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1. Trends in chronic hepatitis B virus infection in Italy over a 10-year period: Clues from the nationwide PITER and MASTER cohorts toward elimination

Author

Brancaccio, G, Coco, B, Nardi, A, Quaranta, M, Tosti, M, Ferrigno, L, Cacciola, I, Messina, V, Chessa, L, Morisco, F, Milella, M, Barbaro, F, Ciancio, A, Russo, F, Coppola, N, Blanc, P, Claar, E, Verucchi, G, Puoti, M, Zignego, A, Chemello, L, Madonia, S, Fagiuoli, S, Marzano, A, Ferrari, C, Lampertico, P, Di Marco, V, Craxì, A, Santantonio, T, Raimondo, G, Brunetto, M, Gaeta, G, Kondili, L, Pasulo, L, Coppola, C, Pisano, F, Romano, M, Porcu, C, Bottalico, I, Cossiga, V, Tata, X, Sagnelli, C, Pierotti, P, Degasperi, E, Rosato, V, Badia, L, Ieluzzi, D, Monti, M, Bavetta, M, Cavalletto, L, Toniutto, P, Fornasiere, E, Colecchia, A, Ferrarese, A, Nardone, G, Rocco, A, Viganò, M, Foschi, F, Conti, F, Morsica, G, Salpietro, S, Torti, C, Costa, C, Federico, A, Dallio, M, Giorgini, A, Anselmo, M, De Leo, P, Zaltron, S, Cambianica, A, Piscaglia, F, Serio, I, Schivazappa, S, Mastroianni, A, Chidichimo, L, Massari, M, Mazzaro, C, Marrone, A, D'Amore, F, D'Offizi, G, Licata, A, Niro, G, Pollicino, T, Aghemo, A, Brancaccio G., Coco B., Nardi A., Quaranta M. G., Tosti M. E., Ferrigno L., Cacciola I., Messina V., Chessa L., Morisco F., Milella M., Barbaro F., Ciancio A., Russo F. P., Coppola N., Blanc P., Claar E., Verucchi G., Puoti M., Zignego A. L., Chemello L., Madonia S., Fagiuoli S., Marzano A., Ferrari C., Lampertico P., Di Marco V., Craxì A., Santantonio T. A., Raimondo G., Brunetto M. R., Gaeta G. B., Kondili L. A., Pasulo L., Coppola C., Pisano F., Romano M., Porcu C., Bottalico I. F., Cossiga V., Tata X., Sagnelli C., Pierotti P., Degasperi E., Rosato V., Badia L., Ieluzzi D., Monti M., Bavetta M. G., Cavalletto L., Toniutto P., Fornasiere E., Colecchia A., Ferrarese A., Nardone G., Rocco A., Viganò M., Foschi F. G., Conti F., Morsica G., Salpietro S., Torti C., Costa C., Federico A., Dallio M., Giorgini A., Anselmo M., De Leo P., Zaltron S., Cambianica A., Piscaglia F., Serio I., Schivazappa S., Mastroianni A., Chidichimo L., Massari M., Mazzaro C., Marrone A., D'Amore F. M., D'Offizi G., Licata A., Niro G. A., Pollicino T., Aghemo A., Brancaccio, G, Coco, B, Nardi, A, Quaranta, M, Tosti, M, Ferrigno, L, Cacciola, I, Messina, V, Chessa, L, Morisco, F, Milella, M, Barbaro, F, Ciancio, A, Russo, F, Coppola, N, Blanc, P, Claar, E, Verucchi, G, Puoti, M, Zignego, A, Chemello, L, Madonia, S, Fagiuoli, S, Marzano, A, Ferrari, C, Lampertico, P, Di Marco, V, Craxì, A, Santantonio, T, Raimondo, G, Brunetto, M, Gaeta, G, Kondili, L, Pasulo, L, Coppola, C, Pisano, F, Romano, M, Porcu, C, Bottalico, I, Cossiga, V, Tata, X, Sagnelli, C, Pierotti, P, Degasperi, E, Rosato, V, Badia, L, Ieluzzi, D, Monti, M, Bavetta, M, Cavalletto, L, Toniutto, P, Fornasiere, E, Colecchia, A, Ferrarese, A, Nardone, G, Rocco, A, Viganò, M, Foschi, F, Conti, F, Morsica, G, Salpietro, S, Torti, C, Costa, C, Federico, A, Dallio, M, Giorgini, A, Anselmo, M, De Leo, P, Zaltron, S, Cambianica, A, Piscaglia, F, Serio, I, Schivazappa, S, Mastroianni, A, Chidichimo, L, Massari, M, Mazzaro, C, Marrone, A, D'Amore, F, D'Offizi, G, Licata, A, Niro, G, Pollicino, T, Aghemo, A, Brancaccio G., Coco B., Nardi A., Quaranta M. G., Tosti M. E., Ferrigno L., Cacciola I., Messina V., Chessa L., Morisco F., Milella M., Barbaro F., Ciancio A., Russo F. P., Coppola N., Blanc P., Claar E., Verucchi G., Puoti M., Zignego A. L., Chemello L., Madonia S., Fagiuoli S., Marzano A., Ferrari C., Lampertico P., Di Marco V., Craxì A., Santantonio T. A., Raimondo G., Brunetto M. R., Gaeta G. B., Kondili L. A., Pasulo L., Coppola C., Pisano F., Romano M., Porcu C., Bottalico I. F., Cossiga V., Tata X., Sagnelli C., Pierotti P., Degasperi E., Rosato V., Badia L., Ieluzzi D., Monti M., Bavetta M. G., Cavalletto L., Toniutto P., Fornasiere E., Colecchia A., Ferrarese A., Nardone G., Rocco A., Viganò M., Foschi F. G., Conti F., Morsica G., Salpietro S., Torti C., Costa C., Federico A., Dallio M., Giorgini A., Anselmo M., De Leo P., Zaltron S., Cambianica A., Piscaglia F., Serio I., Schivazappa S., Mastroianni A., Chidichimo L., Massari M., Mazzaro C., Marrone A., D'Amore F. M., D'Offizi G., Licata A., Niro G. A., Pollicino T., and Aghemo A.

Abstract

Objectives: The study measures trends in the profile of patients with chronic hepatitis B virus linked to care in Italy. Methods: A cross-sectional, multicenter, observational cohort (PITER cohort) of consecutive patients with hepatitis B surface antigen (HBsAg) over the period 2019-2021 from 46 centers was evaluated. The reference was the MASTER cohort collected over the years 2012-2015. Standard statistical methods were used. Results: The PITER cohort enrolled 4583 patients, of whom 21.8% were non-Italian natives. Compared with those in MASTER, the patients were older and more often female. The prevalence of hepatitis B e antigen (HBeAg) declined (7.2% vs 12.3; P <0.0001) and that of anti-hepatitis D virus (HDV) remained stable (9.3% vs 8.3%). In both cohorts, about 25% of the patients had cirrhosis, and those in the PITER cohort were older. HBeAg-positive was 5.0% vs 12.6% (P <0.0001) and anti-HDV positive 24.8% vs 17.5% (P <0.0017). In the logistic model, the variables associated with cirrhosis were anti-HDV-positive (odds ratio = 10.08; confidence interval 7.63-13.43), age, sex, and body mass index; the likelihood of cirrhosis was reduced by 40% in the PITER cohort. Among non-Italians, 12.3% were HBeAg-positive (vs 23.4% in the MASTER cohort; P <0.0001), and 12.3% were anti-HDV-positive (vs 11.1%). Overall, the adherence to the European Association for the Study of the Liver recommendations for antiviral treatment increased over time. Conclusion: Chronic hepatitis B virus infection appears to be in the process of becoming under control in Italy; however, HDV infection is still a health concern in patients with cirrhosis and in migrants.

Published
2023

2. Omalizumab for chronic spontaneous urticaria in “complex” patients: data from real-life clinical practice

Author

Vollono L, Piccolo A, Lanna C, Esposito M, Bavetta M, Campione E, Bianchi L, and Diluvio L

Subjects
chronic spontaneous urticaria, omalizumab, oncologic, cardiovascular, allergic and immunologic conditions, comorbidities, Therapeutics. Pharmacology, RM1-950
Abstract

