bluuebunny/crossref_metadata_2025_split huggingface dataset:
P23 Primary penile melanoma and penile lichen sclerosus
Authors: Dear Kate , Kravvas George , Sim Sharmaine , James Mariel , Watchorn Richard , Haider Aiman , Ellery Peter , Freeman Alex , Alnajjar Hussain , Muneer Asif , Bunker Chris 
Published: June 2023

Abstract
The association between squamous cell malignancies and genital lichen sclerosus (GLSc) is well established. There is an increasing literature regarding the relationship of GLSc with genital malignant melanoma (MM). While there have been several reported cases of vulvar melanoma associated with lichen sclerosus (LSc), there have been fewer cases published with regard to male genital (M)GLSc and penile (Pe)MM. The aims of this study were to explore the relationship between PeMM and MGLSc by reviewing all cases managed by our multidisciplinary service over a period of 11 years. All patients known to our tertiary urology and male genital dermatology service with a diagnosis of penile MM and where histology was available for review were identified over an 11-year period (2011–2022). Two independent dermatologists reviewed the clinical records and photographs where available. Two independent mutually blinded histopathologists reviewed the histology and recorded features of GLSc where present. In cases of discordance between histopathologists, a third independent histopathologist reviewed the cases. Eleven patients were identified for inclusion in the study. Overall, GLSc was present on histopathology in nine of 11 cases (82%). Findings were concordantly positive in five cases and concordantly negative in one case. In cases with discordant findings (n = 5), the third histopathologist determined GLSc to be present in four cases and absent in one case. Clinical photographs were available for three cases and clinical features of GLSc were seen in all of them; they also all had positive histopathological findings. Clinical notes, including electronic notes and letters, were available for review in eight cases. Symptoms in keeping with GLSc were mentioned in only one case, and signs suggestive of GLSc were documented in three cases. Penile MM is a rare entity accounting for 0.7% of penile cancer and 0.1% of MM cases. Like other malignancies, MM is a multifactorial disease caused by a combination of environmental factors and altered host responses contributing to an alteration of regulatory processes. Although ultraviolet exposure is important in the pathogenesis of extragenital MM, this cannot be a factor for genital disease. However, specific risk factors for genital MM have not yet been elucidated. To our knowledge, there have only been three previously documented cases (all from our group) of PeMM coexisting with GLSc. This present study finding of GLSc in 9 of 11 men with PeMM, is suggestive of a causative relationship. We postulate that this is related to chronic melanocytic distress created by chronic inflammation secondary to LSc.
P42 Are chest X-rays still necessary for prebiologic tuberculosis screening? A retrospective audit
Authors: Tan Daniel Yi Liang , Kim Younghoon , Hasan Zeeshaan , Bewley Anthony , Mehrtens Sarah , Mohandas Padma 
Published: June 2023

Abstract
Biologics are commonly used in autoimmune dermatological conditions as an option if other treatments are unsuccessful or contraindicated. However, one major side-effect of biologics is immunosuppression, which may lead to the reactivation of latent tuberculosis (TB) in patients. The British Association of Dermatology has implemented guidelines that require doctors to screen for TB before prescribing biologics to patients. The 2020 guidelines advise screening questions, performance of a chest X-ray (CXR) and an interferon-γ release assay (IGRA). Current studies show that CXR has a sensitivity of 15% when diagnosing latent TB. While there is no gold standard for diagnosing latent TB, the IGRA is a commonly used test and is shown to be four times more effective than the tuberculin skin test. This study questions the diagnostic value of CXR in the screening of TB in asymptomatic patients, and whether it should be removed from the guidelines for such patients. A retrospective audit of dermatological patients in our trust was done over a 24-month period (January 2020–January 2022). Patients selected for the audit were those diagnosed with psoriasis or hidradenitis suppurativa and started on biologics during this 24-month period. Patients were assessed on the following: patient history, CXR results, IGRA results and screening outcomes. The data were quantitatively analysed to uncover the necessity of performing a CXR on patients starting biologics. Between January 2020 and January 2022, 77 patients were scheduled for prebiologic TB screening; CXRs were performed in 74 patients (96%), while 72 (94%) of patients had IGRA tests. During this period, three patients (4%) were diagnosed with latent TB based on positive IGRA results and normal CXR findings. They were subsequently treated for latent TB infection prior to biologic therapy. None of the patients with negative IGRA results had positive CXR findings for TB. This finding suggests that CXR is unnecessary at the initial stage of prebiologic TB screening for asymptomatic patients. IGRA can detect both latent and active TB, while CXR is recommended for the diagnosis of active TB. Mandating CXR comes at a cost to the National Health Service and subjects patients to unnecessary radiation exposure. We propose that CXR be done only for patients who are either symptomatic for TB or have a positive IGRA result.
