Publications by authors named "Aldo Morrone"

104 Publications

Lower response to BNT162b2 vaccine in patients with myelofibrosis compared to polycythemia vera and essential thrombocythemia.

J Hematol Oncol 2021 07 29;14(1):119. Epub 2021 Jul 29.

Hematology Unit, Department of Research and Clinical Oncology, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

In a population of 42 Philadelphia negative myeloproliferative neoplasm patients, all on systemic active treatment, the likelihood of responding to anti-SARS-CoV-2 BNT162b2 vaccine at 2 weeks after the second dose was significantly lower in the ten patients with myelofibrosis compared to the 32 with essential thrombocythemia (n = 17) and polycythemia vera (n = 15) grouped together, both in terms of neutralizing anti-SARS-CoV-2 IgG titers and seroprotection rates (32.47 AU/mL vs 217.97 AU/mL, p = 0.003 and 60% vs 93.8%, p = 0.021, respectively). Ruxolitinib, which was the ongoing treatment in five patients with myelofibrosis and three with polycythemia vera, may be implicated in reducing vaccine immunogenicity (p = 0.076), though large prospective study is needed to address this issue.
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http://dx.doi.org/10.1186/s13045-021-01130-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8319901PMC
July 2021

Health and Social Inequalities in Women Living in Disadvantaged Conditions: A Focus on Gynecologic and Obstetric Health and Intimate Partner Violence.

Health Equity 2021 15;5(1):408-413. Epub 2021 Jun 15.

Primary Care Services, Eleemosynaria Apostolica, Vatican City State, Vatican City.

Gynecologic and obstetric health and intimate partner violence are particularly influenced by social determinants of health, such as poverty, low education, and poor nutritional status, and by ethnic and racial factors. In this study, we evaluated health and social inequalities of women living in disadvantaged neighborhoods in the city of Rome, Italy. The study included 128 women living in socioeconomically disadvantaged neighborhoods. For each woman, a medical record was compiled and a gynecologic examination with screening for cervical cancer was performed. Family network, risk factors for gender-based violence, and psychological abuse were also evaluated. The largest part of the sample, although had adequate schooling, was unemployed or had a low-status job; this was at the basis of intimate partner violence in about one-third of our sample. Nearly 35% of our sample was composed of pregnant women; about half of them were not assisted by the public health system for routine obstetric examinations. Common findings at gynecologic examination for nonpregnant women were infections (=18, 19.9%), pregnancy planning (=13, 13.7%), menopause management (=12, 12.6%), ovarian fibromas (=6, 6.3%), and post-partum assistance (=3, 3.2%). Screening for cervical cancer was executed in 62 women; 9 (14.5%) had low- or high-grade squamous intraepithelial lesion or cervical carcinoma. Health and social inequalities are frequent in women living in disadvantaged conditions, with serious consequences for health and quality of life of women and of their children. Prevention and treatment, especially for the most vulnerable subjects, should be a priority for the public health system.
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http://dx.doi.org/10.1089/heq.2020.0133DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8237099PMC
June 2021

Early Onset of SARS-COV-2 Antibodies after First Dose of BNT162b2: Correlation with Age, Gender and BMI.

Vaccines (Basel) 2021 Jun 22;9(7). Epub 2021 Jun 22.

Scientific Direction, IRCCS Regina Elena National Cancer Institute, Istituti Fisioterapici Ospitalieri (IFO), 00144 Rome, Italy.

Background: The first goal of the study was to analyse the antibody titre 21 days after the first dose of the BNT162b2 vaccine in a group of 252 healthcare workers (HCW). The second goal was to analyse how the antibody titre changes in correlation with age, gender and body mass index (BMI).

Methods: Participants had a nasopharyngeal swab for SARS-CoV-2 and were assessed for the presence of SARS-CoV-2 antibodies at baseline and 21 days after the BNT162b2 priming dose.

Results: First dose of BNT162b2 activated immune responses in 98% of the participants. Five HWC had no increase in antibody titre 21 days after the first dose. Antibody titre was greater in young (<38 years) vs. older participants (<38 vs. 47-56 = 0.002; <38 vs. >56 = 0.001). Higher antibody levels were detected in underweight vs. pre-obesity group ( = 0.026) and in normal-weight vs. pre-obesity group ( = 0.007). This association was confirmed after adjusting for age ( = 0.0001) and gender ( = 0.00001).

Conclusions: Our study demonstrates that a single dose of BNT162b2 activates the immune response, and being young and normal-weight correlate positively with this response. Larger specifically designed clinical trials are needed to validate these results.
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http://dx.doi.org/10.3390/vaccines9070685DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8310011PMC
June 2021

Predictors of Oral Infection by Mucosal and Cutaneous Human Papillomaviruses in HIV-Infected and Uninfected Men Who Have Sex with Men of the OHMAR Study.

J Clin Med 2021 Jun 25;10(13). Epub 2021 Jun 25.

STI/HIV Unit, San Gallicano Dermatological Institute IRCCS, 00144 Rome, Italy.