Laura Vollono1, Arianna Piccolo1, Caterina Lanna1, Maria Esposito2, Mauro Bavetta1, Elena Campione1, Luca Bianchi1, Laura Diluvio1 1Dermatology Department, University of Rome, Tor Vergata, Italy; 2Dermatology Department, University of L’Aquila, L’Aquila, ItalyCorrespondence: Laura VollonoDermatology Department, University of Rome Tor Vergata, Viale Oxford 81, Rome 00133, ItalyTel +39 06 2090 0252Email laura.vollono@gmail.comIntroduction: Omalizumab is a recombinant humanized anti-IgE monoclonal antibody, approved for patients affected by chronic spontaneous urticaria resistant to antihistamines. Although the clinical benefit of omalizumab has been established in several clinical trials, there are very little data about long-term treatment with this drug and real-life reports regarding its use in patients affected by comorbidities other than urticaria are lacking.Objectives: To assess omalizumab efficacy and safety in a heterogeneous population of patients affected by chronic spontaneous urticaria and several comorbidities in a real-world setting.Materials and methods: Patients affected by chronic spontaneous urticaria with weekly urticaria activity score >16 resistant to antihistamines were treated with omalizumab 300 mg injection as add-on to H1-antihistamines administered every 4 weeks for 6 months. Clinical assessment of weekly urticaria activity score, dermatology life quality index and blood tests were performed at baseline, 12, 24 and 52 weeks of treatment. Response was assessed based on reduction weekly urticaria activity score.Results: Thirty-two patients (22F; 10M) with a mean age of 52.4 years (range 27–72) affected by chronic spontaneous urticaria were enrolled. Comorbidities affecting our study population were divided into 6 categories: cardio-metabolic (77%), oncologic (19%), infectious (16%), allergic (45%) immunologic (41%) and others (18%). Omalizumab determined a satisfactory reduction of symptoms of chronic spontaneous urticaria and an amelioration of quality of life within our population. No relevant alterations regarding patients’ underlying conditions were encountered. This is the first study regarding the use of omalizumab for chronic spontaneous urticaria in a population of adult patients affected by several comorbidities, eg, cardio-metabolic, oncologic, infectious, allergic, immunologic and psychiatric diseases. Real-life data represent a valuable source of information about a drug’s safety and efficacy profile, especially in patients affected by different comorbidities that are widely diffused in Western countries.Keywords: chronic spontaneous urticaria, omalizumab, oncologic, cardiovascular, allergic and immunologic conditions, comorbidities

Published
2019

3. Effectiveness of risankizumab in the treatment of palmoplantar psoriasis: A 52-week Italian real-life experience

Author

Caldarola, Giacomo, Zangrilli, A., Palmisano, Gerardo, Bavetta, M., Moretta, G., Pagnanelli, G., Panasiti, V., Bianchi, L., De Simone, Clara, Peris, Ketty, Caldarola G. (ORCID:0000-0002-8837-9232), Palmisano G., De Simone C. (ORCID:0000-0002-0898-0045), Peris K. (ORCID:0000-0002-5237-0463), Caldarola, Giacomo, Zangrilli, A., Palmisano, Gerardo, Bavetta, M., Moretta, G., Pagnanelli, G., Panasiti, V., Bianchi, L., De Simone, Clara, Peris, Ketty, Caldarola G. (ORCID:0000-0002-8837-9232), Palmisano G., De Simone C. (ORCID:0000-0002-0898-0045), and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Background: Data on the treatment of palmoplantar psoriasis (PP) are scarce, representing a therapeutic challenge. This study aims to assess the efficacy and safety of risankizumab in a population of patients with psoriasis with a palmoplantar involvement, over a 52-week treatment period. Methods: We performed a retrospective analysis in a cohort of patients with PP, with or without involvement of other skin sites. Palmoplantar Psoriasis Area and Severity Index (ppPASI) was assessed at baseline and after 4, 16, 28 and 52 weeks, to evaluate the PP severity. Results: Sixteen patients were enrolled. The rates of ppPASI90 responses constantly increased during the period of observation and were 18.7%, 62.2%, 75.0% and 81.2% at weeks 4, 16, 28 and 52, respectively. Only two patients suspended treatment because of ineffectiveness at week 16. Conclusion: Our data from a series of 16 patients reveal that risankizumab could represent an effective and safe therapeutic choice in patients with PP.

Published
2023

4. 2-Year Experience with Risankizumab in the Treatment of Plaque Psoriasis in Lazio Region, Italy

Author

Caldarola, Giacomo, De Luca, Eleonora, Bavetta, M., Bernardini, N., Dattola, Carmelo Alberto, De Simone, Clara, Gracefa, D., Bonifati, C., Tribuzi, P., Giordano, D., Mariani, Marco, Moretta, G., Pagnanelli, G., Panasiti, V., Provini, A., Richetta, A., Zangrilli, A., Bianchi, L., Pellacani, G., Peris, Ketty, Caldarola G. (ORCID:0000-0002-8837-9232), De Luca E., Dattola A., De Simone C. (ORCID:0000-0002-0898-0045), Mariani M., Peris K. (ORCID:0000-0002-5237-0463), Caldarola, Giacomo, De Luca, Eleonora, Bavetta, M., Bernardini, N., Dattola, Carmelo Alberto, De Simone, Clara, Gracefa, D., Bonifati, C., Tribuzi, P., Giordano, D., Mariani, Marco, Moretta, G., Pagnanelli, G., Panasiti, V., Provini, A., Richetta, A., Zangrilli, A., Bianchi, L., Pellacani, G., Peris, Ketty, Caldarola G. (ORCID:0000-0002-8837-9232), De Luca E., Dattola A., De Simone C. (ORCID:0000-0002-0898-0045), Mariani M., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Background. Given the chronic relapsing, remitting course of psoriasis, data about long-term efectiveness may be useful to assess the maintenance of clinical response over time. Objective. To evaluate 2-year drug survival of risankizumab and identify any predictive factor of discontinuation for inefectiveness. Materials and Methods. A multicenter retrospective study was conducted in patients who initiated risankizumab between July 2019 and December 2020. PASI was measured at baseline and after 104 weeks. Any adverse event was registered during visits. Univariable and multivariable logistic regressions were used to assess baseline patients’ characteristics that predicted clinical response. Te drug survival analysis was descriptively performed using the Kaplan–Meier survival curve. Results. 112 patients with moderate-to-severe plaque psoriasis were included. Te overall median observation time was 35.3 months (26.7–37.3); the estimated survivor cumulative function at months 12 and 24 was 93.6% and 90.6%, respectively. No diferences in BMI, disease duration, disease severity, or previous biological therapies were observed in patients who responded or did not respond to treatment. No signifcant adverse events were reported, but there was relapse of psoriatic arthritis and ulcerative colitis in a patient. Conclusions. We found that risankizumab was associated with long-term efectiveness, and a favorable safety profle in a population of psoriatic patients was observed, over a period of 2 years.

Published
2023

7. Risankizumab for the treatment of moderate-to-severe psoriasis: A multicenter, retrospective, 1 year real-life study

Author

Caldarola, G., Zangrilli, A., Bernardini, N., Bavetta, M., De Simone, C., Graceffa, D., Bonifati, C., Faleri, S., Giordano, D., Mariani, M., Micheli, A., Moretta, G., Pagnanelli, G., Panasiti, V., Provini, A., Richetta, A., Peris, K., Bianchi, L., Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), Micheli A., Peris K. (ORCID:0000-0002-5237-0463), Caldarola, G., Zangrilli, A., Bernardini, N., Bavetta, M., De Simone, C., Graceffa, D., Bonifati, C., Faleri, S., Giordano, D., Mariani, M., Micheli, A., Moretta, G., Pagnanelli, G., Panasiti, V., Provini, A., Richetta, A., Peris, K., Bianchi, L., Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), Micheli A., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Several new biologic agents targeting IL23/Th17 axis, such as risankizumab, have been developed for the treatment of psoriasis. The aim of the present study was to analyze the efficacy and safety of risankizumab in patients with moderate-to-severe psoriasis over a 52-week period. A multicentric retrospective study was conducted in patients who initiated risankizumab between July 2019 and December 2020. Psoriasis Area and Severity Index—PASI was measured at baseline and after 4, 16, 28 and 52 weeks. Clinical responses were evaluated by PASI75, PASI90 and PASI100 at the same timepoints. Potential safety issues and adverse events (AEs) were collected. Univariable and multivariable logistic regressions were performed for variables predicting clinical response. One hundred and twelve patients with psoriasis were included. PASI90 response was achieved by 17.86% of patients at week 4, 72.22% at week 16, 91.0% at week 28 and 95.24% at week 52 (as observed analysis). No associations between the considered variables and the efficacy endpoints were retrieved, influence of variables such as Body Mass Index (BMI), baseline PASI or previous biologics were not shown. No serious safety issues or discontinuations related to adverse events were reported. Risankizumab showed high efficacy and a favorable safety profile, regardless of patient- and disease-related factors.

