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1. Long-term Effectiveness and Safety of Upadacitinib for Atopic Dermatitis in a Real-world Setting: An Interim Analysis Through 48 Weeks of Observation

Author

Chiricozzi, Andrea, Ortoncelli, M., Schena, D., Gori, Niccolo', Ferrucci, S. M., Babino, G., Napolitano, M., Fargnoli, Maria Concetta, Stingeni, L., Rossi, M., Romanelli, Margherita, Balestri, R., Pellegrino, M., Parodi, A., Bertoldi, A. M., Palazzo, G., Antonelli, Flaminia, Pitino, A., Tripepi, G., Fabbrocini, G., Balato, A., Marzano, A. V., Girolomoni, G., Ribero, S., Peris, Ketty, Chiricozzi A. (ORCID:0000-0002-6739-0387), Gori N., Fargnoli M. C., Romanelli M., Antonelli F., Peris K. (ORCID:0000-0002-5237-0463), Chiricozzi, Andrea, Ortoncelli, M., Schena, D., Gori, Niccolo', Ferrucci, S. M., Babino, G., Napolitano, M., Fargnoli, Maria Concetta, Stingeni, L., Rossi, M., Romanelli, Margherita, Balestri, R., Pellegrino, M., Parodi, A., Bertoldi, A. M., Palazzo, G., Antonelli, Flaminia, Pitino, A., Tripepi, G., Fabbrocini, G., Balato, A., Marzano, A. V., Girolomoni, G., Ribero, S., Peris, Ketty, Chiricozzi A. (ORCID:0000-0002-6739-0387), Gori N., Fargnoli M. C., Romanelli M., Antonelli F., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Background: Janus kinase (JAK) inhibitors, including upadacitinib, have been recently approved for the treatment of moderate-severe atopic dermatitis (AD) and real-world data on upadacitinib effectiveness and safety are limited. This interim analysis aimed to assess effectiveness and safety of upadacitinib throughout 48 weeks of observation in a real-world adult AD population. Methods: This prospective study collected data on adult patients affected by moderate-to-severe AD and treated with upadacitinib at the dosage of either 15 mg or 30 mg daily based on the physician decision. Upadacitinib was prescribed in the context of a national compassionate use programme. In this interim analysis, within patient comparisons of continuous scores of different scales (namely Eczema Area and Severity Index [EASI], body surface area [BSA], Dermatology Life Quality Index [DLQI], Patient Oriented Eczema Measure [POEM], Numeric Rating Scale [NRS] subtests) were performed. The percentage of patients achieving EASI 75, EASI 90 and EASI 100 at Week 16, 32 and 48 was also evaluated. Results: One hundred and forty-six patients were included in the analysis. Upadacitinib 15 mg or 30 mg daily was prescribed as monotherapy in most cases (127/146, 87.0%). Upadacitinib was initially prescribed at the dosage of 30 mg daily in 118 of 146 (80.8%) patients and 15 mg daily in 28/146 (19.2%) patients. A significant improvement in the clinical signs and symptoms of AD was detected by Week 16 and throughout the study period. EASI 75, EASI 90 and EASI 100 responses were achieved by 87.6%, 69.1% and 44.3% at Week 48, associated with a sustained reduction in the mean values of all physician-reported (EASI and BSA) and patient-reported (Itch- Sleep- and Pain-NRS, DLQI, and POEM) disease severity outcomes, up to 48 weeks of treatment. Treatment response observed in 15 mg upadacitinib-treated patients was comparable with that detected in 30 mg upadacitinib-treated patients, revealing no statisti

Published
2023

2. A 52-week update of a multicentre Italian real-world experience on effectiveness and safety of dupilumab in adolescents with moderate-to-severe atopic dermatitis

Author

Stingeni, L., Bianchi, L., Antonelli, E., Caroppo, E. S., Ferrucci, S. M., Gurioli, C., Ortoncelli, M., Fabbrocini, G., Nettis, E., Schena, D., Napolitano, M., Gola, M., Bonzano, L., Rossi, M., Belloni Fortina, A., Balato, A., Peris, Ketty, Foti, C., Guarneri, F., Romanelli, M., Patruno, C., Savoia, P., Esposito, M., Russo, F., Errichetti, E., Bianchelli, T., Pellacani, G., Feliciani, C., Offidani, A., Corazza, M., Micali, G., Milanesi, N., Malara, G., Chiricozzi, Andrea, Tramontana, M., Hansel, K., Buligan, C., Caroppo, F., Bello, G. D., Dastoli, S., Di Brizzi, E. V., Del Giudice, M. B. D. F., Diluvio, L., Fargnoli, Maria Concetta, Gelmetti, A., Giacchetti, A., Grieco, T., Iannone, M., Macchia, L., Marietti, R., Musumeci, M. L., Motolese, A., Neri, I., Radi, G., Ribero, S., Romita, P., Tavecchio, S., Tronconi, G., Veronese, F., Peris K. (ORCID:0000-0002-5237-0463), Chiricozzi A. (ORCID:0000-0002-6739-0387), Fargnoli M. C., Stingeni, L., Bianchi, L., Antonelli, E., Caroppo, E. S., Ferrucci, S. M., Gurioli, C., Ortoncelli, M., Fabbrocini, G., Nettis, E., Schena, D., Napolitano, M., Gola, M., Bonzano, L., Rossi, M., Belloni Fortina, A., Balato, A., Peris, Ketty, Foti, C., Guarneri, F., Romanelli, M., Patruno, C., Savoia, P., Esposito, M., Russo, F., Errichetti, E., Bianchelli, T., Pellacani, G., Feliciani, C., Offidani, A., Corazza, M., Micali, G., Milanesi, N., Malara, G., Chiricozzi, Andrea, Tramontana, M., Hansel, K., Buligan, C., Caroppo, F., Bello, G. D., Dastoli, S., Di Brizzi, E. V., Del Giudice, M. B. D. F., Diluvio, L., Fargnoli, Maria Concetta, Gelmetti, A., Giacchetti, A., Grieco, T., Iannone, M., Macchia, L., Marietti, R., Musumeci, M. L., Motolese, A., Neri, I., Radi, G., Ribero, S., Romita, P., Tavecchio, S., Tronconi, G., Veronese, F., Peris K. (ORCID:0000-0002-5237-0463), Chiricozzi A. (ORCID:0000-0002-6739-0387), and Fargnoli M. C.

