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
Corresponding author
Servicio de Dermatología, Hospital Universitario de La Princesa, Madrid, España
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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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Silvestre" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1111/jdv.12450" "Revista" => array:6 [ "tituloSerie" => "J Eur Acad Dermatol Venereol" "fecha" => "2015" "volumen" => "29" "paginaInicial" => "1027" "paginaFinal" => "1028" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/24629127" "web" => "Medline" ] ] ] ] ] ] ] ] 6 => array:3 [ "identificador" => "bib0070" "etiqueta" => "7" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "S.J. Teach" 1 => "M.A. Gill" 2 => "A. Togias" 3 => "C.A. Sorkness" 4 => "S.J. Arbes Jr." 5 => "A. Calatroni" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.jaci.2015.09.008" "Revista" => array:6 [ "tituloSerie" => "J Allergy Clin Immunol" "fecha" => "2015" "volumen" => "136" "paginaInicial" => "1476" "paginaFinal" => "1485" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/26518090" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/15782190/0000010800000004/v1_201704280927/S1578219017300604/v1_201704280927/en/main.assets" "Apartado" => array:4 [ "identificador" => "6157" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Case and Research Letters" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/15782190/0000010800000004/v1_201704280927/S1578219017300604/v1_201704280927/en/main.pdf?idApp=UINPBA000044&text.app=https://actasdermo.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1578219017300604?idApp=UINPBA000044" ]
| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 13 | 12 | 25 |
| 2024 October | 105 | 45 | 150 |
| 2024 September | 112 | 46 | 158 |
| 2024 August | 132 | 75 | 207 |
| 2024 July | 110 | 34 | 144 |
| 2024 June | 129 | 40 | 169 |
| 2024 May | 149 | 45 | 194 |
| 2024 April | 126 | 43 | 169 |
| 2024 March | 89 | 44 | 133 |
| 2024 February | 71 | 34 | 105 |
| 2024 January | 79 | 29 | 108 |
| 2023 December | 87 | 21 | 108 |
| 2023 November | 95 | 26 | 121 |
| 2023 October | 83 | 18 | 101 |
| 2023 September | 98 | 25 | 123 |
| 2023 August | 44 | 15 | 59 |
| 2023 July | 71 | 28 | 99 |
| 2023 June | 83 | 28 | 111 |
| 2023 May | 60 | 21 | 81 |
| 2023 April | 64 | 29 | 93 |
| 2023 March | 63 | 32 | 95 |
| 2023 February | 47 | 29 | 76 |
| 2023 January | 68 | 38 | 106 |
| 2022 December | 91 | 36 | 127 |
| 2022 November | 32 | 35 | 67 |
| 2022 October | 29 | 22 | 51 |
| 2022 September | 24 | 45 | 69 |
| 2022 August | 44 | 49 | 93 |
| 2022 July | 37 | 45 | 82 |
| 2022 June | 24 | 25 | 49 |
| 2022 May | 48 | 47 | 95 |
| 2022 April | 40 | 49 | 89 |
| 2022 March | 69 | 70 | 139 |
| 2022 February | 50 | 32 | 82 |
| 2022 January | 69 | 39 | 108 |
| 2021 December | 49 | 46 | 95 |
| 2021 November | 46 | 44 | 90 |
| 2021 October | 53 | 54 | 107 |
| 2021 September | 45 | 30 | 75 |
| 2021 August | 48 | 28 | 76 |
| 2021 July | 39 | 28 | 67 |
| 2021 June | 55 | 35 | 90 |
| 2021 May | 58 | 49 | 107 |
| 2021 April | 116 | 69 | 185 |
| 2021 March | 71 | 23 | 94 |
| 2021 February | 76 | 23 | 99 |
| 2021 January | 33 | 19 | 52 |
| 2020 December | 28 | 20 | 48 |
| 2020 November | 34 | 25 | 59 |
| 2020 October | 38 | 13 | 51 |
| 2020 September | 50 | 22 | 72 |
| 2020 August | 30 | 19 | 49 |
| 2020 July | 35 | 14 | 49 |
| 2020 June | 28 | 36 | 64 |
| 2020 May | 14 | 9 | 23 |
| 2020 April | 35 | 20 | 55 |
| 2020 March | 32 | 13 | 45 |
| 2020 February | 7 | 0 | 7 |
| 2019 December | 4 | 0 | 4 |
| 2019 November | 4 | 0 | 4 |
| 2019 September | 7 | 0 | 7 |
| 2019 August | 8 | 0 | 8 |
| 2019 July | 7 | 0 | 7 |
| 2019 June | 4 | 0 | 4 |
| 2019 May | 5 | 0 | 5 |
| 2019 April | 20 | 2 | 22 |
| 2019 March | 3 | 0 | 3 |
| 2019 February | 5 | 0 | 5 |
| 2019 January | 3 | 0 | 3 |
| 2018 December | 9 | 0 | 9 |
| 2018 November | 14 | 0 | 14 |
| 2018 October | 4 | 2 | 6 |
| 2018 September | 6 | 0 | 6 |
| 2018 February | 25 | 7 | 32 |
| 2018 January | 43 | 14 | 57 |
| 2017 December | 24 | 12 | 36 |
| 2017 November | 32 | 10 | 42 |
| 2017 October | 26 | 10 | 36 |
| 2017 September | 28 | 14 | 42 |
| 2017 August | 40 | 10 | 50 |
| 2017 July | 19 | 10 | 29 |
| 2017 June | 49 | 9 | 58 |
| 2017 May | 57 | 31 | 88 |
| 2017 April | 10 | 26 | 36 |
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