{"title":"Real-world evidence for comprehensive evaluation of guselkumab in the treatment of psoriasis","authors":"Diamant Thaçi","doi":"10.1111/jdv.20554","DOIUrl":"https://doi.org/10.1111/jdv.20554","url":null,"abstract":"<p>Diamant Thaçi</p><p>While randomized controlled trials (RCTs) remain the gold standard of evidence-based medicine, real-world evidence (RWE) is becoming increasingly important.<span><sup>1</sup></span> Despite potential challenges with data sources, such as missing/limited data and the lack of patient randomization, RWE is considered more relatable to daily clinical practice and aids investigation of long-term effectiveness and treatment safety.<span><sup>1</sup></span> This is particularly relevant for chronic conditions like moderate-to-severe psoriasis, which usually requires long-term treatment and is associated with numerous comorbidities.</p><p>Guselkumab, a human monoclonal antibody that inhibits interleukin-23, was approved for the treatment of moderate-to-severe psoriasis in 2017. This supplemental issue of <i>JEADV</i> discusses guselkumab RWE as an important evidence source to complement RCTs in psoriasis, presenting five non-interventional studies (PERSIST,<span><sup>2</sup></span> G-EPOSS,<span><sup>3</sup></span> GULLIVER,<span><sup>4</sup></span> SPRING<span><sup>5</sup></span> and a study by Tskhvarashvili et al.<span><sup>6</sup></span>) comprising >1400 guselkumab-treated patients across five European countries.<span><sup>2-6</sup></span> Together, they describe effectiveness, health-related quality of life (HRQoL) and safety outcomes with guselkumab treatment, as well as drug persistence, in a real-world setting.</p><p>The limitations of RWE noted above emphasize the importance of conducting non-interventional studies with robust methodology. PERSIST, G-EPOSS and GULLIVER were prospective, multicentre, observational studies conducted in Germany<span><sup>2, 3</sup></span> and Italy.<span><sup>4</sup></span> They had predefined patient eligibility criteria and study endpoints, and their population sizes were planned using rigorous statistical methodology. SPRING and the Tskhvarashvili et al. study were multicentre, retrospective studies conducted in Spain<span><sup>5</sup></span> and Finland/Sweden,<span><sup>6</sup></span> respectively, with defined patient eligibility criteria. Tskhvarashvili et al. conducted sensitivity analyses to account for biases in drug availability, changing treatment practices and uncertainty in drug discontinuation dates.<span><sup>6</sup></span></p><p>Although RCTs typically provide rigorous evaluation of a drug's efficacy and safety profile, the controlled conditions and stringent patient eligibility criteria may limit the generalizability of the results obtained.<span><sup>1</sup></span> For example, patients enrolled in the guselkumab RCTs VOYAGE 1 and 2 were required to have a baseline Psoriasis Area and Severity Index (PASI) ≥ 12;<span><sup>7, 8</sup></span> as such, baseline PASI was lower in the guselkumab non-interventional studies.<span><sup>2-5</sup></span> Additionally, patients typically have received fewer biologics prior to enrolment in RCTs, compared with RWE studies, which can i","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":"39 S1","pages":"3-5"},"PeriodicalIF":8.4,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdv.20554","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143489778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Reply to: EuroGuiderm Guideline on lichen sclerosus-introduction into lichen sclerosus.","authors":"G Kravvas, R Watchorn, A Spencer, C B Bunker","doi":"10.1111/jdv.20612","DOIUrl":"https://doi.org/10.1111/jdv.20612","url":null,"abstract":"","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":" ","pages":""},"PeriodicalIF":8.4,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143483570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Noor F Goandal, Gregor B E Jemec, Ditte M L Saunte
{"title":"Botulinum toxin type A efficacy on pain and suppuration in hidradenitis suppurativa.","authors":"Noor F Goandal, Gregor B E Jemec, Ditte M L Saunte","doi":"10.1111/jdv.20611","DOIUrl":"https://doi.org/10.1111/jdv.20611","url":null,"abstract":"","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":" ","pages":""},"PeriodicalIF":8.4,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143483568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Risk of second primary cancers in patients with Merkel cell carcinoma: A systematic review and meta-analysis.","authors":"Ioannis-Alexios Koumprentziotis, Aikaterini Tsiogka, Natalia Rompoti, Stergios Soulaidopoulos, Vasiliki Nikolaou, Stamatios Gregoriou, Electra Nicolaidou, Alexander Stratigos","doi":"10.1111/jdv.20615","DOIUrl":"https://doi.org/10.1111/jdv.20615","url":null,"abstract":"","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":" ","pages":""},"PeriodicalIF":8.4,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Richard G Langley, Alexander Egeberg, Melinda Gooderham, Robert Bissonnette, Julien Ringuet, Sunil Kalia, Laura Park-Wyllie, Nastaran Abbarin, Diana Tran, Anthony Zara, Ya Wen Yang, Bruce Strober