Published
2022

10. Predictive factors of lack of response to adalimumab among bio-naive patients suffering from moderate-to severe psoriasis: analysis of a multicenter data collection in Italy

Author

Zangrilli, A., Caldarola, Giacomo, Bernardini, N., Bavetta, M., Graceffa, D., Bonifati, C., Cantoresi, F., Faleri, S., Giordano, D., Mariani, M., Micheli, Giuseppe Annibale, Moretta, G., Pirro, Federico, Pagnanelli, G., Panasiti, V., Provini, A., Richetta, A., Sacchelli, L., Bianchi, L., Peris, Ketty, Caldarola G. (ORCID:0000-0002-8837-9232), Micheli A., Pirro F., Peris K. (ORCID:0000-0002-5237-0463), Zangrilli, A., Caldarola, Giacomo, Bernardini, N., Bavetta, M., Graceffa, D., Bonifati, C., Cantoresi, F., Faleri, S., Giordano, D., Mariani, M., Micheli, Giuseppe Annibale, Moretta, G., Pirro, Federico, Pagnanelli, G., Panasiti, V., Provini, A., Richetta, A., Sacchelli, L., Bianchi, L., Peris, Ketty, Caldarola G. (ORCID:0000-0002-8837-9232), Micheli A., Pirro F., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Introduction: Efficacy of anti-TNF-a agents seems inferior to IL-17 and IL-23 inhibitors. Nevertheless, after biosimilars approval, anti TNF-a agents are recommended as first-line for psoriatic patients, for economic reasons. Methods: Predictive factors of response or non-response to adalimumab in bionaive patients who started adalimumab (originator or biosimilar) over 12 years in 9 dermatologic centers in Italy. Effectiveness was assessed with Psoriasis Area and Severity Index (PASI75 and PASI90) at weeks 12, 24 and 48. Multiple logistic regressions were used for variables predicting clinical response; Kaplan–Meier survival curves and Cox regression for drug survival. Results: The drug survival analysis showed reduced hazard ratio of overall discontinuation with male gender and scalp localization. In contrast, baseline PASI and genital psoriasis were significantly associated with increased risk of overall discontinuation. Predictive factors of non-response seemed elevated in patients with baseline PASI, older age groups, previously treated patients with phototherapy, females or patients with palmo-plantar while scalp psoriasis, previous cyclosporine and acitretin appeared as a positive predictive factor. Conclusions: This real-life analysis might be useful for clinicians in case of bio-naive patients with moderate-to-severe psoriasis and various comorbidities.

Published
2021

11. The effects of association of topical polydatin improves the preemptive systemic treatment on EGFR inhibitors cutaneous adverse reactions

Author

Bavetta, M., Silvaggio, D., Campione, E., Sollena, P., Formica, V., Coletta, D., Graziani, Giovanni, Romano, M. C. P., Roselli, M., Peris, Ketty, Bianchi, L., Graziani G., Peris K. (ORCID:0000-0002-5237-0463), Bavetta, M., Silvaggio, D., Campione, E., Sollena, P., Formica, V., Coletta, D., Graziani, Giovanni, Romano, M. C. P., Roselli, M., Peris, Ketty, Bianchi, L., Graziani G., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Epidermal Growth Factor Receptor inhibitors (EGFRi) are approved as therapeutic options in several solid tumors. Cutaneous papulopustular eruption is the most frequent cutaneous adverseevent (AE), usually treated with emollient or corticosteroids according to toxicity grade. Our study evaluated the efficacy and safety of a topical product containing polydatin, a glycosylated polyphenol, natural precursor of resveratrol showing anti-inflammatory and anti-oxidative activities, for the prevention and treatment of skin papulopustular rash in EGFRi-treated patients. Forty oncologic patients treated with EGFRi were enrolled in two groups: group-A, 20 patients with papulopustular AE, and group-B, 20 patients without cutaneous manifestations. The study consisted of twicedaily application of polydatin cream 1.5% (group-A) and 0.8% (group-B) for 6 months. In group-A patients, we observed at week 4 a remarkable improvement of skin manifestation and quality of life evaluated with National-Cancer-Institute-Common-Terminology-Criteria for Adverse-Events (NCICTCAE), Dermatology-Life-Quality-Index (DLQI) score and Visual-Analogue-Scale (VAS) pruritus, with a statistical significance of p < 0.05. None of the patients of group-B developed skin AEs to EGFRi. No cutaneous AEs related to the polydatin product were reported in both groups. Polydatin can be a good topical aid for the prevention and management of papulopustular rash in cancer patients receiving EGFRi, also capable of improving cancer patients’ quality of life.

Published
2021

15. Skin Lesion: unexpected uptake PET/CT

Author

Dianzani C, Sergio Chimenti, Bavetta M, Ambrogi, F Specchio, Carboni I, Steven Paul Nisticò, and E Campione

Subjects
PET-CT, medicine.medical_specialty, business.industry, medicine, Radiology, Bioinformatics, business, Skin lesion, Omics
Published
2015
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17. Detection of Adalimumab and Anti-Adalimumab Levels by ELISA: Clinical Considerations

Author

Marinari, B, Botti, E, Bavetta, M, Spallone, G, Zangrilli, A, Talamonti, M, Richetta, A, Chimenti, S, and Costanzo, A

Subjects
promonitor assay, Settore MED/35 - Malattie Cutanee e Veneree, Tumor Necrosis Factor-alpha, anti-adalimumab antibody, Adalimumab, Enzyme-Linked Immunosorbent Assay, assay, Antibodies, Monoclonal, Humanized, Severity of Illness Index, Antibodies, Treatment Outcome, Antirheumatic Agents, Monoclonal, Quality of Life, adalimumab, serum concentrations, Humans, Psoriasis, Humanized
Abstract

Psoriasis (Ps) is a common and stigmatizing chronic inflammatory skin disease that may cause other chronic inflammatory conditions with overlapping pathology, such as rheumatoid arthritis (RA). Tumor necrosis factor (TNF) is a proinflammatory cytokine that plays a pivotal role in chronic inflammatory and autoimmune diseases such as uveitis, multiple sclerosis, systemic lupus, arthritis, Ps, and Crohn's disease. The TNF superfamily and receptors represent active targets for drug development. Anti-TNF biological therapies, such as infliximab, adalimumab (ADL), and etanercept, are effective in treating RA, spondyloarthritis, Ps, and inflammatory bowel diseases, but long-term treatment can induce anti-drug antibody (ADA) formation associated with lower drug levels and clinical nonresponse. An investigation of the relationship between serum ADL/anti-adalimumab antibody (AAA) concentration, and clinical response in moderate to severe Ps, confirmed an association between ADL and AAA levels and response. Although the detection of ADAs can be used to determine the cause of nonresponse and aid therapy decisions, the contrary observation of long-term responders with low drug levels and detectable ADA suggests that another mechanism is also involved.

Published
2014

20. Quality of life of psoriatic patients evaluated by a new psychometric assessment tool: PsoDisk

Author

Chiricozzi, Andrea, Bianchi, L., Zangrilli, A., Bavetta, M., Giunta, A., Chimenti, S., Saraceno, R., Chiricozzi A. (ORCID:0000-0002-6739-0387), Chiricozzi, Andrea, Bianchi, L., Zangrilli, A., Bavetta, M., Giunta, A., Chimenti, S., Saraceno, R., and Chiricozzi A. (ORCID:0000-0002-6739-0387)

Abstract

Background: Psoriasis is a chronic skin disorder which negatively impacts a patient’s quality of life (QoL). A recently published assessment tool, PsoDisk, has been proposed to evaluate patient’s QoL. Objective: The aim of this study was to test PsoDisk as a QoL assessment tool in psoriatic patients undergoing treatment with adalimumab. Methods: A retrospective, monocentric study, including patients who completed at least 48 weeks of both adalimumab therapy and PsoDisk assessment. PASI was assessed by the physician whereas the PsoDisk test was self-performed by the patient. Both were evaluated at each control visit throughout the study-period in order to detect changes in disease severity and the impact of quality of life, respectively. Results: In total, we evaluated 31 patients selected from our database. At baseline, all aspects of patients’ psycho-emotional and social lives were impaired. PASI score reduction correlated with a PsoDisk score decrease (r = 0.97; p = 0.02), reflecting an overall improvement of patient’s QoL. Conclusion: PsoDisk was found to be easy to administer and intuitive for interpreting clinical results.

Published
2015

21. HBV reactivation in patients with HCV/ HBV cirrhosis on treatment with direct-acting antivirals.

Author

Calvaruso, V., Ferraro, D., Licata, A., Bavetta, M. G., Petta, S., Bronte, F., Colomba, G., Craxì, A., and Di Marco, V.

Subjects
HEPATITIS C treatment, TREATMENT of cirrhosis of the liver, HEPATITIS C, ANTIVIRAL agents, VIRUS reactivation, GENETICS
Abstract

Anecdotal reports suggest that patients with chronic hepatitis C virus ( HCV) hepatitis and overt or occult hepatitis B virus ( HBV) coinfection may reactivate HBV when HCV is suppressed or cleared by direct-acting antivirals ( DAAs). We assessed the prevalence of overt or previous HBV coinfection and the risk of HBV reactivation in patients with HCV cirrhosis treated with DAAs. This was a retrospective cohort of 104 consecutive patients with HCV cirrhosis treated with DAAs. Serum HCV- RNA and HBV- DNA were tested at weeks 4, 8 and 12 of DAAs therapy and at week 12 of follow-up. At the start of DAAs, eight patients (7.7%) were HBsAg positive/ HBeAg negative with undetectable HBV- DNA and low levels of quantitative HBsAg (four on nucleos(t)ide analogues [ NUCs] and four inactive carriers), 37 patients (35.6%) had markers of previous HBV infection (25 anti- HBc positive, 12 anti- HBc/anti- HBs positive) and 59 (56.7%) had no evidence of HBV infection. Sixty-seven patients (64.4%) were HCV- RNA negative at week 4 and 98 (94.2%) achieved sustained virological response. All four HBsAg-positive patients treated with NUCs remained HBV- DNA negative, but three of four untreated patients showed an increase in HBV- DNA of 2-3 log without a biochemical flare and achieved HBV- DNA suppression when given NUCs. During or after DAAs, by conventional assay, HBV- DNA remained not detectable in all 37 anti- HBc-positive patients but in three of them (8.1%) HBV- DNA became detectable with a highly sensitive PCR. HBV reactivation is likely to occur in untreated HBV/ HCV-coinfected cirrhotic patients when they undergo HCV treatment with DAAs. Pre-emptive therapy with NUCs should be considered in this setting. Anti- HBc-positive patients rarely reactivate HBV without clinical or virological outcomes. [ABSTRACT FROM AUTHOR]

