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quality of life&#44; disease activity&#44; or control perceived by the patient&#46; Scales present a moderate correlation between them &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;301&#8211;0&#46;501&#41;&#44;<a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">3&#44;4</span></a> but in some cases&#44; discrepancies could lead to different choices at switching antihistamine drug therapy to omalizumab&#46; Recently&#44; the EAACI&#47;GA<span class="elsevierStyleSup">2</span>LEN&#47;EuroGuiDerm&#47;APAAACI guide<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> recommends the Urticaria Control Test &#40;UCT&#41; as the parameter for pharmacological decisions&#44; which is based on the patient perception of control in the last month&#44; replacing the previous recommendation of use UAS7 &#40;Urticaria Activity Score&#41; which considers the activity of the disease in the last week according to the intensity and frequency of the symptoms&#46; Since these two tools have different parameters&#44; &#8220;control&#8221; definition is also different&#44; and this have implications for the decisions in treatment changes&#46; These choices can have a great impact in health system&#44; especially for economic burden since it may involve the transition from a relatively low-cost and affordable therapy &#40;antihistamines&#41; to a substantially more expensive one &#40;omalizumab&#41;&#44; especially in low-middle income countries&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Here&#44; we evaluated the frequency of omalizumab indication according to UAS7&#44; or the UCT&#46; Additionally&#44; we evaluated the frequency of control achieved with omalizumab according to the different scales&#46; These results will explore the impact of these changes from a social cost perspective&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">We selected patients with CSU who required the use of top-dose antihistamines &#40;four times the conventional dose&#41;&#44; and we evaluated the level of control according to UAS7 and UCT&#46; After at least one month with antihistamines&#44; those patients who according to some of these two scales have not control &#40;UAS7<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>6 points&#44; UCT<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>12 points&#41; were treated with omalizumab at dose of 300<span class="elsevierStyleHsp" style=""></span>mg per month and follow-up by 6 months&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Patients were recruited during 2020&#8211;2021 for the URTICA cohort from 3 different centers in Colombia&#46; Patients were older than 12 years&#44; with a diagnosis of chronic urticaria according to international guidelines&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> Exclusion criteria were systemic disease presentation that could explain the hives and systemic steroids usage during the last 3 weeks before recruitment or any other therapy that could interfere with the evaluation of symptoms&#46; Patients with only angioedema were excluded&#46; This study was approved by the Ethics Committee of IPS Universitaria Clinics and the University of Antioquia &#40;registry no&#46; BE-IIM 200910 and no&#46; IN13-2013&#44; respectively&#41;&#46; All subjects or their legal guardian &#40;younger than 18 years&#41; signed an informed consent approving their voluntary participation in the study&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Statistical analyses were done using SPSS version 26&#46;0 &#40;SPSS Inc&#44; Chicago&#44; Ill&#41; and PRISMA version 9&#46; Total number and proportions were reported for categorical data&#46; Frequency rates and their 95&#37; CIs were obtained&#46; Mann&#8211;Whitney <span class="elsevierStyleItalic">U</span> test was used for comparison of continuous variables at baseline and patients with omalizumab after six months&#46; Differences between proportions were analyzed by Pearson chi-square test &#40;or McNemar test when appropriate&#41;&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Four-hundred-twenty patients were included &#40;mean age&#58; 47 years&#44; range 16&#8211;68&#59; <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>300 &#40;71&#46;4&#37;&#41; females&#41;&#46; The mean UAS7 was 13&#46;2 points &#40;SD 10&#46;8&#41; and UCT was 9&#46;7 &#40;SD 4&#41;&#46; Low and high points in UAS7 and UCT indicates control respectively&#59; the two scales were inversely correlated &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#8722;0&#46;370&#59; &#8722;0&#46;280 to &#8722;0&#46;451 95&#37; CI&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46; Both agreed on the decision to administer omalizumab &#40;20&#46;2&#37;&#41; or not &#40;40&#46;9&#37;&#41; in 257 patients &#40;61&#46;1&#37;&#41;&#46; With UCT&#44; the need for omalizumab was significantly more frequent