Mucosal Human Papillomaviruses (HPVs) play a role in the development of a subset of head and neck cancers. Cutaneous HPVs are abundantly present in the oral cavity. The determinants of these infections have not been extensively investigated. We assessed the correlates of oral infection by alpha and beta and/or gamma HPVs in HIV-infected and uninfected men who have sex with men (MSM). Oral rinse-and-gargles were collected with a mouthwash. Alpha and beta/gamma HPVs were detected using the Linear Array HPV genotyping test and a multiplex PCR combined with Luminex technology, respectively. Multiple logistic regression was performed to identify independent predictors of oral HPV infection. Overall, 193 HIV-uninfected and 117 HIV-infected MSM were enrolled. Among HIV-infected MSM, the only determinant of alpha HPV infection was the number of lifetime oral sex partners (AOR: 8.26, 95% CI: 2.26-30.16). The strongest determinant of beta/gamma HPV infection was represented by practicing condomless receptive oral sex (AOR: 10.76, 95% CI: 1.56-74.17). Age was independently associated with alpha HPV infection in HIV-uninfected MSM. Beta/gamma HPV infection was not associated with sexual behavior in these subjects. In conclusion, predictors of oral infection differ between HIV-infected and uninfected MSM, as well as between alpha and beta/gamma HPVs.
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http://dx.doi.org/10.3390/jcm10132804DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8269418PMC
June 2021

Initial observations on age, gender, BMI and hypertension in antibody responses to SARS-CoV-2 BNT162b2 vaccine.

EClinicalMedicine 2021 Jun 4;36:100928. Epub 2021 Jun 4.

Scientific Direction, IRCCS Regina Elena National Cancer Institute, Istituti Fisioterapici Ospitalieri (IFO), Rome, Italy.

Background: Literature data suggests that age, gender and body mass index (BMI) could be associated with difference in immune responses to vaccines. The first goal of the study was to analyze the antibody titre seven days after the second dose of BNT162b2 vaccine in a group of 248 healthcare workers (HCWs). The second goal was to analyze how antibody titre changes in correlation with age, gender, BMI and hypertension.

Methods: An immunogenicity evaluation was carried out among HCWs vaccinated at the Istituti Fisioterapici Ospitalieri (IFO), Rome, Italy. All HCWs were asked to be vaccinated by the Italian national vaccine campaign at the beginning of 2021. 260 vaccinated HCWs were enrolled in the study. All eligible participants were assigned to receive the priming dose in two weeks' time and the booster dose exactly 21 days thereafter. Blood and nasopharyngeal swabs were collected at baseline and 7 days after second dose of vaccine. Quantitative measurements of IgG antibodies against S1/S2 antigens of SARS-CoV-2 were performed with a commercial chemiluminescent immunoassay. Presence of SARS-Cov-2 in nasopharyngeal swab was determined by commercial RT-PCR testing.

Findings: 248 HWCs were analyzed, 158 women (63.7%) and 90 men (36.3%). After the second dose of BNT162b2 vaccine, 99.5% of participants developed a humoral immune response. The geometric mean concentration of antibodies among the vaccinated subjects after booster dose (285.9 AU/mL 95% CI: 249.5-327.7) was higher than that of human convalescent sera (39.4 AU/mL, 95% CI: 33.1-46.9), with <0.0001. Multivariate linear regression analysis of AU/mL by age, gender and BMI multivariate was performed by the inclusion of covariates. This analysis demonstrated that age (<0.0001) and gender ( = 0.038) are statistically associated with differences in antibody response after vaccination, whereas BMI and hypertension have no statistically significant association ( = 0.078 and  = 0.52 respectively).

Interpretation: 99.5% of HCW developed a humoral immune response and female and young participants seem to have an increased capacity to mount humoral immune responses. BMI and hypertension seem not associated with difference in immune response to the vaccine.

Funding: None.
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http://dx.doi.org/10.1016/j.eclinm.2021.100928DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8177433PMC
June 2021

Fifth-week immunogenicity and safety of anti-SARS-CoV-2 BNT162b2 vaccine in patients with multiple myeloma and myeloproliferative malignancies on active treatment: preliminary data from a single institution.

J Hematol Oncol 2021 05 17;14(1):81. Epub 2021 May 17.

Hematology Unit, Department of Research and Clinical Oncology, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Background: Safety and immunogenicity of BNT162b2 mRNA vaccine are unknown in hematological patients; both were evaluated prospectively in 42 patients with multiple myeloma (MM) and 50 with myeloproliferative malignancies (MPM) (20 chronic myeloid leukemias and 30 myeloproliferative neoplasms), all of them on active anti-cancer treatment, in comparison with 36 elderly controls not suffering from cancer. Subjects serologically and/or molecularly (by nasal/throat swab) positives at basal for SARS-CoV-2 were excluded. Primary endpoint was to compare titers of neutralizing anti-SARS-CoV-2 IgG and seroprotection rates among the cohorts at 3 and 5 weeks from first dose.

