Bilastine in Refractory Chronic Spontaneous Urticaria: Disease Control and Cytokine Modulation in an Open-label Prospective Study

The treatment options for chronic spontaneous urticaria (CSU) primarily include second generation non-sedative antihistamine (SGAHs). Bilastine is a newer, nonsedating SGAH approved for urticaria in February 2019 by the Drugs Controller General of India. Its major advantages are in terms of superior...

Full description

Saved in:
Bibliographic Details
Published in:Indian journal of dermatology 2024-03, Vol.69 (2), p.132-136
Main Authors: De, Abhishek, Singh, Sushil, Chakraborty, Disha, Sarda, Aarti, Godse, Kiran
Format: Article
Language:English
Subjects:
antihistamines
autoimmunity
bilastine
chronic spontaneous urticaria
Cytokines
Histamine
Original
Urticaria
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by
cites cdi_FETCH-LOGICAL-c468t-1c88cff2daeec8388da98ea0fa00f09171572d104b3111fb351160723e0813323
container_end_page 136
container_issue 2
container_start_page 132
container_title Indian journal of dermatology
container_volume 69
creator De, Abhishek
Singh, Sushil
Chakraborty, Disha
Sarda, Aarti
Godse, Kiran
description The treatment options for chronic spontaneous urticaria (CSU) primarily include second generation non-sedative antihistamine (SGAHs). Bilastine is a newer, nonsedating SGAH approved for urticaria in February 2019 by the Drugs Controller General of India. Its major advantages are in terms of superior efficacy, lack of drug interactions and adverse effects, including sedation, compared to conventional SGAHs. The role of cytokines in the pathogenesis of CSU is well known. However, there is a shortage of data regarding the change in serum levels of proinflammatory cytokines following H1 antihistamines. We conducted this trial to evaluate the role of bilastine in cytokine modulation and autoimmunity, thereby explaining its role in modifying the disease process in CSU. This prospective study was conducted in a tertiary institute in Kolkata on patients aged 12 years and above with a CSU >6 months. These patients had an unsatisfactory response, as per the Urticaria Activity Score 7 (UAS7), to previous antihistamine therapies in standard doses. Treatment effectiveness was determined by comparing the UAS7 at baseline with that at weeks 4, 8 and 12. Also, baseline serum interleukin-6 (IL-6) and IL-17 were compared with those at the end of the study, that is, 12 weeks. Thirty patients who matched the inclusion criteria and signed informed consent were included in the study. At the end of 12 weeks, 10% of patients ( = 3) achieved a complete treatment response (UAS = 0), whereas 43.33% of patients ( = 13) were labelled as having well-controlled urticaria (UAS
doi_str_mv 10.4103/ijd.ijd_722_23
format article
fullrecord <record><control><sourceid>proquest_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_0b924d82011a4cf5b54667d035673436</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><doaj_id>oai_doaj_org_article_0b924d82011a4cf5b54667d035673436</doaj_id><sourcerecordid>3065274249</sourcerecordid><originalsourceid>FETCH-LOGICAL-c468t-1c88cff2daeec8388da98ea0fa00f09171572d104b3111fb351160723e0813323</originalsourceid><addsrcrecordid>eNp9kktv1DAUhSMEotPCliWyxIZNBl8_EocNKuFVqaiI0rXl2E7rIWMHO6k0y_5zHKYUyoKFbcn3-LsPn6J4BnjNANNXbmPWecmaEEnog2IFTSNKWgE8LFYYQ1Ny4OygOExpgzGjIOBxcUCFYEAIXxU3b92g0uS8Rc6jr7aPSk8h7lB7FYN3Gp2PwU_K2zAndBEnp1V06jV655JVyaI2R2MYkPIGtbspfF9In4OZBzW54Beo8uhstL4cVGcH9CWGNFo9uWuLzqfZ7J4Uj3o1JPv09jwqLj68_9Z-Kk_PPp60x6elZpWYStBC6L4nRlmrRW7AqEZYhXuFcY8bqIHXxABmHQWAvqMcoMI1oRYLoJTQo-JkzzVBbeQY3VbFnQzKyV8XIV5KtfQ3WIm7hjAjCAZQTPe846yqaoMpr2rKaJVZb_asce621mibh6CGe9D7Ee-u5GW4lrk01tRNkwkvbwkx_JhtmuTWJW2HYT9qSXHFSc0IW6Qv_pFuwhx9npWkwAhv8l79X5WzsopTnFXrvUrnb0jR9nc1A5aLoeRipj-Gyg-e_93pnfy3g-hPLGjHeA</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3111446530</pqid></control><display><type>article</type><title>Bilastine in Refractory Chronic Spontaneous Urticaria: Disease Control and Cytokine Modulation in an Open-label Prospective Study</title><source>DAOJ: Directory of Open Access Journals</source><source>PubMed Central</source><creator>De, Abhishek ; Singh, Sushil ; Chakraborty, Disha ; Sarda, Aarti ; Godse, Kiran</creator><creatorcontrib>De, Abhishek ; Singh, Sushil ; Chakraborty, Disha ; Sarda, Aarti ; Godse, Kiran</creatorcontrib><description>The treatment options for chronic spontaneous urticaria (CSU) primarily include second generation