than with UAS7 &#40;276 &#40;65&#46;7&#37;&#41; vs 231 &#40;55&#37;&#41; &#40;difference 10&#46;7&#37;&#44; 95&#37; CI 7&#46;6&#8211;14&#46;5&#37;&#59; <span class="elsevierStyleItalic">p</span> 0&#46;01&#41;&#46; The use of only the UCT to determine the use or not of omalizumab generates an increase in its indication of 10&#46;7&#37;&#44; which could significantly increase spending for the health system&#46; On the contrary&#44; the use of the two scales could reduce this cost and would allow the therapy to be selected in patients who are more inclined to receive it&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">A total of 335 &#40;79&#46;7&#37;&#41; patients have indication of omalizumab according UAS7 or UCT &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41; but 292 patients decided not to receive it&#58; The reasons for not receiving omalizumab were&#58; patient considers not needing omalizumab because considers himself&#47;herself controlled &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>150&#44; 51&#46;3&#37;&#41;&#44; logistic barriers &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>72&#44; 24&#46;6&#37;&#41;&#44; fears related to the drug or the way of application &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>36&#44; 12&#46;3&#37;&#41;&#44; other reasons &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>34&#44; 11&#46;6&#37;&#41;&#46; In Colombia&#44; all patients within the general health plan that covers 98&#37; of the population have free access to omalizumab&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">Forty-three patients agreed to receive omalizumab&#59; 35 had indication according UAS7 and 30 according to UCT&#46; After omalizumab&#44; 20 &#40;46&#46;5&#37;&#41; additional patients have control with UAS7 and 22 &#40;51&#46;1&#37;&#41; with UCT&#46; There was not statistically or clinically significant difference in the net benefit of control obtained using either scale for the evaluation of clinical control with omalizumab &#40;20 vs 22&#58; net difference 2 of 43 &#40;4&#46;6&#37;&#41;&#44; <span class="elsevierStyleItalic">p</span> 0&#46;3&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0045" class="elsevierStylePara elsevierViewall">Clinimetric scales are useful for patient follow-up and decision-making&#46; Other aspects besides disease activity &#40;e&#46;g&#46;&#44; patients&#8217; perspective&#41; have become important to define the control of the disease and recently&#44; some guidelines suggest the replacement the UAS7 for UCT to take treatment decisions about pharmacotherapy in urticaria&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> UCT has the advantages over the UAS7 that it considers the patient&#39;s perception of the impact of the disease on daily activities&#46; In addition&#44; the UAS7 requires a 7-day evaluation&#44; which often makes it difficult to perform it correctly&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">However&#44; according to our results&#44; this change could have an impact on the health system since with the use of UCT there is an increase in the indication of omalizumab&#44; hence a higher cost in health system&#46; The evaluation between the cost of therapies and their benefit is a relevant issue in decision-making especially for health care regulation&#46; In our study a high number of patients preferred not to use omalizumab even though had no control according one of the scales&#59; the majority of those who agreed to use omalizumab presented lack of control according both UAS7 and UCT&#46; Each scale evaluates a specific aspect&#44; and our results indicate the need to evaluate multiple parameters&#44; to better recognize patient&#39;s preferences before starting a new therapy&#46; These could result in a reduction of unnecessary treatments with a benefit for the patient and health system&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">In conclusion&#44; among CSU patients who use high doses of antihistamines the UCT identifies a greater number of patients requiring omalizumab over UAS7&#46; It is necessary to evaluate the control of the patient from different aspects to define if the benefit obtained justifies the higher cost&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interest</span><p id="par0060" class="elsevierStylePara elsevierViewall">The authors declare they have no conflict of interest&#46;</p></span></span>"
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Case and Research Letter
Indication of Omalizumab for Chronic Urticaria Using the ‘Urticaria Control Test’ Instead of ‘Urticaria Activity Score’: Possible Impact for Health Systems
Indicación de omalizumab para la urticaria crónica utilizando el Urticaria Control Test en lugar del Urticaria Activity Score: posibles repercusiones en los sistemas sanitarios
J. Sáncheza,
Autor para correspondencia
jorgem.sanchez@udea.edu.co

Corresponding author.
