A meta-analysis of therapeutic trials of topical ruxolitinib cream for the treatment of vitiligo: therapeutic efficacy, safety, and implications for therapeutic practice

Vitiligo, an autoimmune condition characterized by depigmented skin patches due to the loss of functional melanocytes, has been linked to dysregulation in the JAK-STAT signaling pathway, particularly in IFN-g signaling. The use of JAK inhibitors, such as ruxolitinib cream, a JAK1 and JAK2 inhibitor,...

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Veröffentlicht in:Archives of dermatological research 2024-08, Vol.316 (8), p.518, Article 518
Hauptverfasser: Hussein, Abbas F. Abdul, Shams, Ahmed S., Hosny, Nora, Elrosasy, Amr, Kobtan, Marwan, Shafik, Yasmin Ahmed, Alnatsheh, Zeinab Raed, Zeid, Mohamed Abo, Qarma, Mugahed, Ibrahim, Yathrib K., Al-Sultany, Hussein Abbas
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container_start_page 518
container_title Archives of dermatological research
container_volume 316
creator Hussein, Abbas F. Abdul
Shams, Ahmed S.
Hosny, Nora
Elrosasy, Amr
Kobtan, Marwan
Shafik, Yasmin Ahmed
Alnatsheh, Zeinab Raed
Zeid, Mohamed Abo
Qarma, Mugahed
Ibrahim, Yathrib K.
Al-Sultany, Hussein Abbas
description Vitiligo, an autoimmune condition characterized by depigmented skin patches due to the loss of functional melanocytes, has been linked to dysregulation in the JAK-STAT signaling pathway, particularly in IFN-g signaling. The use of JAK inhibitors, such as ruxolitinib cream, a JAK1 and JAK2 inhibitor, presents a promising approach for vitiligo treatment. This study aims to systematically assess the effectiveness and safety of ruxolitinib cream in patients with vitiligo. We conducted a systematic review and meta-analysis following PRISMA guidelines to evaluate the efficacy and safety of ruxolitinib cream for the treatment of vitiligo. A comprehensive search of PubMed, Google Scholar, and Cochrane Library databases for randomized controlled trials (RCTs). Data selection, screening, extraction, and risk of bias assessment were meticulously performed. Statistical analysis was conducted using Review Manager Software, version 5.4, with significant heterogeneity addressed through appropriate methods. Our meta-analysis included 3 studies with 830 vitiligo patients. Significant improvements were observed in F-VASI, T-VASI, F-BSA, and T-BSA scores, with greater efficacy at 24 weeks compared to 12 weeks [MD –24.17, 95% CI (–31.78 to –16.56), P 
doi_str_mv 10.1007/s00403-024-03267-8
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Abdul ; Shams, Ahmed S. ; Hosny, Nora ; Elrosasy, Amr ; Kobtan, Marwan ; Shafik, Yasmin Ahmed ; Alnatsheh, Zeinab Raed ; Zeid, Mohamed Abo ; Qarma, Mugahed ; Ibrahim, Yathrib K. ; Al-Sultany, Hussein Abbas</creator><creatorcontrib>Hussein, Abbas F. Abdul ; Shams, Ahmed S. ; Hosny, Nora ; Elrosasy, Amr ; Kobtan, Marwan ; Shafik, Yasmin Ahmed ; Alnatsheh, Zeinab Raed ; Zeid, Mohamed Abo ; Qarma, Mugahed ; Ibrahim, Yathrib K. ; Al-Sultany, Hussein Abbas</creatorcontrib><description><![CDATA[Vitiligo, an autoimmune condition characterized by depigmented skin patches due to the loss of functional melanocytes, has been linked to dysregulation in the JAK-STAT signaling pathway, particularly in IFN-g signaling. The use of JAK inhibitors, such as ruxolitinib cream, a JAK1 and JAK2 inhibitor, presents a promising approach for vitiligo treatment. This study aims to systematically assess the effectiveness and safety of ruxolitinib cream in patients with vitiligo. We conducted a systematic review and meta-analysis following PRISMA guidelines to evaluate the efficacy and safety of ruxolitinib cream for the treatment of vitiligo. A comprehensive search of PubMed, Google Scholar, and Cochrane Library databases for randomized controlled trials (RCTs). Data selection, screening, extraction, and risk of bias assessment were meticulously performed. Statistical analysis was conducted using Review Manager Software, version 5.4, with significant heterogeneity addressed through appropriate methods. Our meta-analysis included 3 studies with 830 vitiligo patients. Significant improvements were observed in F-VASI, T-VASI, F-BSA, and T-BSA scores, with greater efficacy at 24 weeks compared to 12 