Abstract

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Published
2023

3. Current treatment goals are achieved by the majority of patients with atopic dermatitis treated with tralokinumab: results from a multicentric, multinational, retrospective, cohort study

Author

Chiricozzi, Andrea, Ferrucci, S. M., Di Nardo, Lucia, Gori, Niccolo', Balato, A., Ortoncelli, M., Maurelli, M., Galluzzo, M., Munera Campos, M., Seremet, T., Caldarola, Giacomo, De Simone, Clara, Ippoliti, Elena, Torres, T., Gkalpakiotis, S., Conrad, C., Carrascosa, J. M., Bianchi, L., Argenziano, G., Ribero, S., Girolomoni, G., Marzano, A. V., Peris, Ketty, Chiricozzi A. (ORCID:0000-0002-6739-0387), Di Nardo L., Gori N., Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), Ippoliti E., Peris K. (ORCID:0000-0002-5237-0463), Chiricozzi, Andrea, Ferrucci, S. M., Di Nardo, Lucia, Gori, Niccolo', Balato, A., Ortoncelli, M., Maurelli, M., Galluzzo, M., Munera Campos, M., Seremet, T., Caldarola, Giacomo, De Simone, Clara, Ippoliti, Elena, Torres, T., Gkalpakiotis, S., Conrad, C., Carrascosa, J. M., Bianchi, L., Argenziano, G., Ribero, S., Girolomoni, G., Marzano, A. V., Peris, Ketty, Chiricozzi A. (ORCID:0000-0002-6739-0387), Di Nardo L., Gori N., Caldarola G. (ORCID:0000-0002-8837-9232), De Simone C. (ORCID:0000-0002-0898-0045), Ippoliti E., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Background: Tralokinumab is a human monoclonal antibody targeting interleukin-13 that is approved for the treatment of moderate-severe atopic dermatitis. Studies analyzing the efficacy and safety of tralokinumab in a real-world setting are scarce. Research design and methods: A European, multicentric, real-world, retrospective cohort study was defined to assess the effectiveness and safeness profile of tralokinumab, investigating the achievement of pre-specified treatment goals; and to detect potential differences in terms of effectiveness and safeness across some selected patient subcohorts. Results: A total of 194 adult patients were included in this study. A significant improvement in physician-assessed disease severity was detected at each follow-up visit as compared with baseline and similar trend was observed for patient-reported outcomes and quality of life. No meaningful difference in effectiveness was found when considering patient age (<65 versus ≥65 years), neither dissecting patient cohort in dupilumab-naive vs dupilumab-treated subjects. Among tralokinumab-treated patients, 88% achieved at least one currently identified real-world therapeutic goal at week 16. Conclusions: This retrospective multicenter study confirmed the effectiveness and safeness of tralokinumab throughout 32 weeks of observation, showing the achievement of therapeutic goals identified in both trial and real-world settings in a large proportion of tralokinumab-treated patients.

Published
2023

5. Moderate-to-severe atopic dermatitis in adolescents treated with dupilumab: A multicentre Italian real-world experience

