Case and Research Letter
Efficacy and Safety of Omalizumab in a Patient With Chronic Spontaneous Urticaria and Active Hepatitis B Virus Infection
Eficacia y seguridad de omalizumab en un paciente con urticaria crónica espontánea e infección activa por el virus de la hepatitis B
P. Chicharro
, P. Rodríguez-Jiménez, D. de Argila
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Servicio de Dermatología, Hospital Universitario de La Princesa, Madrid, España
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"apellidos" => "Arenas" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S0001731016303581" "doi" => "10.1016/j.ad.2016.10.006" "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/S0001731016303581?idApp=UINPBA000044" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1578219017300562?idApp=UINPBA000044" "url" => "/15782190/0000010800000004/v1_201704280927/S1578219017300562/v1_201704280927/en/main.assets" ] "en" => array:16 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Case and Research Letter</span>" "titulo" => "Efficacy and Safety of Omalizumab in a Patient With Chronic Spontaneous Urticaria and Active Hepatitis B Virus Infection" "tieneTextoCompleto" => true "saludo" => "To the Editor:" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "383" "paginaFinal" => "384" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "P. Chicharro, P. Rodríguez-Jiménez, D. de Argila" "autores" => array:3 [ 0 => array:4 [ "nombre" => "P." "apellidos" => "Chicharro" "email" => array:1 [ 0 => "somniem@gmail.com" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "P." "apellidos" => "Rodríguez-Jiménez" ] 2 => array:2 [ "nombre" => "D." "apellidos" => "de Argila" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Dermatología, Hospital Universitario de La Princesa, Madrid, España" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Eficacia y seguridad de omalizumab en un paciente con urticaria crónica espontánea e infección activa por el virus de la hepatitis B" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 841 "Ancho" => 1664 "Tamanyo" => 64111 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Changes in Urticaria Activity Score 7 (UAS7) scores and hepatitis B viral loads measured by polymerase chain reaction (PCR HBV) during treatment with omazlizumab.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Chronic spontaneous urticaria (CSU) has a significant impact on patient quality of life. It is defined as the persistence of wheals, with or without angioedema, for a period of longer than 6 weeks in the absence of an evident trigger. Nonsedating H<span class="elsevierStyleInf">1</span> antihistamines are considered the first-line treatment for CSU, but some patients respond poorly, even at doses 4 times the usual dose. Third-line treatments include ciclosporin and omalizumab, a humanized recombinant monoclonal antibody that selectively binds to free immunoglobulin (Ig) E and was recently approved for the treatment of CSU.<a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">1–3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">We report the case of a 56-year-old woman with a history of untreated active chronic hepatitis B virus (HBV) infection who had experienced frequent episodes of generalized wheals on a frequent basis over the past 15 years. In the previous year, the wheals had appeared daily. She had been on maintenance treatment with H<span class="elsevierStyleInf">1</span> antihistamines (ebastine 20<span class="elsevierStyleHsp" style=""></span>mg/12<span class="elsevierStyleHsp" style=""></span>h) for the past 10 years. In the past year, despite antihistamine therapy, she had required various cycles of oral prednisone to control her symptoms and had visited the emergency department on 2 occasions in the month before being referred to our department. There were no evident triggers. In the initial study, the patient