Pub Date : 2024-12-01Epub Date: 2024-01-23DOI: 10.1080/09546634.2024.2304025
Tamara W van Hal, Juul M P A van den Reek, Mark H Wenink, Marisol E Otero, Paul M Ossenkoppele, Marcellus D Njoo, Annet Oostveen, Bas Peters, Milan Tjioe, Else N Kop, John E M Körver, Sharon R P Dodemont, Marloes M Kleinpenning, Maartje A M Berends, Wendelien R Veldkamp, Martijn B A van Doorn, Johannes M Mommers, Robert-Jan Lindhout, Astrid L A Kuijpers, Paula P van Lümig, C Els J de Jonge, Ron A Tupker, Judith Hendricksen, Romy R Keijsers, Frank H J van den Hoogen, Johanna E Vriezekolk, Elke M G J de Jong
Background: Little is known about the extent of impairments in work and activities of daily life (ADL) in patients with psoriasis, and the influence of contextual factors such as disease-related characteristics and treatment. Therefore, this study aimed to assess these impairments in patients with psoriasis who started using biologicals/small molecule inhibitors.Methods: Using data from the prospective BioCAPTURE registry, we collected patient, disease, and treatment parameters, as well as work/ADL impairments at baseline, 6 and 12 months. Changes in impairment parameters and correlations between impairment and patient/disease characteristics were assessed using generalized estimating equations.Results: We included 194 patients in our analysis. After biological initiation, disease activity decreased significantly (PASI 11.2 at baseline versus 3.9 at 12 months, p < 0.001). Work-for-pay in this cohort was lower than in the Dutch general population (53% versus 67%, p = 0.01). In patients who had work-for-pay, presenteeism improved over time (5% at baseline versus 0% at 12 months, p = 0.04). Up to half of the patients reported impairments in ADL, which did not change over time. Associations between impairments and contextual factors varied, but all impairments were associated with worse mental/physical general functioning.Conclusion: Patients with psoriasis using biologicals are less likely to have work-for-pay. Treatment improves the work productivity of employed patients, but we were unable to detect changes in ADL performance.
{"title":"Impairment in work and activities of daily life in patients with psoriasis: results of the prospective BioCAPTURE registry.","authors":"Tamara W van Hal, Juul M P A van den Reek, Mark H Wenink, Marisol E Otero, Paul M Ossenkoppele, Marcellus D Njoo, Annet Oostveen, Bas Peters, Milan Tjioe, Else N Kop, John E M Körver, Sharon R P Dodemont, Marloes M Kleinpenning, Maartje A M Berends, Wendelien R Veldkamp, Martijn B A van Doorn, Johannes M Mommers, Robert-Jan Lindhout, Astrid L A Kuijpers, Paula P van Lümig, C Els J de Jonge, Ron A Tupker, Judith Hendricksen, Romy R Keijsers, Frank H J van den Hoogen, Johanna E Vriezekolk, Elke M G J de Jong","doi":"10.1080/09546634.2024.2304025","DOIUrl":"10.1080/09546634.2024.2304025","url":null,"abstract":"<p><p><b>Background:</b> Little is known about the extent of impairments in work and activities of daily life (ADL) in patients with psoriasis, and the influence of contextual factors such as disease-related characteristics and treatment. Therefore, this study aimed to assess these impairments in patients with psoriasis who started using biologicals/small molecule inhibitors.<b>Methods:</b> Using data from the prospective BioCAPTURE registry, we collected patient, disease, and treatment parameters, as well as work/ADL impairments at baseline, 6 and 12 months. Changes in impairment parameters and correlations between impairment and patient/disease characteristics were assessed using generalized estimating equations.<b>Results:</b> We included 194 patients in our analysis. After biological initiation, disease activity decreased significantly (PASI 11.2 at baseline versus 3.9 at 12 months, <i>p</i> < 0.001). Work-for-pay in this cohort was lower than in the Dutch general population (53% versus 67%, <i>p</i> = 0.01). In patients who had work-for-pay, presenteeism improved over time (5% at baseline versus 0% at 12 months, <i>p</i> = 0.04). Up to half of the patients reported impairments in ADL, which did not change over time. Associations between impairments and contextual factors varied, but all impairments were associated with worse mental/physical general functioning.<b>Conclusion:</b> Patients with psoriasis using biologicals are less likely to have work-for-pay. Treatment improves the work productivity of employed patients, but we were unable to detect changes in ADL performance.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2304025"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139542597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-05-16DOI: 10.1080/09546634.2024.2350231
Hongbin Song, Zhonghui Hu, Shiyu Zhang, Lu Yang, Jindi Feng, Lu Lu, Yuehua Liu, Tao Wang
Background: Mycosis fungoides (MF) is the most common type of cutaneous T-cell lymphoma.