Author

Stingeni, L., Bianchi, L., Antonelli, E., Caroppo, E. S., Ferrucci, S. M., Ortoncelli, M., Fabbrocini, G., Nettis, E., Schena, D., Napolitano, M., Gola, M., Bonzano, L., Rossi, M., Belloni Fortina, A., Balato, A., Peris, K., Foti, C., Guarneri, F., Romanelli, M., Patruno, C., Savoia, P., Fargnoli, M. C., Russo, F., Errichetti, E., Bianchelli, T., Pellacani, G., Feliciani, C., Offidani, A., Corazza, M., Micali, G., Milanesi, N., Malara, G., Chiricozzi, A., Tramontana, M., Hansel, K., Bini, V., Buligan, C., Caroppo, F., Dal Bello, G., Dastoli, S., Di Brizzi, E. V., De Felici Del Giudice, M. B., Diluvio, L., Esposito, M., Gelmetti, A., Giacchetti, A., Grieco, T., Iannone, M., Macchia, L., Marietti, R., Musumeci, M. L., Peccerillo, F., Pluchino, F., Radi, G., Ribero, S., Romita, P., Tavecchio, S., Tronconi, G., Veronese, F., Stingeni, L, Bianchi, L, Antonelli, E, Caroppo, E S, Ferrucci, S M, Ortoncelli, M, Fabbrocini, G, Nettis, E, Schena, D, Napolitano, M, Gola, M, Bonzano, L, Rossi, M, Belloni Fortina, A, Balato, A, Peris, K, Foti, C, Guarneri, F, Romanelli, M, Patruno, C, Savoia, P, Fargnoli, M C, Russo, F, Errichetti, E, Bianchelli, T, Pellacani, G, Feliciani, C, Offidani, A, Corazza, M, Micali, G, Milanesi, N, Malara, G, Chiricozzi, A, Tramontana, M, and Hansel, K

Subjects
SARS-CoV-2, Pruritus, Eczema, COVID-19, Dermatitis, Dermatology, Antibodies, Monoclonal, Humanized, Severity of Illness Index, Atopic, Antibodies, COVID-19 Drug Treatment, Dermatitis, Atopic, Treatment Outcome, Settore MED/35, Infectious Diseases, Double-Blind Method, Monoclonal, Humans, Prospective Studies, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Pandemics, Humanized
Abstract

Background Moderate-to-severe atopic dermatitis (AD) in the adolescence is a high burden disease, and its treatment can be very challenging due to paucity of approved systemic drugs for this age and their side-effects. Dupilumab was recently approved for treatment of adolescent AD. Objectives A multicentre, prospective, real-world study on the effectiveness and safety of dupilumab in adolescents (aged from >= 12 to

Published
2022

6. Management of patients with atopic dermatitis undergoing systemic therapy during COVID-19 pandemic in Italy: Data from the DA-COVID-19 registry

Author

Chiricozzi, A, Talamonti, M, De Simone, C, Galluzzo, M, Gori, N, Fabbrocini, G, Marzano, A, Girolomoni, G, Offidani, A, Rossi, M, Bianchi, L, Cristaudo, A, Fierro, M, Stingeni, L, Pellacani, G, Argenziano, G, Patrizi, A, Pigatto, P, Romanelli, M, Savoia, P, Rubegni, P, Foti, C, Milanesi, N, Belloni Fortina, A, Bongiorno, M, Grieco, T, Di Nuzzo, S, Fargnoli, M, Carugno, A, Motolese, A, Rongioletti, F, Amerio, P, Balestri, R, Potenza, C, Micali, G, Patruno, C, Zalaudek, I, Lombardo, M, Feliciani, C, Di Nardo, L, Guarneri, F, Peris, K, Caldarola, G, Silvaggio, D, Dattola, A, Napolitano, M, Ferrucci, S, Dal Bello, G, Bianchelli, T, Rovati, C, Pigliacelli, F, Ortoncelli, M, Hansel, K, Calabrese, G, Loi, C, Iannone, M, Veronese, F, Romita, P, Tronconi, G, Caroppo, F, Tilotta, G, Sernicola, A, Esposito, M, Raponi, F, Gualdi, G, Rech, G, Musumeci, M, Nistico, S, Campitiello, A, Bonzano, L, Piras, V, Chiricozzi A., Talamonti M., De Simone C., Galluzzo M., Gori N., Fabbrocini G., Marzano A. V., Girolomoni G., Offidani A., Rossi M. T., Bianchi L., Cristaudo A., Fierro M. T., Stingeni L., Pellacani G., Argenziano G., Patrizi A., Pigatto P., Romanelli M., Savoia P., Rubegni P., Foti C., Milanesi N., Belloni Fortina A., Bongiorno M. R., Grieco T., Di Nuzzo S., Fargnoli M. C., Carugno A., Motolese A., Rongioletti F., Amerio P., Balestri R., Potenza C., Micali G., Patruno C., Zalaudek I., Lombardo M., Feliciani C., Di Nardo L., Guarneri F., Peris K., Caldarola G., Silvaggio D., Dattola A., Napolitano M., Ferrucci S. M., Dal Bello G., Bianchelli T., Rovati C., Pigliacelli F., Ortoncelli M., Hansel K., Calabrese G., Loi C., Iannone M., Veronese F., Romita P., Tronconi G., Caroppo F., Tilotta G., Sernicola A., Esposito M., Raponi F., Gualdi G., Rech G., Musumeci M. L., Nistico S. P., Campitiello A., Bonzano L., Piras V., Chiricozzi, A, Talamonti, M, De Simone, C, Galluzzo, M, Gori, N, Fabbrocini, G, Marzano, A, Girolomoni, G, Offidani, A, Rossi, M, Bianchi, L, Cristaudo, A, Fierro, M, Stingeni, L, Pellacani, G, Argenziano, G, Patrizi, A, Pigatto, P, Romanelli, M, Savoia, P, Rubegni, P, Foti, C, Milanesi, N, Belloni Fortina, A, Bongiorno, M, Grieco, T, Di Nuzzo, S, Fargnoli, M, Carugno, A, Motolese, A, Rongioletti, F, Amerio, P, Balestri, R, Potenza, C, Micali, G, Patruno, C, Zalaudek, I, Lombardo, M, Feliciani, C, Di Nardo, L, Guarneri, F, Peris, K, Caldarola, G, Silvaggio, D, Dattola, A, Napolitano, M, Ferrucci, S, Dal Bello, G, Bianchelli, T, Rovati, C, Pigliacelli, F, Ortoncelli, M, Hansel, K, Calabrese, G, Loi, C, Iannone, M, Veronese, F, Romita, P, Tronconi, G, Caroppo, F, Tilotta, G, Sernicola, A, Esposito, M, Raponi, F, Gualdi, G, Rech, G, Musumeci, M, Nistico, S, Campitiello, A, Bonzano, L, Piras, V, Chiricozzi A., Talamonti M., De Simone C., Galluzzo M., Gori N., Fabbrocini G., Marzano A. V., Girolomoni G., Offidani A., Rossi M. T., Bianchi L., Cristaudo A., Fierro M. T., Stingeni L., Pellacani G., Argenziano G., Patrizi A., Pigatto P., Romanelli M., Savoia P., Rubegni P., Foti C., Milanesi N., Belloni Fortina A., Bongiorno M. R., Grieco T., Di Nuzzo S., Fargnoli M. C., Carugno A., Motolese A., Rongioletti F., Amerio P., Balestri R., Potenza C., Micali G., Patruno C., Zalaudek I., Lombardo M., Feliciani C., Di Nardo L., Guarneri F., Peris K., Caldarola G., Silvaggio D., Dattola A., Napolitano M., Ferrucci S. M., Dal Bello G., Bianchelli T., Rovati C., Pigliacelli F., Ortoncelli M., Hansel K., Calabrese G., Loi C., Iannone M., Veronese F., Romita P., Tronconi G., Caroppo F., Tilotta G., Sernicola A., Esposito M., Raponi F., Gualdi G., Rech G., Musumeci M. L., Nistico S. P., Campitiello A., Bonzano L., and Piras V.