Published
2018
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22. Ustekinumab for treatment of plaque psoriasis in a patient with down syndrome

Author

Talamonti, M., Galluzzo, M., Chiricozzi, Andrea, Teoli, M., Bavetta, M., Costanzo, A., Chimenti, S., Chiricozzi A. (ORCID:0000-0002-6739-0387), Talamonti, M., Galluzzo, M., Chiricozzi, Andrea, Teoli, M., Bavetta, M., Costanzo, A., Chimenti, S., and Chiricozzi A. (ORCID:0000-0002-6739-0387)

Abstract

Down syndrome (DS) is the most common chromosomal disorder and a major cause of mental retardation. Down syndrome phenotype is complex and may present a combination of dysmorphic features, congenital heart disease and immunological deficiency. Psoriasis it has been noted to be 0.5%-8% in patients with DS and numerous factors can limit the use of therapeutic options, in particular long-term organ-specific toxicity, and the risk of opportunistic infections. It is still debated whether the use of biologics in the treatment of DS-related psoriasis is safe. We have valuated the efficacy and safety of ustekinumab treatment in-patient with DS suffering from plaque type psoriasis. A 31-year-old patient suffering from plaque type psoriasis since the age of 14, showed a PASI score of 12 after the failure of anti-TNF agents. We switched the patient to ustekinumab treatment at the standard dose of 45 mg subcutaneously initially and 4 weeks later, followed by 45 mg every 12 weeks. The patient showed a significant improvement of the PASI score already after 4 weeks of treatment and further improvements were observed throughout the treatment. We report the first case of DS-correlated psoriasis patient treated for a long-term period with various biologics, showing a satisfactory safety profile undergoing treatment. In our experience, ustekinumab has demonstrated a high efficacy, relatively rapid onset of action, favorable safety profile, and can be considered a good treatment option even after failure to respond to other biologic therapies in patient with DS. Copyright © 2012 Journal of Drugs in Dermatology.

Published
2012

28. Trends in chronic hepatitis B virus infection in Italy over a 10-year period: Clues from the nationwide PITER and MASTER cohorts toward elimination

Author

Giuseppina Brancaccio, Barbara Coco, Alessandra Nardi, Maria Giovanna Quaranta, Maria Elena Tosti, Luigina Ferrigno, Irene Cacciola, Vincenzo Messina, Luchino Chessa, Filomena Morisco, Michele Milella, Francesco Barbaro, Alessia Ciancio, Francesco Paolo Russo, Nicola Coppola, Pierluigi Blanc, Ernesto Claar, Gabriella Verucchi, Massimo Puoti, Anna Linda Zignego, Liliana Chemello, Salvatore Madonia, Stefano Fagiuoli, Alfredo Marzano, Carlo Ferrari, Pietro Lampertico, Vito Di Marco, Antonio Craxì, Teresa Antonia Santantonio, Giovanni Raimondo, Maurizia R. Brunetto, Giovanni Battista Gaeta, Loreta A. Kondili, Luisa Pasulo, Carmine Coppola, Federica Pisano, Mariarosaria Romano, Carmen Porcu, Irene Francesca Bottalico, Valentina Cossiga, Xhimi Tata, Caterina Sagnelli, Piera Pierotti, Elisabetta Degasperi, Valerio Rosato, Lorenzo Badia, Dontella Ieluzzi, Monica Monti, Maria Grazia Bavetta, Luisa Cavalletto, Pierluigi Toniutto, Ezio Fornasiere, Antonio Colecchia, Alberto Ferrarese, Gerardo Nardone, Alba Rocco, Mauro Viganò, Francesco Giuseppe Foschi, Fabio Conti, Giulia Morsica, Stefania Salpietro, Carlo Torti, Chiara Costa, Alessandro Federico, Marcello Dallio, Alessia Giorgini, Marco Anselmo, Pasqualina De Leo, Serena Zaltron, Anna Cambianica, Fabio Piscaglia, Ilaria Serio, Simona Schivazappa, Antonio Mastroianni, Luciana Chidichimo, Marco Massari, Cesare Mazzaro, Aldo Marrone, Francesca Maria D'Amore, Gianpiero D'Offizi, Anna Licata, Grazia Anna Niro, Teresa Pollicino, Alessio Aghemo, Brancaccio, G., Coco, B., Nardi, A., Quaranta, M. G., Tosti, M. E., Ferrigno, L., Cacciola, I., Messina, V., Chessa, L., Morisco, F., Milella, M., Barbaro, F., Ciancio, A., Russo, F. P., Coppola, N., Blanc, P., Claar, E., Verucchi, G., Puoti, M., Zignego, A. L., Chemello, L., Madonia, S., Fagiuoli, S., Marzano, A., Ferrari, C., Lampertico, P., Di Marco, V., Craxi, A., Santantonio, T. A., Raimondo, G., Brunetto, M. R., Gaeta, G. B., Kondili, L. A., Pasulo, L., Coppola, C., Pisano, F., Romano, M., Porcu, C., Bottalico, I. F., Cossiga, V., Tata, X., Sagnelli, C., Pierotti, P., Degasperi, E., Rosato, V., Badia, L., Ieluzzi, D., Monti, M., Bavetta, M. G., Cavalletto, L., Toniutto, P., Fornasiere, E., Colecchia, A., Ferrarese, A., Nardone, G., Rocco, A., Vigano, M., Foschi, F. G., Conti, F., Morsica, G., Salpietro, S., Torti, C., Costa, C., Federico, A., Dallio, M., Giorgini, A., Anselmo, M., De Leo, P., Zaltron, S., Cambianica, A., Piscaglia, F., Serio, I., Schivazappa, S., Mastroianni, A., Chidichimo, L., Massari, M., Mazzaro, C., Marrone, A., D'Amore, F. M., D'Offizi, G., Licata, A., Niro, G. A., Pollicino, T., Aghemo, A., Brancaccio, G, Coco, B, Nardi, A, Quaranta, M, Tosti, M, Ferrigno, L, Cacciola, I, Messina, V, Chessa, L, Morisco, F, Milella, M, Barbaro, F, Ciancio, A, Russo, F, Coppola, N, Blanc, P, Claar, E, Verucchi, G, Puoti, M, Zignego, A, Chemello, L, Madonia, S, Fagiuoli, S, Marzano, A, Ferrari, C, Lampertico, P, Di Marco, V, Craxì, A, Santantonio, T, Raimondo, G, Brunetto, M, Gaeta, G, Kondili, L, Pasulo, L, Coppola, C, Pisano, F, Romano, M, Porcu, C, Bottalico, I, Cossiga, V, Tata, X, Sagnelli, C, Pierotti, P, Degasperi, E, Rosato, V, Badia, L, Ieluzzi, D, Monti, M, Bavetta, M, Cavalletto, L, Toniutto, P, Fornasiere, E, Colecchia, A, Ferrarese, A, Nardone, G, Rocco, A, Viganò, M, Foschi, F, Conti, F, Morsica, G, Salpietro, S, Torti, C, Costa, C, Federico, A, Dallio, M, Giorgini, A, Anselmo, M, De Leo, P, Zaltron, S, Cambianica, A, Piscaglia, F, Serio, I, Schivazappa, S, Mastroianni, A, Chidichimo, L, Massari, M, Mazzaro, C, Marrone, A, D'Amore, F, D'Offizi, G, Licata, A, Niro, G, Pollicino, T, and Aghemo, A

Subjects
Microbiology (medical), Infectious Diseases, Epidemiology, Hepatitis Delta, Migrant, General Medicine, Chronic, Hepatitis B, Migrants, Hepatitis control
Abstract

Objectives: The study measures trends in the profile of patients with chronic hepatitis B virus linked to care in Italy. Methods: A cross-sectional, multicenter, observational cohort (PITER cohort) of consecutive patients with hepatitis B surface antigen (HBsAg) over the period 2019-2021 from 46 centers was evaluated. The reference was the MASTER cohort collected over the years 2012-2015. Standard statistical methods were used. Results: The PITER cohort enrolled 4583 patients, of whom 21.8% were non-Italian natives. Compared with those in MASTER, the patients were older and more often female. The prevalence of hepatitis B e antigen (HBeAg) declined (7.2% vs 12.3; P

Published
2023

29. HepatomiRNoma: The proposal of a new network of targets for diagnosis, prognosis and therapy in hepatocellular carcinoma

Author

BRONTE, Fabrizio, BRONTE, Giuseppe, FANALE, Daniele, CARUSO, Stefano, BRONTE, Enrico, BAVETTA, Maria Grazia, FIORENTINO, Eugenio, Rolfo, Christian Diego, BAZAN, Viviana, Marco, V., RUSSO, Antonio, CALVARUSO, Vincenza, Bronte, F., Bronte, G., Fanale, D., Caruso, S., Bronte, E., Bavetta, M., Fiorentino, E., Rolfo, C., Bazan, V., Marco, V., and Russo, A.

