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&#8805;21&#44; and a lack of response&#44; and intolerance or contraindication to treatment with cyclosporine&#46; None of the patients included started treatment within a clinical trial&#46; Patients were assessed by a clinician at baseline and 4 weeks after starting dupilumab&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The administration of dupilumab was started following the indications set forth in a data sheet&#46; Patients who were on other systemic treatments for AD when they started dupilumab&#44; continued to receive this treatment during the study follow-up&#44; without any dosage changes&#46; Topical emollients&#44; corticosteroids or calcineurin inhibitors were maintained&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">The statistical analysis was performed using IBM SPSS 22&#46;0 &#40;IBM SPSS Statistics Base&#41; software&#44; as shown in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">A total of 24 patients &#40;17 men and 7 women&#41; were included&#46; All patients had severe AD at baseline&#44; defined as an EASI &#8805;21&#44; SCORAD &#8805;50&#44; BSA &#8805;10&#44; and PGA &#8805;3&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Other allergic disesases were reported by 17 patients &#40;70&#46;8&#37;&#41;&#44; with allergic rhinitis being the most frequent &#40;70&#46;8&#37;&#41;&#44; followed by allergic conjuntivitis &#40;62&#46;5&#37;&#41;&#44; bronchial asthma &#40;45&#46;8&#37;&#41;&#44; food allergies &#40;29&#46;2&#37;&#41; and nasal polyposis &#40;8&#46;3&#37;&#41;&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">The mean of previous systemic treatments was 3&#46;54 drugs&#44; with 19 patients &#40;79&#46;2&#37;&#41; undergoing three or more previous systemic treatments&#46; All patients had used oral corticosteroids and cyclosporine in the past&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">A total of 11 patients &#40;45&#46;8&#37;&#41; were undergoing systemic treatment for AD when they started dupilumab&#44; 5 of whom &#40;20&#46;8&#37;&#41; were on corticosteroids&#44; 5 &#40;20&#46;8&#37;&#41; on cyclosporine and 1 &#40;4&#46;1&#37;&#41; on azathioprine&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">After 4 weeks on dupilumab&#44; a statistically significant improvement was observed in all the measured variables as shown in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Variables NRS-itch and NRS-sleep were measured on a daily basis&#44; obtaining a weekly mean shown in <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#46; An improvement in itching and sleep quality was observed since the first week of treatment&#44; achieving statistical significance on weeks 2&#44; 3 and 4&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0060" class="elsevierStylePara elsevierViewall">These results are similar to those from other studies published in clinical trials and real-world studies&#46;<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">2&#44;3</span></a> It remarkable that variables related to quality of life such as NRS-itch&#44; NRS-sleep&#44; or DLQI achieved a faster and greater improvement vs other variables measuring the severity of skin disease such as POEM&#44; EASI or SCORAD&#44; as seen in <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Given that a 4-week washout period of systemic immunosuppressive drugs went by in dupilumab pivotal clinical trials&#44; it is unknown how to transition between classic systemic treatments for AD and dupilumab under real-world clinical practice conditions in which no washout periods are undertaken&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Following different author&#39;s proposals&#44;<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">4&#44;5</span></a> in our sample&#44; all patients on a classic immunosuppressant when dupilumab was started &#40;11&#47;24&#44; 45&#46;8&#37;&#41; went on with it without any dose changes within the first 4 weeks of treatment&#46; 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                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\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&nbsp;\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">Week 4&nbsp;\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"><span class="elsevierStyleItalic">p</span> value&nbsp;\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">Test&nbsp;\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">EASI&#44; median &#40;IQR&#41;&nbsp;\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">26 &#40;22&#46;75&#8211;29&#41;&nbsp;\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 &#40;10&#8211;16&#46;25&#41;&nbsp;\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="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleBold">&#60;0&#46;001</span>&nbsp;\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">&#40;c&#41;&nbsp;\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">SCORAD&#44; mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>SD&nbsp;\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">60&#46;19<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>10&#46;77&nbsp;\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">38&#46;36<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>12&#46;88&nbsp;\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="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleBold">&#60;0&#46;001</span>&nbsp;\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">&#40;a&#41;&nbsp;\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">PGA&#44; median &#40;IQR&#41;&nbsp;\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 &#40;4&#8211;4&#41;&nbsp;\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">2 &#40;2&#8211;3&#41;&nbsp;\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="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleBold">&#60;0&#46;001</span>&nbsp;\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">&#40;c&#41;&nbsp;\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">BSA&#44; median &#40;IQR&#41;&nbsp;\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">23 &#40;13&#46;5&#8211;61&#46;25&#41;&nbsp;\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">10&#46;5 &#40;7&#46;75&#8211;35&#41;&nbsp;\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="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleBold">0&#46;012</span>&nbsp;\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">&#40;c&#41;&nbsp;\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">NRS-itch&#44; median &#40;IQR&#41;&nbsp;\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">8 &#40;5&#46;7&#8211;9&#41;&nbsp;\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">2&#46;5 &#40;1&#46;9&#8211;4&#41;&nbsp;\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="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleBold">&#60;0&#46;001</span>&nbsp;\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">&#40;c&#41;&nbsp;\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">NRS-sleep&#44; median &#40;IQR&#41;&nbsp;\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">8 &#40;6&#46;75&#8211;9&#46;25&#41;&nbsp;\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">2 &#40;0&#46;75&#8211;4&#46;25&#41;&nbsp;\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="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleBold">&#60;0&#46;001</span>&nbsp;\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">&#40;c&#41;&nbsp;\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">POEM&#44; median &#40;IQR&#41;&nbsp;\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">23 &#40;18&#8211;25&#46;5&#41;&nbsp;\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">10&#46;5 &#40;9&#8211;13&#46;25&#41;&nbsp;\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="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleBold">&#60;0&#46;001</span>&nbsp;\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">&#40;c&#41;&nbsp;\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">DLQI&#44; mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>SD&nbsp;\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">15&#46;79<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>6&nbsp;\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">8&#46;29<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;95&nbsp;\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="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleBold">&#60;0&#46;001</span>&nbsp;\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">&#40;a&#41;&nbsp;\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">Serum total IgE &#40;IU&#47;mL&#41;&#44; median &#40;IQR&#41;&nbsp;\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">1553 &#40;342&#46;75&#8211;6169&#46;25&#41;&nbsp;\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">446&#46;5 &#40;225&#8211;2735&#46;75&#41;&nbsp;\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="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;942&nbsp;\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">&#40;c&#41;&nbsp;\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">Serum LDH &#40;U&#47;L&#41;&#44; mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>SD&nbsp;\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">263&#46;83<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>72&#46;63&nbsp;\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">231&#46;33<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>74&#46;29&nbsp;\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="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;516&nbsp;\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">&#40;c&#41;&nbsp;\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">Total serum eosinophil count &#40;10<span class="elsevierStyleSup">3</span><span class="elsevierStyleHsp" style=""></span>&#956;&#47;L&#41;&#44; median &#40;IQR&#41;&nbsp;\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&#46;41 &#40;0&#46;21&#8211;0&#46;65&#41;&nbsp;\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&#46;3 &#40;0&#46;19&#8211;0&#46;8&#41;&nbsp;\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="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleBold">&#60;0&#46;001</span>&nbsp;\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">&#40;a&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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        "descripcion" => array:1 [
          "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Comparison of clinical and analytical variables at baseline and after 4 weeks of treatment with dupilumab&#46;</p>"
        ]
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      "titulo" => "References"
      "seccion" => array:1 [
        0 => array:2 [
          "identificador" => "bibs0015"
          "bibliografiaReferencia" => array:5 [
            0 => array:3 [
              "identificador" => "bib0030"
              "etiqueta" => "1"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "The psychology of atopic dermatitis"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:2 [
                            0 => "A&#46; Courtney"
                            1 => "J&#46;C&#46; Su"
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                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.3390/jcm13061602"
                      "Revista" => array:5 [
                        "tituloSerie" => "J Clin Med"
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Case and Research Letter
Early Impact of Dupilumab in Disease Severity and Quality of Life of Patients Affected by Moderate-to-severe Atopic Dermatitis: A Prospective Study
Impacto temprano de dupilumab en la severidad y la calidad de vida de pacientes afectados por dermatitis atópica modera-severa: un estudio prospectivo
G.G. Garriga-Martinaa, J.A. Suárez-Péreza,b,
Corresponding author
jorgealonsosuarez@gmail.com

Corresponding author.
