Ciclosporin: An Old Ally in the Treatment of Chronic Spontaneous Urticaria

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Pinilla Martín, F. Tous Romero, F.J. Ortiz de Frutos" "autores" => array:3 [ 0 => array:4 [ "nombre" => "B." "apellidos" => "Pinilla Martín" "email" => array:1 [ 0 => "belenpinillamartin@gmail.com" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "F." "apellidos" => "Tous Romero" ] 2 => array:2 [ "nombre" => "F.J." "apellidos" => "Ortiz de Frutos" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Dermatología, Hospital Universitario 12 de Octubre, Madrid, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Ciclosporina: una vieja amiga en el tratamiento de la urticaria crónica espontánea" ] ] "textoCompleto" => "Since the introduction of omalizumab for the treatment of chronic spontaneous urticaria (CSU), it has been possible to control the disease in a high percentage of patients who had been refractory to treatment with high doses of antihistamines<a class="elsevierStyleCrossRef" href="#bib0005">1</a>. According to the most recent European guidelines<a class="elsevierStyleCrossRef" href="#bib0010">2</a>, treatment with ciclosporin is indicated in cases where omalizumab has already failed. In this indication, it is prescribed off-label, although it has traditionally been used for treatment of CSU<a class="elsevierStyleCrossRef" href="#bib0015">3</a>. Published data are scarce, and only 2 randomized clinical trials involving no more than 16 weeks<a class="elsevierStyleCrossRef" href="#bib0020">4</a> and 8 weeks<a class="elsevierStyleCrossRef" href="#bib0025">5</a> of treatment have been performed. Nevertheless, there are cohorts and case series of patients treated with this drug at low doses for longer periods (i.e., up to 10 years)<a class="elsevierStyleCrossRef" href="#bib0030">6</a>. We performed the present study to improve our knowledge of ciclosporin for treatment of CSU in patients whose therapy with omalizumab had already failed.We designed an observational, longitudinal, prospective study of patients diagnosed with CSU and treated with ciclosporin at our center. Previous treatment with omalizumab had failed. We recorded epidemiological and clinical data and assessed the severity of urticaria using the 7-day Urticaria Activity Score (UAS7d). We also recorded the dose of ciclosporin at different points during treatment (baseline, maximum dose, end of treatment), duration of treatment and follow-up, and adverse effects observed.Of a total of 38 patients who had received treatment with omalizumab, 3 (7.9%) did not respond to the biologic and were switched to ciclosporin (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>). The UAS7d score at initiation of treatment with ciclosporin was 24, 41, and 42. Ciclosporin was started at 3.8, 3.15, and 3.85 mg/kg/d, respectively. The disease was controlled (UAS7d < 7) in all 3 patients at the first month of treatment, thus making it possible to gradually taper the dose of ciclosporin without flare-ups before suspending it altogether after 5, 14, and 12 months, with doses ranging from 0.46 and 0.68 mg/kg/d. We recorded no recurrences of urticaria in any of the patients. Similarly, no relevant adverse effects were reported during follow-up.<elsevierMultimedia ident="tbl0005"></elsevierMultimedia>While ciclosporin has traditionally been used for treatment of CSU, no definitive regimens have been established. A meta-analysis published in 2017<a class="elsevierStyleCrossRef" href="#bib0035">7</a> analyzed various studies from the literature, including 2 clinical trials<a class="elsevierStyleCrossRefs" href="#bib0020">4,5</a>. The results indicate that ciclosporin is an effective treatment for CSU, although they are difficult to extrapolate to real life, since candidates for this approach have long-standing CSU that does not respond to omalizumab and often requires cycles of oral corticosteroids. We must go back to articles published before approval of omalizumab if we are to find regimens for affected patients in the medium term, without inducing the feared adverse effects of ciclosporin. Kessel and Toubi<a class="elsevierStyleCrossRef" href="#bib0030">6</a> performed a prospective study of 20 patients with CSU that could not be controlled with ciclosporin at 3 mg/kg/d for 3 months who received the drug at 1-2 mg/kg/d continuously until control was achieved. In 8 cases, the drug could be discontinued after 8-14 months of treatment; the remaining 12 patients continued to receive ciclosporin for 60-120 months without adverse effects.Boubouka et al.<a class="elsevierStyleCrossRef" href="#bib0040">8</a> reported similar results from their prospective study, in which a cohort of 30 patients with CSU received treatment with ciclosporin at doses ranging from 1.5 to 2.5 mg/kg/d depending on symptoms for 5 months. The disease was controlled in 88% of cases with a final dose of 0.55 mg/kg/d.Our experience indicates that ciclosporin is an option for treating CSU after failure of omalizumab. In our opinion, the most appropriate regimen (i.e., fewer adverse effects with the same efficacy) is an initial dose of 3-4 mg/kg/d until the disease is controlled, followed by gradual tapering to very low doses (<1 mg/kg/d)." "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Pinilla Martín B, Tous Romero F, Ortiz de Frutos FJ. Ciclosporina: una vieja amiga en el tratamiento de la urticaria crónica espontánea. Actas Dermosifiliogr. 2021. https://doi.org/10.1016/j.ad.2020.01.012" ] ] "multimedia" => array:1 [ 0 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Sex \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Age at onset, y \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Baseline UAS24 h \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Baseline UAS7 d \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Baseline dose, mg/kg \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">UAS24 h at 1 mo \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">UAS7d at 1 mo \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Final dose \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Duration of treatment, mo \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Duration of follow-up, mo \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Patient 1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Female \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">42 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">42 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3.85 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.68 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">12 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Patient 2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Female \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">44 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">41 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3.15 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">14 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; 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Letter to the Editor

Ciclosporin: An Old Ally in the Treatment of Chronic Spontaneous Urticaria

Ciclosporina: una vieja amiga en el tratamiento de la urticaria crónica espontánea

B. Pinilla Martín

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belenpinillamartin@gmail.com

Corresponding author.