Subjects
Serum, 0301 basic medicine, Carcinoma, Hepatocellular, Hepatocellular carcinoma, Prognosi, medicine.medical_treatment, Bioinformatics, Targeted therapy, 03 medical and health sciences, 0302 clinical medicine, Prognostic classification, Biomarkers, Tumor, medicine, Humans, Prospective cohort study, High risk patients, business.industry, Liver Neoplasms, MicroRNA, Hematology, Prognosis, medicine.disease, Cancer treatment, Clinical Practice, MicroRNAs, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, Human medicine, Diagnosis, Geriatrics and Gerontology, business, Diagnosi
Abstract

The diagnosis and treatment of hepatocellular carcinoma (HCC) underwent a huge advancement in the last years. Recently, microRNAs (miRNAs) have been also studied to provide a new tool for early diagnosis of high risk patients, for prognostic classification to identify those patients who benefit cancer treatment and for predictive definition to select the right targeted drug. In this review we revised all the available data obtained to explore the role of miRNAs in HCC. This analysis led to identification of miRNAs which could gain a diagnostic, prognostic or predictive role. The results of studies on miRNAs involved in HCC are initial and far from providing scientific evidences to translate into clinical practice. We propose a classification of these miRNAs, that we could name HepatomiRNoma as a whole. Anyway prospective studies have to be designed to clarify the real clinical impact of this new tool. (C) 2015 Elsevier Ireland Ltd. All rights reserved.

Published
2016
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30. What links BRAF to the heart function? new insights from the cardiotoxicity of BRAF inhibitors in cancer treatment

Author

Viviana Bazan, Giuseppe Lo Re, Fabrizio Bronte, Giuseppe Bronte, Clara Natoli, Salvatore Novo, Antonio Russo, Enrico Bronte, M.G. Bavetta, Giuseppina Novo, Giuseppe Brancatelli, Bronte, E., Bronte, G., Novo, G., Bronte, F., Bavetta, M., Re, G., Brancatelli, G., Bazan, V., Natoli, C., Novo, S., and Russo, A.

Subjects
Sorafenib, Proto-Oncogene Proteins B-raf, B-RAF inhibitors, cardio-oncology, Skin Neoplasms, cardiotoxicity, Antineoplastic Agents, Review, B-RAF inhibitor, Pharmacology, QT interval, Sudden cardiac death, chemistry.chemical_compound, Regorafenib, medicine, Animals, Humans, Molecular Targeted Therapy, dabrafenib, Vemurafenib, Melanoma, Protein Kinase Inhibitors, Cardiotoxicity, Clinical Trials as Topic, business.industry, B-RAF, Dabrafenib, Arrhythmias, Cardiac, Heart, medicine.disease, Oncology, chemistry, Cancer research, business, medicine.drug, Signal Transduction
Abstract

The RAS-related signalling cascade has a fundamental role in cell. It activates differentiation and survival. It is particularly important one of its molecules, B-RAF. B-RAF has been a central point for research, especially in melanoma. Indeed, it lacked effective therapeutic weapons since the early years of its study. Molecules targeting B-RAF have been developed. Nowadays, two classes of molecules are approved by FDA. Multi-target molecules, such as Sorafenib and Regorafenib, and selective molecules, such as Vemurafenib and Dabrafenib. Many other molecules are still under investigation. Most of them are studied in phase 1 trials. Clinical studies correlate B-RAF inhibitors and QT prolongation. Though this cardiovascular side effect is not common using these drugs, it must be noticed early and recognize its signals. Indeed, Oncologists and Cardiologists should work in cooperation to prevent lethal events, such as fatal arrhythmias or sudden cardiac death. These events could originate from an uncontrolled QT prolongation.

Published
2015

31. HBV reactivation in patients with HCV/HBV cirrhosis on treatment with direct-acting antivirals

Author

Donatella Ferraro, Anna Licata, V. Di Marco, M.G. Bavetta, Giuseppina Maria Elena Colomba, Antonio Craxì, Salvatore Petta, Fabrizio Bronte, Vincenza Calvaruso, Calvaruso, V., Ferraro, D., Licata, A., Bavetta, M., Petta, S., Bronte, F., Colomba, G., Craxi, A., and DI MARCO, V.

Subjects
Adult, Liver Cirrhosis, Male, Hepatitis B virus, HBsAg, Cirrhosis, Hepacivirus, medicine.disease_cause, Antiviral Agents, Virus, 03 medical and health sciences, Hepatitis B, Chronic, 0302 clinical medicine, Virology, medicine, Humans, HBV-DNA reactivation, nucleos(t)ide analogues therapy, Aged, Retrospective Studies, Hepatitis, Hepatology, biology, Coinfection, business.industry, virus diseases, Retrospective cohort study, Hepatitis C, Chronic, Middle Aged, medicine.disease, biology.organism_classification, previous HBV infection, digestive system diseases, Infectious Diseases, HBV/HCV coinfection, 030220 oncology & carcinogenesis, DNA, Viral, RNA, Viral, Female, Virus Activation, 030211 gastroenterology & hepatology, sustained virological response, business
Abstract

Anecdotal reports suggest that patients with chronic hepatitis C virus (HCV) hepatitis and overt or occult hepatitis B virus (HBV) coinfection may reactivate HBV when HCV is suppressed or cleared by direct-acting antivirals (DAAs). We assessed the prevalence of overt or previous HBV coinfection and the risk of HBV reactivation in patients with HCV cirrhosis treated with DAAs. This was a retrospective cohort of 104 consecutive patients with HCV cirrhosis treated with DAAs. Serum HCV-RNA and HBV-DNA were tested at weeks 4, 8 and 12 of DAAs therapy and at week 12 of follow-up. At the start of DAAs, eight patients (7.7%) were HBsAg positive/HBeAg negative with undetectable HBV-DNA and low levels of quantitative HBsAg (four on nucleos(t)ide analogues [NUCs] and four inactive carriers), 37 patients (35.6%) had markers of previous HBV infection (25 anti-HBc positive, 12 anti-HBc/anti-HBs positive) and 59 (56.7%) had no evidence of HBV infection. Sixty-seven patients (64.4%) were HCV-RNA negative at week 4 and 98 (94.2%) achieved sustained virological response. All four HBsAg-positive patients treated with NUCs remained HBV-DNA negative, but three of four untreated patients showed an increase in HBV-DNA of 2-3 log without a biochemical flare and achieved HBV-DNA suppression when given NUCs. During or after DAAs, by conventional assay, HBV-DNA remained not detectable in all 37 anti-HBc-positive patients but in three of them (8.1%) HBV-DNA became detectable with a highly sensitive PCR. HBV reactivation is likely to occur in untreated HBV/HCV-coinfected cirrhotic patients when they undergo HCV treatment with DAAs. Pre-emptive therapy with NUCs should be considered in this setting. Anti-HBc-positive patients rarely reactivate HBV without clinical or virological outcomes.

Published
2018

32. Comparison of Histochemical Stainings in Evaluation of Liver Fibrosis and Correlation with Transient Elastography in Chronic Hepatitis

Author

Antonino Giulio Giannone, Vito Di Marco, M.G. Bavetta, Fabrizio Bronte, Marcello Maida, Salvatore Petta, Vincenza Calvaruso, Rossana Porcasi, Sabrina Ingrao, Daniela Cabibi, Cabibi, D., Bronte, F., Porcasi, R., Ingrao, S., Giannone, A., Maida, M., Grazia Bavetta, M., Petta, S., Di Marco, V., and Calvaruso, V.

Subjects
Adult, Liver Cirrhosis, Male, Cancer Research, Pathology, medicine.medical_specialty, Article Subject, Adolescent, liver fibrosis, elastography, Digital Image Analysis, liver biopsy, Settore MED/08 - Anatomia Patologica, Pathology and Forensic Medicine, chemistry.chemical_compound, Young Adult, Trichrome, Fibrosis, Image Processing, Computer-Assisted, Medicine, Humans, Orcein, Sirius Red, RC254-282, Aged, Hepatitis, Chronic, Hepatitis, Settore MED/12 - Gastroenterologia, medicine.diagnostic_test, QH573-671, Staining and Labeling, business.industry, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Cell Biology, General Medicine, Middle Aged, medicine.disease, Staining, chemistry, Liver biopsy, Molecular Medicine, Elasticity Imaging Techniques, Female, business, Transient elastography, Cytology, Research Article
Abstract

Background and Aim. The best staining to evaluate liver fibrosis in liver hepatitis is still a debated topic. This study aimed to compare Masson’s trichrome (MT), Sirius Red (SR), and orcein stainings in evaluating liver fibrosis in chronic HCV hepatitis (CHC) with semiquantitative and quantitative methods (Collagen Proportionate Area (CPA) by Digital Image Analysis (DIA)) and correlate them with transient elastography (TE).Methods. Liver stiffness evaluation of 111 consecutive patients with CHC was performed by TE. Semiquantitative staging by Metavir score system and CPA by DIA were assessed on liver biopsy stained with MT, SR, and orcein.Results. MT, SR, and orcein staining showed concordant results in 89.6% of cases in staging CHC, without significant difference in both semiquantitative and quantitative evaluations of fibrosis. TE values were concordant with orcein levels in 86.5% of the cases and with MT/RS in 77.5% (P<0.001). No significant correlation between the grade of necroinflammatory activity and TE values was found.Conclusion. In CHC, SR/MT and orcein stainings are almost concordant and when discordant, orcein staining is better related to TE values than MT/RS. This suggests that elastic fibers play a more important role than reticular or collagenous ones in determining stiffness values in CHC.

