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Long-term efficacy and safety of secukinumab in patients with moderate-to-severe hidradenitis suppurativa: week 104 results from the SUNSHINE and SUNRISE extension trial. secukinumab治疗中重度化脓性汗腺炎的长期疗效和安全性:SUNSHINE和SUNRISE扩展试验的第104周结果
IF 11 1区 医学
British Journal of Dermatology Pub Date : 2025-03-18 DOI: 10.1093/bjd/ljae469
Alexa B Kimball, Falk G Bechara, Aysha Badat, Evangelos J Giamarellos-Bourboulis, Alice B Gottlieb, Gregor B E Jemec, Ziad Reguiai, Axel P Villani, Ivette Alarcon, Amita Bansal, Francesca Gasperoni, Ruvie Martin, Bertrand Paguet, Lorenz Uhlmann, Hichem Zouater, Shoba Ravichandran, Afsaneh Alavi
{"title":"Long-term efficacy and safety of secukinumab in patients with moderate-to-severe hidradenitis suppurativa: week 104 results from the SUNSHINE and SUNRISE extension trial.","authors":"Alexa B Kimball, Falk G Bechara, Aysha Badat, Evangelos J Giamarellos-Bourboulis, Alice B Gottlieb, Gregor B E Jemec, Ziad Reguiai, Axel P Villani, Ivette Alarcon, Amita Bansal, Francesca Gasperoni, Ruvie Martin, Bertrand Paguet, Lorenz Uhlmann, Hichem Zouater, Shoba Ravichandran, Afsaneh Alavi","doi":"10.1093/bjd/ljae469","DOIUrl":"10.1093/bjd/ljae469","url":null,"abstract":"<p><strong>Background: </strong>The SUNSHINE and SUNRISE phase III trials demonstrated sustained clinical efficacy of secukinumab in patients with moderate-to-severe hidradenitis suppurativa (HS) through 52 weeks. Patients completing the core trials could enter a 4-year extension trial.</p><p><strong>Objectives: </strong>To evaluate the long-term efficacy, safety/tolerability and maintenance of clinical response to secukinumab through week 104 in the extension trial.</p><p><strong>Methods: </strong>Patients with a hidradenitis suppurativa (HS) clinical response (HiSCR) at week 52 of the core trials (extension trial baseline visit) entered a randomized withdrawal period. HiSCR responders receiving subcutaneous secukinumab 300 mg every 2 or 4 weeks (SECQ2W/SECQ4W) through week 52 in the core trials were randomized 2 : 1 to continue secukinumab (SECQ2W-R-Q2W or SECQ4W-R-Q4W) or receive placebo (SECQ2W-R-PBO or SECQ4W-R-PBO) through week 104. The primary endpoint was time to loss of response (LOR; newly defined for this trial) through week 104 in week 52 HiSCR responders (SECQ2W-R-Q2W vs. SECQ2W-R-PBO and SECQ4W-R-Q4W vs. SECQ4W-R-PBO). Time to LOR was tested at 1.25% (one-sided) for each comparison (one-sided familywise alpha of 2.5%) through week 104. If LOR was met, patients could remain in the trial on open-label secukinumab treatment. Additional endpoints included safety and HiSCR. The trial was registered with ClinicalTrials.gov (NCT04179175).</p><p><strong>Results: </strong>Overall, 84.3% of patients who completed the core trials entered the extension trial; 55.9% were week 52 HiSCR responders. The primary endpoint was not met for either secukinumab dosing regimen. The estimated risk reduction for LOR was 13% (SECQ2W-R-Q2W vs. SECQ2W-R-PBO; one-sided P = 0.25) and 30% (SECQ4W-R-Q4W vs. SECQ4W-R-PBO; one-sided P = 0.04). The median time to LOR was numerically longer in the secukinumab arms vs. placebo {SECQ2W-R-Q2W [283 days; 95% confidence interval (CI) 176, -] vs. SECQ2W-R-PBO [239 days; 95% CI 120, -]; SECQ4W-R-Q4W [365 days 95% CI 225, -] vs. SECQ4W-R-PBO [171 days; 95% CI 113-337]}. In week 52 HiSCR responders reporting LOR, 44% (SECQ2W-R-Q2W), 58% (SECQ2W-R-PBO), 40% (SECQ4W-R-Q4W) and 34% (SECQ4W-R-PBO) were achieving HiSCR at the time of LOR. Overall, the safety of secukinumab was consistent with the core trials.