, F. Tous Romero, F.J. Ortiz de Frutos

Servicio de Dermatología, Hospital Universitario 12 de Octubre, Madrid, Spain

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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Since the introduction of omalizumab for the treatment of chronic spontaneous urticaria &#40;CSU&#41;&#44; it has been possible to control the disease in a high percentage of patients who had been refractory to treatment with high doses of antihistamines<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46; According to the most recent European guidelines<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a>&#44; treatment with ciclosporin is indicated in cases where omalizumab has already failed&#46; In this indication&#44; it is prescribed off-label&#44; although it has traditionally been used for treatment of CSU<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a>&#46; Published data are scarce&#44; and only 2 randomized clinical trials involving no more than 16 weeks<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> and 8 weeks<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> of treatment have been performed&#46; Nevertheless&#44; there are cohorts and case series of patients treated with this drug at low doses for longer periods &#40;i&#46;e&#46;&#44; up to 10 years&#41;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a>&#46; We performed the present study to improve our knowledge of ciclosporin for treatment of CSU in patients whose therapy with omalizumab had already failed&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">We designed an observational&#44; longitudinal&#44; prospective study of patients diagnosed with CSU and treated with ciclosporin at our center&#46; Previous treatment with omalizumab had failed&#46; We recorded epidemiological and clinical data and assessed the severity of urticaria using the 7-day Urticaria Activity Score &#40;UAS7d&#41;&#46; We also recorded the dose of ciclosporin at different points during treatment &#40;baseline&#44; maximum dose&#44; end of treatment&#41;&#44; duration of treatment and follow-up&#44; and adverse effects observed&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Of a total of 38 patients who had received treatment with omalizumab&#44; 3 &#40;7&#46;9&#37;&#41; did not respond to the biologic and were switched to ciclosporin &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; The UAS7d score at initiation of treatment with ciclosporin was 24&#44; 41&#44; and 42&#46; Ciclosporin was started at 3&#46;8&#44; 3&#46;15&#44; and 3&#46;85&#8201;mg&#47;kg&#47;d&#44; respectively&#46; The disease was controlled &#40;UAS7d&#8201;&#60;&#8201;7&#41; in all 3 patients at the first month of treatment&#44; thus making it possible to gradually taper the dose of ciclosporin without flare-ups before suspending it altogether after 5&#44; 14&#44; and 12 months&#44; with doses ranging from 0&#46;46 and 0&#46;68&#8201;mg&#47;kg&#47;d&#46; We recorded no recurrences of urticaria in any of the patients&#46; Similarly&#44; no relevant adverse effects were reported during follow-up&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0020" class="elsevierStylePara elsevierViewall">While ciclosporin has traditionally been used for treatment of CSU&#44; no definitive regimens have been established&#46; A meta-analysis published in 2017<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> analyzed various studies from the literature&#44; including 2 clinical trials<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;5</span></a>&#46; The results indicate that ciclosporin is an effective treatment for CSU&#44; although they are difficult to extrapolate to real life&#44; since candidates for this approach have long-standing CSU that does not respond to omalizumab and often requires cycles of oral corticosteroids&#46; We must go back to articles published before approval of omalizumab if we are to find regimens for affected patients in the medium term&#44; without inducing the feared adverse effects of ciclosporin&#46; Kessel and Toubi<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> performed a prospective study of 20 patients with CSU that could not be controlled with ciclosporin at 3&#8201;mg&#47;kg&#47;d for 3 months who received the drug at 1-2&#8201;mg&#47;kg&#47;d continuously until control was achieved&#46; In 8 cases&#44; the drug could be discontinued after 8-14 months of treatment&#59; the remaining 12 patients continued to receive ciclosporin for 60-120 months without adverse effects&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Boubouka et al&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> reported similar results from their prospective study&#44; in which a cohort of 30 patients with CSU received treatment with ciclosporin at doses ranging from 1&#46;5 to 2&#46;5&#8201;mg&#47;kg&#47;d depending on symptoms for 5 months&#46; The disease was controlled in 88&#37; of cases with a final dose of 0&#46;55&#8201;mg&#47;kg&#47;d&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Our experience indicates that ciclosporin is an option for treating CSU after failure of omalizumab&#46; In our opinion&#44; the most appropriate regimen &#40;i&#46;e&#46;&#44; fewer adverse effects with the same efficacy&#41; is an initial dose of 3-4&#8201;mg&#47;kg&#47;d until the disease is controlled&#44; followed by gradual tapering to very low doses &#40;&#60;1&#8201;mg&#47;kg&#47;d&#41;&#46;</p></span>"
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Article information

ISSN: 15782190
Original language: English

DOI:10.1016/j.adengl.2021.07.002

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