Objectives: This study was conducted to evaluate efficacy and safety of interferon (IFN) α-2a combined with phototherapy for early-stage MF.
Methods: Thirteen patients with early-stage MF received subcutaneous injections of IFN α-2a at 3 million IU combined with phototherapy three times per week for 6 months. Treatment efficacy was measured by changes in body surface area (BSA) score and modified severity-weighted assessment tool (mSWAT) score at 1, 3, and 6 months after treatment. Histopathologic examinations of skin lesions were performed before and after treatment.
Results: After 3 months of treatment, all 13 patients achieved a partial response, and BSA and mSWAT scores were significantly lower than those at baseline (p < 0.001). After 6 months, BSA and mSWAT scores were significantly lower than those at baseline (p < 0.001) and after 3 months (p < 0.05). Eleven patients achieved complete remission and two patients achieved a partial response (overall response rate, 100%). Histopathologic examination showed a significant decrease in the number of atypical lymphocytes in both epidermis and dermis. No severe adverse effects occurred.
Conclusion: IFN α-2a in combination with phototherapy may be an effective and safe alternative modality for early-stage MF.
{"title":"Effectiveness and safety of interferon α-2a combined with phototherapy for patients with early-stage mycosis fungoides - a single-arm prospective study in 13 patients.","authors":"Hongbin Song, Zhonghui Hu, Shiyu Zhang, Lu Yang, Jindi Feng, Lu Lu, Yuehua Liu, Tao Wang","doi":"10.1080/09546634.2024.2350231","DOIUrl":"https://doi.org/10.1080/09546634.2024.2350231","url":null,"abstract":"<p><p><b>Background:</b> Mycosis fungoides (MF) is the most common type of cutaneous T-cell lymphoma.</p><p><p><b>Objectives:</b> This study was conducted to evaluate efficacy and safety of interferon (IFN) α-2a combined with phototherapy for early-stage MF.</p><p><p><b>Methods:</b> Thirteen patients with early-stage MF received subcutaneous injections of IFN α-2a at 3 million IU combined with phototherapy three times per week for 6 months. Treatment efficacy was measured by changes in body surface area (BSA) score and modified severity-weighted assessment tool (mSWAT) score at 1, 3, and 6 months after treatment. Histopathologic examinations of skin lesions were performed before and after treatment.</p><p><p><b>Results:</b> After 3 months of treatment, all 13 patients achieved a partial response, and BSA and mSWAT scores were significantly lower than those at baseline (<i>p</i> < 0.001). After 6 months, BSA and mSWAT scores were significantly lower than those at baseline (<i>p</i> < 0.001) and after 3 months (<i>p</i> < 0.05). Eleven patients achieved complete remission and two patients achieved a partial response (overall response rate, 100%). Histopathologic examination showed a significant decrease in the number of atypical lymphocytes in both epidermis and dermis. No severe adverse effects occurred.</p><p><p><b>Conclusion:</b> IFN α-2a in combination with phototherapy may be an effective and safe alternative modality for early-stage MF.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2350231"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140961016","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-06-16DOI: 10.1080/09546634.2024.2359511
Sun Young Choi, Young Gue Koh, Yang Won Lee, Hyung Seok Son, Yi Na Yoon, Gyeonghoon Kim, Chonghyun Won, Hyesoo Cho, Joo-Sun Son, Eun-Kyoung Kim, Beom Joon Kim
Botulinum toxin type A (BoNT-A) was first isolated in 1946, and since then, several formulations have been developed and widely used to treat wrinkles by inducing muscle paralysis. This multicenter, double-blind, randomized, parallel-group, active-controlled phase 3 clinical trial was designed to evaluate the efficacy and safety of a newly developed BoNT-A formulation, BMI2006, in improving moderate to severe glabellar wrinkles and to compare with existing onabotulinumtoxin A (OBoNT) injections. A total of 276 subjects were enrolled and received 20 units of the randomized material, which was intramuscularly injected into five different locations on the forehead. The primary endpoint, assessed at 4 weeks, showed no statistically significant difference in the improvement rate of glabellar wrinkles between the two groups, with BMI2006 demonstrating non-inferiority to comparator BoNT-A. Secondary endpoints, evaluated by both treating investigators and independent investigators, also exhibited similar improvement rates throughout the study period. Both groups reported high levels of satisfaction with no statistical difference between the two groups. Safety evaluations indicated mild and transient adverse events, with no serious reactions observed. In conclusion, BMI2006 is an effective and safe BoNT-A for treating glabellar wrinkles with an expected duration of action between 8 and 12 weeks.