P46 A step toward zero leprosy: experiences of Nepal in leprosy data verification
Authors: Baskota Rabindra , Baral Rashmi 
Published: June 2023

Abstract
Records and reports are the sources of data for health programme planning, monitoring and evaluation. Accurate and timely data are crucial to ensure quality leprosy services, including drug supply, complication management and disability prevention. Data verification and validation are the initial steps to achieve the global goal of zero leprosy. The objectives of leprosy data verification were to strengthen the reporting system, to update personal health records and to provide onsite training to leprosy focal persons. Leprosy data verification was conducted in 15 endemic districts of Nepal by a team of national leprosy programme managers, leprosy focal persons, statisticians, dermatologists, paramedic health workers and World Health Organization consultants. The team visited health facilities that provide leprosy services and their corresponding municipalities from August 2021 to December 2021. The team examined the completeness and accuracy of data and information on the patient card, treatment register and monthly reporting form. Data were then compared with the municipal and national database, and edited, cleaned and verified for duplications, and onsite coaching was provided to the leprosy focal persons. Verification of 1210 health records of 15 districts from four provinces was conducted. The number of new leprosy cases was found to be under-reported by 5.5%. Likewise, under-reporting was observed in released-from-treatment cases (19.2% variation) and transfer-out cases (21.4% variation). Over-reporting was observed in re-treatment cases (7% variation), defaulter cases (10.6% variation) and new paediatric cases (38% variation). Common reasons for data variation were error in counting while reporting, error in compiling data from health facilities and a lack of training of focal persons in data recording and reporting. A limitation of the data verification study was that it was conducted in the selected 15 endemic districts and municipalities only. The study suggested that verification, validation and on-site coaching are effective approaches to obtaining quality data on leprosy. Such programmes can be conducted routinely or even during the integrated monitoring and supervision visits of experts from the centre to the local health facilities but should be carried out at the data entry site.
P54 Blood tumour burden does not correlate with skin tumour burden in early-stage mycosis fungoides: analysis of the PROspective Cutaneous Lymphoma International Prognostic Index international registry
Authors: Charalambides Maria , Rooke Bethanie , Shah Farida , Irwin Clive , Murray Duncan , Evison Felicity , Scarisbrick Julia 
Published: June 2023

Abstract
Blood involvement B1, defined as absolute counts 250–1000 IU of an aberrant CD4+CD7– or CD4+CD26– phenotype, may be found in early-stage mycosis fungoides (MF). There is a suggestion that B1 blood involvement is a poor prognostic marker, but there is limited evidence investigating the prognostic significance of B0 or B1 blood involvement in early-stage MF. Loss of CD26 and/or CD7 expression on CD4 cells may occur in MF; however, it is unclear whether loss of either one of these immunophenotypic markers bears more significance on prognosis. For B2 blood involvement (&gt; 1000 IU), the International Society for Cutaneous Lymphomas (ISCL) criteria define Sézary syndrome as CD26 loss of &gt; 30% or CD7 loss of &gt; 40%. Understanding the impact of B1 and comparative loss of CD26 and/or CD7 in early-stage MF may allow patients at higher risk of stage progression to be identified and selected for better therapeutic options. The aims of this study were to analyse B0 vs. B1 blood involvement at diagnosis in patients with early-stage MF (IA–IIA) and evaluate the relative CD4+CD7– and CD4+CD26– absolute cell counts. Prospective data from the PROCLIPI registry were analysed. Ninety-four patients with early-stage MF were identified from our database, 67 (71%) of whom were B0 [stage IA, n = 23 (34%); stage IB, n = 24 (36%); stage IIA, n = 20 (30%)] and 27 (29%) were B1 [stage IA, n = 12 (44%); stage IB, n = 10 (37%); stage IIA, n = 5 (18%)]. Median age at diagnosis in B0 patients was 