</p><p><strong>Conclusions: </strong>The primary endpoint of this trial was not met. HiSCR was maintained in many patients at the time of LOR. The safety of secukinumab was consistent with the previously characterized safety profile in the core trials.</p>","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"629-640"},"PeriodicalIF":11.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142749984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Long-term management of moderate-to-severe atopic dermatitis with lebrikizumab and concomitant topical corticosteroids: a 68-week randomized double-blind placebo-controlled phase III trial in Japan (ADhere-J). 使用来曲珠单抗并同时使用局部皮质类固醇激素治疗中重度特应性皮炎的长期疗法:在日本进行的一项为期 68 周的随机、双盲、安慰剂对照 III 期试验 (ADhere-J)。
IF 11 1区 医学
British Journal of Dermatology Pub Date : 2025-03-18 DOI: 10.1093/bjd/ljae394
Norito Katoh, Akio Tanaka, Hidetoshi Takahashi, Ryosuke Shimizu, Yoko Kataoka, Hitoe Torisu-Itakura, Yoji Morisaki, Chie Yamamoto, Ken Igawa
{"title":"Long-term management of moderate-to-severe atopic dermatitis with lebrikizumab and concomitant topical corticosteroids: a 68-week randomized double-blind placebo-controlled phase III trial in Japan (ADhere-J).","authors":"Norito Katoh, Akio Tanaka, Hidetoshi Takahashi, Ryosuke Shimizu, Yoko Kataoka, Hitoe Torisu-Itakura, Yoji Morisaki, Chie Yamamoto, Ken Igawa","doi":"10.1093/bjd/ljae394","DOIUrl":"10.1093/bjd/ljae394","url":null,"abstract":"<p><strong>Background: </strong>Moderate-to-severe atopic dermatitis (AD) affects the quality of life of patients. More treatment options are urgently needed to manage this chronic disease. Lebrikizumab is a monoclonal antibody that binds to interleukin-13, a key mediator in AD pathogenesis. In Japanese patients, lebrikizumab has been evaluated through week 16 in the randomized placebo-controlled phase III ADhere-J study.</p><p><strong>Objectives: </strong>To evaluate the long-term efficacy and safety of lebrikizumab in combination with topical corticosteroids (TCS) in the ADhere-J study.</p><p><strong>Methods: </strong>Patients aged ≥12 years weighing ≥ 40 kg with moderate-to-severe AD and receiving either subcutaneous lebrikizumab 250 mg -every 2 weeks (Q2W)/every 4 weeks (Q4W) or placebo during the 16-week induction period were evaluated during the long-term maintenance period from week 16 to week 68. Responders achieved the co-primary endpoints at week 16: an Investigator's Global Assessment score of 0 or 1 [IGA (0,1)] with ≥ 2-point improvement from baseline and/or ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI 75). In this analysis, week 16 responders received lebrikizumab 250 mg Q2W or Q4W combined with TCS during the maintenance period (maintenance primary population; MPP); week 16 per-protocol nonresponders received lebrikizumab Q2W with TCS (maintenance escape population; MEP). Major endpoints included IGA (0,1) with ≥ 2-point improvement from baseline and EASI 75 through week 68. Other outcomes included quality of life, itch and serum thymus and activation-regulated chemokine. The trial was registered with ClinicalTrials.gov (NCT04760314).</p><p><strong>Results: </strong>At week 68, 66-81% of 103 patients in the MPP and 32-38% of 168 patients in the MEP achieved IGA (0,1) with ≥ 2-point improvement from baseline. EASI 75 was maintained by 83-89% of patients in the MPP, while 71-80% of patients in the MEP achieved this outcome by week 68. Across treatment arms, patients in the MPP tended to maintain improvements recorded at week 16, while patients in the MEP steadily improved across the maintenance period. No new safety signals were reported, and most treatment-emergent adverse events were mild or moderate in severity in both populations. Safety outcomes were consistent with previous reports for lebrikizumab treatment in global studies.