{"title":"A multicenter, double-blind, randomized, parallel-group, active-controlled, phase 3 clinical trial to compare the effectiveness and safety of two botulinum toxin type A formulations for improving moderate to severe glabellar wrinkles in Asians.","authors":"Sun Young Choi, Young Gue Koh, Yang Won Lee, Hyung Seok Son, Yi Na Yoon, Gyeonghoon Kim, Chonghyun Won, Hyesoo Cho, Joo-Sun Son, Eun-Kyoung Kim, Beom Joon Kim","doi":"10.1080/09546634.2024.2359511","DOIUrl":"10.1080/09546634.2024.2359511","url":null,"abstract":"<p><p>Botulinum toxin type A (BoNT-A) was first isolated in 1946, and since then, several formulations have been developed and widely used to treat wrinkles by inducing muscle paralysis. This multicenter, double-blind, randomized, parallel-group, active-controlled phase 3 clinical trial was designed to evaluate the efficacy and safety of a newly developed BoNT-A formulation, BMI2006, in improving moderate to severe glabellar wrinkles and to compare with existing onabotulinumtoxin A (OBoNT) injections. A total of 276 subjects were enrolled and received 20 units of the randomized material, which was intramuscularly injected into five different locations on the forehead. The primary endpoint, assessed at 4 weeks, showed no statistically significant difference in the improvement rate of glabellar wrinkles between the two groups, with BMI2006 demonstrating non-inferiority to comparator BoNT-A. Secondary endpoints, evaluated by both treating investigators and independent investigators, also exhibited similar improvement rates throughout the study period. Both groups reported high levels of satisfaction with no statistical difference between the two groups. Safety evaluations indicated mild and transient adverse events, with no serious reactions observed. In conclusion, BMI2006 is an effective and safe BoNT-A for treating glabellar wrinkles with an expected duration of action between 8 and 12 weeks.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2359511"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141332799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-11-19DOI: 10.1080/09546634.2024.2426626
Michael James Kim, Jovian Wan, Lopatkina Oksana, Lavrik Yuliia, Olena Chugay, Olena Platonova, Olena Sydorchuk, Kyu-Ho Yi
Introduction: This study examines the therapeutic efficacy of polynucleotide-based therapies, specifically REJURAN®, for managing scars and burns. Scars and burns present significant challenges in dermatology, often affecting patients' quality of life. Traditional treatments can be limited in effectiveness, prompting the exploration of innovative approaches like polynucleotide therapy, which utilizes salmon DNA to stimulate tissue repair, modulate inflammation, and enhance collagen production.
Methods: A series of case studies was conducted, including diverse patient profiles with various types of scars and burns. The study evaluated the impact of REJURAN® on scar appearance, texture, and overall skin quality. Some cases also explored the combination of polynucleotide therapy with other treatments such as Platelet-Rich Plasma (PRP) and botulinum toxin.
Results: Notable improvements were observed across cases, including reduced scar visibility and enhanced skin texture. The therapy proved effective in treating post-traumatic, post-operative, and burn-related scars, demonstrating its versatility and potential benefits. Combination therapies showed promising results, though further research is needed.
Conclusion: Polynucleotide-based therapy with REJURAN® shows promise in scar and burn management, offering a novel approach that leverages the body's regenerative processes. Further studies are recommended to confirm these findings and refine treatment protocols.