Abstract

Background: Few and small studies have described the management of immunomodulant/immunosuppressive therapies or phototherapy in atopic dermatitis (AD) patients during coronavirus disease 2019 (COVID-19) pandemic. Methods: A national registry, named DA-COVID-19 and involving 35 Italian dermatology units, was established in order to evaluate the impact of COVID-19 pandemic on the management of adult AD patients treated with systemic immunomodulant/immunosuppressive medications or phototherapy. Demographic and clinical data were obtained at different timepoints by teledermatology during COVID-19 pandemic, when regular visits were not allowed due to sanitary restrictions. Disease severity was assessed by both physician- and patient-reported assessment scores evaluating itch intensity, sleep disturbances, and AD severity. Results: A total of 1831 patients were included, with 1580/1831 (86.3%) continuing therapy during pandemic. Most patients were treated with dupilumab (86.1%, 1576/1831) that was interrupted in only 9.9% (156/1576) of cases, while systemic immunosuppressive compounds were more frequently withdrawn. Treatment interruption was due to decision of the patient, general practitioner, or dermatologist in 39.9% (114/286), 5.6% (16/286), and 30.1% (86/286) of cases, respectively. Fear of increased susceptibility to SARS-CoV-2 infection (24.8%, 71/286) was one of the main causes of interruption. Sixteen patients (0.9%) resulted positive to SARS-CoV-2 infection; 3 of them (0.2%) were hospitalized but no cases of COVID-related death occurred. Conclusions: Most AD patients continued systemic treatments during COVID pandemic and lockdown period, without high impact on disease control, particularly dupilumab-treated patients.

Published
2021

7. Dupilumab in atopic dermatitis: predictors of treatment outcome and time to response

Author

Nettis, E., Ferrucci, S. M., Pellacani, G., Di Leo, E., Argenziano, G., Foti, C., Rongioletti, F., Patruno, C., Ortoncelli, M., Macchia, L., Tavecchio, S., Bonzano, L., Di Bona, D., Calabrese, G., Fabbrocini, G., Romita, P, Piras, V, Bennardo, L, Ribero, S, Napolitano, M, Bilancia, M, Detoraki, A, Nettis, E., Ferrucci, S. M., Pellacani, G., Di Leo, E., Argenziano, G., Foti, C., Rongioletti, F., Patruno, C., Ortoncelli, M., Macchia, L., Tavecchio, S., Bonzano, L., Di Bona, D., Calabrese, G., Fabbrocini, G., Romita, P, Piras, V, Bennardo, L, Ribero, S, Napolitano, M, Bilancia, M, and Detoraki, A

Subjects
medicine.medical_specialty, business.industry, Treatment outcome, MEDLINE, Eczema, Patient characteristics, Dermatology, Atopic dermatitis, medicine.disease, Antibodies, Monoclonal, Humanized, Dupilumab, Severity of Illness Index, Dermatitis, Atopic, Infectious Diseases, Treatment Outcome, Medicine, Humans, business, Human
Abstract

Recently, dupilumab, an anti-IL-4Rα antibody, has become available for the treatment of moderate-to-severe atopic dermatitis (AD).1-4 Baseline patient characteristics that can be used as predictors of response to dupilumab treatment in AD patients have not yet been identified.

