American Journal of Clinical Dermatology最新文献

{"title":"Ruxolitinib Cream Monotherapy Improved Symptoms and Quality of Life in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Patient-Reported Outcomes from Two Phase III Studies.","authors":"Eric L Simpson, Matthias Augustin, Diamant Thaçi, Laurent Misery, April W Armstrong, Andrew Blauvelt, Kim A Papp, Jacek C Szepietowski, Mark Boguniewicz, Shawn G Kwatra, Howard Kallender, Daniel Sturm, Haobo Ren, Leon Kircik","doi":"10.1007/s40257-024-00901-z","DOIUrl":"https://doi.org/10.1007/s40257-024-00901-z","url":null,"abstract":"<p><strong>Background: </strong>Atopic dermatitis (AD) is associated with itch, skin pain, sleep disturbances, and diminished quality of life (QoL). Ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream demonstrated efficacy and safety in adults and adolescents with mild-to-moderate AD in two phase III studies (TRuE-AD1/TRuE-AD2). In TRuE-AD1/TRuE-AD2, significant improvements in itch were observed as early as 12 h following application of ruxolitinib cream.</p><p><strong>Objective: </strong>The aim of this paper was to assess additional patient-reported outcomes (PROs) in the vehicle-controlled (VC) and long-term safety (LTS) periods of TRuE-AD1/TRuE-AD2.</p><p><strong>Methods: </strong>In the TRuE-AD studies, patients aged ≥12 years with AD were randomized 2:2:1 to apply twice-daily 1.5% ruxolitinib cream, 0.75% ruxolitinib cream, or vehicle cream continuously for 8 weeks (VC period). During the LTS period, patients applied the same ruxolitinib cream strength, but on an as-needed basis; patients who initially applied vehicle were re-randomized to apply 0.75% or 1.5% ruxolitinib cream. Pooled data from both study periods were analyzed. PRO assessments included symptoms (itch [Patient-Oriented Eczema Measure, POEM], skin pain [numerical rating scale], and sleep [POEM and Patient-Reported Outcomes Measurement Information System]) and assessments of disease-specific QoL (Dermatology Life Quality Index [DLQI] and the children's version [CDLQI]).</p><p><strong>Results: </strong>A total of 1208 and 1031 patients from the VC and LTS periods, respectively, were included in the analysis. Significant improvements in skin pain were observed within 12 h among patients who applied ruxolitinib cream versus vehicle; improvements continued throughout the VC period. Improvements in patient-reported symptoms (including sleep) were observed within 2 weeks (first assessment) of ruxolitinib cream application. At Week 2, significant improvements in symptom burden and overall QoL were observed with ruxolitinib cream (0.75%/1.5%) versus vehicle in POEM (-8.9/-9.8 vs -2.2; both p < 0.0001), DLQI (mean changes from baseline, -5.8/-6.1 vs -1.2; both p < 0.0001), and CDLQI (-4.3/-5.3 vs -1.3; both p < 0.0001). Further symptom burden and QoL improvements were reported during the VC period and were maintained through the end of the LTS period (Week 52).</p><p><strong>Conclusions: </strong>Consistent with the previously reported itch response data, ruxolitinib cream improved skin pain within 12 h of application. Ruxolitinib cream improved patient-reported AD symptom burden and overall QoL by Week 2. Improvements continued or were maintained for 52 weeks. (Graphical abstract and plain language summary available).</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifiers, NCT03745638 and NCT03745651 (both studies were registered on November 19, 2018).</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":" ","pages":""},"PeriodicalIF":8.6,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638554","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}