简介:本研究探讨了基于多核苷酸的疗法(特别是 REJURAN®)在治疗疤痕和烧伤方面的疗效。疤痕和烧伤是皮肤科面临的重大挑战,通常会影响患者的生活质量。传统治疗方法的效果可能有限,这促使人们探索创新方法,如利用鲑鱼 DNA 刺激组织修复、调节炎症和促进胶原蛋白生成的多核苷酸疗法:方法:进行了一系列病例研究,包括不同类型的疤痕和烧伤患者。研究评估了 REJURAN® 对疤痕外观、质地和整体皮肤质量的影响。一些病例还探讨了多核苷酸疗法与其他疗法(如富血小板血浆(PRP)和肉毒杆菌毒素)的结合:各病例均有明显改善,包括疤痕减淡和皮肤质地改善。该疗法在治疗创伤后、术后和烧伤相关疤痕方面效果显著,证明了它的多功能性和潜在优势。尽管还需要进一步研究,但联合疗法显示出了良好的效果:基于 REJURAN® 的多核苷酸疗法在疤痕和烧伤治疗方面大有可为,提供了一种利用人体再生过程的新方法。建议开展进一步研究,以证实这些发现并完善治疗方案。
{"title":"Polynucleotide-based treatments for various facial scars including combat injuries.","authors":"Michael James Kim, Jovian Wan, Lopatkina Oksana, Lavrik Yuliia, Olena Chugay, Olena Platonova, Olena Sydorchuk, Kyu-Ho Yi","doi":"10.1080/09546634.2024.2426626","DOIUrl":"https://doi.org/10.1080/09546634.2024.2426626","url":null,"abstract":"<p><strong>Introduction: </strong>This study examines the therapeutic efficacy of polynucleotide-based therapies, specifically REJURAN<sup>®</sup>, for managing scars and burns. Scars and burns present significant challenges in dermatology, often affecting patients' quality of life. Traditional treatments can be limited in effectiveness, prompting the exploration of innovative approaches like polynucleotide therapy, which utilizes salmon DNA to stimulate tissue repair, modulate inflammation, and enhance collagen production.</p><p><strong>Methods: </strong>A series of case studies was conducted, including diverse patient profiles with various types of scars and burns. The study evaluated the impact of REJURAN<sup>®</sup> on scar appearance, texture, and overall skin quality. Some cases also explored the combination of polynucleotide therapy with other treatments such as Platelet-Rich Plasma (PRP) and botulinum toxin.</p><p><strong>Results: </strong>Notable improvements were observed across cases, including reduced scar visibility and enhanced skin texture. The therapy proved effective in treating post-traumatic, post-operative, and burn-related scars, demonstrating its versatility and potential benefits. Combination therapies showed promising results, though further research is needed.</p><p><strong>Conclusion: </strong>Polynucleotide-based therapy with REJURAN<sup>®</sup> shows promise in scar and burn management, offering a novel approach that leverages the body's regenerative processes. Further studies are recommended to confirm these findings and refine treatment protocols.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2426626"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142678149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-11-17DOI: 10.1080/09546634.2024.2419931
Elke Niebergall-Roth, Kathrin Dieter, Markus H Frank, Mark A Kluth
Background: The ability of mesenchymal stromal cells (MSCs) to facilitate regenerative responses in inflamed and injured tissues, coupled with preclinical data suggesting potential to restore defective collagen VII at the dermo-epidermal junction, has raised the hope that MSCs may provide an effective disease-modifying therapy for patients suffering from recessive dystrophic epidermolysis bullosa (RDEB).
Methods: We present a descriptive analysis of the clinical research on systemic MSC administration to RDEB patients available in PubMed, including six early-phase studies and one case report, involving 59 patients who received 1-3 intravenous infusions of MSCs from various sources.
Results: Based on 133 MSC infusions, a total of 44 mostly mild adverse events were reported as definitely, possibly or likely related to the study treatment, only two of which led to treatment discontinuation. Improvements were seen in skin manifestations, disease activity, pain, pruritus and quality of life, with considerable heterogeneity in reported outcome variables and measurement tools between studies, and large inter-patient variability within studies.
Conclusions: Although the current evidence base is limited, reflecting the typical challenges of clinical research in rare diseases, the reported results suggest potential treatment benefits for patients and provide a rationale for continuing to pursue this therapeutic approach.
{"title":"Systemic treatment of recessive dystrophic epidermolysis bullosa with mesenchymal stromal cells: a scoping review of the literature and conclusions for future clinical research.","authors":"Elke Niebergall-Roth, Kathrin Dieter, Markus H Frank, Mark A Kluth","doi":"10.1080/09546634.2024.2419931","DOIUrl":"10.1080/09546634.2024.2419931","url":null,"abstract":"<p><p><b>Background:</b> The ability of mesenchymal stromal cells (MSCs) to facilitate regenerative responses in inflamed and injured tissues, coupled with preclinical data suggesting potential to restore defective collagen VII at the dermo-epidermal junction, has raised the hope that MSCs may provide an effective disease-modifying therapy for patients suffering from recessive dystrophic epidermolysis bullosa (RDEB).</p><p><p><b>Methods:</b> We present a descriptive analysis of the clinical research on systemic MSC administration to RDEB patients available in PubMed, including six early-phase studies and one case report, involving 59 patients who received 1-3 intravenous infusions of MSCs from various sources.</p><p><p><b>Results:</b> Based on 133 MSC infusions, a total of 44 mostly mild adverse events were reported as definitely, possibly or likely related to the study treatment, only two of which led to treatment discontinuation. Improvements were seen in skin manifestations, disease activity, pain, pruritus and quality of life, with considerable heterogeneity in reported outcome variables and measurement tools between studies, and large inter-patient variability within studies.</p><p><p><b>Conclusions:</b> Although the current evidence base is limited, reflecting the typical challenges of clinical research in rare diseases, the reported results suggest potential treatment benefits for patients and provide a rationale for continuing to pursue this therapeutic approach.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2419931"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142650078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-06-19DOI: 10.1080/09546634.2024.2368066
Le Han, Yuchen Jiang, Miaojian Wan
Purpose: To evaluate the efficacy of Mohs micrographic surgery (MMS) combined with photodynamic therapy (PDT) in treating non-invasive extramammary Paget's disease (EMPD).