, E.A. Martínez-Garcíaa, E. Herrera-Acostaa,b
a Servicio de Dermatología, Hospital Clínico Virgen de la Victoria, Malaga, Spain
b Universidad de Málaga, Málaga, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The main symptom of atopic dermatitis &#40;AD&#41; is itching&#44; which can affect the patients&#8217; quality of life&#44; preventing a good night sleep and negatively affecting the patients&#8217; work or academic productivity&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The main aim of this study was to assess the early safety&#44; efficacy&#44; and improvement of quality of life of dupilumab in adult patients with severe AD within the first 4 weeks of treatment&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">We conducted a prospective study including all patients who started dupilumab from February 2020 through January 2021 in a single center in Spain&#46; The inclusion criteria were&#58; patients older than 18 years with a baseline Eczema Area and Severity Index &#40;EASI&#41; &#8805;21&#44; and a lack of response&#44; and intolerance or contraindication to treatment with cyclosporine&#46; None of the patients included started treatment within a clinical trial&#46; Patients were assessed by a clinician at baseline and 4 weeks after starting dupilumab&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The administration of dupilumab was started following the indications set forth in a data sheet&#46; Patients who were on other systemic treatments for AD when they started dupilumab&#44; continued to receive this treatment during the study follow-up&#44; without any dosage changes&#46; Topical emollients&#44; corticosteroids or calcineurin inhibitors were maintained&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">The statistical analysis was performed using IBM SPSS 22&#46;0 &#40;IBM SPSS Statistics Base&#41; software&#44; as shown in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">A total of 24 patients &#40;17 men and 7 women&#41; were included&#46; All patients had severe AD at baseline&#44; defined as an EASI &#8805;21&#44; SCORAD &#8805;50&#44; BSA &#8805;10&#44; and PGA &#8805;3&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Other allergic disesases were reported by 17 patients &#40;70&#46;8&#37;&#41;&#44; with allergic rhinitis being the most frequent &#40;70&#46;8&#37;&#41;&#44; followed by allergic conjuntivitis &#40;62&#46;5&#37;&#41;&#44; bronchial asthma &#40;45&#46;8&#37;&#41;&#44; food allergies &#40;29&#46;2&#37;&#41; and nasal polyposis &#40;8&#46;3&#37;&#41;&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">The mean of previous systemic treatments was 3&#46;54 drugs&#44; with 19 patients &#40;79&#46;2&#37;&#41; undergoing three or more previous systemic treatments&#46; All patients had used oral corticosteroids and cyclosporine in the past&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">A total of 11 patients &#40;45&#46;8&#37;&#41; were undergoing systemic treatment for AD when they started dupilumab&#44; 5 of whom &#40;20&#46;8&#37;&#41; were on corticosteroids&#44; 5 &#40;20&#46;8&#37;&#41; on cyclosporine and 1 &#40;4&#46;1&#37;&#41; on azathioprine&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">After 4 weeks on dupilumab&#44; a statistically significant improvement was observed in all the measured variables as shown in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Variables NRS-itch and NRS-sleep were measured on a daily basis&#44; obtaining a weekly mean shown in <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#46; An improvement in itching and sleep quality was observed since the first week of treatment&#44; achieving statistical significance on weeks 2&#44; 3 and 4&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0060" class="elsevierStylePara elsevierViewall">These results are similar to those from other studies published in clinical trials and real-world studies&#46;<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">2&#44;3</span></a> It remarkable that variables related to quality of life such as NRS-itch&#44; NRS-sleep&#44; or DLQI achieved a faster and greater improvement vs other variables measuring the severity of skin disease such as POEM&#44; EASI or SCORAD&#44; as seen in <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Given that a 4-week washout period of systemic immunosuppressive drugs went by in dupilumab pivotal clinical trials&#44; it is