{"title":"Intravenous Immunoglobulin Therapy for Pyoderma Gangrenosum: A Multicenter Retrospective Analysis in 81 Patients.","authors":"Moritz Ronicke, Lukas Sollfrank, Martin V Vitus, Lukas J Walter, Manuel Krieter, Maurice Moelleken, Joachim Dissemond, Erwin Schultz, Felix Lauffer, Peter von den Driesch, Cornelia Erfurt-Berge","doi":"10.1007/s40257-024-00904-w","DOIUrl":"https://doi.org/10.1007/s40257-024-00904-w","url":null,"abstract":"<p><strong>Background: </strong>Pyoderma gangrenosum (PG) is rare neutrophil skin disease causing painful, progressively enlarging ulcers. Among the treatment options, intravenous immunoglobulin (IVIG) is a therapy of first choice for paraneoplastic PG. Otherwise, it is used in therapy-refractory courses.</p><p><strong>Objective: </strong>To assess the efficacy and safety of IVIG therapy in patients with PG.</p><p><strong>Methods: </strong>A retrospective chart review for patients in five dermatologic wound centres in Germany was performed.</p><p><strong>Results: </strong>Overall, 81 patients were included. IVIG was used as adjunct therapy with (methyl-) prednisolone and/or a steroid sparing therapy in 77 (95.1%) cases. Response to treatment (combined complete and partial, defined as tendency to heal and cessation of lesion progression, respectively) was 49.3% 1 month after initiation of IVIG. In total 18.8% had a complete response after 6 months. Statistically significantly higher response rates were observed in patients with diabetes mellitus and thyroid disease [odds ratio (OR) 3.49, confidence interval (CI) 1.13-10.80 and OR 6.64, CI 1.01-43.57, respectively]. Patients with solid malignancy tended to have better response (OR 4.36, CI 0.79-23.91). A higher IVIG dose was also associated with a tendency towards better response rates (OR 2.70, CI 0.84-8.63). In total, 1 (1.2%) severe adverse event (myocardial infarction with consequent death) was observed as well as three moderate adverse events, with two thromboembolic events (2.5%) and one acute kidney injury (1.2%). Other adverse events were mild or unlikely to be associated with IVIG therapy, with 14 events in 10 patients overall (12.3%).</p><p><strong>Conclusions: </strong>This multicentre retrospective study shows the important role of adjunctive IVIG therapy in patients with PG with recalcitrant courses. Identifying subgroups with a higher probability of response could improve future response rates and save patients from ineffective treatment and potential adverse events.</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":" ","pages":""},"PeriodicalIF":8.6,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612544","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}

{"title":"Managing Urticarial Vasculitis: A Clinical Decision-Making Algorithm Based on Expert Consensus.","authors":"Nikolai Dario Rothermel, Carolina Vera Ayala, Margarida Gonçalo, Jie Shen Fok, Leonie Shirin Herzog, Emek Kocatürk, Sophia Neisinger, Manuel P Pereira, Indrashis Podder, Polina Pyatilova, Aiste Ramanauskaite, Melba Munoz, Karoline Krause, Marcus Maurer, Hanna Bonnekoh, Pavel Kolkhir","doi":"10.1007/s40257-024-00902-y","DOIUrl":"https://doi.org/10.1007/s40257-024-00902-y","url":null,"abstract":"<p><p>Urticarial vasculitis (UV) is a rare and difficult-to-treat, small-vessel leukocytoclastic vasculitis presenting with recurrent long-lasting wheals. So far, no guidelines and treatment algorithms exist that could help clinicians with the management of UV. In this review, we describe evidence on systemic treatments used for UV and propose a clinical decision-making algorithm for UV management based on the Urticarial Vasculitis Activity Score assessed for 7 days (UVAS7). Patients with occasional UV-like urticarial lesions and patients with UV with skin-limited manifestations and/or mild arthralgia/malaise (total UVAS7 ≤7 of 70) can be initially treated using the step-wise algorithm for chronic urticaria including second-generation H1-antihistamines, omalizumab, and cyclosporine A. Patients with UV with more severe symptoms (UVAS7 >7), especially those with hypocomplementemic UV, may require a multidisciplinary approach, particularly if underlying diseases, for example, systemic lupus erythematosus, cancer, or infection, are present. Immunomodulatory therapy is based on clinical signs and symptoms, and the drug availability and safety profile, and includes systemic corticosteroids, dapsone, hydroxychloroquine, anti-interleukin-1 agents, and other therapies. The level of evidence for all UV treatments is low. Prospective studies with current and novel drugs are needed and could provide further insights into UV pathogenesis and treatment.</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":" ","pages":""},"PeriodicalIF":8.6,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612546","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}