{"title":"Mission impossible? Caveats in interpreting and comparing long-term efficacy in biologic studies for moderate-to-severe plaque psoriasis.","authors":"Richard G Langley, Alexander Egeberg, Melinda Gooderham, Robert Bissonnette, Julien Ringuet, Sunil Kalia, Laura Park-Wyllie, Nastaran Abbarin, Diana Tran, Anthony Zara, Ya Wen Yang, Bruce Strober","doi":"10.1111/jdv.20555","DOIUrl":"https://doi.org/10.1111/jdv.20555","url":null,"abstract":"","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":" ","pages":""},"PeriodicalIF":8.4,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Reactional genital leukokeratosis as a new clinico-histological variant of penile squamous hyperplasia in young men.","authors":"Syrine Benammou, Romain Salle, Bénédicte Cavelier-Balloy, Sébastien Fouéré, Jean-David Bouaziz, Tu-Anh Duong, Jean-Noël Dauendorffer","doi":"10.1111/jdv.20613","DOIUrl":"https://doi.org/10.1111/jdv.20613","url":null,"abstract":"","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":" ","pages":""},"PeriodicalIF":8.4,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Atopic dermatitis in the French cohort CONSTANCES (PreDDA study): Focus on persistence and remission in adulthood.","authors":"Khaled Ezzedine, Virginie Hourblin, Sophie Connétable, Fabrice Ruiz, Abdlekrim Ziad, Amélie Sobczak, Sofiane Kab, Adeline Renuy, Marcel Goldberg, Marie Zins, Audrey Nosbaum","doi":"10.1111/jdv.20595","DOIUrl":"https://doi.org/10.1111/jdv.20595","url":null,"abstract":"","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":" ","pages":""},"PeriodicalIF":8.4,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Algün Polat Ekinci, Ahmet Alperen Çevik, Rodi Sari Polat, Fatma Kübra Gül
{"title":"Two cases of cerebrovascular accidents following the induction dose of risankizumab.","authors":"Algün Polat Ekinci, Ahmet Alperen Çevik, Rodi Sari Polat, Fatma Kübra Gül","doi":"10.1111/jdv.20608","DOIUrl":"https://doi.org/10.1111/jdv.20608","url":null,"abstract":"","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":" ","pages":""},"PeriodicalIF":8.4,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143458386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"High prevalence of extracutaneous involvement in ITG junctional epidermolysis bullosa.","authors":"Julie Bonigen, Fabienne Charbit-Henrion, Stéphanie Leclerc-Mercier, Jean-Marc Rosenthal, Anne-Claire Bursztejn, Romain Berthaud, Julie Steffan, Christine Chiaverini, Smail Hadj-Rabia, Christine Bodemer","doi":"10.1111/jdv.20579","DOIUrl":"https://doi.org/10.1111/jdv.20579","url":null,"abstract":"","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":" ","pages":""},"PeriodicalIF":8.4,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
X Wortsman, F Alfageme, V Dini, F J García-Martínez, R D Caposiena Caro, J Frew, C Gonzalez, I H Hamzavi, I Kohli, P K Krajewski, M Kuyumllian, J Liu, A Mandava, G Nazzaro, E O'Brien, T Oranges, M Pelizzari, J Rezende, J Romani, R Sigrist, E Taleb, L Zattar, J Zavariz, A Martorell
{"title":"International consensus statement on the use of ultrasound in hidradenitis suppurativa.","authors":"X Wortsman, F Alfageme, V Dini, F J García-Martínez, R D Caposiena Caro, J Frew, C Gonzalez, I H Hamzavi, I Kohli, P K Krajewski, M Kuyumllian, J Liu, A Mandava, G Nazzaro, E O'Brien, T Oranges, M Pelizzari, J Rezende, J Romani, R Sigrist, E Taleb, L Zattar, J Zavariz, A Martorell","doi":"10.1111/jdv.20600","DOIUrl":"https://doi.org/10.1111/jdv.20600","url":null,"abstract":"<p><strong>Background: </strong>So far, the evidence on the use of ultrasound (US) in hidradenitis suppurativa (HS) demonstrates the utility of US in the diagnosis, scoring and assessment of HS; however, to date, there is no international consensus statement on the use of US in HS, and several published guidelines do not include this topic.</p><p><strong>Objectives: </strong>To create an international consensus statement on using US in HS that can cover and validate relevant aspects.</p><p><strong>Methods: </strong>A three-round Delphi study with a panel of international experts representing four continents and working with US in HS in their daily practice. The inclusion criteria of the experts and the set of questions in the survey were defined by a steering committee. A consensus of recommendation was defined when the percentage of agreement (sum of strongly agree and agree) was ε 70%. In between 50% and 69% of agreement, a suggestion was considered. Lower than 50% meant no consensus.</p><p><strong>Results: </strong>Twenty-four international experts from 14 countries participated in the study. A high percentage of consensus (96.4%) was achieved for important aspects of the use of US in HS, including the ultrasonographic indications, technical considerations, training, diagnostic criteria, staging systems, monitoring, support of US-guided procedures and planning of surgery, and the need for US in research and clinical trials.</p><p><strong>Conclusions: </strong>An international group of experts created a consensus statement with validated recommendations on the use of US in HS. Despite the challenges of the implementation of ultrasound in HS, this task force highly recommends the use of US in HS.</p>","PeriodicalId":17351,"journal":{"name":"Journal of the European Academy of Dermatology and Venereology","volume":" ","pages":""},"PeriodicalIF":8.4,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143441364","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}