Methods: Titration was done using LIAISON® SARS-CoV-2 S1/S2 IgG test, a quantitative chemiluminescent immunoassay approved by FDA on the basis of robust evidences of concordance (94.4%) between the test at cutoff of 15 AU/mL and the Plaque Reduction Neutralization Test 90% at 1:40 ratio. Cutoff of 15 AU/mL was assumed to discriminate responders to vaccination with a protective titer. Cohorts were compared using Fisher' exact test and the Mann-Whitney test as appropriated. Geometric mean concentrations (GMCs), geometric mean ratios and response rates after 1st and 2nd dose were compared in each cohort by Wilcoxon and McNemar tests, respectively.

Results: At 5 weeks, GMC of IgG in elderly controls was 353.3 AU/mL versus 106.7 in MM (p = 0.003) and 172.9 in MPM patients (p = 0.049). Seroprotection rate at cutoff of 15 AU/mL was 100% in controls compared to 78.6% in MM (p = 0.003) and 88% in MPM patients (p = 0.038). In terms of logarithm of IgG titer, in a generalized multivariate linear model, no gender effect was observed (p = 0.913), while there was a significant trend toward lower titers by increasing age (p < 0.001) and in disease cohorts with respect to controls (MM: p < 0.001 and MPM: p < 0.001). An ongoing treatment without daratumumab was associated with higher likelihood of response in MM patients (p = 0.003). No swabs resulted positive on each time point. No safety concerns were observed.

Conclusions: BNT162b2 has demonstrated to be immunogenic at different extent among the cohorts. Response was 88% and robust in MPM patients. MM patients responded significantly less, particularly those on anti-CD38-based treatment. These latter patients should be advised to maintain masks and social distancing regardless of vaccination status, and their cohabiting family members need to be vaccinated in order to reduce the risk of contagion from the family. Additional boosters and titer monitoring could be considered. Trial registration Study was formally approved by the IRCCS Central Ethical Committee of Regione Lazio in January 2021 (Prot. N-1463/21).
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http://dx.doi.org/10.1186/s13045-021-01090-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8128283PMC
May 2021

Short Communication: HIV Viral Load Trends During the Coronavirus Disease 2019 Pandemic in a Reference Center for HIV in Rome, Italy.

AIDS Res Hum Retroviruses 2021 08;37(8):624-626

Clinical Department, National Institute for the Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy.

Coronavirus disease 2019 (COVID-19) pandemic has reduced the access of HIV patients to reference centers. However, retention-in-care is critical to maintain adherence to therapy and viral suppression. During lockdown in Italy, our center implemented several measures to ensure HIV-care continuum. To assess whether these efforts were successful, we investigated HIV viral load trend for a 1-year period (September 2019-August 2020), which included lockdown and partial lockdown months in our country. No significant changes overtime in the proportion of undetectable HIV-RNA were observed. Continuity of service made it possible to maintain viral suppression in our patients.
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http://dx.doi.org/10.1089/AID.2021.0044DOI Listing
August 2021

Emerging Skin Toxicities in Patients with Breast Cancer Treated with New Cyclin-Dependent Kinase 4/6 Inhibitors: A Systematic Review.

Drug Saf 2021 Jul 6;44(7):725-732. Epub 2021 May 6.

Department of Dermatology, San Gallicano Dermatological Institute-IRCCS, Via Elio Chianesi 53, 00144, Rome, Italy.

Three cyclin-dependent kinases 4/6, including palbociclib, ribociclib, and abemaciclib, have been approved for the treatment of patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer. The objective of this study was to evaluate the occurrence and clinical spectrum of cutaneous adverse events in patients with breast cancer following therapy with cyclin-dependent kinase 4/6 inhibitors. A systematic literature search was performed in the PubMed, Cochrane, and EMBASE databases up to November 2020 to evaluate studies published from 2015 to 2020. Articles were selected by title, abstract, and full text as required. In addition, a manual search was performed from among the references of articles included. Forty-one articles were included with a total of 13 reported dermatologic reactions including alopecia, bullous skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, radiation recall and radiation dermatitis, Henoch-Schonlein purpura, cutaneous leukocytoclastic vasculitis, subacute and chronic cutaneous lupus erythematosus, histiocytoid Sweet syndrome, vitiligo-like lesions, and erythema dyschromicum perstans. Skin toxicity is an important issue because it usually affects a patient's quality of life and could lead to a discontinuation of therapies; therefore, it is of fundamental importance to recognize and adequately manage the adverse skin reactions associated with these types of drugs.
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http://dx.doi.org/10.1007/s40264-021-01071-1DOI Listing
July 2021

Precision Medicine and Melanoma: Multi-Omics Approaches to Monitoring the Immunotherapy Response.

Int J Mol Sci 2021 Apr 7;22(8). Epub 2021 Apr 7.

Radiology and Diagnostic Imaging Unit, Department of Clinical and Dermatological Research, San Gallicano Dermatological Institute IRCCS, 00144 Rome, Italy.