Published
2021

8. Moderate-to-severe atopic dermatitis in adolescents treated with dupilumab: A multicentre Italian real-world experience

Author

Stingeni, L, Bianchi, L, Antonelli, E, Caroppo, E S, Ferrucci, S M, Ortoncelli, M, Fabbrocini, G, Nettis, E, Schena, D, Napolitano, M, Gola, M, Bonzano, L, Rossi, M, Belloni Fortina, A, Balato, A, Peris, Ketty, Foti, C, Guarneri, F, Romanelli, M, Patruno, C, Savoia, P, Fargnoli, M C, Russo, F, Errichetti, E, Bianchelli, T, Pellacani, G, Feliciani, C, Offidani, A, Corazza, M, Micali, G, Milanesi, N, Malara, G, Chiricozzi, Andrea, Tramontana, M, Hansel, K, Peris, K (ORCID:0000-0002-5237-0463), Chiricozzi, A (ORCID:0000-0002-6739-0387), Stingeni, L, Bianchi, L, Antonelli, E, Caroppo, E S, Ferrucci, S M, Ortoncelli, M, Fabbrocini, G, Nettis, E, Schena, D, Napolitano, M, Gola, M, Bonzano, L, Rossi, M, Belloni Fortina, A, Balato, A, Peris, Ketty, Foti, C, Guarneri, F, Romanelli, M, Patruno, C, Savoia, P, Fargnoli, M C, Russo, F, Errichetti, E, Bianchelli, T, Pellacani, G, Feliciani, C, Offidani, A, Corazza, M, Micali, G, Milanesi, N, Malara, G, Chiricozzi, Andrea, Tramontana, M, Hansel, K, Peris, K (ORCID:0000-0002-5237-0463), and Chiricozzi, A (ORCID:0000-0002-6739-0387)

Abstract

Background Moderate-to-severe atopic dermatitis (AD) in the adolescence is a high burden disease, and its treatment can be very challenging due to paucity of approved systemic drugs for this age and their side-effects. Dupilumab was recently approved for treatment of adolescent AD. Objectives A multicentre, prospective, real-world study on the effectiveness and safety of dupilumab in adolescents (aged from >= 12 to <18 years) with moderate-to-severe AD was conducted. The main AD clinical phenotypes were also examined. Methods Data of adolescents with moderate-to-severe AD treated with dupilumab at label dosage for 16 weeks were collected. Treatment outcome was assessed by EASI, NRS itch, NRS sleep loss and CDLQI scores at baseline and after 16 weeks of treatment. The clinical scores were also evaluated according to clinical phenotypes. Results One hundred and thirty-nine adolescents were enrolled in the study. Flexural eczema and head and neck eczema were the most frequent clinical phenotypes, followed by hand eczema and portrait-like dermatitis. Coexistence of more than 1 phenotype was documented in 126/139 (88.5%) adolescents. Three patients (2.1%) contracted asymptomatic SARS-CoV-2 infection and 1 of the discontinued dupilumab treatment before the target treatment period. A significant improvement in EASI, NRS itch, NRS sleep loss and CDLQI was observed after 16 weeks of treatment with dupilumab. This outcome was better than that observed in clinical trials. Dupilumab resulted effective in all AD phenotypes, especially in diffuse eczema. Twenty-eight (20.1%) patients reported adverse events, conjunctivitis and flushing being the most frequent. None of patients discontinued dupilumab due to adverse event. Conclusions Dupilumab in adolescent AD showed excellent effectiveness at week 16 with consistent improvement of all clinical scores. Moreover, dupilumab showed a good safety profile also in this COVID-19 pandemic era.

Published
2022

9. Real-world evidence of biologic treatments in moderate–severe psoriasis in Italy: Results of the CANOVA (EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: An obserVAtional longitudinal study of real-life clinical practice) study

Author

Colombo, Dario Angelo, Bianchi, L., Fabbrocini, G., Corrao, S., Offidani, A., Stingeni, L., Costanzo, Rosa Maria Alba, Pellacani, G., Peris, Ketty, Bardazzi, F., Argenziano, G., Ruffolo, S., Dapavo, P., Carrera, C., Fargnoli, Maria Concetta, Parodi, A., Romanelli, Margherita, Malagoli, P., Talamonti, M., Megna, M., Raspanti, M., Paolinelli, Marco, Hansel, K., Narcisi, A., Conti, A., De Simone, Clara, Chessa, M. A., De Rosa, A., Provenzano, Katia Elisabetta, Ortoncelli, M., Moltrasio, C., Fidanza, R., Burlando, M., Tonini, A., Gaiani, F. M., Simoni, L., Ori, A., Fiocchi, M., Zagni, E., Colombo D., Costanzo A., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Romanelli M., Paolinelli M., De Simone C. (ORCID:0000-0002-0898-0045), Provenzano E., Colombo, Dario Angelo, Bianchi, L., Fabbrocini, G., Corrao, S., Offidani, A., Stingeni, L., Costanzo, Rosa Maria Alba, Pellacani, G., Peris, Ketty, Bardazzi, F., Argenziano, G., Ruffolo, S., Dapavo, P., Carrera, C., Fargnoli, Maria Concetta, Parodi, A., Romanelli, Margherita, Malagoli, P., Talamonti, M., Megna, M., Raspanti, M., Paolinelli, Marco, Hansel, K., Narcisi, A., Conti, A., De Simone, Clara, Chessa, M. A., De Rosa, A., Provenzano, Katia Elisabetta, Ortoncelli, M., Moltrasio, C., Fidanza, R., Burlando, M., Tonini, A., Gaiani, F. M., Simoni, L., Ori, A., Fiocchi, M., Zagni, E., Colombo D., Costanzo A., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Romanelli M., Paolinelli M., De Simone C. (ORCID:0000-0002-0898-0045), and Provenzano E.