59 years (range 20–91) vs. 61 years (range 21–81) in B1 patients. Median CD4+CD7– cell count was 16.4% (range 0–41%) in patients with B0 involvement and 28.1% (range12–45%) in B1 patients. Median CD4+CD26– cell count was 16% (range 0–39.1%) in B0 and 28% (range 0–44%) in B1 patients. The Median Modified Severity-Weighted Assessment Tool score in B1 patients was 11 (range 1–73) vs. 20 (range 0.5–100) in B0 patients. There was no significant difference in progression to the advanced stage between B0 and B1 (P = 0.112) patients or overall survival between B0 and B1 patients during median follow-ups of 49 months and 45 months, respectively. These results suggest that blood tumour burden in early-stage MF, measured by the percentage aberrancy in CD4+CD7– and CD4+CD26– cell counts, does not correlate with clinical stage, skin tumour burden or stage progression. This suggests that in B1 involvement, atypical lymphocytes may lose their skin-homing properties. Interestingly, levels of CD4+7– and CD26– are similar in B1 involvement, despite the ISCL criteria defining B2 involvement as a lower relative loss of CD26–. Identifying B1 patients is important as certain therapeutic options such as extracorporeal photopheresis and mogamulizumab may be indicated in patients with early-stage MF, refractory to skin-directed therapies.
P55 Real-world clinical and patient-reported outcomes of talimogene laherparepvec (T-VEC) treatment for melanoma in transit and nodal metastases at a UK centre
Authors: Bennett Hannah , Butterfield Kellie , Robinson Joanne , Sugden Joh , Muinonen-Martin Andrew , Mitra Angana 
Published: June 2023

Abstract
Talimogene laherparepvec (T-VEC) is a National Institute for Health and Care Excellence-approved oncolytic viral intralesional immunotherapy licensed for unresectable stage III(B)–IV(M1a) melanoma. It is a genetically modified herpes simplex virus that selectively replicates in tumour cells, leading to local and systemic antitumour immune responses, improving overall survival. The randomized phase III OPTiM trial reported a complete response in 28.2% of patients (Andtbacka RH, Collichio F, Harrington KJ et al. Final analyses of OPTiM: a randomized phase III trial of talimogene laherparepvec vs. granulocyte-macrophage colony-stimulating factor in unresectable stage III–IV melanoma. J Immunother Cancer 2019; 7:145). We report a retrospective review of clinical and patient-reported outcomes of a dermatology-led T-VEC service at a regional UK melanoma centre between January 2019 and January 2023. Treatment involves a loading dose and then two-weekly nurse-delivered intralesional injections. Patient demographics, clinical characteristics, toxicities, treatment responses and patient satisfaction were recorded. Sixteen patients (11 women and five men) were treated; the average patient age was 73 years (range 42–87). Seven patients had stage IIIB disease, six stage IIIC and three stage IVM1a. Eight had received prior nonsurgical treatments (adjuvant therapy, electrochemotherapy, diphencyprone). The number of lesions treated per visit ranged from 1 to 24 (median 5) over a median of six visits (range 2–24). Four patients (25%) had a complete response (CR), with median time to CR being 8 weeks; all have maintained the response (range 6–45 months). Eight (50%) showed partial response (PR), with three continuing treatment. Nine patients overall had progressive disease (five in the PR group and four who were nonresponders). In total, five patients died. Patients experienced mainly flu-like symptoms (44%), pyrexia (31%), fatigue (19%), muscle pain (19%), nausea (19%), headache (19%), diarrhoea (6%), joint pain (6%), local swelling (19%), lymphadenopathy (6%) and mild pain (25%). No grade 3 or 4 toxicity occurred. A patient satisfaction questionnaire was returned by seven of eight patients who completed treatment. All said they received adequate information to make treatment decisions. Eighty-six per cent rated the service excellent. Our results show comparable efficacy and side-effects to published clinical trials and demonstrate that T-VEC is a well-tolerated and safe treatment option, delaying or potentially avoiding need for more toxic systemic agents. We highlight that dermatologists and nurse specialists are well placed to deliver T-VEC in patients with melanoma.