Published
2015

33. Effects of Eradicating Hepatitis C Virus Infection in Patients With Cirrhosis Differ With Stage of Portal Hypertension

Author

Antonio Craxì, S. Peralta, F. Simone, Giuseppe Cabibbo, Elisabetta Conte, Vincenza Calvaruso, Rosaria Maria Pipitone, A. Arini, Donatella Ferraro, Calogero Cammà, Vito Di Marco, M.G. Bavetta, Stefania Grimaudo, Di Marco, V., Calvaruso, V., Ferraro, D., Bavetta, M., Cabibbo, G., Conte, E., Cammà, C., Grimaudo, S., Pipitone, R., Simone, F., Peralta, S., Arini, A., and Craxì, A.

Subjects
Liver Cirrhosis, Male, Cirrhosis, Sustained Virologic Response, Hepacivirus, Esophagu, Gastroenterology, Polyethylene Glycols, Liver disease, chemistry.chemical_compound, 0302 clinical medicine, Esophageal varices, Prospective Studies, Prospective cohort study, Hazard ratio, virus diseases, Middle Aged, Portal Pressure, Hepatitis C, Recombinant Proteins, Intention to Treat Analysis, Italy, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, 030211 gastroenterology & hepatology, Female, medicine.medical_specialty, Interferon alpha-2, Lower risk, Esophageal and Gastric Varices, Antiviral Agents, 03 medical and health sciences, Internal medicine, Hypertension, Portal, Ribavirin, medicine, Humans, Aged, Proportional Hazards Models, Hepatology, business.industry, Bleeding, Interferon-alpha, Long-Term Outcome, medicine.disease, digestive system diseases, chemistry, business, Follow-Up Studies
Abstract

Clearance of hepatitis C virus (HCV) via antiviral treatment changes the course of liver disease. We evaluated the benefit of sustained virologic response (SVR) in patients with HCV and cirrhosis without (stage 1) and with (stage 2) esophageal varices (EV).We performed a prospective cohort study of 444 patients with HCV and compensated cirrhosis (218 with stage 1 and 226 with stage 2 disease) treated with peg-interferon and ribavirin from June 2001 through December 2009 at the University of Palermo, Italy and followed for a median of 7.6 years (range, 1-12.6 years). We used Cox regression analysis to identify variables associated with appearance or progression of EVs, development of hepatocellular carcinoma (HCC), liver decompensation, and overall survival.In the intention-to-treat analysis, 67 patients with stage 1 disease (30.7%) and 41 patients with stage 2 disease (18.1%) achieved an SVR (P = .003). Patients with stage 1 disease and an SVR were less likely to develop EVs than stage 1 patients without an SVR (hazard ratio [HR], 0.23; 95% confidence interval [CI], 0.11-0.48; P.001). However, SVR did not affect whether patients with stage 2 disease developed further EVs (HR, 1.58; 95% CI, 0.33-1.03; P = .07, by log-rank test). An SVR was associated with lower risk for HCC (HR, 0.25; 95% CI, 0.12-0.55; P.001). Patients with stage 2 disease, regardless of SVR, were at greater risk than patients with stage 1 disease for liver decompensation (HR, 2.82; 95% CI, 1.73-4.59; P.001) or death (HR, 1.77; 95% CI, 1.12-2.80; P = .015). A lower proportion of patients with stage 1 disease and an SVR died from HCC (2.9%), compared with those without an SVR (11.9%) (P = .03) or developed liver decompensation (none vs 7.1% without an SVR; P = .009). A lower proportion of patients with stage 2 disease and an SVR died from causes secondary to HCC (2.0%) compared with those without an SVR (18.4%) (P = .003). Death from causes secondary to liver decompensation did not differ significantly between patients with stage 2 disease with or without an SVR (12.1% vs 25.4%; P = .15).In a prospective study of 444 patients with HCV and compensated cirrhosis, HCV eradication reduced risk for liver decompensation, HCC, and death, regardless of whether the patients had EVs.

Published
2015

35. A rs4374383 Single Nucleotide Polymorphisms of MERTK gene is linked to a higher likelihood of hepatocellular carcinoma in patients with HCV cirrhosis

Author

Di Marco, Vito, Calvaruso, Vincenza, Grimaudo, Stefania, Ferraro, Donatella, Bavetta, Maria Grazia, Di Cristina, Antonietta, Giuseppe Cabibbo, Conte, Elisabetta, Craxi, Antonio, DI MARCO, V., Calvaruso, V., Grimaudo, S., Ferraro, D., Bavetta, M., Di Cristina, A., Cabibbo, G., Conte, E., and Craxi, A.

Subjects
MERTK gene,rs4374383 ,cirrhosis,HCC

36. Vesicles: New Advances in the Treatment of Neurodegenerative Diseases.

Author

Nuzzo D, Girgenti A, Palumbo L, Naselli F, Bavetta M, Marfia G, and Picone P

Subjects
Animals, Humans, Nanotechnology methods, Nanoparticle Drug Delivery System chemistry, Nanoparticle Drug Delivery System pharmacology, Blood-Brain Barrier drug effects, Blood-Brain Barrier metabolism, Extracellular Vesicles chemistry, Extracellular Vesicles metabolism, Neurodegenerative Diseases therapy
Abstract

Neurodegenerative diseases are characterized by brain lesions that limit normal daily activities and represent a major challenge to healthcare systems worldwide, with a significant economic impact. Nanotechnology is the science of manipulating matter at the nanoscale, where materials exhibit unique properties that are significantly different from their larger counterparts. These properties can be exploited for a wide range of applications, including medicine. Among the emerging therapeutic approaches for the treatment of neurodegenerative diseases, nanotechnologies are gaining prominence as a promising avenue to explore. Here, we review the state of the art of biological and artificial vesicles and their biological properties in the context of neurodegenerative diseases. Indeed, nanometric structures such as extracellular vesicles and artificial vesicles represent a promising tool for the treatment of such disorders due to their size, biocompatibility, and ability to transport drugs, proteins, and genetic material across the blood-brain barrier to target specific cells and brain areas. In the future, a deeper and broader synergy between materials science, bioengineering, biology, medicine, and the discovery of new, increasingly powerful delivery systems will certainly enable a more applied use of nanotechnology in the treatment of brain disorders.

Published
2024
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37. Effectiveness of risankizumab for the treatment of psoriatic arthritis: a multicenter, real-world study.

Author

Graceffa D, Zangrilli A, Caldarola G, Lora V, Orsini D, Moretta G, Pagnanelli G, Provini A, Masini C, Bavetta M, Giordano D, Richetta A, Tolino E, Bianchi L, Peris K, Sperati F, and Bonifati C

Subjects
Humans, Male, Female, Middle Aged, Adult, Prospective Studies, Treatment Outcome, Aged, Ultrasonography, Interleukin-23 Subunit p19 antagonists & inhibitors, Interleukin-23 Subunit p19 immunology, Joints diagnostic imaging, Enthesopathy drug therapy, Arthritis, Psoriatic drug therapy, Severity of Illness Index, Quality of Life, Antibodies, Monoclonal therapeutic use
Abstract

Background: IL-23 inhibitors were recently approved for the treatment of skin psoriasis and psoriatic arthritis (PsA). Risankizumab, a humanized monoclonal antibody that specifically binds the p19 subunit of IL-23, has proven effective on PsA in two randomized controlled trials. To date, only a few real-world data are available on this topic., Methods: Our study aimed to prospectively evaluate the effectiveness of risankizumab in patients with PsA in a real-world setting. For this purpose, both rheumatologic and dermatologic assessments were performed at baseline and after 28-40 weeks of continuous risankizumab administration. Moreover, joint and entheses ultrasound assessment was performed at the mentioned time points. The rheumatologic assessment was carried out by means of the following scores: (i) clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA); (ii) Leeds Enthesitis Index (LEI); (iii) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and (iii) Bath Ankylosing Spondylitis Functional Index (BASFI). The degree of skin involvement was measured by both the Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA). Quality of life was assessed by the Health Assessment Questionnaire (HAQ) and Dermatology Life Quality Index (DLQI). Ultrasound assessment of joints and entheses was performed on the basis of the EULAR-OMERACT score., Results: After treatment, cDAPSA decreased from a mean value of 12.9 ± 7.6 to 7.0 ± 6.1 (P < 0.001), and the median PD score significantly decreased from baseline (3; range 1-8) to TP1 (1; range 0-7) (P < 0.001). PASI score also decreased from 8.4 ± 4.9 to 0.3 ± 0.5 (P < 0.001), and PGA from 3.1 ± 1.0 to 0.4 ± 0.5 (P < 0.001)., Conclusion: We can conclude that risankizumab led to substantial improvement in both skin and joint involvement., (© 2024 the International Society of Dermatology.)