Materials and methods: A 77-year-old male patient with non-invasive EMPD was treated with MMS followed by PDT. Preoperative fluorescence localization using 5-aminolevulinic acid (ALA) was performed to determine the surgical scope. MMS was conducted under lumbar anesthesia with intraoperative frozen-section pathology. Postoperative PDT was administered weekly for three sessions.
Results: The patient achieved negative surgical margins after two rounds of intraoperative pathology. Postoperative follow-up over two years showed no recurrence, and the patient did not experience significant adverse reactions.
Conclusion: The combination of MMS and PDT was effective in treating non-invasive EMPD, demonstrating favorable clinical outcomes and no recurrence over the two-year follow-up period.
{"title":"Preliminary analysis of the efficacy of Mohs micrographic surgery combined with photodynamic therapy in a case of noninvasive extramammary Paget's disease.","authors":"Le Han, Yuchen Jiang, Miaojian Wan","doi":"10.1080/09546634.2024.2368066","DOIUrl":"10.1080/09546634.2024.2368066","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the efficacy of Mohs micrographic surgery (MMS) combined with photodynamic therapy (PDT) in treating non-invasive extramammary Paget's disease (EMPD).</p><p><strong>Materials and methods: </strong>A 77-year-old male patient with non-invasive EMPD was treated with MMS followed by PDT. Preoperative fluorescence localization using 5-aminolevulinic acid (ALA) was performed to determine the surgical scope. MMS was conducted under lumbar anesthesia with intraoperative frozen-section pathology. Postoperative PDT was administered weekly for three sessions.</p><p><strong>Results: </strong>The patient achieved negative surgical margins after two rounds of intraoperative pathology. Postoperative follow-up over two years showed no recurrence, and the patient did not experience significant adverse reactions.</p><p><strong>Conclusion: </strong>The combination of MMS and PDT was effective in treating non-invasive EMPD, demonstrating favorable clinical outcomes and no recurrence over the two-year follow-up period.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2368066"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141428603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-10-10DOI: 10.1080/09546634.2024.2411855
Luigi Gargiulo, Luciano Ibba, Angela Alfano, Piergiorgio Malagoli, Fabrizio Amoruso, Anna Balato, Francesca Barei, Anna G Burroni, Stefano Caccavale, Piergiacomo Calzavara-Pinton, Maria Esposito, Maria C Fargnoli, Silvia M Ferrucci, Caterina Foti, Giampiero Girolomoni, Massimo Gola, Mario B Guanti, Carlotta Gurioli, Manfredi Magliulo, Martina Maurelli, Pietro Morrone, Maria L Musumeci, Maddalena Napolitano, Michela Ortoncelli, Cataldo Patruno, Bianca M Piraccini, Elena Pezzolo, Simone Ribero, Mariateresa Rossi, Paola Savoia, Claudio Sciarrone, Benedetta Tirone, Marco Vaccino, Federica Veronese, Antonio Costanzo, Alessandra Narcisi
Aim: Abrocitinib is a JAK-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD). We conducted a 16-week multicenter retrospective study to assess the short-term effectiveness and safety of abrocitinib in patients with moderate-to-severe AD.
Our retrospective study included 85 adult patients from 14 Italian Dermatology Units affected by moderate-to-severe AD treated with abrocitinib 100/200 mg.
Methods: Effectiveness of abrocitinib at weeks 4 and 16 was assessed by using the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA), the peak pruritus and sleep- Numerical Rating Scale (PP-NRS and S-NRS, respectively).
Results: At week 16, improvement of at least 90% in EASI (EASI90) and IGA 0/1 was observed in 49.4% and 61.2% of patients, respectively. A reduction of at least 4 points in PP-NRS and S-NRS compared with baseline was achieved by 70.6% of patients for both endpoints. No significant safety reports were observed during the study period. Naïve patients had better rates of EASI 90 compared to patients who previously failed dupilumab.Conclusion: Our data confirm the effectiveness of abrocitinib in a real-world setting with better clinical responses at weeks 4 and 16, compared with Phase-III clinical trials. Longer analyses are required to further establish the safety profile of abrocitinib.