, L. Alvarezb, J.F. Lópeza
a Group of Clinical and Experimental Allergy, University of Antioquia, IPSU Clinic, Medellín, Colombia
b Pharmacoeconomic Evaluation Group, SURA Company, Colombia
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          "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Indication of omalizumab and control according to UAS7 and UCT&#46; UAS7 control<span class="elsevierStyleHsp" style=""></span>&#8804;<span class="elsevierStyleHsp" style=""></span>6 points&#59; UCT control<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>12 points&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Chronic spontaneous urticaria &#40;CSU&#41; is a disease with a high impact on patients and relatives&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a> Studies in France and Germany suggest that the estimated cost generated by pharmacological treatment is around 900&#8211;3000<span class="elsevierStyleHsp" style=""></span>dollars&#47;year per person&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a> The use of antihistamines in conventional or higher doses allows control in 20&#8211;70&#37; of patients and when a therapeutic failure occurs&#44; the use of omalizumab and&#47;or cyclosporine provides an additional 30&#8211;40&#37; of control&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> The measures to define control with these treatments use different parameters&#58; quality of life&#44; disease activity&#44; or control perceived by the patient&#46; Scales present a moderate correlation between them &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;301&#8211;0&#46;501&#41;&#44;<a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">3&#44;4</span></a> but in some cases&#44; discrepancies could lead to different choices at switching antihistamine drug therapy to omalizumab&#46; Recently&#44; the EAACI&#47;GA<span class="elsevierStyleSup">2</span>LEN&#47;EuroGuiDerm&#47;APAAACI guide<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> recommends the Urticaria Control Test &#40;UCT&#41; as the parameter for pharmacological decisions&#44; which is based on the patient perception of control in the last month&#44; replacing the previous recommendation of use UAS7 &#40;Urticaria Activity Score&#41; which considers the activity of the disease in the last week according to the intensity and frequency of the symptoms&#46; Since these two tools have different parameters&#44; &#8220;control&#8221; definition is also different&#44; and this have implications for the decisions in treatment changes&#46; These choices can have a great impact in health system&#44; especially for economic burden since it may involve the transition from a relatively low-cost and affordable therapy &#40;antihistamines&#41; to a substantially more expensive one &#40;omalizumab&#41;&#44; especially in low-middle income countries&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Here&#44; we evaluated the frequency of omalizumab indication according to UAS7&#44; or the UCT&#46; Additionally&#44; we evaluated the frequency of control achieved with omalizumab according to the different scales&#46; These results will explore the impact of these changes from a social cost perspective&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">We selected patients with CSU who required the use of top-dose antihistamines &#40;four times the conventional dose&#41;&#44; and we evaluated the level of control according to UAS7 and UCT&#46; After at least one month with antihistamines&#44; those patients who according to some of these two scales have not control &#40;UAS7<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>6 points&#44; UCT<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>12 points&#41; were treated with omalizumab at dose of 300<span class="elsevierStyleHsp" style=""></span>mg per month and follow-up by 6 months&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Patients were recruited during 2020&#8211;2021 for the URTICA cohort from 3 different centers in Colombia&#46; Patients were older than 12 years&#44; with a diagnosis of chronic urticaria according to international guidelines&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> Exclusion criteria were systemic disease presentation that could explain the hives and systemic steroids usage during the last 3 weeks before recruitment or any other therapy that could interfere with the evaluation of symptoms&#46; Patients with only angioedema were excluded&#46; This study was approved by the Ethics Committee of IPS Universitaria Clinics and the University of Antioquia &#40;registry no&#46; BE-IIM 200910 and no&#46; IN13-2013&#44; respectively&#41;&#46; All subjects or their legal guardian &#40;younger than 18 years&#41; signed an informed consent approving their voluntary participation in the study&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Statistical analyses were done using SPSS version 26&#46;0 &#40;SPSS Inc&#44; Chicago&#44; Ill&#41; and PRISMA version 9&#46; Total number and proportions were reported for categorical data&#46; Frequency rates and their 95&#37; CIs were obtained&#46; Mann&#8211;Whitney <span class="elsevierStyleItalic">U</span> test was used for comparison of continuous variables at baseline and patients with omalizumab after six months&#46; Differences between proportions were analyzed by Pearson chi-square test &#40;or McNemar test when