The treatment and management of patients with metastatic melanoma have evolved considerably in the "era" of personalized medicine. Melanoma was one of the first solid tumors to benefit from immunotherapy; life expectancy for patients in advanced stage of disease has improved. However, many progresses have yet to be made considering the (still) high number of patients who do not respond to therapies or who suffer adverse events. In this scenario, precision medicine appears fundamental to direct the most appropriate treatment to the single patient and to guide towards treatment decisions. The recent multi-omics analyses (genomics, transcriptomics, proteomics, metabolomics, radiomics, etc.) and the technological evolution of data interpretation have allowed to identify and understand several processes underlying the biology of cancer; therefore, improving the tumor clinical management. Specifically, these approaches have identified new pharmacological targets and potential biomarkers used to predict the response or adverse events to treatments. In this review, we will analyze and describe the most important omics approaches, by evaluating the methodological aspects and progress in melanoma precision medicine.
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http://dx.doi.org/10.3390/ijms22083837DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8067863PMC
April 2021

History of the Santa Maria and San Gallicano Dermatological Hospital.

Ital J Dermatol Venerol 2021 Feb;156(1):20-28

Scientific Direction, IRCCS San Gallicano Dermatological Institute, IFO, Rome, Italy -

The Santa Maria and San Gallicano Hospital represents one of the first dermatological centers founded in the world; since its establishment its aim is to treat widespread skin diseases such as leprosy, scabies, ringworm, prurigo and mange. Its construction began on March 14, 1725 with a ceremony held for the laying of the foundation stone. Its official inauguration, however, is dated October 6, 1726 when Pope Benedict XIII issued the Bonus ille Seal. The hospital's origins stem from the apostolic and charitable work by Father Emilio Lami, who was its first prior, and by the tenacious will of Cardinal Pietro Marcellino Corradini who was its protector. As can be seen by the marble plaque, still preserved and dated 1725, the health facility was intended for people with skin diseases. Venereal affections, such as syphilis and gonorrhea, were instead treated starting from the second half of the 19 century under the direction of Dr. Pietro Shilling and subsequently Dr. Gaetano Ciarrocchi. Since the 18 century, the hospital, built initially by architect Filippo Raguzzini, underwent expansion work including the construction of the "Nuova Corsia dei ragazzi tignoselli" ward, the "Anatomical Theater" of great artistic value and of the "Celtic Rooms." More recently, from the 1939, the hospital obtained, and still maintains today, the recognition as an Institute for Hospitalization and Care of a Scientific Nature (IRCCS); a clear indication of its authoritativeness and value during almost three centuries of history.
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http://dx.doi.org/10.23736/S2784-8671.19.06416-2DOI Listing
February 2021

Homeless Shelter Characteristics and Prevalence of SARS-CoV-2.

West J Emerg Med 2021 03 2;22(2):232-233. Epub 2021 Mar 2.

Eleemosynaria Apostolica, Primary Care Services, Vatican City State.

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http://dx.doi.org/10.5811/westjem.2020.11.50337DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7972400PMC
March 2021

The Conundrum of Giglio Island: Unraveling the dynamics of an apparent resistance to COVID-19 - A descriptive study.

Comput Struct Biotechnol J 2021 2;19:1467-1471. Epub 2021 Mar 2.

Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.

Objectives: Despite an extensive risk of exposure to COVID-19, the residents of Giglio Island, Italy, did not develop any symptom of SARS-CoV-2. The present study aims to characterize the nature of exposure and to describe the local population dynamics underlying its apparent resistance to COVID-19.

Methods: Descriptive study of an islander partially-segregated population cohort based on a seroprevalence screening conducted from Aprile 29 to May 3, 2020 and including SARS-CoV-2 seroprevalence and viral prevalence in samples of saliva assessed through RT-qPCR. Serologic testing was performed using a COVID-19 IgG/IgM rapid test while molecular analyses were carried out by Allplex 2019-nCoV Assay (Seegene).

Results: A total of 634 residents out of 748 (84.8%) present at the time, and 89 non-residents underwent serological testing. 364 males and 359 females with a median age of 58.5 years. The serological screening identified one positive, asymptomatic subject. The Nucleic Acid Amplification Tests (NAAT) did not yield any positive result.

Conclusion: Despite extensive exposure to SARS-CoV-2, possibly only one new asymptomatic infection occurred in this population, as documented by IgM positivity not confirmed by RT-qPCR. This may be due to unknown protective factors or chance. On the basis of this baseline study, using its population as a reference model, further investigations will be conducted to test the advanced hypotheses, focusing on the evaluation of a possible cross-reactivity to SARS-CoV-2 from exposure to endemic viruses.
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http://dx.doi.org/10.1016/j.csbj.2021.02.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7920805PMC
March 2021

Instrumental evaluation of skin barrier function and clinical outcomes during dupilumab treatment for atopic dermatitis: An observational study.

Skin Res Technol 2021 Mar 2. Epub 2021 Mar 2.

San Gallicano Dermatological Institute, IRCCS, Rome, Italy.

Background: Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by pruritus, xerosis, and skin barrier dysfunction. Skin barrier alteration is associated with an increase in trans-epidermal water loss (TEWL) and reduction in skin hydration. Dupilumab is a monoclonal antibody targeting interleukin-13 modulating pro-inflammatory signal transduction, which has been approved for moderate to severe AD. The aim of this study is to evaluate the effects of Dupilumab on skin barrier functions, using non-invasive instruments and clinical evaluation.