unknown how to transition between classic systemic treatments for AD and dupilumab under real-world clinical practice conditions in which no washout periods are undertaken&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Following different author&#39;s proposals&#44;<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">4&#44;5</span></a> in our sample&#44; all patients on a classic immunosuppressant when dupilumab was started &#40;11&#47;24&#44; 45&#46;8&#37;&#41; went on with it without any dose changes within the first 4 weeks of treatment&#46; None of them presented an initial exacerbation of AD&#46; No negative impact in terms of safety was seen either&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">Among the limitations of this study&#44; those derived from the small sample size and short follow-up period are most notable&#46; Studies conducted in the routine clinical practice with a larger number of patients and longer follow-up time will be necessary to evaluate the long-term effectiveness of dupilumab and establish differences between subgroups of patients&#46; Among the study strengths&#44; we can highlight its prospective design and the multiple scores and variables analyzed&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interests</span><p id="par0080" class="elsevierStylePara elsevierViewall">The authors state that they have no conflict of interests&#46;</p></span></span>"
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      0 => array:7 [
        "identificador" => "fig0005"
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Weekly progression of itching and sleep using the NRS-itch and NRS-sleep scales&#46; Baseline measurements were compared with the weekly means obtained from the daily measurements of both variables&#46; Bonferroni correction was used considering <span class="elsevierStyleItalic">p</span> values &#60;0&#46;005 statistically significant&#46;</p>"
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          "leyenda" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">IQR&#58; interquartile range&#59; SD&#58; standard deviation&#59; EASI&#58; Eczema Area and Severity Index&#59; SCORAD&#58; scoring atopic dermatitis&#59; PGA&#58; physician global assesment&#59; BSA&#58; body surface area&#59; NRS&#58; numerical rating scale&#59; POEM&#58; patient-oriented eczema measure&#59; DLQI&#58; Dermatology Life Quality Index&#59; IgE&#58; immunoglobulin E&#59; LDH&#58; lactate dehydrogenase&#46;</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">&#40;a&#41; Student&#39;s <span class="elsevierStyleItalic">t</span>-test assuming homogeneity of variances&#59; &#40;b&#41; Student&#39;s <span class="elsevierStyleItalic">t</span>-test when homogeneity of variances is not met&#59; &#40;c&#41; Mann&#8211;Whitney&#8211;Wilcoxon <span class="elsevierStyleItalic">U</span> test&#46;</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Bold values are the statistically significant variables &#40;<span class="elsevierStyleItalic">p</span> &#60; 0&#46;05&#41;&#46;</p>"
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                  \t\t\t\t">&#40;a&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">PGA&#44; median &#40;IQR&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleBold">&#60;0&#46;001</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">BSA&#44; median &#40;IQR&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">NRS-itch&#44; median &#40;IQR&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">NRS-sleep&#44; median &#40;IQR&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">2 &#40;0&#46;75&#8211;4&#46;25&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">POEM&#44; median &#40;IQR&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">23 &#40;18&#8211;25&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleBold">&#60;0&#46;001</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Serum total IgE &#40;IU&#47;mL&#41;&#44; median &#40;IQR&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">446&#46;5 &#40;225&#8211;2735&#46;75&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#46;41 &#40;0&#46;21&#8211;0&#46;65&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0&#46;3 &#40;0&#46;19&#8211;0&#46;8&#41;&nbsp;\t\t\t\t\t\t\n
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Article information
ISSN: 00017310
Original language: English
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