{"title":"Short-term effectiveness and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis: results from a 16-week real-world multicenter retrospective study - il AD (Italian landscape atopic dermatitis).","authors":"Luigi Gargiulo, Luciano Ibba, Angela Alfano, Piergiorgio Malagoli, Fabrizio Amoruso, Anna Balato, Francesca Barei, Anna G Burroni, Stefano Caccavale, Piergiacomo Calzavara-Pinton, Maria Esposito, Maria C Fargnoli, Silvia M Ferrucci, Caterina Foti, Giampiero Girolomoni, Massimo Gola, Mario B Guanti, Carlotta Gurioli, Manfredi Magliulo, Martina Maurelli, Pietro Morrone, Maria L Musumeci, Maddalena Napolitano, Michela Ortoncelli, Cataldo Patruno, Bianca M Piraccini, Elena Pezzolo, Simone Ribero, Mariateresa Rossi, Paola Savoia, Claudio Sciarrone, Benedetta Tirone, Marco Vaccino, Federica Veronese, Antonio Costanzo, Alessandra Narcisi","doi":"10.1080/09546634.2024.2411855","DOIUrl":"https://doi.org/10.1080/09546634.2024.2411855","url":null,"abstract":"<p><p><b>Aim:</b> Abrocitinib is a JAK-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD). We conducted a 16-week multicenter retrospective study to assess the short-term effectiveness and safety of abrocitinib in patients with moderate-to-severe AD.</p><p><p>Our retrospective study included 85 adult patients from 14 Italian Dermatology Units affected by moderate-to-severe AD treated with abrocitinib 100/200 mg.</p><p><p><b>Methods:</b> Effectiveness of abrocitinib at weeks 4 and 16 was assessed by using the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA), the peak pruritus and sleep- Numerical Rating Scale (PP-NRS and S-NRS, respectively).</p><p><p><b>Results:</b> At week 16, improvement of at least 90% in EASI (EASI90) and IGA 0/1 was observed in 49.4% and 61.2% of patients, respectively. A reduction of at least 4 points in PP-NRS and S-NRS compared with baseline was achieved by 70.6% of patients for both endpoints. No significant safety reports were observed during the study period. Naïve patients had better rates of EASI 90 compared to patients who previously failed dupilumab.<b>Conclusion:</b> Our data confirm the effectiveness of abrocitinib in a real-world setting with better clinical responses at weeks 4 and 16, compared with Phase-III clinical trials. Longer analyses are required to further establish the safety profile of abrocitinib.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2411855"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142402547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-10-27DOI: 10.1080/09546634.2024.2420825
Annunziata Dattola, Nicoletta Bernardini, Francesca Svara, Anna Balato, Giacomo Caldarola, Domenico D'Amico, Clara De Simone, Eugenia Veronica Di Brizzi, Maria Esposito, Claudia Giofrè, Domenico Giordano, Claudio Guarneri, Francesco Loconsole, Viviana Lora, Gaia Moretta, Diego Orsini, Severino Persechino, Concetta Potenza, Simone Ragonesi, Giovanni Pellacani, Ketty Peris, Maria Concetta Fargnoli, Antonio Giovanni Richetta
Introduction: Psoriasis is a chronic immune-mediated disease that can be challenging to treat, especially in patients with severe disease or high body weight. Tildrakizumab is a monoclonal antibody which inhibits IL-23, approved for moderate-to-severe psoriasis with a standard 100 mg dose. A 200 mg dose may provide greater efficacy for patients over 90 kg or with high disease burden.
Methods: This multicenter, prospective study evaluated the effectiveness and safety of tildrakizumab 200 mg in patients with moderate-to-severe psoriasis, focusing on those with specific challenges: body weight over 90 kg, baseline PASI ≥20, and difficult-to-treat areas. The study also compared bio-naive versus bio-experienced and male versus female patients. Adults received tildrakizumab 200 mg subcutaneously at weeks 0 and 4, then every 12 weeks.
Results: Clinical improvements were assessed using PASI, DLQI, genital PASI, and NAPSI scores. After 24 weeks, the mean PASI score dropped from 14.6 to 0.4, with PASI 90 and PASI 100 scores exceeding 80% (100.0% and 80.3%, respectively). DLQI scores improved from 14.2 to 1.8, and significant improvements were seen in genital PASI and NAPSI scores. No significant adverse events occurred.