P71 Dupilumab improves patient-reported itch and other signs and symptoms of disease in adults with prurigo nodularis (LIBERTY-PN PRIME and PRIME2)
Authors: Kwatra Shawn G , Yosipovitch Gil , Ständer Sonja , Guillemin Isabelle , Msihid Jérôme , Wiggins Simmi , Levit Noah A , McDonald Robert , Bansal Ashish , O’Malley John T , Bahloul Donia , Thomas Ryan B 
Published: June 2023

Abstract
Prurigo nodularis (PN) is characterized by the presence of itchy nodules on the trunk/extremities and is often accompanied by skin pain and sleep disruption. Patient needs are highest regarding symptom control and improvement of itch, which is one of the main hallmarks of PN. Using pooled blinded data from two randomized, double-blind, placebo-controlled phase III trials of dupilumab in adults with PN uncontrolled on topical therapies, LIBERTY-PN PRIME (NCT04183335) and PRIME2 (NCT04202679), the psychometric validation and within-patient meaningful change thresholds for three patient-reported outcome (PRO) instruments of the trial were assessed in patients with PN: Worst Itch Numerical Rating Scale (WI-NRS), Skin Pain-NRS and Sleep-NRS. The proportion of patients achieving clinically meaningful improvement in these PRO scores in LIBERTY-PN PRIME and PRIME2 was investigated in this post hoc analysis. Adults with PN inadequately controlled on topical prescription therapies, or when those therapies were not advisable, were randomized 1 : 1 to dupilumab 300 mg every 2 weeks or matched placebo. Here, we report the proportion of patients meeting a defined improvement threshold in weekly averages from baseline to week 24 of ≥ 4 points in WI-NRS, ≥ 4 points in Skin Pain-NRS and ≥ 2 points in Sleep-NRS (within-patient meaningful improvement thresholds defined in the context of the LIBERTY-PN PRIME and PRIME2 studies, range 0–10), and the proportion of patients who achieved a new composite endpoint, meaningful improvement in WI-NRS and either Skin Pain-NRS or Sleep-NRS at week 24. A total of 311 patients were randomized (dupilumab, n = 153; placebo, n = 158). Baseline scores for WI-NRS, Skin Pain-NRS and Sleep-NRS were balanced between treatment groups. Significantly more patients treated with dupilumab vs. placebo achieved in-­patient meaningful improvement in WI-NRS (58.8% vs. 19.0%; P &lt; 0.001), Skin Pain-NRS (49.7% vs. 20.9%; P &lt; 0.001) and Sleep-NRS (42.5% vs. 23.4%; P &lt; 0.001) from baseline to week 24. More patients treated with dupilumab experienced clinically meaningful improvement in WI-NRS and either Skin Pain-NRS or Sleep-NRS vs. placebo (53.6% vs. 18.4%; P &lt; 0.001). Adults with PN uncontrolled on topical therapies treated with dupilumab achieved statistically significant and clinically meaningful improvement in itch, skin pain and sleep quality individually, and in itch combined with either skin pain or sleep. The safety profile of dupilumab was consistent with the known safety profile in its approved indications.
Funding sources: research sponsored by Sanofi and Regeneron Pharmaceuticals Inc.