weeks [MD –24.17, 95% CI (–31.78 to –16.56), P < 0.00001], [MD –14.12, 95% CI (–20.54 to –7.70); P < 0.0000], [MD –16.25, 95% CI (–22.20 to –10.31), P  < 0.00001], [MD –9.19, 95% CI (–13.47 to –4.92); P < 0.00001]. Ruxolitinib showed increased risk ratios for F-VASI75, F-VASI90, and F-VASI50, indicating better outcomes with longer treatment durations [MD 2.9, 95% CI 1.88–4.49; P < 0.00001], [MD 4.66, 95% CI 2.09–10.39; P = 0.0002], [MD 2.53, 95% CI 1.84–3.46; P < 0.00001]. No significant differences were found in mild and moderate adverse events, while severe cases favored ruxolitinib. Placebo had a significant advantage in any adverse events, with no significant difference in drug-related adverse events. Serious adverse events did not significantly differ between groups. The findings strongly support the efficacy of ruxolitinib therapy in improving various parameters over time for treating vitiligo. However, thorough consideration of its safety profile, particularly concerning adverse events and potential side effects, is warranted. 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Abdul</creatorcontrib><creatorcontrib>Shams, Ahmed S.</creatorcontrib><creatorcontrib>Hosny, Nora</creatorcontrib><creatorcontrib>Elrosasy, Amr</creatorcontrib><creatorcontrib>Kobtan, Marwan</creatorcontrib><creatorcontrib>Shafik, Yasmin Ahmed</creatorcontrib><creatorcontrib>Alnatsheh, Zeinab Raed</creatorcontrib><creatorcontrib>Zeid, Mohamed Abo</creatorcontrib><creatorcontrib>Qarma, Mugahed</creatorcontrib><creatorcontrib>Ibrahim, Yathrib K.</creatorcontrib><creatorcontrib>Al-Sultany, Hussein Abbas</creatorcontrib><title>A meta-analysis of therapeutic trials of topical ruxolitinib cream for the treatment of vitiligo: therapeutic efficacy, safety, and implications for therapeutic practice</title><title>Archives of dermatological research</title><addtitle>Arch Dermatol Res</addtitle><addtitle>Arch Dermatol Res</addtitle><description><![CDATA[Vitiligo, an autoimmune condition characterized by depigmented skin patches due to the loss of functional melanocytes, has been linked to dysregulation in the JAK-STAT signaling pathway, particularly in IFN-g signaling. The use of JAK inhibitors, such as ruxolitinib cream, a JAK1 and JAK2 inhibitor, presents a promising approach for vitiligo treatment. This study aims to systematically assess the effectiveness and safety of ruxolitinib cream in patients with vitiligo. We conducted a systematic review and meta-analysis following PRISMA guidelines to evaluate the efficacy and safety of ruxolitinib cream for the treatment of vitiligo. A comprehensive search of PubMed, Google Scholar, and Cochrane Library databases for randomized controlled trials (RCTs). Data selection, screening, extraction, and risk of bias assessment were meticulously performed. Statistical analysis was conducted using Review Manager Software, version 5.4, with significant heterogeneity addressed through appropriate methods. Our meta-analysis included 3 studies with 830 vitiligo patients. Significant improvements were observed in F-VASI, T-VASI, F-BSA, and T-BSA scores, with greater efficacy at 24 weeks compared to 12 weeks [MD –24.17, 95% CI (–31.78 to –16.56), P < 0.00001], [MD –14.12, 95% CI (–20.54 to –7.70); P < 0.0000], [MD –16.25, 95% CI (–22.20 to –10.31), P  < 0.00001], [MD –9.19, 95% CI (–13.47 to –4.92); P < 0.00001]. Ruxolitinib showed increased risk ratios for F-VASI75, F-VASI90, and F-VASI50, indicating better outcomes with longer treatment durations [MD 2.9, 95% CI 1.88–4.49; P < 0.00001], [MD 4.66, 95% CI 2.09–10.39; P = 0.0002], [MD 2.53, 95% CI 1.84–3.46; P < 0.00001]. No significant differences were found in mild and moderate adverse events, while severe cases favored ruxolitinib. Placebo had a significant advantage in any adverse events, with no significant difference in drug-related adverse events. Serious adverse events did not significantly differ between groups. The findings strongly support the efficacy of ruxolitinib therapy in improving various parameters over time for treating vitiligo. However, thorough consideration of its safety profile, particularly concerning adverse events and potential side effects, is warranted. Further studies with larger sample sizes are needed to confirm these conclusions.]]