</p><p><strong>Conclusions: </strong>These results support the use of lebrikizumab in combination with TCS for the treatment of moderate-to-severe AD in the Japanese population in the long term.</p>","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"597-610"},"PeriodicalIF":11.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142495467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Skin microbiome dynamics in patients with polymorphic light eruption in response to ultraviolet radiation. 多形性光糜烂患者皮肤微生物群对紫外线辐射的动态反应。
IF 11 1区 医学
British Journal of Dermatology Pub Date : 2025-03-18 DOI: 10.1093/bjd/ljae464
Yacine Amar, Sebastian Niedermeier, Rafaela Silva, Susanne Kublik, Michael Schloter, Tilo Biedermann, Martin Köberle, Bernadette Eberlein
{"title":"Skin microbiome dynamics in patients with polymorphic light eruption in response to ultraviolet radiation.","authors":"Yacine Amar, Sebastian Niedermeier, Rafaela Silva, Susanne Kublik, Michael Schloter, Tilo Biedermann, Martin Köberle, Bernadette Eberlein","doi":"10.1093/bjd/ljae464","DOIUrl":"10.1093/bjd/ljae464","url":null,"abstract":"<p><strong>Background: </strong>Polymorphic light eruption (PLE) is the most frequent photodermatosis in Europe, with an estimated prevalence of 10-20%, particularly in temperate climates. Itching or burning lesions appear only in sun-exposed areas, predominantly on the chest, arms and forearms, within a few hours following exposure. The cause of the disease remains unknown, yet studies have suggested that microbial elements in the skin may play a role in its pathogenesis.</p><p><strong>Objectives: </strong>To investigate the skin microbiome of a cohort of patients with PLE upon exposure to ultraviolet radiation (UVR), to assess its role in the onset of PLE lesions.</p><p><strong>Methods: </strong>Forty-one skin swabs were collected from 11 patients with PLE at baseline and after 3 days of exposure to UVR, and from healthy control participants. The collected swabs were analysed for their microbial composition using a 16S amplicon sequencing approach.</p><p><strong>Results: </strong>PLE skin showed a dysbalanced microbiome at baseline, with significantly reduced microbial diversity and noticeable colonization by bacterial pathogens, including Staphylococcus aureus. Upon UVR exposure, the PLE microbiome exhibited further loss of diversity and a reduction in beneficial skin commensals. In line with this, we found that UVR exerted strong antimicrobial effects in vitro against representative skin residents.</p><p><strong>Conclusions: </strong>UVR can lead to profound changes in the skin microbiome, allowing the proliferation of dysbiotic members that can release a variety of elements able to trigger PLE lesions. This is the first study to investigate the cutaneous microbiome changes in patients with PLE upon UVR exposure, offering new insights into disease pathogenesis that has so far been unexplored.</p>","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"684-696"},"PeriodicalIF":11.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comment on 'Oncogenic alterations in KIR3DL1 in cutaneous acral CD8+ lymphoproliferative disorder' by Wobser et al. 对Wobser等人“皮肤肢端CD8+淋巴增生性疾病中KIR3DL1的致癌改变”的评论。
IF 11 1区 医学
British Journal of Dermatology Pub Date : 2025-03-18 DOI: 10.1093/bjd/ljae487
Baptiste Louveau, Fanélie Jouenne, Caroline Ram-Wolff, Maxence Mancini, Adèle De Masson, Samia Mourah, Maxime Battistella