Abstract

EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: An obserVAtional (CANOVA) study was aimed at providing real-world evidence of the effectiveness of biologics in Italian patients with moderate–severe psoriasis. It was an observational, retro-prospective cohort study conducted in 17 Italian dermatology clinics. Adult patients with moderate–severe plaque psoriasis, who started a biologic treatment between 24 weeks and 24 months before enrolment, were included. With a follow-up visit at 6 months after enrolment, each patient had at least 12 months of observation. The primary objective was to describe the clinical response rates (PASI 75) after 16/24/52 weeks from biologic treatment start. Secondary outcomes were sustained response, quality of life, and treatment satisfaction. Of the 669 eligible patients (64% males), 52% were naïve to biologics, though a mean duration of psoriasis since first diagnosis of 18.6 years (SD 13.2). The most frequently prescribed biologics were secukinumab (41%), ustekinumab (25%), TNF-inhibitors (22%) and ixekizumab (12%). PASI 75 was achieved by 86% of patients (95% CI: 82%–89%) at 16 weeks, 90% (87%–93%) at 24 weeks, and 91% (89%–94%) at 52 weeks. Patients achieving PASI 90 and PASI 100 at 52 weeks were 75% (71%–79%) and 53% (49%–57%), respectively. Sustained PASI 75 response after 1 year from treatment start was achieved by 78% (74%–82%) of patients. Mean DLQI total score was 2.3 (SD 3.9) at enrollment and decreased at the final visit to 1.8 (3.6). A high level of treatment satisfaction was expressed by patients over the study period. This large real-world study confirms in the clinical practice the good effectiveness and acceptability of biologics in psoriasis patients.

Published
2022

10. Use of Dupilumab in 543 Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Retrospective Study

Author

Nettis, E, primary, Ferrucci, SM, additional, Ortoncelli, M, additional, Pellacani, G, additional, Foti, C, additional, Di Leo, E, additional, Patruno, C, additional, Rongioletti, F, additional, Argenziano, G, additional, Macchia, L, additional, Tavecchio, S, additional, Napolitano, M, additional, Ribero, S, additional, Bonzano, L, additional, Romita, P, additional, Di Bona, D, additional, Nisticò, SP, additional, Piras, V, additional, Calabrese, G, additional, Detoraki, C, additional, Carbonara, M, additional, and Fabbrocini, G, additional

Published
2022
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11. Effectiveness and Safety of Long-Term Dupilumab Treatment in Elderly Patients with Atopic Dermatitis: A Multicenter Real-Life Observational Study

Author

Patruno, C., Fabbrocini, G., Longo, G., Argenziano, G., Ferrucci, S. M., Stingeni, L., Peris, K., Ortoncelli, M., Offidani, A., Amoruso, G. F., Talamonti, M., Girolomoni, G., Grieco, T., Iannone, M., Nettis, E., Foti, C., Rongioletti, F., Corazza, M., Veneri, M. D., Napolitano, M., Angileri, L., Bianchelli, T., Borghi, A., Calabrese, G., Chello, C., Dal Bello, G., Dastoli, S., Ferrillo, M., Galluzzo, M., Gori, N., Hansel, K., Macchia, L., Piras, V., Provenzano, E., Ribero, S., Romanelli, M., Romita, P., Patruno, C., Fabbrocini, G., Longo, G., Argenziano, G., Ferrucci, S. M., Stingeni, L., Peris, K., Ortoncelli, M., Offidani, A., Amoruso, G. F., Talamonti, M., Girolomoni, G., Grieco, T., Iannone, M., Nettis, E., Foti, C., Rongioletti, F., Corazza, M., Veneri, M. D., Napolitano, M., Angileri, L., Bianchelli, T., Borghi, A., Calabrese, G., Chello, C., Dal Bello, G., Dastoli, S., Ferrillo, M., Galluzzo, M., Gori, N., Hansel, K., Macchia, L., Piras, V., Provenzano, E., Ribero, S., Romanelli, M., and Romita, P.