non-sedative antihistamine (SGAHs). Bilastine is a newer, nonsedating SGAH approved for urticaria in February 2019 by the Drugs Controller General of India. Its major advantages are in terms of superior efficacy, lack of drug interactions and adverse effects, including sedation, compared to conventional SGAHs. The role of cytokines in the pathogenesis of CSU is well known. However, there is a shortage of data regarding the change in serum levels of proinflammatory cytokines following H1 antihistamines. We conducted this trial to evaluate the role of bilastine in cytokine modulation and autoimmunity, thereby explaining its role in modifying the disease process in CSU. This prospective study was conducted in a tertiary institute in Kolkata on patients aged 12 years and above with a CSU &gt;6 months. These patients had an unsatisfactory response, as per the Urticaria Activity Score 7 (UAS7), to previous antihistamine therapies in standard doses. Treatment effectiveness was determined by comparing the UAS7 at baseline with that at weeks 4, 8 and 12. Also, baseline serum interleukin-6 (IL-6) and IL-17 were compared with those at the end of the study, that is, 12 weeks. Thirty patients who matched the inclusion criteria and signed informed consent were included in the study. At the end of 12 weeks, 10% of patients ( = 3) achieved a complete treatment response (UAS = 0), whereas 43.33% of patients ( = 13) were labelled as having well-controlled urticaria (UAS &lt;6). At 12 weeks, the mean UAS7 score (6.47 ± 4.45) was statistically significant compared to the baseline score (25.47 ± 7.74). The mean values of serum IL-6 (pg/ml) and IL-17 (pg/ml) at baseline were 5.96 ± 5.24 pg/ml and 6.96 ± 5.97 pg/ml, respectively. At the end of treatment, that is, 3 months, the mean values were reduced to 4.61 ± 4.56 pg/ml and 5.08 ± 3.87 pg/ml. The reduction was statistically significant for both serum IL-6 ( &lt; 0.001) and IL-17 ( &lt; 0.0001). We conclude that bilastine at a once-daily continuous dose of 40 mg for 3 months is safe and effective in CSU patients who are refractory to treatment at the standard doses of SGAHs. Improved symptomatic control with bilastine was also associated with better control over the inflammatory process, as suggested by the lowering of mean cytokine levels in our study.</description><identifier>ISSN: 0019-5154</identifier><identifier>EISSN: 1998-3611</identifier><identifier>DOI: 10.4103/ijd.ijd_722_23</identifier><identifier>PMID: 38841225</identifier><language>eng</language><publisher>India: Medknow Publications &amp; Media Pvt. Ltd</publisher><subject>antihistamines ; autoimmunity ; bilastine ; chronic spontaneous urticaria ; Cytokines ; Histamine ; Original ; Urticaria</subject><ispartof>Indian journal of dermatology, 2024-03, Vol.69 (2), p.132-136</ispartof><rights>Copyright: © 2024 Indian Journal of Dermatology.</rights><rights>2024. This article is published under (http://creativecommons.org/licenses/by-nc-sa/3.0/) (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Copyright: © 2024 Indian Journal of Dermatology 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c468t-1c88cff2daeec8388da98ea0fa00f09171572d104b3111fb351160723e0813323</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11149799/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11149799/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,27900,27901,53765,53767</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38841225$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>De, Abhishek</creatorcontrib><creatorcontrib>Singh, Sushil</creatorcontrib><creatorcontrib>Chakraborty, Disha</creatorcontrib><creatorcontrib>Sarda, Aarti</creatorcontrib><creatorcontrib>Godse, Kiran</creatorcontrib><title>Bilastine in Refractory Chronic Spontaneous Urticaria: Disease Control and Cytokine Modulation in an Open-label Prospective Study</title><title>Indian journal of dermatology</title><addtitle>Indian J Dermatol</addtitle><description>The treatment options for chronic spontaneous urticaria (CSU) primarily include second generation non-sedative antihistamine (SGAHs). Bilastine is a newer, nonsedating SGAH approved for urticaria in February 2019 by the Drugs Controller General of India. Its major advantages are in terms of superior efficacy, lack of drug interactions and adverse effects, including sedation, compared to conventional SGAHs. The role of cytokines in the pathogenesis of CSU is well known. However, there