had a viral load of 20<span class="elsevierStyleHsp" style=""></span>200<span class="elsevierStyleHsp" style=""></span>IU/mL and IgE levels of 370<span class="elsevierStyleHsp" style=""></span>kU/L. The other parameters in the workup were within normal ranges. With a diagnosis of CSU, the patient was started on bilastine 40<span class="elsevierStyleHsp" style=""></span>mg/12<span class="elsevierStyleHsp" style=""></span> combined with a 4-week cycle of prednisone. Response was poor and the symptoms returned on initiation of prednisone tapering. In view of the patient's failure to respond to the first- and second-line treatments and her clinical progress, we decided to step up the intensity of treatment. Following discussion with the hepatology unit, it was agreed that there were no current indications to treat the HBV infection but that it was necessary to avoid immunosuppressants such as ciclosporin. We therefore started treatment with omalizumab 300<span class="elsevierStyleHsp" style=""></span>mg every 4 weeks. The dose of bilastine was gradually reduced. Over the next 6 months, the patient experienced no new episodes of urticaria, even after complete withdrawal of the bilastine. The Urticaria Activity Score 7 (UAS7) decreased from an initial score of 37 (on a scale of 0-42) to a score that consistently ranged between 0 and 5 after the second dose of omalizumab. No adverse effects were observed. There was no evident worsening of the HBV infection and we actually observed a reduction in viral load to 627<span class="elsevierStyleHsp" style=""></span>IU/mL at the end of the 6-month treatment cycle. <a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a> shows the changes in UAS7 score and viral loads over the treatment period.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0015" class="elsevierStylePara elsevierViewall">Based on our review of the literature, we believe that this is the first report of the effective and safe use of omalizumab in a patient with CSU and active HBV infection. Brodska and Schmid-Grendelmeier<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">4</span></a> described the case of a patient with cold urticaria and chronic HBV infection treated with omalizumab. The treatment was effective and well tolerated, but no information was provided on the clinical features of the infection or on subsequent progress. Antonicelli et al.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">5</span></a> described the case of a patient with HCV infection who achieved asthma control after 19 months of treatment with omalizumab. There was no worsening of liver function and the patient subsequently underwent HVC eradication treatment with interferon and ribavarin. Finally, Leiva-Salinas et al.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">6</span></a> published a case in which omalizumab proved to be both effective and safe in a patient with CSU and HVC infection. No worsening of liver disease was observed, but the authors did not provide information on viral loads. Omalizumab was effective in our patient and did not worsen the underlying HBV infection. It was, in fact, even associated with a reduction in viral load. We cannot provide a clear explanation for this reduction, but other authors have described improved interferon-α immune response to rhinovirus in patients on interferon-α therapy.<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">7</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Omalizumab may be an effective and safe treatment alternative for refractory CSU in patients with HVB infection. There is, however, no evidence as yet on possible adverse effects or worsening of viral infection in our patient or in similar cases.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of Interest</span><p id="par0025" class="elsevierStylePara elsevierViewall">P. Chicharro and P. Rodríguez-Jiménez declare that they have no conflicts of interest. D. de Argila has worked as a clinical advisor and participated in clinical trials sponsored by Novartis.