Conclusions: Tildrakizumab 200 has been shown to be an effective therapeutic option, particularly for patients with high body weight, significant disease burden, and involvement of sensitive areas with no new safety signals.
简介:银屑病是一种慢性免疫介导疾病,治疗难度很大,尤其是病情严重或体重较重的患者。Tildrakizumab是一种抑制IL-23的单克隆抗体,已被批准用于治疗中度至重度银屑病,标准剂量为100毫克。对于体重超过90公斤或疾病负担较重的患者,200毫克的剂量可能会有更好的疗效:这项多中心、前瞻性研究评估了替雷珠单抗 200 毫克对中重度银屑病患者的有效性和安全性,重点关注那些面临特殊挑战的患者:体重超过 90 千克、基线 PASI ≥20 和难以治疗的区域。研究还比较了无生物反应和有生物反应经验的患者,以及男性和女性患者。成人患者在第0周和第4周皮下注射200毫克替雷珠单抗,然后每12周注射一次:使用 PASI、DLQI、生殖器 PASI 和 NAPSI 评分评估临床改善情况。24 周后,PASI 平均分从 14.6 分降至 0.4 分,PASI 90 分和 PASI 100 分超过 80%(分别为 100.0% 和 80.3%)。DLQI评分从14.2分降至1.8分,生殖器PASI和NAPSI评分也有显著改善。未发生重大不良事件:Tildrakizumab 200已被证明是一种有效的治疗选择,尤其适用于体重较重、疾病负担较重、敏感部位受累的患者,且没有出现新的安全信号。
{"title":"Effectiveness of tildrakizumab 200 mg: an Italian multicenter study.","authors":"Annunziata Dattola, Nicoletta Bernardini, Francesca Svara, Anna Balato, Giacomo Caldarola, Domenico D'Amico, Clara De Simone, Eugenia Veronica Di Brizzi, Maria Esposito, Claudia Giofrè, Domenico Giordano, Claudio Guarneri, Francesco Loconsole, Viviana Lora, Gaia Moretta, Diego Orsini, Severino Persechino, Concetta Potenza, Simone Ragonesi, Giovanni Pellacani, Ketty Peris, Maria Concetta Fargnoli, Antonio Giovanni Richetta","doi":"10.1080/09546634.2024.2420825","DOIUrl":"https://doi.org/10.1080/09546634.2024.2420825","url":null,"abstract":"<p><p><b>Introduction:</b> Psoriasis is a chronic immune-mediated disease that can be challenging to treat, especially in patients with severe disease or high body weight. Tildrakizumab is a monoclonal antibody which inhibits IL-23, approved for moderate-to-severe psoriasis with a standard 100 mg dose. A 200 mg dose may provide greater efficacy for patients over 90 kg or with high disease burden.</p><p><p><b>Methods:</b> This multicenter, prospective study evaluated the effectiveness and safety of tildrakizumab 200 mg in patients with moderate-to-severe psoriasis, focusing on those with specific challenges: body weight over 90 kg, baseline PASI ≥20, and difficult-to-treat areas. The study also compared bio-naive versus bio-experienced and male versus female patients. Adults received tildrakizumab 200 mg subcutaneously at weeks 0 and 4, then every 12 weeks.</p><p><p><b>Results:</b> Clinical improvements were assessed using PASI, DLQI, genital PASI, and NAPSI scores. After 24 weeks, the mean PASI score dropped from 14.6 to 0.4, with PASI 90 and PASI 100 scores exceeding 80% (100.0% and 80.3%, respectively). DLQI scores improved from 14.2 to 1.8, and significant improvements were seen in genital PASI and NAPSI scores. No significant adverse events occurred.</p><p><p><b>Conclusions:</b> Tildrakizumab 200 has been shown to be an effective therapeutic option, particularly for patients with high body weight, significant disease burden, and involvement of sensitive areas with no new safety signals.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2420825"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142515608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-06-24DOI: 10.1080/09546634.2024.2366532
Tina Bhutani, Sayeli Jayade, Sanika Rege, Hannah Penton, Vardhaman Patel, Samaneh Kalirai, Daniel Wolin, Kimberly Boyle, Lauren Seigel
Purpose: This noninterventional, cross-sectional survey estimated the prevalence and consequences of residual disease in apremilast-treated US adults with moderate to severe psoriasis. Materials and Methods: Residual disease was defined as experiencing moderate, severe, or very severe psoriasis over the past week or having ≥3% body surface area affected, despite treatment. Factors associated with residual disease and its effects on flare-ups, humanistic burden, and health care resource utilization (HCRU) were evaluated. Results: Of the 344 apremilast users (mean age, 44.9 years; female, 65.4%), 174 (50.6%) had residual disease. It was more prevalent in Black versus White participants (OR, 4.5; 95% CI, 1.6-12.2), those receiving apremilast for ≥1 versus <1 year (OR, 16.5; 95% CI, 7.9-34.4), those reporting ≥2 versus 0 to 1 flare-ups during the past 3 months (OR, 10.0; 95% CI, 5.0-20.1), and those with ≥4 versus 1 to 3 body regions affected at time of survey (OR, 8.6; 95% CI, 3.8-19.8). Participants with versus without residual disease self-reported more psoriasis flare-ups over the past 3 months (mean, 4.7 vs 0.9; p < .001) and more anxiety (89.7% vs 50.0%; p < .001) and depression (69.0% vs 23.6%; p < .001) over the past 30 days. Conclusion: Generally, participants with versus without residual disease also had significantly more comorbidities and greater HCRU.