Published
2024
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38. Effectiveness of risankizumab in the treatment of palmoplantar psoriasis: a 52-week Italian real-life experience.

Author

Caldarola G, Zangrilli A, Palmisano G, Bavetta M, Moretta G, Pagnanelli G, Panasiti V, Bianchi L, De Simone C, and Peris K

Abstract

Background: Data on the treatment of palmoplantar psoriasis (PP) are scarce, representing a therapeutic challenge. This study aims to assess the efficacy and safety of risankizumab in a population of patients with psoriasis with a palmoplantar involvement, over a 52-week treatment period., Methods: We performed a retrospective analysis in a cohort of patients with PP, with or without involvement of other skin sites. Palmoplantar Psoriasis Area and Severity Index (ppPASI) was assessed at baseline and after 4, 16, 28 and 52 weeks, to evaluate the PP severity., Results: Sixteen patients were enrolled. The rates of ppPASI90 responses constantly increased during the period of observation and were 18.7%, 62.2%, 75.0% and 81.2% at weeks 4, 16, 28 and 52, respectively. Only two patients suspended treatment because of ineffectiveness at week 16., Conclusion: Our data from a series of 16 patients reveal that risankizumab could represent an effective and safe therapeutic choice in patients with PP., Competing Interests: Disclosure and potential conflicts of interest: G Caldarola has received consulting fees, honoraria and support for attending meetings from Abbvie, Lilly, Janssen, UCB, Novartis and Leopharma; A Zangrilli has received support for consulting fees, honoraria and support for attending meetings from Abbvie; L Bianchi has received support for consulting fees, honoraria, support for attending meetings and taken part in advisory boards for Amgen, Abbvie, Novartis, Janssen-Cilag, Pfizer, UCB, Sanofi and LeoPharma; C De Simone has received support for consulting fees, honoraria and support for attending meetings from Abbvie, Lilly, Janssen, UCB, Novartis, Leopharma, Sanofi and Almiral; K Perris has received support for consulting fees and honoraria from Abbvie, Almirall, Biogen, Celgene, Fresenius Kabi, Galderma, Novartis, Lilly, Novartis, Pierre Fabre, Sandoz, Sanofi and Sun Pharma. All other authors declare that they have no conflicts of interest relevant to this manuscript. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the author is available for download at: https://www.drugsincontext.com/wp-content/uploads/2023/03/dic.2023-1-8-COI.pdf, (Copyright © 2023 Caldarola G, Zangrilli A, Palmisano G, Bavetta M, Moretta G, Pagnanelli G, Panasiti V, Bianchi L, De Simone C, Peris K.)

Published
2023
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39. Risankizumab for the treatment of moderate-to-severe psoriasis: A multicenter, retrospective, 1 year real-life study.

Author

Caldarola G, Zangrilli A, Bernardini N, Bavetta M, De Simone C, Graceffa D, Bonifati C, Faleri S, Giordano D, Mariani M, Micheli A, Moretta G, Pagnanelli G, Panasiti V, Provini A, Richetta A, Peris K, and Bianchi L

Subjects
Antibodies, Monoclonal, Humans, Retrospective Studies, Severity of Illness Index, Treatment Outcome, Psoriasis diagnosis, Psoriasis drug therapy
Abstract

Several new biologic agents targeting IL23/Th17 axis, such as risankizumab, have been developed for the treatment of psoriasis. The aim of the present study was to analyze the efficacy and safety of risankizumab in patients with moderate-to-severe psoriasis over a 52-week period. A multicentric retrospective study was conducted in patients who initiated risankizumab between July 2019 and December 2020. Psoriasis Area and Severity Index-PASI was measured at baseline and after 4, 16, 28 and 52 weeks. Clinical responses were evaluated by PASI75, PASI90 and PASI100 at the same timepoints. Potential safety issues and adverse events (AEs) were collected. Univariable and multivariable logistic regressions were performed for variables predicting clinical response. One hundred and twelve patients with psoriasis were included. PASI90 response was achieved by 17.86% of patients at week 4, 72.22% at week 16, 91.0% at week 28 and 95.24% at week 52 (as observed analysis). No associations between the considered variables and the efficacy endpoints were retrieved, influence of variables such as Body Mass Index (BMI), baseline PASI or previous biologics were not shown. No serious safety issues or discontinuations related to adverse events were reported. Risankizumab showed high efficacy and a favorable safety profile, regardless of patient- and disease-related factors., (© 2022 The Authors. Dermatologic Therapy published by Wiley Periodicals LLC.)

Published
2022
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40. Skin advanced glycation end products as a diagnostic and monitoring tool among psoriatic patients: how the therapy helps reduce cardiovascular disease risk.

Author

Lanna C, Zangrilli A, Bavetta M, Diluvio L, Campione E, and Bianchi L

Subjects
Adalimumab therapeutic use, Adult, Child, Glycation End Products, Advanced, Humans, Pain chemically induced, Prospective Studies, Severity of Illness Index, Treatment Outcome, Tumor Necrosis Factor-alpha, Cardiovascular Diseases chemically induced, Cardiovascular Diseases prevention & control, Psoriasis complications, Psoriasis drug therapy, Psoriasis metabolism
Abstract

Background and Aims: Psoriasis is a disturbing and burdensome inflammatory skin disorder, with a global prevalence of 2-3%. An increased risk of cardiometabolic disease between psoriatic patients has been recently demonstrated. This is probably due to the psoriasis systemic inflammation and the increased levels of inflammatory cytokines, such as IL-17, IL-23, and TNF-α. Advanced glycation end products (AGEs) are the products of nonenzymatic glycation and oxidation of proteins and lipids which modify their structure and function. They have a significant role in the pathogenesis of diabetic nephropathy, atherosclerosis, and cardiovascular diseases of diabetic adults and children. The accumulation of AGEs can be measured by skin autofluorescence (SAF). Adalimumab (Humira ®) is a fully human monoclonal antibody, administered via subcutaneous injection, which binds the tumor necrosis factor (TNF) and is used to treat moderate-to-severe chronic plaque psoriasis. We performed an observational prospective study of 24 weeks to assess the reduction of AGEs through SAF measurement during treatment with adalimumab., Methods: SAF measurements in patients were performed at T0 and after 24 weeks of therapy. Adalimumab efficacy was assessed using Psoriasis Area and Severity Index (PASI), Visual Analogue Scale (VAS) for pain, and erythrocyte sedimentation rate (ESR)., Results: ESR, AGEs, PASI, and VAS for pain decreased throughout the study period., Conclusion: Adalimumab reduced AGEs in psoriatic patients. Biologic therapies may also prevent cardiovascular disease, suggesting a new approach of combined therapy for psoriasis and cardiovascular diseases., (© 2021 the International Society of Dermatology.)

Published
2022
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41. Psoriasis in difficult to treat areas: treatment role in improving health-related quality of life and perception of the disease stigma.

Author

Lanna C, Galluzzi C, Zangrilli A, Bavetta M, Bianchi L, and Campione E

Subjects
Adalimumab, Humans, Perception, Severity of Illness Index, Treatment Outcome, Psoriasis drug therapy, Quality of Life
Abstract

Background: When psoriasis affects scalp, nails, palms and soles, it is considered difficult to treat and causes severe impairment of life quality., Objective: We evaluated which difficult site most impacts on the patient's quality of life and how quality of life changes during treatment., Methods: We conducted a prospective observational study in patients receiving adalimumab over a 24 weeks period, through assessment at weeks 0, 4 and 24 using PASI, PAIN VAS, ITCH VAS, DLQI, NAPSI, PSSI. Pearson correlation was used to evaluate the relationship between the various measurements on the basis of three different deltas (between T0 and T24, between T0 and T4, between T0 and average between T4 and T24)., Results: The correlation matrix between T0 and T24 shows a significant correlation between delta PASI and delta ITCH and delta ITCH and delta DLQI and a significant correlation between ITCH delta and DLQI delta and a correlation close to significance between DLQI and NAPSI., Conclusion: We identified itching as a mediator between the cutaneous extension of psoriasis and the impact on quality of life. We also documented the predominant role of nail psoriasis in defining the impact on the quality of life of the psoriatic patient.

Published
2022
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42. Predictive factors of lack of response to adalimumab among bio-naive patients suffering from moderate-to severe psoriasis: analysis of a multicenter data collection in Italy.