is a shortage of data regarding the change in serum levels of proinflammatory cytokines following H1 antihistamines. We conducted this trial to evaluate the role of bilastine in cytokine modulation and autoimmunity, thereby explaining its role in modifying the disease process in CSU. This prospective study was conducted in a tertiary institute in Kolkata on patients aged 12 years and above with a CSU &gt;6 months. These patients had an unsatisfactory response, as per the Urticaria Activity Score 7 (UAS7), to previous antihistamine therapies in standard doses. Treatment effectiveness was determined by comparing the UAS7 at baseline with that at weeks 4, 8 and 12. Also, baseline serum interleukin-6 (IL-6) and IL-17 were compared with those at the end of the study, that is, 12 weeks. Thirty patients who matched the inclusion criteria and signed informed consent were included in the study. At the end of 12 weeks, 10% of patients ( = 3) achieved a complete treatment response (UAS = 0), whereas 43.33% of patients ( = 13) were labelled as having well-controlled urticaria (UAS &lt;6). At 12 weeks, the mean UAS7 score (6.47 ± 4.45) was statistically significant compared to the baseline score (25.47 ± 7.74). The mean values of serum IL-6 (pg/ml) and IL-17 (pg/ml) at baseline were 5.96 ± 5.24 pg/ml and 6.96 ± 5.97 pg/ml, respectively. At the end of treatment, that is, 3 months, the mean values were reduced to 4.61 ± 4.56 pg/ml and 5.08 ± 3.87 pg/ml. The reduction was statistically significant for both serum IL-6 ( &lt; 0.001) and IL-17 ( &lt; 0.0001). We conclude that bilastine at a once-daily continuous dose of 40 mg for 3 months is safe and effective in CSU patients who are refractory to treatment at the standard doses of SGAHs. Improved symptomatic control with bilastine was also associated with better control over the inflammatory process, as suggested by the lowering of mean cytokine levels in our study.</description><subject>antihistamines</subject><subject>autoimmunity</subject><subject>bilastine</subject><subject>chronic spontaneous urticaria</subject><subject>Cytokines</subject><subject>Histamine</subject><subject>Original</subject><subject>Urticaria</subject><issn>0019-5154</issn><issn>1998-3611</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNp9kktv1DAUhSMEotPCliWyxIZNBl8_EocNKuFVqaiI0rXl2E7rIWMHO6k0y_5zHKYUyoKFbcn3-LsPn6J4BnjNANNXbmPWecmaEEnog2IFTSNKWgE8LFYYQ1Ny4OygOExpgzGjIOBxcUCFYEAIXxU3b92g0uS8Rc6jr7aPSk8h7lB7FYN3Gp2PwU_K2zAndBEnp1V06jV655JVyaI2R2MYkPIGtbspfF9In4OZBzW54Beo8uhstL4cVGcH9CWGNFo9uWuLzqfZ7J4Uj3o1JPv09jwqLj68_9Z-Kk_PPp60x6elZpWYStBC6L4nRlmrRW7AqEZYhXuFcY8bqIHXxABmHQWAvqMcoMI1oRYLoJTQo-JkzzVBbeQY3VbFnQzKyV8XIV5KtfQ3WIm7hjAjCAZQTPe846yqaoMpr2rKaJVZb_asce621mibh6CGe9D7Ee-u5GW4lrk01tRNkwkvbwkx_JhtmuTWJW2HYT9qSXHFSc0IW6Qv_pFuwhx9npWkwAhv8l79X5WzsopTnFXrvUrnb0jR9nc1A5aLoeRipj-Gyg-e_93pnfy3g-hPLGjHeA</recordid><startdate>20240301</startdate><enddate>20240301</enddate><creator>De, Abhishek</creator><creator>Singh, Sushil</creator><creator>Chakraborty, Disha</creator><creator>Sarda, Aarti</creator><creator>Godse, Kiran</creator><general>Medknow Publications &amp; Media Pvt. Ltd</general><general>Wolters Kluwer - Medknow</general><general>Wolters Kluwer Medknow Publications</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20240301</creationdate><title>Bilastine in Refractory Chronic Spontaneous Urticaria: Disease Control and Cytokine Modulation in an Open-label Prospective Study</title><author>De, Abhishek ; Singh, Sushil ; Chakraborty, Disha ; Sarda, Aarti ; Godse, Kiran</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c468t-1c88cff2daeec8388da98ea0fa00f09171572d104b3111fb351160723e0813323</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>antihistamines</topic><topic>autoimmunity</topic><topic>bilastine</topic><topic>chronic spontaneous urticaria</topic><topic>Cytokines</topic><topic>Histamine</topic><topic>Original</topic><topic>Urticaria</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>De, Abhishek</creatorcontrib><creatorcontrib>Singh, Sushil</creatorcontrib><creatorcontrib>Chakraborty, Disha</creatorcontrib><creatorcontrib>Sarda, Aarti</creatorcontrib><creatorcontrib>Godse, Kiran</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DAOJ: Directory of Open Access Journals</collection><jtitle>Indian journal of dermatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>De, Abhishek</au><au>Singh, Sushil</au><au>Chakraborty, Disha</au><au>Sarda, Aarti</au><au>Godse, Kiran</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bilastine