Materials And Methods: Thirty patients affected by moderate-severe AD, who had been administered dupilumab, were evaluated by clinical examination and through the instrumental measurements of TEWL and corneometry at the baseline (T0) and 8 weeks (T1) on lesional skin. The clinical evaluation was performed using the Eczema Area and Severity Index (EASI) score. Moreover, a Dermatology Life Quality Index (DLQI) and 7-day numeric rating scale (NRS) questionnaires were administered to each patient.

Results: The instrumental parameters of skin barrier recovery confirmed the clinical improvement outcomes with a statistically significant reduction of TEWL at T1.

Conclusion: Our data confirm the clinical outcomes already reported in the literature and show that there was an inverse proportional correlation between TEWL levels and clinical severity after 8 weeks of treatment with dupilumab.
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http://dx.doi.org/10.1111/srt.13025DOI Listing
March 2021

Ribociclib-Induced Erythema Dyschromicum Perstans (Ashy Dermatosis)-Like Pigmentation in a Metastatic Breast Cancer Patient.

J Breast Cancer 2021 Feb;24(1):117-121

San Gallicano Dermatological Institute-IRCCS, Rome, Italy.

Ribociclib is a selective cyclin-dependent kinase (CDK) 4/6 inhibitor that has been approved in combination with endocrine therapy for the treatment of hormone receptor-positive/human epidermal growth factor 2-negative advanced or metastatic breast cancer. The main dermatological adverse events associated with CDK 4/6 inhibitors that are described in the literature include skin rash, an increased risk of alopecia, and stomatitis. Erythema dyschromicum perstans (EDP), also known as ashy dermatosis, is characterized by acquired small and large slate-gray hyperpigmented macules with erythematous borders. There are currently no published reports of EDP-like or pigmentary changes induced by CDK 4/6 inhibitors. This report describes the first case of EDP-like pigmentation associated with ribociclib therapy.
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http://dx.doi.org/10.4048/jbc.2021.24.e1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7920864PMC
February 2021

NB-UVB plus oral Polypodium leucotomos extract display higher efficacy than NB-UVB alone in patients with vitiligo.

Dermatol Ther 2021 03 5;34(2):e14776. Epub 2021 Feb 5.

Clinical Dermatology Department, S. Gallicano Dermatological Institute, IRCCS, Rome, Italy.

Polypodium leucotomos displayed a synergic effect with NB-UVB in psoriasis, but its application on vitiligo remains understudied. The aim of this study was to investigate whether oral supplementation with leaves extract of Polypodium leucotomos (PL) improves narrow band (NB) UVB phototherapy-induced repigmentation. Forty-four patients with generalized vitiligo were enrolled in this randomized, prospective, placebo controlled study. Twenty-three patients were randomly selected to receive combined treatment with NB-UVB phototherapy and 480 mg oral PL twice daily while 21 patients received NB-UVB phototherapy combined with placebo. All subjects were treated with NB-UVB twice weekly for 6 months. Our results demonstrated that oral PL combined with NB-UVB improved repigmentation as well as increased the response rate compared with patients treated with NB-UVB alone (47.8% vs 22%). Our study suggests that oral supplementation of PL and NB-UVB phototherapy enhance the extent of repigmentation.
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http://dx.doi.org/10.1111/dth.14776DOI Listing
March 2021

Assessment of SARS-CoV-2 infection through rapid serology testing in the homeless population in the City of Rome, Italy. Preliminary results.

J Public Health Res 2020 Oct 22;9(4):1986. Epub 2020 Dec 22.

Primary Care Services, Eleemosynaria Apostolica, Vatican City State.

The development of COVID-19 pandemic has affected all segments of the population; however, it had a significant impact on vulnerable subjects, such as in people experiencing homelessness. The aim of this study was to evaluate the prevalence of COVID-19 spread in homeless persons in the city of Rome, Italy. Patients included in the study underwent a clinical evaluation and rapid antibody analysis on capillary blood for the presence of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to SARS-CoV-2 virus. Symptomatic patients were not included in the screening and immediately referred to local hospitals for further evaluation. One-hundred seventy-three patients of both sexes were tested for SARS-CoV-2 infection through rapid serological test. Age range was 10-80 years; people came from 35 different countries of origin and 4 continents. Test results were negative for most patients (170-98.2%); two patients had positive IgM (1.2%) and one patient had positive IgG (0.6%). Our study is the first to evaluate the prevalence of SARS-CoV-2 infection in people experiencing homelessness in the city of Rome, Italy. Most patients were negative for COVID- 19, although several factors may have had an impact on this result, such as the exclusion of symptomatic patients, the limited sensitivity of rapid serological tests in the initial stage of infection and the prevention measures adopted in these populations. Larger studies on fragile populations are needed to prevent and intercept new clusters of infection in the upcoming months.
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http://dx.doi.org/10.4081/jphr.2020.1986DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7772753PMC
October 2020

Psoriasis in Tigray, Ethiopia: Focusing on available treatments.