{"title":"Disseminated Superficial Actinic Porokeratosis: A Systematic Treatment Review.","authors":"Stephanie Tan, Ernest Tan","doi":"10.1007/s40257-024-00903-x","DOIUrl":"https://doi.org/10.1007/s40257-024-00903-x","url":null,"abstract":"<p><strong>Background: </strong>Disseminated superficial actinic porokeratosis (DSAP) is a disorder of keratinization characterised by small, brown plaques with elevated keratotic rims, typically occurring on sun exposed areas. DSAP poses a risk for malignant transformation, emphasising the need for effective management strategies.</p><p><strong>Objective: </strong>The aim of this study was to review the current reported management options for DSAP.</p><p><strong>Methods: </strong>This systematic review was based on a comprehensive search of databases (Cochrane, PubMed, Medline, Embase, Emcare, ProQuest, Web of Science, CINAHL) from inception to 15 March 2024. Studies reporting management of DSAP were included irrespective of study design.</p><p><strong>Results: </strong>Of 923 citations, 61 studies were included, predominantly comprising case reports and retrospective case series. A limited number of randomized and open-label trials were identified. Various treatment modalities were reported, including topical and systemic agents, photodynamic therapy, and laser therapy.</p><p><strong>Conclusion: </strong>Multiple management options are available for DSAP, including topical and systemic agents, photodynamic therapy and laser treatments. However, these approaches vary in their balance between efficacy and toxicity. Currently, there is a paucity of high-quality clinical trial data to guide treatment decisions. Further studies are required to determine the most effective and safe management strategies for DSAP. PROSPERO REGISTRATION: CRD42024514558.</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":" ","pages":""},"PeriodicalIF":8.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142562479","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}

{"title":"Patient-Reported Hair Loss and Its Impacts as Measured by the Alopecia Areata Patient Priority Outcomes Instrument in Patients Treated with Ritlecitinib: The ALLEGRO Phase 2b/3 Randomized Clinical Trial.","authors":"Rodney Sinclair, Natasha Mesinkovska, Debanjali Mitra, Dalia Wajsbrot, Ernest H Law, Robert Wolk, Brett King","doi":"10.1007/s40257-024-00899-4","DOIUrl":"https://doi.org/10.1007/s40257-024-00899-4","url":null,"abstract":"<p><strong>Background: </strong>The ALLEGRO phase 2b/3 study investigated the efficacy and safety of ritlecitinib in patients with alopecia areata (AA).</p><p><strong>Objective: </strong>To describe the impact of ritlecitinib on patient-reported hair loss using the Alopecia Areata Patient Priority Outcomes (AAPPO) instrument and evaluate the relationship between clinically meaningful hair regrowth and improvements in patient-reported impacts.</p><p><strong>Methods: </strong>In ALLEGRO-2b/3, patients aged ≥ 12 years with AA and ≥ 50% scalp hair loss received once-daily ritlecitinib 50 or 30 mg (± 4-week 200-mg daily loading dose), 10 mg, or placebo for 24 weeks and then continued ritlecitinib or switched from placebo to ritlecitinib 200/50 or 50 mg for 24 weeks. The AAPPO instrument evaluated improvement in hair loss, emotional symptoms (ES), and activity limitations (AL) from weeks 4 to 48 (secondary endpoint). Mean changes in ES and AL domain scores and individual items at weeks 24 and 48 were calculated for Severity of Alopecia Tool (SALT) score ≤ 20 responders and nonresponders (exploratory endpoint).</p><p><strong>Results: </strong>Overall, 718 patients were randomized. At week 24, 5-36% of patients receiving ritlecitinib 10-200/50 mg reported improvement in scalp hair loss versus 9% receiving placebo. The results for eyebrow, eyelash, and body hair loss were similar. Mean change from baseline in ES and AL scores at weeks 24 and 48 was small and similar between groups. Mean change was larger for individual hair loss and ES items at weeks 24 and 48 in SALT score ≤ 20 responders versus nonresponders.</p><p><strong>Conclusions: </strong>The AAPPO instrument demonstrated the beneficial impact of ritlecitinib on patient-reported hair growth, which was consistent with improvements in clinician-reported outcomes.</p><p><strong>Clinical trial registration: </strong>NCT03732807. INFOGRAPHIC.</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":" ","pages":""},"PeriodicalIF":8.6,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493054","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}