{"title":"Comment on 'Oncogenic alterations in KIR3DL1 in cutaneous acral CD8+ lymphoproliferative disorder' by Wobser et al.","authors":"Baptiste Louveau, Fanélie Jouenne, Caroline Ram-Wolff, Maxence Mancini, Adèle De Masson, Samia Mourah, Maxime Battistella","doi":"10.1093/bjd/ljae487","DOIUrl":"10.1093/bjd/ljae487","url":null,"abstract":"","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"769-771"},"PeriodicalIF":11.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A personalized and systematically designed adherence intervention improves photoprotection in adults with xeroderma pigmentosum (XP): results of the XPAND randomized controlled trial. 个性化和系统化设计的坚持干预可提高成人色素性皮肤病(XP)患者的光保护能力:XPAND随机对照试验的结果。
IF 11 1区 医学
British Journal of Dermatology Pub Date : 2025-03-18 DOI: 10.1093/bjd/ljae393
Jessica Walburn, Sam Norton, Robert Sarkany, Martha Canfield, Kirby Sainsbury, Paul McCrone, Vera Araújo-Soares, Myfanwy Morgan, Janette Boadu, Lesley Foster, Jakob Heydenreich, Adrian P Mander, Falko F Sniehotta, Hans Christian Wulf, John Weinman
{"title":"A personalized and systematically designed adherence intervention improves photoprotection in adults with xeroderma pigmentosum (XP): results of the XPAND randomized controlled trial.","authors":"Jessica Walburn, Sam Norton, Robert Sarkany, Martha Canfield, Kirby Sainsbury, Paul McCrone, Vera Araújo-Soares, Myfanwy Morgan, Janette Boadu, Lesley Foster, Jakob Heydenreich, Adrian P Mander, Falko F Sniehotta, Hans Christian Wulf, John Weinman","doi":"10.1093/bjd/ljae393","DOIUrl":"10.1093/bjd/ljae393","url":null,"abstract":"<p><strong>Background: </strong>Poor adherence to photoprotection in xeroderma pigmentosum (XP) increases morbidity and shortens lifespan due to skin cancers.</p><p><strong>Objectives: </strong>To test a highly personalized intervention (XPAND) to reduce the dose of ultraviolet radiation (UVR) reaching the face in adults with XP, designed using known psychosocial determinants of poor photoprotection.</p><p><strong>Methods: </strong>A two-arm parallel group randomized controlled trial, including patients with suboptimal photoprotection to receive XPAND or a delayed-intervention control arm that received XPAND the following year. XPAND comprises seven 1 : 1 sessions targeting photoprotection barriers (e.g. misconceptions about UVR) supported by personalized text messages, activity sheets and educational materials incorporating behaviour change techniques. The primary outcome, mean daily UVR dose to face across 21 days in June-July 2018, was calculated by combining UVR exposure at the wrist with a face photoprotection activity diary. Secondary outcomes were UVR dose to face across 21 days in August 2018, time spent outside, photoprotective measures used outside, mood, automaticity and confidence to photoprotect. Financial costs and quality-adjusted life years (QALYs) were calculated.</p><p><strong>Results: </strong>Sixteen patients were randomized; 13 provided sufficient data for primary outcome analysis. The XPAND group (n = 8) had lower mean daily UVR dose to face [0.03 standard error of difference (SED) (SD 0.02)] compared with controls (n = 7) [0.43 SED (SD 0.17)] (adjusted difference = -0.25, P < 0.001, Hedge's g = 2.21) at the June 2018 assessment. No significant between-group differences were observed in time spent outside, photoprotection outside, mood or confidence. The delayed-intervention control showed improvements in UVR dose to face (adjusted difference = -0.05; Hedge's g = -0.1), time outside (adjusted difference = -69.9; Hedge's g = -0.28) and photoprotection (adjusted difference = -0.23, Hedge's g = 0.45) after receiving XPAND (June 2019 assessment). XPAND was associated with lower treatment costs [-£2642; 95% confidence interval (CI) -£8715 to £3873] and fewer QALYs (-0.0141; 95% CI -0.0369 to 0.0028).</p><p><strong>Conclusions: </strong>XPAND was associated with a lower UVR dose to face in patients with XP and was cost-effective.</p>","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"728-737"},"PeriodicalIF":11.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142458440","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Drug survival and safety of biosimilars for treating psoriasis compared with originator adalimumab: a multinational cohort study. 生物仿制药与原研药阿达木单抗治疗银屑病的药物生存期和安全性比较:一项多国队列研究。