Dermatol Ther 2020 Dec 27:e14718. Epub 2020 Dec 27.

San Gallicano Dermatological Institute IRCCS, Rome, Italy.

Psoriasis has been reported to be rare in people with skin of color. However, the actual prevalence is probably underestimated by the lack of wide epidemiological studies. The aim of the study is to present our experience in Tigray, Ethiopia, focusing on the issues related to diagnosis, clinical features and therapies. A total of 1288 people affected by psoriasis were visited and 954 were included in a retrospective analysis through the review of medical records of patients attending at three Dermatologic Centers in Ethiopia from 2005 to 2016. The most common clinical form is plaque psoriasis (62.9%), followed by guttate (13.9%), pustular (9.5%), inverse (7.5%), and erythrodermic (6.1%) ones. The prevalence of psoriatic arthritis is 17%. It is often diagnosed late resulting in particularly deforming and debilitating disease. Patients with severe psoriasis often require hospitalization due to the reduced availability of effective treatments and appropriate skin care, resulting in a prolonged recurrence rate or decreased disease-free interval. In poorer rural areas, patients use some traditional African plants such as Kigelia africana which have been shown to have partial benefits in the treatment of psoriasis. Unfortunately, the only available conventional therapies are topical steroids, salicylic acid, methotrexate, and the sun. More studies concerning the appropriate management of people with psoriasis in low income countries, including standardization of indigenous therapies and a reduction of costs of conventional drugs, could help the care of people with psoriasis.
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http://dx.doi.org/10.1111/dth.14718DOI Listing
December 2020

Asymptomatic patients as a source of transmission of COVID-19 in homeless shelters.

Int J Infect Dis 2021 Feb 13;103:243-245. Epub 2020 Dec 13.

Primary Care Services, Eleemosynaria Apostolica, Vatican City State; Direzione di Sanità e Igiene, Vatican City State; Department of Biomedicine and Prevention, Tor Vergata University, Rome, Italy.

Objectives: Asymptomatic carriers account for over a third of all Coronavirus Disease 19 (COVID-19) cases and are characterized by the absence of symptoms but the same infectivity as symptomatic infections. The high percentage of asymptomatic COVID-19 patients is significant in settings with specific vulnerabilities, such as homeless shelters, where the consequences of an outbreak may be dramatic. In this work, we briefly report our experience on residents and staff of homeless shelters in the City of Rome, Italy, with a particular focus on asymptomatic transmission, and compare it with the available evidence.

Methods: We performed routine Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) nasopharyngeal swab tests in all residents and staff of homeless shelters managed by the Eleemosynaria Apostolica of the Vatican City State in the city of Rome, Italy, in addition to daily symptom screening, body temperature monitoring, and application of other prevention measures.

Results: We evaluated 298 persons and identified twelve positive cases (4%). Most of the positive cases (75%) were asymptomatic, while only three patients reported symptoms that included fever, diarrhea, and cough.

Conclusions: Our data confirm the importance of early identification of asymptomatic carriers that could, in vulnerable conditions such as homeless shelters, spread the infection and cause outbreaks with severe consequences on individual and public health.
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http://dx.doi.org/10.1016/j.ijid.2020.12.031DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834802PMC
February 2021

Effectiveness of anti-interleukin 23 biologic drugs in psoriasis patients who failed anti-interleukin 17 regimens. A real-life experience.

Dermatol Ther 2021 01 6;34(1):e14584. Epub 2020 Dec 6.

Department of Clinical Dermatology; Center for the Study and Treatment of Psoriasis, San Gallicano Dermatological Institute, IRCCS, Rome, Italy.

Among the most recent biologic drugs available for psoriasis therapy, those targeting interleukin-17 (secukinumab and ixekizumab) or its receptor (brodalumab) have been shown to be quickly effective. However, in those patients who failed one or more of the above-cited drugs, real-life data on the effectiveness of switching to one anti-interleukin-23 biologic (guselkumab, risankizumab, or tildrakizumab) are very scarce. Here, we report our experience in treating 12 multi-failure psoriatic patients, prospectively followed-up over 6 months, who showed a significant improvement in their psoriasis after switching from an anti-interleukn-17 to an anti-interleukin-23 drug.
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http://dx.doi.org/10.1111/dth.14584DOI Listing
January 2021

Did the coronavirus pandemic reveal old neglected infections?

Int J Dermatol 2020 Nov 19;59(11):1391-1392. Epub 2020 Oct 19.

STI/HIV Unit, San Gallicano Dermatologic Institute IRCCS, Rome, Italy.

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http://dx.doi.org/10.1111/ijd.15174DOI Listing
November 2020

Oral mucositis: the hidden side of cancer therapy.

J Exp Clin Cancer Res 2020 Oct 7;39(1):210. Epub 2020 Oct 7.

SAFU Laboratory, Department of Research, Advanced Diagnostic, and Technological Innovation, IRCCS, Regina Elena National Cancer Institute, Via Elio Chianesi, 53, 00144, Rome, Italy.