</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 "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Chicharro P, Rodríguez-Jiménez P, de Argila D. Eficacia y seguridad de omalizumab en un paciente con urticaria crónica espontánea e infección activa por el virus de la hepatitis B. Actas Dermosifiliogr. 2017;108:383–384.</p>" ] ] "multimedia" => array:1 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 841 "Ancho" => 1664 "Tamanyo" => 64111 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Changes in Urticaria Activity Score 7 (UAS7) scores and hepatitis B viral loads measured by polymerase chain reaction (PCR HBV) during treatment with omazlizumab.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:7 [ 0 => array:3 [ "identificador" => "bib0040" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "The EAACI/GA(2)LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: The 2013 revision and update" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "T. 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| año/Mes | Html | Total | |
|---|---|---|---|
| 2024 Noviembre | 14 | 12 | 26 |
| 2024 Octubre | 105 | 45 | 150 |
| 2024 Septiembre | 112 | 46 | 158 |
| 2024 Agosto | 132 | 75 | 207 |
| 2024 Julio | 110 | 34 | 144 |
| 2024 Junio | 129 | 40 | 169 |
| 2024 Mayo | 149 | 45 | 194 |
| 2024 Abril | 126 | 43 | 169 |
| 2024 Marzo | 89 | 44 | 133 |
| 2024 Febrero | 71 | 34 | 105 |
| 2024 Enero | 79 | 29 | 108 |
| 2023 Diciembre | 87 | 21 | 108 |
| 2023 Noviembre | 95 | 26 | 121 |
| 2023 Octubre | 83 | 18 | 101 |
| 2023 Septiembre | 98 | 25 | 123 |
| 2023 Agosto | 44 | 15 | 59 |
| 2023 Julio | 71 | 28 | 99 |
| 2023 Junio | 83 | 28 | 111 |
| 2023 Mayo | 60 | 21 | 81 |
| 2023 Abril | 64 | 29 | 93 |
| 2023 Marzo | 63 | 32 | 95 |
| 2023 Febrero | 47 | 29 | 76 |
| 2023 Enero | 68 | 38 | 106 |
| 2022 Diciembre | 91 | 36 | 127 |
| 2022 Noviembre | 32 | 35 | 67 |
| 2022 Octubre | 29 | 22 | 51 |
| 2022 Septiembre | 24 | 45 | 69 |
| 2022 Agosto | 44 | 49 | 93 |
| 2022 Julio | 37 | 45 | 82 |
| 2022 Junio | 24 | 25 | 49 |
| 2022 Mayo | 48 | 47 | 95 |
| 2022 Abril | 40 | 49 | 89 |
| 2022 Marzo | 69 | 70 | 139 |
| 2022 Febrero | 50 | 32 | 82 |
| 2022 Enero | 69 | 39 | 108 |
| 2021 Diciembre | 49 | 46 | 95 |
| 2021 Noviembre | 46 | 44 | 90 |
| 2021 Octubre | 53 | 54 | 107 |
| 2021 Septiembre | 45 | 30 | 75 |
| 2021 Agosto | 48 | 28 | 76 |
| 2021 Julio | 39 | 28 | 67 |
| 2021 Junio | 55 | 35 | 90 |
| 2021 Mayo | 58 | 49 | 107 |
| 2021 Abril | 116 | 69 | 185 |
| 2021 Marzo | 71 | 23 | 94 |
| 2021 Febrero | 76 | 23 | 99 |
| 2021 Enero | 33 | 19 | 52 |
| 2020 Diciembre | 28 | 20 | 48 |
| 2020 Noviembre | 34 | 25 | 59 |
| 2020 Octubre | 38 | 13 | 51 |
| 2020 Septiembre | 50 | 22 | 72 |
| 2020 Agosto | 30 | 19 | 49 |
| 2020 Julio | 35 | 14 | 49 |
| 2020 Junio | 28 | 36 | 64 |
| 2020 Mayo | 14 | 9 | 23 |
| 2020 Abril | 35 | 20 | 55 |
| 2020 Marzo | 32 | 13 | 45 |
| 2020 Febrero | 7 | 0 | 7 |
| 2019 Diciembre | 4 | 0 | 4 |
| 2019 Noviembre | 4 | 0 | 4 |
| 2019 Septiembre | 7 | 0 | 7 |
| 2019 Agosto | 8 | 0 | 8 |
| 2019 Julio | 7 | 0 | 7 |
| 2019 Junio | 4 | 0 | 4 |
| 2019 Mayo | 5 | 0 | 5 |
| 2019 Abril | 20 | 2 | 22 |
| 2019 Marzo | 3 | 0 | 3 |
| 2019 Febrero | 5 | 0 | 5 |
| 2019 Enero | 3 | 0 | 3 |
| 2018 Diciembre | 9 | 0 | 9 |
| 2018 Noviembre | 14 | 0 | 14 |
| 2018 Octubre | 4 | 2 | 6 |
| 2018 Septiembre | 6 | 0 | 6 |
| 2018 Febrero | 25 | 7 | 32 |
| 2018 Enero | 43 | 14 | 57 |
| 2017 Diciembre | 24 | 12 | 36 |
| 2017 Noviembre | 32 | 10 | 42 |
| 2017 Octubre | 26 | 10 | 36 |
| 2017 Septiembre | 28 | 14 | 42 |
| 2017 Agosto | 40 | 10 | 50 |
| 2017 Julio | 19 | 10 | 29 |
| 2017 Junio | 49 | 9 | 58 |
| 2017 Mayo | 57 | 31 | 88 |
| 2017 Abril | 10 | 26 | 36 |
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