Subjects
Male, medicine.medical_specialty, Time Factors, Injections, Subcutaneous, Socio-culturale, Dermatology, Antibodies, Monoclonal, Humanized, Eczema Area and Severity Index, elderly, Severity of Illness Index, Drug Administration Schedule, Dermatitis, Atopic, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Settore MED/35, Internal medicine, atopic dermatitis, dupilumab, medicine, Humans, Adverse effect, Contraindication, Aged, Retrospective Studies, Aged, 80 and over, business.industry, Pruritus, Age Factors, General Medicine, Atopic dermatitis, Dermatology Life Quality Index, medicine.disease, Conjunctivitis, Dupilumab, Injection Site Reaction, Treatment Outcome, Quality of Life, Observational study, Female, Settore MED/35 - MALATTIE CUTANEE E VENEREE, business
Abstract

Objective: The objective of this study was to assess the effectiveness and safety of dupilumab in treating elderly patients with atopic dermatitis from baseline to 52 weeks. Methods: A retrospective observational real-life study was conducted in a group of elderly patients with severe atopic dermatitis treated with dupilumab for 52 weeks. Inclusion criteria were: age ≥ 65 years; diagnosis of atopic dermatitis made by an expert dermatologist; Eczema Area and Severity Index ≥ 24; and a contraindication, side effects, or failure to respond to cyclosporine. The primary outcome was the mean percentage reduction in the Eczema Area and Severity Index score from baseline to week 52. Secondary measures includedthe mean percentage reduction in the Pruritus and Sleep Numerical Rating Scales and the Dermatology Life Quality Index, and the types and rates of adverse events from baseline to week 52. Results: One hundred and five patients were eligible for the study. Flexural dermatitis was the most frequent clinical phenotype (63.8%). The coexistence of more than one clinical phenotype was found in 70/105 (66.6%) patients. We observed a reduction in all disease severity scores from baseline to week 52 (p < 0.001). Adverse events were recorded in 30/105 (28.6%) patients, with conjunctivitis and injection-site reaction the most frequent. Conclusions: In this study, dupilumab is an effective and safe treatment for the long-term management of atopic dermatitis in patients aged over 65 years.

Published
2021

12. Dupilumab therapy of atopic dermatitis of the elderly: a multicentre, real-life study

Author

Patruno C., Napolitano M., Argenziano G., Peris K., Ortoncelli M., Girolomoni G., Offidani A., Ferrucci S. M., Amoruso G. F., Rossi M., Stingeni L., Malara G., Grieco T., Foti C., Gattoni M., Loi C., Iannone M., Talamonti M., Stinco G., Rongioletti F., Pigatto P. D., Cristaudo A., Nettis E., Corazza M., Guarneri F., Amerio P., Esposito M., Belloni Fortina A., Potenza C., Fabbrocini G., Angileri L., Bianchelli T., Borghi A., Buligan C., Calabrese G., Calzavara Pinton P., Caroppo F., Chello C., Dal Bello G., Damiani G., Fargnoli M. C., Ferrillo M., Galluzzo M., Gori N., Gualdi G., Hansel K., Macchia L., Mariano M., Nistico S. P., Pertusi G., Piras V., Provenzano E., Ravaioli G. M., Ribero S., Romanelli M., Romita P., Tolino E., Trifiro C., Patruno, C., Napolitano, M., Argenziano, G., Peris, K., Ortoncelli, M., Girolomoni, G., Offidani, A., Ferrucci, S. M., Amoruso, G. F., Rossi, M., Stingeni, L., Malara, G., Grieco, T., Foti, C., Gattoni, M., Loi, C., Iannone, M., Talamonti, M., Stinco, G., Rongioletti, F., Pigatto, P. D., Cristaudo, A., Nettis, E., Corazza, M., Guarneri, F., Amerio, P., Esposito, M., Belloni Fortina, A., Potenza, C., Fabbrocini, G., Angileri, L., Bianchelli, T., Borghi, A., Buligan, C., Calabrese, G., Calzavara Pinton, P., Caroppo, F., Chello, C., Dal Bello, G., Damiani, G., Fargnoli, M. C., Ferrillo, M., Galluzzo, M., Gori, N., Gualdi, G., Hansel, K., Macchia, L., Mariano, M., Nistico, S. P., Pertusi, G., Piras, V., Provenzano, E., Ravaioli, G. M., Ribero, S., Romanelli, M., Romita, P., Tolino, E., and Trifiro, C.

Subjects
Adult, medicine.medical_specialty, Adolescent, multicentre, Treatment outcome, Eczema, Socio-culturale, Dermatitis, Dupilumab, atopic dermatitis, multicentre, real-life study, Dermatology, Antibodies, Monoclonal, Humanized, elderly, Severity of Illness Index, Antibodies, Atopic, Dermatitis, Atopic, 030207 dermatology & venereal diseases, 03 medical and health sciences, Young Adult, Settore MED/35, 0302 clinical medicine, Internal medicine, Aged, Humans, Middle Aged, Retrospective Studies, Monoclonal, Medicine, 030212 general & internal medicine, Adverse effect, Humanized, atopic dermatitis, business.industry, dupilumab, Atopic dermatitis, medicine.disease, humanities, Safety profile, Infectious Diseases, Observational study, real-life study, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Life study, business, Prurigo nodularis
Abstract