{"title":"From Compression to Itch: Exploring the Link Between Nerve Compression and Neuropathic Pruritus.","authors":"Kayla D Mashoudy, Sarah G Brooks, Luis F Andrade, Jaxon D Wagner, Gil Yosipovitch","doi":"10.1007/s40257-024-00898-5","DOIUrl":"https://doi.org/10.1007/s40257-024-00898-5","url":null,"abstract":"<p><p>Neuropathic itch is a type of chronic pruritus resulting from neural dysfunction along the afferent pathway. It is often accompanied by abnormal sensations such as paresthesia, hyperesthesia, or hypoesthesia. This condition, which may involve motor or autonomic neural damage, significantly impacts patients' quality of life, causing severe itch and associated comorbidities such as depression, disrupted sleep, and social strain. Neuropathic itch accounts for 8% of chronic pruritus cases, though this may be underestimated. This comprehensive review focuses on nerve impingement as the primary pathophysiological mechanism for various forms of neuropathic itch including brachioradial pruritus (BRP), notalgia paresthetica (NP), and anogenital itch. BRP, often seen in middle-aged white women, manifests as pruritus in the dorsolateral forearms typically exacerbated by ultraviolet (UV) exposure and related to cervical spine pathology. NP, prevalent in middle-aged women, presents as pruritus in the upper back due to thoracic spine nerve compression. Anogenital pruritus, affecting 1-5% of adults, is often linked to lumbosacral spine issues after ruling out dermatologic conditions such as lichen sclerosus or lichen simplex chronicus. The pathophysiology of neuropathic itch involves both peripheral and central mechanisms, with nerve damage being a key factor. Diagnosis requires a thorough history, physical examination, and potentially imaging studies. Topical agents such as menthol, capsaicin, and lidocaine are used for mild cases, while systemic medications such as gabapentin, pregabalin, and antidepressants are prescribed for moderate to severe cases; however, no US Food and Drug Administration (FDA)-approved therapies currently exist specifically for neuropathic itch. Understanding the underlying neural dysfunction and appropriate therapeutic strategies is crucial for managing neuropathic itch effectively.</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":" ","pages":""},"PeriodicalIF":8.6,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456057","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}

{"title":"Authors’ Reply to Wang et al., “Comment on ‘Efficacy and Safety of Brodalumab, an Anti‑interleukin‑17 Receptor A Monoclonal Antibody, for Palmoplantar Pustulosis: 16‑Week Results of a Randomized Clinical Trial’”","authors":"Yukari Okubo,&nbsp;Satomi Kobayashi,&nbsp;Masamoto Murakami,&nbsp;Shigetoshi Sano,&nbsp;Natsuko Kikuta,&nbsp;Yoshiumi Ouchi,&nbsp;Tadashi Terui","doi":"10.1007/s40257-024-00896-7","DOIUrl":"10.1007/s40257-024-00896-7","url":null,"abstract":"","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 6","pages":"1025 - 1027"},"PeriodicalIF":8.6,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11511741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456055","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}

{"title":"Comment on “Efficacy and Safety of Brodalumab, an Anti‑interleukin‑17 Receptor A Monoclonal Antibody, for Palmoplantar Pustulosis: 16‑Week Results of a Randomized Clinical Trial”","authors":"Lu-Ying Wang,&nbsp;Yi-Hang Ding,&nbsp;Xiu-Juan Hou,&nbsp;Chen Li","doi":"10.1007/s40257-024-00895-8","DOIUrl":"10.1007/s40257-024-00895-8","url":null,"abstract":"","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 6","pages":"1023 - 1024"},"PeriodicalIF":8.6,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456056","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}