IF 11 1区 医学
British Journal of Dermatology Pub Date : 2025-03-18 DOI: 10.1093/bjd/ljae454
Duc Binh Phan, Hugo Jourdain, Miguel Angel Descalzo-Gallego, Alicia González-Quesada, Mahmoud Zureik, Raquel Rivera-Díaz, Antonio Sahuquillo-Torralba, Mark Lunt, Ignacio Garcia-Doval, Emilie Sbidian, Richard B Warren, Zenas Z N Yiu
{"title":"Drug survival and safety of biosimilars for treating psoriasis compared with originator adalimumab: a multinational cohort study.","authors":"Duc Binh Phan, Hugo Jourdain, Miguel Angel Descalzo-Gallego, Alicia González-Quesada, Mahmoud Zureik, Raquel Rivera-Díaz, Antonio Sahuquillo-Torralba, Mark Lunt, Ignacio Garcia-Doval, Emilie Sbidian, Richard B Warren, Zenas Z N Yiu","doi":"10.1093/bjd/ljae454","DOIUrl":"10.1093/bjd/ljae454","url":null,"abstract":"<p><strong>Background: </strong>The lack of evidence from routine clinical settings has limited the widespread adoption of adalimumab biosimilars for the treatment of psoriasis.</p><p><strong>Objectives: </strong>To compare the drug survival and safety of adalimumab biosimilars with Humira® in psoriasis.</p><p><strong>Methods: </strong>We conducted a prevalent new-user cohort study using data from the French National Health Data System (SNDS), the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) and the Spanish Registry of Systemic Therapy in Psoriasis (BIOBADADERM). Adalimumab-naïve patients initiating adalimumab biosimilars (new users) were compared with Humira new users. Patients switching from Humira to biosimilars (switchers) were compared with those who continued Humira treatment. Patients were matched 1 : 1 based on previous adalimumab exposure time to create equal-sized cohorts of biosimilar and Humira users. Co-primary outcomes included drug discontinuation and serious adverse events (SAEs). Hazard ratios (HRs) were calculated using Cox proportional hazard models. Meta-analyses using random-effect models were performed to combine results from the three databases.</p><p><strong>Results: </strong>In total, 7387 biosimilar new users and 3654 switchers were matched and compared with Humira users. No differences in all-cause discontinuation were found between biosimilar and Humira new users [HR 0.99, 95% confidence interval (CI) 0.94-1.04]. Switching from Humira to biosimilars was associated with a higher discontinuation rate than remaining on Humira (HR 1.35, 95% CI 1.19-1.52). Similar results were observed for discontinuation due to ineffectiveness or adverse events. Risks of SAEs were similar between biosimilar new users and Humira new users [incidence rate ratio (IRR) 0.91, 95% CI 0.80-1.05] or between switchers and continuous Humira users (IRR 0.92, 95% CI 0.83-1.01).</p><p><strong>Conclusions: </strong>Adalimumab biosimilars can be considered viable alternatives to Humira for new patients, with comparable effectiveness and safety. However, owing to the higher likelihood of discontinuation, patients who switch from Humira to biosimilars may require closer monitoring and support.</p>","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"641-652"},"PeriodicalIF":11.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study. Guselkumab用于治疗儿科患者中至重度斑块性银屑病:3期随机、安慰剂对照PROTOSTAR研究结果
IF 11 1区 医学