in Refractory Chronic Spontaneous Urticaria: Disease Control and Cytokine Modulation in an Open-label Prospective Study</atitle><jtitle>Indian journal of dermatology</jtitle><addtitle>Indian J Dermatol</addtitle><date>2024-03-01</date><risdate>2024</risdate><volume>69</volume><issue>2</issue><spage>132</spage><epage>136</epage><pages>132-136</pages><issn>0019-5154</issn><eissn>1998-3611</eissn><abstract>The treatment options for chronic spontaneous urticaria (CSU) primarily include second generation non-sedative antihistamine (SGAHs). Bilastine is a newer, nonsedating SGAH approved for urticaria in February 2019 by the Drugs Controller General of India. Its major advantages are in terms of superior efficacy, lack of drug interactions and adverse effects, including sedation, compared to conventional SGAHs. The role of cytokines in the pathogenesis of CSU is well known. However, there is a shortage of data regarding the change in serum levels of proinflammatory cytokines following H1 antihistamines. We conducted this trial to evaluate the role of bilastine in cytokine modulation and autoimmunity, thereby explaining its role in modifying the disease process in CSU. This prospective study was conducted in a tertiary institute in Kolkata on patients aged 12 years and above with a CSU &gt;6 months. These patients had an unsatisfactory response, as per the Urticaria Activity Score 7 (UAS7), to previous antihistamine therapies in standard doses. Treatment effectiveness was determined by comparing the UAS7 at baseline with that at weeks 4, 8 and 12. Also, baseline serum interleukin-6 (IL-6) and IL-17 were compared with those at the end of the study, that is, 12 weeks. Thirty patients who matched the inclusion criteria and signed informed consent were included in the study. At the end of 12 weeks, 10% of patients ( = 3) achieved a complete treatment response (UAS = 0), whereas 43.33% of patients ( = 13) were labelled as having well-controlled urticaria (UAS &lt;6). At 12 weeks, the mean UAS7 score (6.47 ± 4.45) was statistically significant compared to the baseline score (25.47 ± 7.74). The mean values of serum IL-6 (pg/ml) and IL-17 (pg/ml) at baseline were 5.96 ± 5.24 pg/ml and 6.96 ± 5.97 pg/ml, respectively. At the end of treatment, that is, 3 months, the mean values were reduced to 4.61 ± 4.56 pg/ml and 5.08 ± 3.87 pg/ml. The reduction was statistically significant for both serum IL-6 ( &lt; 0.001) and IL-17 ( &lt; 0.0001). We conclude that bilastine at a once-daily continuous dose of 40 mg for 3 months is safe and effective in CSU patients who are refractory to treatment at the standard doses of SGAHs. Improved symptomatic control with bilastine was also associated with better control over the inflammatory process, as suggested by the lowering of mean cytokine levels in our study.</abstract><cop>India</cop><pub>Medknow Publications &amp; Media Pvt. Ltd</pub><pmid>38841225</pmid><doi>10.4103/ijd.ijd_722_23</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 0019-5154
ispartof Indian journal of dermatology, 2024-03, Vol.69 (2), p.132-136
issn 0019-5154
1998-3611
language eng
recordid cdi_doaj_primary_oai_doaj_org_article_0b924d82011a4cf5b54667d035673436
source DAOJ: Directory of Open Access Journals; PubMed Central
subjects antihistamines
autoimmunity
bilastine
chronic spontaneous urticaria
Cytokines
Histamine
Original
Urticaria
title Bilastine in Refractory Chronic Spontaneous Urticaria: Disease Control and Cytokine Modulation in an Open-label Prospective Study
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-24T09%3A54%3A05IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_doaj_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Bilastine%20in%20Refractory%20Chronic%20Spontaneous%20Urticaria:%20Disease%20Control%20and%20Cytokine%20Modulation%20in%20an%20Open-label%20Prospective%20Study&rft.jtitle=Indian%20journal%20of%20dermatology&rft.au=De,%20Abhishek&rft.date=2024-03-01&rft.volume=69&rft.issue=2&rft.spage=132&rft.epage=136&rft.pages=132-136&rft.issn=0019-5154&rft.eissn=1998-3611&rft_id=info:doi/10.4103/ijd.ijd_722_23&rft_dat=%3Cproquest_doaj_%3E3065274249%3C/proquest_doaj_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c468t-1c88cff2daeec8388da98ea0fa00f09171572d104b3111fb351160723e0813323%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=3111446530&rft_id=info:pmid/38841225&rfr_iscdi=true