></description><subject>Adverse events</subject><subject>Autoimmune diseases</subject><subject>Clinical trials</subject><subject>Dermatology</subject><subject>Humans</subject><subject>Inhibitor drugs</subject><subject>Janus kinase</subject><subject>Janus kinase 2</subject><subject>Janus Kinase Inhibitors - administration &amp; dosage</subject><subject>Janus Kinase Inhibitors - adverse effects</subject><subject>Janus Kinase Inhibitors - therapeutic use</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Melanocytes</subject><subject>Meta-analysis</subject><subject>Nitriles</subject><subject>Pyrazoles - administration &amp; dosage</subject><subject>Pyrazoles - adverse effects</subject><subject>Pyrazoles - therapeutic use</subject><subject>Pyrimidines - administration &amp; dosage</subject><subject>Pyrimidines - therapeutic use</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Review</subject><subject>Side effects</subject><subject>Signal transduction</subject><subject>Skin Cream - administration &amp; dosage</subject><subject>Statistical analysis</subject><subject>Topical medication</subject><subject>Treatment Outcome</subject><subject>Vitiligo</subject><subject>Vitiligo - drug therapy</subject><issn>1432-069X</issn><issn>0340-3696</issn><issn>1432-069X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU9PHSEUxUnTpv5pv0AXDUk3LjqVAQTGnTHWNjFxY5PuCA8uFjMzjMAY30fqtyzPeVrtoqtD7v2dA-Eg9KElX1pC5GEmhBPWEMobwqiQjXqFdlvOaENE9_P1s_MO2sv5hlSTVO1btMO6lnGl-C76fYIHKKYxo-nXOWQcPS6_IJkJ5hIsLimYfpnGKVjT4zTfxz6UMIYVtgnMgH1MG09lwZQBxrLB7yrSh-t4_CIOvK8hdv0ZZ-OhVDWjw2GY-jouIY75Me3JMiVjq8I79MbXp8D7re6jH1_Prk6_NReX599PTy4aS49EaTz3R1wZ6zzt2pUzK6IoeOGIl7aVkjvbdUxJT0EYIp1ided8R4Wgjgou2T46WHKnFG9nyEUPIVvoezNCnLNmpKNMSMp4RT_9g97EOdWf3FJcEkorRRfKpphzAq-nFAaT1rolelOkXorUtUj9UKRW1fRxGz2vBnBPlsfmKsAWINfVeA3p793_if0Dla6s1w</recordid><startdate>20240812</startdate><enddate>20240812</enddate><creator>Hussein, Abbas F. 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Abdul ; Shams, Ahmed S. ; Hosny, Nora ; Elrosasy, Amr ; Kobtan, Marwan ; Shafik, Yasmin Ahmed ; Alnatsheh, Zeinab Raed ; Zeid, Mohamed Abo ; Qarma, Mugahed ; Ibrahim, Yathrib K. ; Al-Sultany, Hussein Abbas</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c256t-f4f548acdf291bdab082ef6d0f7c1774dc99387f2e6a07d83f6ddf92662d26473</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adverse events</topic><topic>Autoimmune diseases</topic><topic>Clinical trials</topic><topic>Dermatology</topic><topic>Humans</topic><topic>Inhibitor drugs</topic><topic>Janus kinase</topic><topic>Janus kinase 2</topic><topic>Janus Kinase Inhibitors - administration &amp; dosage</topic><topic>Janus Kinase Inhibitors - adverse effects</topic><topic>Janus Kinase Inhibitors - therapeutic use</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Melanocytes</topic><topic>Meta-analysis</topic><topic>Nitriles</topic><topic>Pyrazoles - administration &amp; dosage</topic><topic>Pyrazoles - adverse effects</topic><topic>Pyrazoles - therapeutic use</topic><topic>Pyrimidines - administration &amp; dosage</topic><topic>Pyrimidines - therapeutic use</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Review</topic><topic>Side effects</topic><topic>Signal transduction</topic><topic>Skin Cream - administration &amp; dosage</topic><topic>Statistical analysis</topic><topic>Topical medication</topic><topic>Treatment Outcome</topic><topic>Vitiligo</topic><topic>Vitiligo - drug therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hussein, Abbas F. Abdul</creatorcontrib><creatorcontrib>Shams, Ahmed S.</creatorcontrib><creatorcontrib>Hosny, Nora</creatorcontrib><creatorcontrib>Elrosasy, Amr</creatorcontrib><creatorcontrib>Kobtan, Marwan</creatorcontrib><creatorcontrib>Shafik, Yasmin Ahmed</creatorcontrib><creatorcontrib>Alnatsheh, Zeinab Raed</creatorcontrib><creatorcontrib>Zeid, Mohamed Abo</creatorcontrib><creatorcontrib>Qarma, Mugahed</creatorcontrib><creatorcontrib>Ibrahim, Yathrib K.</creatorcontrib><creatorcontrib>Al-Sultany, Hussein Abbas</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Archives of dermatological research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hussein, Abbas F. Abdul</au><au>Shams, Ahmed S.