{"title":"Oral Roflumilast in Patients with Psoriasis: A Real-World Cohort Study.","authors":"Mette Gyldenløve, Christoffer Valdemar Nissen, Sascha Dinsen Wreschner Stave, Simon Francis Thomsen, Alexander Egeberg, Nikolai Loft","doi":"10.1007/s40257-024-00897-6","DOIUrl":"https://doi.org/10.1007/s40257-024-00897-6","url":null,"abstract":"","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":" ","pages":""},"PeriodicalIF":8.6,"publicationDate":"2024-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456058","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}

{"title":"Pembrolizumab for the First-Line Treatment of Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma: Results from the Single-Arm, Open-Label, Phase III KEYNOTE-913 Study","authors":"Laurent Mortier,&nbsp;Lisa Villabona,&nbsp;Ben Lawrence,&nbsp;Ana Arance,&nbsp;Marcus O. Butler,&nbsp;Marie Beylot-Barry,&nbsp;Philippe Saiag,&nbsp;Mahtab Samimi,&nbsp;Paolo A. Ascierto,&nbsp;Francesca Spada,&nbsp;Michel De Pontville,&nbsp;Michele Maio,&nbsp;Alfonso Berrocal,&nbsp;Enrique Espinosa,&nbsp;Jaume Capdevila,&nbsp;Max Levin,&nbsp;Debasmita Das,&nbsp;Clemens Krepler,&nbsp;Dmitri Grebennik,&nbsp;Vanna Chiarion-Sileni","doi":"10.1007/s40257-024-00885-w","DOIUrl":"10.1007/s40257-024-00885-w","url":null,"abstract":"<div><h3>Background</h3><p>The phase III KEYNOTE-913 study was conducted to evaluate the efficacy and safety of pembrolizumab as first-line therapy in patients with advanced Merkel cell carcinoma (MCC).</p><h3>Objective</h3><p>The aim was to report results from the primary analysis of KEYNOTE-913.</p><h3>Patients and Methods</h3><p>Patients with recurrent locally advanced or metastatic MCC received pembrolizumab 200 mg intravenously every 3 weeks for up to 35 treatments (~ 2 years). The primary end point was objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by blinded independent central review (BICR). Secondary end points were duration of response (DOR) and progression-free survival (PFS) per RECIST v1.1 by BICR, overall survival (OS), and safety and tolerability.</p><h3>Results</h3><p>Fifty-five patients were treated with pembrolizumab. The median time from first dose to data cutoff (February 15, 2024) was 50.3 months (range 38.7–59.4). The ORR was 49% (95% confidence interval [CI] 35–63), with 12 complete responses and 15 partial responses. The median DOR was 39.8 months (range 4.8–52.5+), and the 24-month DOR rate was 69%. The median PFS was 9.3 months (95% CI 3–26), and the 24-month PFS rate was 39%. The median OS was 24.3 months (95% CI 12.4 to not reached), and the 24-month OS rate was 51%. Any-grade treatment-related adverse events (AEs) occurred in 38 patients (69%); 13 patients (24%) experienced grade 3–5 AEs. The most common treatment-related AEs were fatigue (<i>n</i> = 12 [22%]), pruritus (<i>n</i> = 12 [22%]), and lipase increase (<i>n</i> = 10 [18%]). One patient died of treatment-related Guillain-Barré syndrome.</p><h3>Conclusions</h3><p>Pembrolizumab provided durable antitumor activity and promising survival and had a manageable safety profile in patients with recurrent locally advanced or metastatic MCC, supporting its use in this population.</p><h3>Trial Registration</h3><p>Clinicaltrials.gov, NCT03783078.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 6","pages":"987 - 996"},"PeriodicalIF":8.6,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11511690/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142387331","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}