Author

Zangrilli A, Caldarola G, Bernardini N, Bavetta M, Graceffa D, Bonifati C, Cantoresi F, Faleri S, Giordano D, Mariani M, Micheli A, Moretta G, Pirro F, Pagnanelli G, Panasiti V, Provini A, Richetta A, Sacchelli L, Bianchi L, and Peris K

Subjects
Adalimumab therapeutic use, Aged, Data Collection, Female, Humans, Male, Severity of Illness Index, Treatment Outcome, Tumor Necrosis Factor Inhibitors, Biosimilar Pharmaceuticals, Psoriasis diagnosis, Psoriasis drug therapy
Abstract

Introduction: Efficacy of anti-TNF-a agents seems inferior to IL-17 and IL-23 inhibitors. Nevertheless, after biosimilars approval, anti TNF-a agents are recommended as first-line for psoriatic patients, for economic reasons., Methods: Predictive factors of response or non-response to adalimumab in bionaive patients who started adalimumab (originator or biosimilar) over 12 years in 9 dermatologic centers in Italy. Effectiveness was assessed with Psoriasis Area and Severity Index (PASI75 and PASI90) at weeks 12, 24 and 48. Multiple logistic regressions were used for variables predicting clinical response; Kaplan-Meier survival curves and Cox regression for drug survival., Results: The drug survival analysis showed reduced hazard ratio of overall discontinuation with male gender and scalp localization. In contrast, baseline PASI and genital psoriasis were significantly associated with increased risk of overall discontinuation. Predictive factors of non-response seemed elevated in patients with baseline PASI, older age groups, previously treated patients with phototherapy, females or patients with palmo-plantar while scalp psoriasis, previous cyclosporine and acitretin appeared as a positive predictive factor., Conclusions: This real-life analysis might be useful for clinicians in case of bio-naive patients with moderate-to-severe psoriasis and various comorbidities.

Published
2021
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43. The Effects of Association of Topical Polydatin Improves the Preemptive Systemic Treatment on EGFR Inhibitors Cutaneous Adverse Reactions.

Author

Bavetta M, Silvaggio D, Campione E, Sollena P, Formica V, Coletta D, Graziani G, Romano MCP, Roselli M, Peris K, and Bianchi L

Abstract

Epidermal Growth Factor Receptor inhibitors (EGFRi) are approved as therapeutic options in several solid tumors. Cutaneous papulopustular eruption is the most frequent cutaneous adverse-event (AE), usually treated with emollient or corticosteroids according to toxicity grade. Our study evaluated the efficacy and safety of a topical product containing polydatin, a glycosylated polyphenol, natural precursor of resveratrol showing anti-inflammatory and anti-oxidative activities, for the prevention and treatment of skin papulopustular rash in EGFRi-treated patients. Forty oncologic patients treated with EGFRi were enrolled in two groups: group-A, 20 patients with papulopustular AE, and group-B, 20 patients without cutaneous manifestations. The study consisted of twice-daily application of polydatin cream 1.5% (group-A) and 0.8% (group-B) for 6 months. In group-A patients, we observed at week 4 a remarkable improvement of skin manifestation and quality of life evaluated with National-Cancer-Institute-Common-Terminology-Criteria for Adverse-Events (NCI-CTCAE), Dermatology-Life-Quality-Index (DLQI) score and Visual-Analogue-Scale (VAS) pruritus, with a statistical significance of p < 0.05. None of the patients of group-B developed skin AEs to EGFRi. No cutaneous AEs related to the polydatin product were reported in both groups. Polydatin can be a good topical aid for the prevention and management of papulopustular rash in cancer patients receiving EGFRi, also capable of improving cancer patients' quality of life.

Published
2021
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45. A linear forehead lesion caused by intralesional injection of triamcinolone acetonide and treated with hyaluronic acid filler: Case report.

Author

Piccolo A, Pensa C, Zangrilli A, Bavetta M, Diluvio L, and Bianchi L

Subjects
Adult, Forehead, Glucocorticoids, Humans, Injections, Intralesional, Hyaluronic Acid adverse effects, Triamcinolone Acetonide adverse effects
Abstract

Intralesional steroid injection is a treatment method frequently used to resolve a large number of orthopedic, rheumatological, dermatological, and neurological disorders. Although this treatment is very effective, it is not without possible side effects, both systemic and local, among which we can mention pain, bleeding, ulceration, atrophy, pigmentary changes, calcification, secondary infections, formation of granulomas, allergic reactions and, in very rare cases, the development of linear atrophy, and hypopigmentation. Here, we present a case of frontal linear skin atrophy after intralesional steroid injection for the treatment of alopecia areata (AA) in a 29 year-old patient, successfully treated with a hyaluronic acid filler., (© 2020 Wiley Periodicals LLC.)

Published
2020
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46. Ixekizumab: One drug for an enigmatic psoriasis.

Author

Piccolo A, Pensa C, Zangrilli A, Bavetta M, Orlandi A, and Bianchi L

Subjects
Antibodies, Monoclonal, Humanized, Humans, Severity of Illness Index, Treatment Outcome, Dermatologic Agents adverse effects, Pharmaceutical Preparations, Psoriasis diagnosis, Psoriasis drug therapy
Published
2020
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47. Efficacy and safety of adalimumab in difficult-to-treat psoriasis.

Author

Lanna C, Zangrilli A, Bavetta M, Campione E, and Bianchi L

Subjects
Adalimumab adverse effects, Adult, Anti-Inflammatory Agents adverse effects, Child, Humans, Prospective Studies, Psoriasis diagnosis, Psoriasis drug therapy, Quality of Life
Abstract

Psoriasis is a chronic immune-mediated inflammatory skin disorder, with a prevalence of 2% to 3% worldwide. Psoriatic lesions affecting scalp, nails, palms, and soles are considered difficult-to-treat and require specific management. When psoriasis involves these areas, it may be considered more severe even if the lesions are not extensive. Adalimumab (Humira) is a fully human monoclonal antibody against tumor necrosis factor (TNF), administered via subcutaneous injection. It has already been used in the treatment of adults and children with moderate-to-severe chronic plaque psoriasis. In literature, few studies investigated its efficacy in difficult-to-treat areas, hence we conducted an observational prospective study of 24 weeks to assess its role in patients with difficult to treat psoriasis. We found out a significant improvement in nail and scalp psoriasis, while palmoplantar and genital psoriasis showed an improvement though not statistically significant. Therefore, adalimumab can be used in difficult-to-treat areas with great results, also allowing an improvement in the quality of life of affected patients, both adults and children., (© 2020 Wiley Periodicals LLC.)

Published
2020
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48. Intrusive thoughts in perinatal obsessive-compulsive disorder.

Author

Challacombe FL, Bavetta M, and DeGiorgio S

Subjects
Cognition, Female, Humans, Infant, Newborn, Mothers, Obsessive-Compulsive Disorder
Abstract

Competing Interests: Competing interests The BMJ has judged that there are no disqualifying financial ties to commercial companies. The authors declare the following other interests: none. MB is co-founder of Maternal OCD, a charity founded to raise awareness and understanding of the condition. Further details of The BMJ policy on financial interests are here: https://www.bmj.com/about-bmj/resources-authors/forms-policies-and-checklists/declaration-competing-interests

Published
2019
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49. Efficacy and safety of adalimumab after failure of other anti-TNFα agents for plaque-type psoriasis: clinician behavior in real life clinical practice.

Author

Esposito M, Prignano F, Rongioletti F, Hansel K, Bianchi L, Pescitelli L, Lazzeri L, Ricceri F, Mugheddu C, Bavetta M, Zangrilli A, Bianchi L, Bini V, and Stingeni L

Subjects
Adult, Aged, Female, Humans, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Tumor Necrosis Factor-alpha antagonists & inhibitors, Adalimumab therapeutic use, Anti-Inflammatory Agents therapeutic use, Drug Substitution, Practice Patterns, Physicians', Psoriasis drug therapy
Abstract

Introduction: During treatment with biologic agents for psoriasis (Pso) in a number of patients a failure may occur and discontinuation with transitioning to another drug or an optimization strategy, consisting in a dose-adjustment or a co-medication with a traditional systemic agent, represent two possible alternatives. Objective: The SAFARI study objective was a retrospective observation of adalimumab efficacy and safety profile after switching from other anti-TNFα agents related to clinician behavior after the failure of the first-line agent. Results: The retrospective multicenter observation demonstrated that after a first-line anti-TNFα failure adalimumab efficacy was consistent at week-12 and 24 with a further significant improvement at week-48 with a proportion of patients achieving PASI75/PASI90/PASI100 of 83.3, 71.6, and 56.9.%, respectively. Clinician strategies to extend drug-survival after first-line anti-TNFα failure, such as co-medication or dose-adjustment, were irrelevant to future drug effectiveness. Conclusions: Adalimumab profile was excellent in this 5-year retrospective observation, showing the clinical validity of interclass transitioning among anti-TNFα options.

Published
2019
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50. Monitoring treatment response in patients affected by actinic keratosis: Dermoscopic assessment and metalloproteinases evaluation after piroxicam 0.8% and sunfilter cream.

Author

Diluvio L, Bavetta M, Costanza G, Orlandi A, Bianchi L, and Campione E

Subjects
Aged, Biopsy, Cyclooxygenase Inhibitors adverse effects, Female, Humans, Immunohistochemistry, Keratosis, Actinic diagnosis, Keratosis, Actinic enzymology, Male, Middle Aged, Piroxicam adverse effects, Predictive Value of Tests, Skin enzymology, Skin pathology, Sunscreening Agents adverse effects, Time Factors, Treatment Outcome, Cyclooxygenase Inhibitors administration & dosage, Dermoscopy, Keratosis, Actinic drug therapy, Matrix Metalloproteinase 1 metabolism, Matrix Metalloproteinase 2 metabolism, Piroxicam administration & dosage, Skin drug effects, Sunscreening Agents administration & dosage
Published
2019
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