P76 Management of aciclovir-resistant mucocutaneous herpes simplex virus infection: a systematic review
Authors: Valladares Herbert Castillo , Rudd Nora , Leslie Kieron 
Published: June 2023

Abstract
Aciclovir resistance results in immunocompromised hosts due to long-term antiviral therapy and ongoing viral replication. Aciclovir resistance in herpes simplex virus (HSV) poses a major concern, as this can lead to chronic and recalcitrant infection that significantly impacts on the quality of life. While different treatment options exist, there are currently no standardized clinical treatment guidelines for mucocutaneous aciclovir-resistant (ACV-R) HSV infection. This systematic review seeks to identify safe and effective treatments for mucocutaneous ACV-R HSV infection. For this systematic review, PubMed/MEDLINE and Embase were searched in September 2022 for all articles published between 1 January 1980 and 1 September 2022. Studies were included if they described the use of a medication for the treatment of mucocutaneous ACV-R HSV infection. From the initial search that yielded 1066 studies, 86 met the inclusion criteria and were selected. Of the 86 studies, 6 were clinical trials and 80 were case reports/series. A total of 318 patients were included in our review. Foscarnet [intravenous (IV) and topical] was studied in 5 clinical trials and 25 case reports/series, leading to complete response in most patients, with adverse effects including renal toxicity and electrolyte abnormalities. Vidarabine (IV) was found to be inferior to foscarnet in a clinical trial and reported in two case reports. Common side-effects included nausea, anaemia and renal impairment. Trifluridine (topical) was studied in a clinical trial and a case report, showing complete response in some patients. Cidofovir (IV, topical, intralesional) was studied in 21 case reports/series, showing complete response in most patients, with renal impairment as the most common adverse effect. Imiquimod (topical) was studied in eight case reports/series, showing complete response and no side-effects. Pritelivir (oral) was reported in two case reports/series, showing complete response and no side-effects. Combination treatment was reported in 10 case reports/series with variable clinical response. Our review also identified reports of less widely used treatments. These include artesunate, zidovudine, varicella-zoster virus vaccine, leflunomide and surgical excision, which achieved variable response rates but have not been widely studied. While foscarnet and cidofovir have the most robust evidence, IV administration of these agents is associated with significant side-effects and may be limiting. Intralesional and topical formulations of cidofovir, trifluridine and imiquimod are alternative options appropriate for outpatient management. Pritelivir is a novel and promising treatment of mucocutaneous ACV-R HSV infection.
P85 Switching from adalimumab originator to biosimilar: a 3-year retrospective cohort analysis
Authors: Killion Lisa , Alsharqi Ali , Kirby Brian 
Published: June 2023

Abstract
Biological drugs have revolutionized the treatment of immune-mediated inflammatory diseases. Clinical experience and evidence suggest that biosimilars can be used as safely and effectively as their originator. However, patients’ perceptions of biosimilars are that they are inferior to the originator. Currently, few studies have assessed the tolerability and efficacy of switching from the adalimumab originator to a biosimilar in patients with well-controlled moderate-to-severe psoriasis. Our objective was to describe the clinical experience of switching patients from the adalimumab originator to a biosimilar and that of switching back to the originator for those intolerant to biosimilars. A single-centre, retrospective cohort study was conducted to identify patients with moderate-to-severe psoriasis who had switched from the adalimumab originator (Humira®) to a biosimilar (Amgevita® or Imraldi®) from 2018 to 2022. Patient data were obtained from a combination of patient records and databases, including the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) and the National High Tech Prescribing Hub. Patients were excluded from the study if their treatment duration on an adalimumab biosimilar was &lt; 16 weeks or if they were being treated for an indication other than psoriasis. From 2018 to 2022, 100 patients who switched from the adalimumab originator to a biosimilar were identified. At week 16, 81 patients (81%) maintained their initial switch from the adalimumab originator to biosimilar. Nineteen (19%) patients who were switched to an adalimumab biosimilar were switched back to the originator secondary to adverse events. Maintenance or improvement in baseline Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) was observed in 91% and 90%, respectively, in patients who remained on a biosimilar. For those intolerant to biosimilars, maintenance or improvement in baseline PASI and DLQI was still observed although in fewer patients: 63% and 47%, respectively. Our study demonstrates that drug efficacy was recaptured and adverse events were ameliorated for all patients switched from an adalimumab biosimilar back to the originator. For patients who did not tolerate biosimilar switch, reasons for switching back to the originator mirrored those reported in the literature. All patients who switched back to the originator from a biosimilar recovered from loss of efficiency and the adverse events they had reported. Physicians should be confident in switching patients with well-controlled psoriasis to adalimumab biosimilars. For the small proportion of patients who experienced loss of efficacy or adverse events, all were recaptured by either switching to an alternative adalimumab biosimilar or switching back to the adalimumab originator.