目的:这是一项非干预性横断面调查,目的是评估经阿普瑞司特治疗的美国中重度银屑病成人中残留疾病的患病率和后果。材料与方法:残留疾病的定义是:尽管接受了治疗,但在过去一周内出现中度、重度或极重度银屑病,或受影响的体表面积≥3%。评估与残留疾病相关的因素及其对复发、人文负担和医疗资源利用率(HCRU)的影响。研究结果在 344 名阿普瑞司特使用者(平均年龄 44.9 岁;女性 65.4%)中,174 人(50.6%)有残留疾病。黑人与白人相比(OR,4.5;95% CI,1.6-12.2),接受阿普瑞司特治疗≥1 次与 p p p p p p p p p p p p p p p p p p p p p p p p p p p p p p p p p 结 论:一般来说,有残留疾病与无残留疾病的参与者之间存在着明显的差异:一般来说,有残留疾病的参与者与无残留疾病的参与者相比,合并症明显更多,HCRU 也更高。
{"title":"Evaluating prevalence and consequence of residual disease in individuals with psoriasis receiving apremilast treatment: results from a US patient survey.","authors":"Tina Bhutani, Sayeli Jayade, Sanika Rege, Hannah Penton, Vardhaman Patel, Samaneh Kalirai, Daniel Wolin, Kimberly Boyle, Lauren Seigel","doi":"10.1080/09546634.2024.2366532","DOIUrl":"https://doi.org/10.1080/09546634.2024.2366532","url":null,"abstract":"<p><p><b>Purpose:</b> This noninterventional, cross-sectional survey estimated the prevalence and consequences of residual disease in apremilast-treated US adults with moderate to severe psoriasis. <b>Materials and Methods:</b> Residual disease was defined as experiencing moderate, severe, or very severe psoriasis over the past week or having ≥3% body surface area affected, despite treatment. Factors associated with residual disease and its effects on flare-ups, humanistic burden, and health care resource utilization (HCRU) were evaluated. <b>Results:</b> Of the 344 apremilast users (mean age, 44.9 years; female, 65.4%), 174 (50.6%) had residual disease. It was more prevalent in Black versus White participants (OR, 4.5; 95% CI, 1.6-12.2), those receiving apremilast for ≥1 versus <1 year (OR, 16.5; 95% CI, 7.9-34.4), those reporting ≥2 versus 0 to 1 flare-ups during the past 3 months (OR, 10.0; 95% CI, 5.0-20.1), and those with ≥4 versus 1 to 3 body regions affected at time of survey (OR, 8.6; 95% CI, 3.8-19.8). Participants with versus without residual disease self-reported more psoriasis flare-ups over the past 3 months (mean, 4.7 vs 0.9; <i>p</i> < .001) and more anxiety (89.7% vs 50.0%; <i>p</i> < .001) and depression (69.0% vs 23.6%; <i>p</i> < .001) over the past 30 days. <b>Conclusion:</b> Generally, participants with versus without residual disease also had significantly more comorbidities and greater HCRU.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2366532"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141447908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-01-11DOI: 10.1080/09546634.2023.2290360
Jarmila Čelakovská, Eva Čermáková, Ctirad Andrýs, Petra Boudkova, Jan Krejsek
{"title":"The differences in the count of B lymphocytes in atopic dermatitis patients with and without dupilumab therapy and in healthy subjects in pollen season and out of pollen season.","authors":"Jarmila Čelakovská, Eva Čermáková, Ctirad Andrýs, Petra Boudkova, Jan Krejsek","doi":"10.1080/09546634.2023.2290360","DOIUrl":"10.1080/09546634.2023.2290360","url":null,"abstract":"","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2290360"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139428203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}