appropriate&#41;&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Four-hundred-twenty patients were included &#40;mean age&#58; 47 years&#44; range 16&#8211;68&#59; <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>300 &#40;71&#46;4&#37;&#41; females&#41;&#46; The mean UAS7 was 13&#46;2 points &#40;SD 10&#46;8&#41; and UCT was 9&#46;7 &#40;SD 4&#41;&#46; Low and high points in UAS7 and UCT indicates control respectively&#59; the two scales were inversely correlated &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#8722;0&#46;370&#59; &#8722;0&#46;280 to &#8722;0&#46;451 95&#37; CI&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46; Both agreed on the decision to administer omalizumab &#40;20&#46;2&#37;&#41; or not &#40;40&#46;9&#37;&#41; in 257 patients &#40;61&#46;1&#37;&#41;&#46; With UCT&#44; the need for omalizumab was significantly more frequent than with UAS7 &#40;276 &#40;65&#46;7&#37;&#41; vs 231 &#40;55&#37;&#41; &#40;difference 10&#46;7&#37;&#44; 95&#37; CI 7&#46;6&#8211;14&#46;5&#37;&#59; <span class="elsevierStyleItalic">p</span> 0&#46;01&#41;&#46; The use of only the UCT to determine the use or not of omalizumab generates an increase in its indication of 10&#46;7&#37;&#44; which could significantly increase spending for the health system&#46; On the contrary&#44; the use of the two scales could reduce this cost and would allow the therapy to be selected in patients who are more inclined to receive it&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">A total of 335 &#40;79&#46;7&#37;&#41; patients have indication of omalizumab according UAS7 or UCT &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41; but 292 patients decided not to receive it&#58; The reasons for not receiving omalizumab were&#58; patient considers not needing omalizumab because considers himself&#47;herself controlled &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>150&#44; 51&#46;3&#37;&#41;&#44; logistic barriers &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>72&#44; 24&#46;6&#37;&#41;&#44; fears related to the drug or the way of application &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>36&#44; 12&#46;3&#37;&#41;&#44; other reasons &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>34&#44; 11&#46;6&#37;&#41;&#46; In Colombia&#44; all patients within the general health plan that covers 98&#37; of the population have free access to omalizumab&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">Forty-three patients agreed to receive omalizumab&#59; 35 had indication according UAS7 and 30 according to UCT&#46; After omalizumab&#44; 20 &#40;46&#46;5&#37;&#41; additional patients have control with UAS7 and 22 &#40;51&#46;1&#37;&#41; with UCT&#46; There was not statistically or clinically significant difference in the net benefit of control obtained using either scale for the evaluation of clinical control with omalizumab &#40;20 vs 22&#58; net difference 2 of 43 &#40;4&#46;6&#37;&#41;&#44; <span class="elsevierStyleItalic">p</span> 0&#46;3&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0045" class="elsevierStylePara elsevierViewall">Clinimetric scales are useful for patient follow-up and decision-making&#46; Other aspects besides disease activity &#40;e&#46;g&#46;&#44; patients&#8217; perspective&#41; have become important to define the control of the disease and recently&#44; some guidelines suggest the replacement the UAS7 for UCT to take treatment decisions about pharmacotherapy in urticaria&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> UCT has the advantages over the UAS7 that it considers the patient&#39;s perception of the impact of the disease on daily activities&#46; In addition&#44; the UAS7 requires a 7-day evaluation&#44; which often makes it difficult to perform it correctly&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">However&#44; according to our results&#44; this change could have an impact on the health system since with the use of UCT there is an increase in the indication of omalizumab&#44; hence a higher cost in health system&#46; The evaluation between the cost of therapies and their benefit is a relevant issue in decision-making especially for health care regulation&#46; In our study a high number of patients preferred not to use omalizumab even though had no control according one of the scales&#59; the majority of those who agreed to use omalizumab presented lack of control according both UAS7 and UCT&#46; Each scale evaluates a specific aspect&#44; and our results indicate the need to evaluate multiple parameters&#44; to better recognize patient&#39;s preferences before starting a new therapy&#46; These could result in a reduction of unnecessary treatments with a benefit for the patient and health system&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">In conclusion&#44; among CSU patients who use high doses of antihistamines the UCT identifies a greater number of patients requiring omalizumab over UAS7&#46; It is necessary to evaluate the control of the patient from different aspects to define if the benefit obtained justifies the higher cost&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interest</span><p id="par0060" class="elsevierStylePara elsevierViewall">The authors declare they have no conflict of interest&#46;</p></span></span>"
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ISSN: 00017310
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