Inflammation response of epithelial mucosa to chemo- radiotherapy cytotoxic effects leads to mucositis, a painful side effect of antineoplastic treatments. About 40% of the patients treated with chemotherapy develop mucositis; this percentage rises to about 90% for head and neck cancer patients (HNC) treated with both chemo- and radiotherapy. 19% of the latter will be hospitalized and will experience a delay in antineoplastic treatment for high-grade mucositis management, resulting in a reduction of the quality of life, a worse prognosis and an increase in patient management costs. Currently, several interventions and prevention guidelines are available, but their effectiveness is uncertain. This review comprehensively describes mucositis, debating the impact of standard chemo-radiotherapy and targeted therapy on mucositis development and pointing out the limits and the benefits of current mucositis treatment strategies and assessment guidelines. Moreover, the review critically examines the feasibility of the existing biomarkers to predict patient risk of developing oral mucositis and their role in early diagnosis. Despite the expression levels of some proteins involved in the inflammation response, such as TNF-α or IL-1β, partially correlate with mucositis process, their presence does not exclude others mucositis-independent inflammation events. This strongly suggests the need to discover biomarkers that specifically feature mucositis process development. Non-coding RNAs might hold this potential.
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http://dx.doi.org/10.1186/s13046-020-01715-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7542970PMC
October 2020

TMPRSS2, a SARS-CoV-2 internalization protease is downregulated in head and neck cancer patients.

J Exp Clin Cancer Res 2020 Sep 23;39(1):200. Epub 2020 Sep 23.

UOSD Clinical Trial Center, Biostatistics and Bioinformatics, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Background: SARS-coronavirus-2 enters host cells through binding of the Spike protein to ACE2 receptor and subsequent S priming by the TMPRSS2 protease. We aim to assess differences in both ACE2 and TMPRSS2 expression in normal tissues from oral cavity, pharynx, larynx and lung tissues as well as neoplastic tissues from the same areas.

Methods: The study has been conducted using the TCGA and the Regina Elena Institute databases and validated by experimental model in HNSCC cells. We also included data from one COVID19 patient who went under surgery for HNSCC.

Results: TMPRSS2 expression in HNSCC was significantly reduced compared to the normal tissues. It was more evident in women than in men, in TP53 mutated versus wild TP53 tumors, in HPV negative patients compared to HPV positive counterparts. Functionally, we modeled the multivariate effect of TP53, HPV, and other inherent variables on TMPRSS2. All variables had a statistically significant independent effect on TMPRSS2. In particular, in tumor tissues, HPV negative, TP53 mutated status and elevated TP53-dependent Myc-target genes were associated with low TMPRSS2 expression. The further analysis of both TCGA and our institutional HNSCC datasets identified a signature anti-correlated to TMPRSS2. As proof-of-principle we also validated the anti-correlation between microRNAs and TMPRSS2 expression in a SARS-CoV-2 positive HNSCC patient tissues Finally, we did not find TMPRSS2 promoter methylation.

Conclusions: Collectively, these findings suggest that tumoral tissues, herein exemplified by HNSCC and lung cancers might be more resistant to SARS-CoV-2 infection due to reduced expression of TMPRSS2. These observations may help to better assess the frailty of SARS-CoV-2 positive cancer patients.
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http://dx.doi.org/10.1186/s13046-020-01708-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7510014PMC
September 2020

Adipose tissue stromal vascular fraction and adipose tissue stromal vascular fraction plus platelet-rich plasma grafting: New regenerative perspectives in genital lichen sclerosus.

Dermatol Ther 2020 11 22;33(6):e14277. Epub 2020 Sep 22.

Department of Plastic and Regenerative Surgery, San Gallicano Dermatological Institute IRCCS, Rome, Italy.

Lichen sclerosus (LS) is a chronic relapsing, inflammatory skin disorder usually involving the anogenital region of both sexes lacking a resolutive therapy. This study compared adipose tissue derived-stromal vascular fraction (AD-SVF) and AD-SVF-enriched platelet-rich plasma (PRP) therapy in the management of genital LS patients. Additionally, in vitro evaluation of cells and growth factors contained in the injected SVF has been evaluated as possible predictive factors for treatment outcome. The study population was 40 patients diagnosed with LS who were symptomatic despite medical treatment. Patients (age 43-78 years) randomized into two groups using a 1:1 allocation ratio, were evaluated clinically and assessing dermatology life quality index (DLQI) before and 6 months after treatment. Both procedures demonstrated a strong safety profile with no complications linked to the therapy. After 6 months, both treatments allowed for a significant improvement respect to baseline. Combinatory therapy demonstrated decreased efficacy in late stage patients. No correlations have been found between clinical and biological findings. AD-SVF and AD-SVF plus PRP are safe and effective regenerative approaches for genital LS patients. Clinical results support the preferential use of combinatory therapy for early stage patients confirming a synergic effect of AD-SVF and PRP. In contrast, AD-SVF plus PRP is discouraged for late stage patients.
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http://dx.doi.org/10.1111/dth.14277DOI Listing
November 2020

Reorganization of Istituti Fisioterapici Ospitalieri, an oncological and dermatological clinical and research center, to face the coronavirus health emergency: adopted measures and metrics of success to achieve and keep a COVID-19-free status.

