with spontaneous CU and IU (23%) were studied together.</p><p id="par0025" class="elsevierStylePara elsevierViewall">We saw that prior to starting omalizumab, high-dose AH were prescribed in up to 94% of the patients with CU. Three and 6 months into treatment, the prescription was more heterogeneous (<a class="elsevierStyleCrossRef" href="#fig0005">figure 1</a>). Regarding the actual use of AH, we saw that prior to starting omalizumab, only 42% of the patients were on high-dose AH (<a class="elsevierStyleCrossRef" href="#fig0005">figure 1</a>). McNemar's test revealed significant differences between the number of patients to whom each dose was prescribed and the number actually taking that dose, indicating low treatment adherence. To study the impact of AH use on the disease, a correlation between disease control and actual AH use was established (<a class="elsevierStyleCrossRef" href="#fig0010">figure 2</a>). No statistically significant differences were found determining greater urticaria control based on the AH dose used.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">This research shows uniformity regarding prescription among dermatologists prior to starting biologics (reflecting the clinical guidelines), a uniformity that is not maintained after the start of omalizumab. There is also no consensus in the literature on what AH regimen should be prescribed after omalizumab has been started. Some studies argue that AH consumption should be on-demand, intensifying AH in case of worsening symptoms, with good results controlling flare-ups.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">2</span></a> Others maintain that the AH dose should be the dose used before starting the biologic therapy, i.e., high doses of AH,<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">3,4</span></a> while others suggest the possibility of stopping AH right from the beginning of biologic therapy. In such cases, as in our research, it has been demonstrated that there is no clear benefit from AH during anti-IgE therapy and it is argued that if a benefit was never to be obtained from these drugs, the best thing to do is discontinue them.<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">5–7</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">On the other hand, there is a significantly low treatment adherence on the patients’ end, which poses the question of what the real cause of this low adherence may be. Melé et al. published a study analyzing AH use during omalizumab treatment through a survey. Among the reasons justifying low AH adherence, a good response to the biologic drug was the most common cause.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">8</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Limitations of this study include its retrospective design, the distinction between spontaneous CU and IU, and the sample size. However, as an advantage, objective data obtained from the prescription system of the Community of Madrid were handled.</p><p id="par0045" class="elsevierStylePara elsevierViewall">In conclusion, it appears that AH use may not be necessary to control CU in patients on omalizumab if the patient is already under control with the biologic drug. It seems necessary to find a pattern in the AH guidelines while on omalizumab and emphasize therapeutic adherence.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0050" class="elsevierStylePara elsevierViewall">None declared.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflicts of interest" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "multimedia" => array:2 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1043 "Ancho" => 2341 "Tamanyo" => 200078 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Shows the number of patients on the vertical axis. Each month of the study is represented on the horizontal axis. Colored lines show the evolution of the different doses of prescribed (left graph) or consumed AH (right graph) by the patients during the study period. The numbers on the lines indicate the exact number of patients who consumed or were prescribed that dose of AH during that studied month. After performing McNemar's test, significant differences were seen between prescribed and consumed AH figures, indicating low treatment adherence.</p> <p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">AH, antihistamines.</p>" ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 783 "Ancho" => 2333 "Tamanyo" => 131026 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Shows the absolute number of patients (vertical axis) consuming each dose of AH (transverse axis) according to the month of treatment studied. Patients are classified based on urticaria activity (represented by colored segments in the columns of each graph), considering controlled CU if UAS7 is 0-6, mild urticaria if between 7 and 15, moderate if between 16 and 27, and severe if between 28 and 42. Only patients diagnosed with spontaneous CU were included in this graph. It becomes obvious that longer biologic regimens of treatment are associated with better disease control, and a lower consumption of AH.</p> <p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">AH, antihistamines; CU, chronic urticaria; UAS7, Urticaria Activity Score over 7 days.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:8 [ 0 => array:3 [ "identificador" => "bib0045" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "T. Zuberbier" 1 => "A.H. Abdul Latiff" 2 => "M. Abuzakouk" 3 => "S. Aquilina" 4 => "R. Asero" 5 => "D. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 12 | 10 | 22 |
| 2024 October | 146 | 54 | 200 |
| 2024 September | 135 | 30 | 165 |
| 2024 August | 253 | 79 | 332 |
| 2024 July | 154 | 60 | 214 |
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| 2024 May | 238 | 70 | 308 |
| 2024 April | 73 | 38 | 111 |