British Journal of Dermatology Pub Date : 2025-03-18 DOI: 10.1093/bjd/ljae502
Vimal H Prajapati, Marieke M B Seyger, Dagmar Wilsmann-Theis, Erzsebet Szakos, Andrzej Kaszuba, Bart van Hartingsveldt, Meg Jett, Gigi Jiang, Shu Li, Vikash Sinha, Herta Crauwels, Cynthia M C DeKlotz, Amy S Paller
{"title":"Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study.","authors":"Vimal H Prajapati, Marieke M B Seyger, Dagmar Wilsmann-Theis, Erzsebet Szakos, Andrzej Kaszuba, Bart van Hartingsveldt, Meg Jett, Gigi Jiang, Shu Li, Vikash Sinha, Herta Crauwels, Cynthia M C DeKlotz, Amy S Paller","doi":"10.1093/bjd/ljae502","DOIUrl":"10.1093/bjd/ljae502","url":null,"abstract":"<p><strong>Background: </strong>No currently approved treatment for paediatric plaque psoriasis selectively targets interleukin (IL)-23. In adults, guselkumab (a selective IL-23 inhibitor that targets the p19 subunit) demonstrated substantial efficacy with a favourable safety profile in treating moderate-to-severe plaque psoriasis.</p><p><strong>Objectives: </strong>To evaluate the efficacy and safety of guselkumab in paediatric patients with moderate-to-severe plaque psoriasis (PROTOSTAR; NCT03451851).</p><p><strong>Methods: </strong>This phase III randomized placebo-controlled study enrolled patients aged ≥ 6 to < 18 years with moderate-to-severe plaque psoriasis. In part 1 [week (W)0-W16], patients were randomized to receive guselkumab, placebo or open-label etanercept (active reference arm). At W16, part 1 patients entered a guselkumab withdrawal/retreatment period or continued/crossed over to receive guselkumab (W16-W52). Co-primary endpoints were Investigator Global Assessment (IGA) 0/1 and ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) [or U.S. Food and Drug Administration-required ≥ 90% improvement in PASI (PASI 90) co-primary endpoint] responses at W16 of part 1. Part 2 evaluated continuous open-label guselkumab treatment (W0-W52).</p><p><strong>Results: </strong>Of 92 and 28 patients enrolled in parts 1 and 2, respectively, 86% and 96% continued treatment through W52. In part 1, at W16, significantly higher proportions of guselkumab-treated compared with placebo-treated patients achieved IGA 0/1 (66% vs. 16%; P < 0.001), PASI 75 (76% vs. 20%; P < 0.001) and PASI 90 (56% vs. 16%; P < 0.01). More than one-third of guselkumab-treated patients achieved clear skin [IGA 0: 39% vs. 4% placebo; 100% improvement in PASI (PASI 100): 34% vs. 0% placebo; both P < 0.01]. In part 2, at W52, 86%, 93% and 82% of guselkumab-treated patients achieved IGA 0/1, PASI 75 and PASI 90, respectively. Through W16 of part 1, 42%, 68% and 58% of guselkumab-, placebo- and etanercept-treated patients, respectively, experienced adverse events (AEs). Rates of AEs with guselkumab were similar through W52 in parts 1 and 2; common AEs included nasopharyngitis, upper respiratory tract infection and COVID-19. No serious or opportunistic infections occurred.</p><p><strong>Conclusions: </strong>Guselkumab demonstrated significant and clinically meaningful responses in paediatric patients with moderate-to-severe plaque psoriasis, and all co-primary and major secondary endpoints were met. Safety outcomes for guselkumab in paediatric patients were similar to placebo and consistent with the established profile in adults, with no new safety signals identified. These findings support the use of guselkumab to treat paediatric patients with moderate-to-severe plaque psoriasis.</p>","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"618-628"},"PeriodicalIF":11.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cutaneous T-cell lymphoma in Australia: what drives the geospatial variation? 澳大利亚皮肤t细胞淋巴瘤:地理空间驱动因素?