J Exp Clin Cancer Res 2020 Sep 1;39(1):177. Epub 2020 Sep 1.

Organizational and Human Capital Development Unit, Istituti Fisioterapici Ospitalieri (IFO), Rome, Italy.

Background: A pronounced polarization of healthcare resources and workforce towards the prevention of the rapid spread of SARS-CoV-2 occurred at the expenses of the majority of chronic diseases and cancer, thus jeopardizing continuity of care and therapy outcomes. In this challenging and overwhelming scenario, our Institute confirmed its mission to provide expert cancer care. Here, we provide a report of strategic decisions made and of articulated measures developed to limit virus spreading while striving to make our hospital closer to patients.

Conclusions: We hope our experience may serve as a resource to inform clinical care models in case of future epidemiological outbreaks.
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http://dx.doi.org/10.1186/s13046-020-01675-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7461151PMC
September 2020

Oral Infection by Mucosal and Cutaneous Human Papillomaviruses in the Men Who Have Sex with Men from the OHMAR Study.

Viruses 2020 08 17;12(8). Epub 2020 Aug 17.

STI/HIV Unit, San Gallicano Dermatological Institute IRCCS, Via Elio Chianesi 53, 00144 Rome, Italy.

Both mucosal and cutaneous Human Papillomaviruses (HPVs) can be detected in the oral cavity, but investigations regarding the epidemiology of cutaneous HPVs at this site are scarce. We assessed mucosal (alpha) and cutaneous (beta and gamma) HPV infection in oral samples of HIV-infected and uninfected men who have sex with men (MSM). Oral rinse-and-gargles were collected from 310 MSM. Alpha HPVs were detected using the Linear Array, whereas beta and gamma HPVs were detected using multiplex PCR and Luminex technology. An amplicon-based next-generation sequencing (NGS) protocol was applied to a subset of samples collected from 30 HIV-uninfected and 30 HIV-infected MSM. Beta HPVs were significantly more common than alpha types (53.8% vs. 23.9% for HIV-infected subjects, < 0.0001; 50.3% vs. 17.1% for HIV-uninfected subjects, < 0.0001). Gamma HPVs were also frequently detected (30.8% and 25.9% in HIV-infected and uninfected MSM, respectively). NGS produced 2,620,725 reads representative of 146 known HPVs (16 alpha-PVs, 53 beta-PVs, 76 gamma-PVs, one unclassified) and eight putative new HPVs, taxonomically assigned to the beta genus. The oral cavity contains a wide spectrum of HPVs, with beta types representing the predominant genus. The prevalence of beta and gamma HPVs is high even in immunorestored HIV-infected individuals. NGS confirmed the abundance of cutaneous HPVs and identified some putative novel beta HPVs. This study confirms that cutaneous HPVs are frequently present at mucosal sites and highlights that their pathological role deserves further investigation since it may not be limited to skin lesions.
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http://dx.doi.org/10.3390/v12080899DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7472018PMC
August 2020

Teledermatology and hygiene practices during the COVID-19 pandemic.

Contact Dermatitis 2020 12 1;83(6):536. Epub 2020 Sep 1.

Clinical Dermatology, San Gallicano Dermatological Institute, Rome, Italy.

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http://dx.doi.org/10.1111/cod.13683DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7436540PMC
December 2020

Comment on "Rescheduling of clinical activities and teleconsulting for public dermatology. Two prompt answers to COVID-19 emergency".

Int J Dermatol 2020 10 25;59(10):1284. Epub 2020 Jul 25.

Department of Oncological and Preventative Dermatology, San Gallicano Dermatological Institute IRCCS, Rome, Italy.

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http://dx.doi.org/10.1111/ijd.15026DOI Listing
October 2020

Scabies coexisting with other dermatoses: the importance of recognizing multiple pathologies in resource-poor settings.

Int J Dermatol 2020 Dec 8;59(12):1502-1505. Epub 2020 Jul 8.

San Gallicano Dermatological Institute, Rome, Italy.

Background: Background Skin Neglected Tropical Diseases (NTDs) are a group of ten diseases often co-endemic in African rural communities and characterized by primary skin involvement. If not diagnosed and treated promptly, they can lead to long-term disfigurement, disability, stigmatization, and socioeconomic loss. Scabies is a parasitic disease and it was added in 2017 to the World Health Organization's (WHO) list of NTDs. Skin NTDs comorbidities differ according to the local diseases burden and are associated to other poverty-related illnesses.

Methods: We report a case series of scabies and comorbidities in children from rural Ethiopia aimed at highlighting diagnostic challenges.

Results: We propose an epidemiological framework to the integrated skin NTDs approach at a community level.

Conclusion: This bottleneck approach may significantly reduce skin diseases burden in rural communities, prevent long-term disabilities, and contain costs.
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http://dx.doi.org/10.1111/ijd.15023DOI Listing
December 2020
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