</au><au>Hosny, Nora</au><au>Elrosasy, Amr</au><au>Kobtan, Marwan</au><au>Shafik, Yasmin Ahmed</au><au>Alnatsheh, Zeinab Raed</au><au>Zeid, Mohamed Abo</au><au>Qarma, Mugahed</au><au>Ibrahim, Yathrib K.</au><au>Al-Sultany, Hussein Abbas</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A meta-analysis of therapeutic trials of topical ruxolitinib cream for the treatment of vitiligo: therapeutic efficacy, safety, and implications for therapeutic practice</atitle><jtitle>Archives of dermatological research</jtitle><stitle>Arch Dermatol Res</stitle><addtitle>Arch Dermatol Res</addtitle><date>2024-08-12</date><risdate>2024</risdate><volume>316</volume><issue>8</issue><spage>518</spage><pages>518-</pages><artnum>518</artnum><issn>1432-069X</issn><issn>0340-3696</issn><eissn>1432-069X</eissn><abstract><![CDATA[Vitiligo, an autoimmune condition characterized by depigmented skin patches due to the loss of functional melanocytes, has been linked to dysregulation in the JAK-STAT signaling pathway, particularly in IFN-g signaling. The use of JAK inhibitors, such as ruxolitinib cream, a JAK1 and JAK2 inhibitor, presents a promising approach for vitiligo treatment. This study aims to systematically assess the effectiveness and safety of ruxolitinib cream in patients with vitiligo. We conducted a systematic review and meta-analysis following PRISMA guidelines to evaluate the efficacy and safety of ruxolitinib cream for the treatment of vitiligo. A comprehensive search of PubMed, Google Scholar, and Cochrane Library databases for randomized controlled trials (RCTs). Data selection, screening, extraction, and risk of bias assessment were meticulously performed. Statistical analysis was conducted using Review Manager Software, version 5.4, with significant heterogeneity addressed through appropriate methods. Our meta-analysis included 3 studies with 830 vitiligo patients. Significant improvements were observed in F-VASI, T-VASI, F-BSA, and T-BSA scores, with greater efficacy at 24 weeks compared to 12 weeks [MD –24.17, 95% CI (–31.78 to –16.56), P < 0.00001], [MD –14.12, 95% CI (–20.54 to –7.70); P < 0.0000], [MD –16.25, 95% CI (–22.20 to –10.31), P  < 0.00001], [MD –9.19, 95% CI (–13.47 to –4.92); P < 0.00001]. Ruxolitinib showed increased risk ratios for F-VASI75, F-VASI90, and F-VASI50, indicating better outcomes with longer treatment durations [MD 2.9, 95% CI 1.88–4.49; P < 0.00001], [MD 4.66, 95% CI 2.09–10.39; P = 0.0002], [MD 2.53, 95% CI 1.84–3.46; P < 0.00001]. No significant differences were found in mild and moderate adverse events, while severe cases favored ruxolitinib. Placebo had a significant advantage in any adverse events, with no significant difference in drug-related adverse events. Serious adverse events did not significantly differ between groups. The findings strongly support the efficacy of ruxolitinib therapy in improving various parameters over time for treating vitiligo. However, thorough consideration of its safety profile, particularly concerning adverse events and potential side effects, is warranted. Further studies with larger sample sizes are needed to confirm these conclusions.]]></abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>39134884</pmid><doi>10.1007/s00403-024-03267-8</doi><orcidid>https://orcid.org/0000-0002-4318-1329</orcidid></addata></record>
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subjects Adverse events
Autoimmune diseases
Clinical trials
Dermatology
Humans
Inhibitor drugs
Janus kinase
Janus kinase 2
Janus Kinase Inhibitors - administration & dosage
Janus Kinase Inhibitors - adverse effects
Janus Kinase Inhibitors - therapeutic use
Medicine
Medicine & Public Health
Melanocytes
Meta-analysis
Nitriles
Pyrazoles - administration & dosage
Pyrazoles - adverse effects
Pyrazoles - therapeutic use
Pyrimidines - administration & dosage
Pyrimidines - therapeutic use
Randomized Controlled Trials as Topic
Review
Side effects
Signal transduction
Skin Cream - administration & dosage
Statistical analysis
Topical medication
Treatment Outcome
Vitiligo
Vitiligo - drug therapy
title A meta-analysis of therapeutic trials of topical ruxolitinib cream for the treatment of vitiligo: therapeutic efficacy, safety, and implications for therapeutic practice
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