IF 11 1区 医学
British Journal of Dermatology Pub Date : 2025-03-18 DOI: 10.1093/bjd/ljaf026
Rosanne Ottevanger, Maarten H Vermeer
{"title":"Cutaneous T-cell lymphoma in Australia: what drives the geospatial variation?","authors":"Rosanne Ottevanger, Maarten H Vermeer","doi":"10.1093/bjd/ljaf026","DOIUrl":"10.1093/bjd/ljaf026","url":null,"abstract":"","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"568-569"},"PeriodicalIF":11.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Global Delphi consensus on treatment goals for generalized pustular psoriasis. 关于全面性脓疱性银屑病治疗目标的全球德尔菲共识。
IF 11 1区 医学
British Journal of Dermatology Pub Date : 2025-03-18 DOI: 10.1093/bjd/ljae491
Jonathan N Barker, Emmylou Casanova, Siew Eng Choon, Peter Foley, Hideki Fujita, César Gonzalez, Melinda Gooderham, Slaheddine Marrakchi, Luís Puig, Ricardo Romiti, Diamant Thaçi, Min Zheng, Bruce Strober
{"title":"Global Delphi consensus on treatment goals for generalized pustular psoriasis.","authors":"Jonathan N Barker, Emmylou Casanova, Siew Eng Choon, Peter Foley, Hideki Fujita, César Gonzalez, Melinda Gooderham, Slaheddine Marrakchi, Luís Puig, Ricardo Romiti, Diamant Thaçi, Min Zheng, Bruce Strober","doi":"10.1093/bjd/ljae491","DOIUrl":"10.1093/bjd/ljae491","url":null,"abstract":"<p><strong>Background: </strong>Generalized pustular psoriasis (GPP) is a chronic, systemic, neutrophilic inflammatory disease. A previous Delphi panel established areas of consensus on GPP, although patient perspectives were not included and aspects of treatment goals remained unclear.</p><p><strong>Objectives: </strong>To identify and achieve consensus on refined, specific treatment goals for GPP treatment via a Delphi panel with patient participation.</p><p><strong>Methods: </strong>Statements were generated based on a systematic literature review and revised by a Steering Committee. Statements were categorized into overarching principles, and short- and long-term treatment goals. A global panel of 30 dermatologists and 3 patient representatives voted in agreement or disagreement with each statement. Consensus was defined as ≥ 80% approval by the panellists.</p><p><strong>Results: </strong>Consensus was reached in the first round of voting and ≥ 90% agreement was reached for 23 of 26 statements. In summary, GPP requires a timely, tailored treatment plan, co-developed by patients and physicians, that involves a multidisciplinary approach and addresses the complexity, heterogeneity and chronicity of the disease. Short-term treatment goals should include pustule clearance within 7 days and prevention of pustule recurrence, reduction of cutaneous symptom burden (-4 or more points on the Itch and Skin Pain Numeric Rating Scale), improvement in systemic symptoms (e.g. resolution of fever within 3 days of treatment initiation and reduced fatigue), prevention of life-threatening complications and progressive improvement of inflammatory biomarkers. In patients with comorbid psoriatic diseases, treatment decisions should prioritize GPP. Long-term treatment goals should include minimizing disease activity through flare prevention and symptom control between flares, sustained disease control, management of comorbidities and improvement in quality of life (QoL). Small differences in perception between patients and physicians regarding the importance of certain treatment goals (e.g. avoiding hair and/or nail loss to improve QoL), reflect the complexity of assessing treatment goals and emphasize the need for a patient-centred approach.</p><p><strong>Conclusions: </strong>In the first global Delphi panel in GPP to include patient perspectives, consensus between dermatologists and patients was achieved on overarching principles of treatment, and short- and long-term treatment goals for GPP. These findings provide valuable insights for developing guidelines that consider the perspectives of patients and physicians in the treatment of GPP.</p>","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"706-716"},"PeriodicalIF":11.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
R(+) propranolol decreases lipid accumulation in haemangioma-derived stem cells. R(+)普萘洛尔可减少血管瘤干细胞的脂质积累。
IF 11 1区 医学
British Journal of Dermatology Pub Date : 2025-03-18 DOI: 10.1093/bjd/ljae452
Jerry Wei Heng Tan, Jill Wylie-Sears, Caroline T Seebauer, John B Mulliken, Mathias Francois, Annegret Holm, Joyce Bischoff
{"title":"R(+) propranolol decreases lipid accumulation in haemangioma-derived stem cells.","authors":"Jerry Wei Heng Tan, Jill Wylie-Sears, Caroline T Seebauer, John B Mulliken, Mathias Francois, Annegret Holm, Joyce Bischoff","doi":"10.1093/bjd/ljae452","DOIUrl":"10.1093/bjd/ljae452","url":null,"abstract":"","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"757-759"},"PeriodicalIF":11.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11918590/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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