Background: Treatment of moderate-to-severe atopic dermatitis (AD) in the elderly may be challenging, due to side-effects of traditional anti-inflammatory drugs and to comorbidities often found in this age group. Furthermore, efficacy and safety of innovative drugs such as dupilumab are not yet well known. Objectives: A multicentre retrospective, observational, real-life study on the efficacy and safety of dupilumab was conducted in a group of patients aged ≥65years and affected by severe AD. Their main clinical features were also examined. Methods: Data of elderly patients with severe (EASI ≥24) AD treated with dupilumab at label dosage for 16weeks were retrospectively collected. Treatment outcome was assessed by comparing objective (EASI) and subjective (P-NRS, S-NRS and DLQI) scores at baseline and after 16weeks of treatment. Results: Two hundred and seventy-six patients were enrolled in the study. They represented 11.37% of all patients with severe AD. Flexural eczema was the most frequent clinical phenotype, followed by prurigo nodularis. The coexistence of more than one phenotype was found in 63/276 (22.82%) subjects. Data on the 16-week treatment with dupilumab were available for 253 (91.67%) patients. Efficacy of dupilumab was demonstrated by a significant reduction of all the scores. No statistically significant difference regarding efficacy was found in elderly patients when compared to the group of our AD patients aged 18–64years, treated with dupilumab over the same period. Furthermore, only 18 (6.52%) patients discontinued the drug due to inefficacy. Sixty-one (22.51%) patients reported adverse events, conjunctivitis and flushing being the most frequent. One (0.36%) patient only discontinued dupilumab due to an adverse event. Conclusions: Therapy with dupilumab led to a significant improvement of AD over a 16-week treatment period, with a good safety profile. Therefore, dupilumab could be considered as an efficacious and safe treatment for AD also in the elderly.

Published
2020

14. A real-world economic analysis of biologic therapies for moderate-to-severe plaque psoriasis in Italy: results of the CANOVA observational longitudinal study

Author

Zagni, E., Bianchi, L., Fabbrocini, G., Corrao, S., Offidani, A., Stingeni, L., Costanzo, Rosa Maria Alba, Pellacani, G., Peris, Ketty, Bardazzi, F., Argenziano, G., Ruffolo, S., Dapavo, P., Carrera, C., Fargnoli, Maria Concetta, Parodi, A., Romanelli, Margherita, Malagoli, P., Talamonti, M., Megna, M., Raspanti, M., Paolinelli, Marco, Hansel, K., Narcisi, A., Conti, A., De Simone, Clara, Chessa, M. A., De Rosa, A., Provenzano, Katia Elisabetta, Ortoncelli, M., Moltrasio, C., Fidanza, R., Burlando, M., Tonini, A., Gaiani, F. M., Simoni, L., Zullo, A., Fiocchi, M., Colombo, Dario Angelo, Costanzo A., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Romanelli M., Paolinelli M., De Simone C. (ORCID:0000-0002-0898-0045), Provenzano E., Colombo D., Zagni, E., Bianchi, L., Fabbrocini, G., Corrao, S., Offidani, A., Stingeni, L., Costanzo, Rosa Maria Alba, Pellacani, G., Peris, Ketty, Bardazzi, F., Argenziano, G., Ruffolo, S., Dapavo, P., Carrera, C., Fargnoli, Maria Concetta, Parodi, A., Romanelli, Margherita, Malagoli, P., Talamonti, M., Megna, M., Raspanti, M., Paolinelli, Marco, Hansel, K., Narcisi, A., Conti, A., De Simone, Clara, Chessa, M. A., De Rosa, A., Provenzano, Katia Elisabetta, Ortoncelli, M., Moltrasio, C., Fidanza, R., Burlando, M., Tonini, A., Gaiani, F. M., Simoni, L., Zullo, A., Fiocchi, M., Colombo, Dario Angelo, Costanzo A., Peris K. (ORCID:0000-0002-5237-0463), Fargnoli M. C., Romanelli M., Paolinelli M., De Simone C. (ORCID:0000-0002-0898-0045), Provenzano E., and Colombo D.

Abstract

Background: Psoriasis is a chronic immune-mediated inflammatory skin disease which can also involve joints. It is often associated with burdensome comorbidities which negatively impact prognosis and quality of life (QoL). Biologic agents have been shown to be effective in controlling disease progression, but their use is associated with higher costs compared with traditional systemic treatments. The economic analysis of the CANOVA (EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: an obserVAtional longitudinal study of real-life clinical practice) study aims to assess the costs and cost-effectiveness of biologics in a real-world context in Italy. Methods: The annualised overall direct costs of moderate-to-severe plaque psoriasis management, the annualised cost of biologic drugs and the cost per responder in the Italian National Health System perspective were assessed. More specifically, the cost per response and cost per sustained response of the most prescribed biologic therapies for the treatment of moderate-to-severe plaque psoriasis within the CANOVA study were assessed using the Psoriasis Area Severity Index (PASI) at several score levels (75, 90 and 100%). Results: The most frequently used biologic therapies for plaque psoriasis were secukinumab, ustekinumab, adalimumab originator, and ixekizumab. Cost of biologics was the driver of expenditure, accounting for about 98% of total costs. Adalimumab originator was the biologic with the lowest cost per responder ratio (range: €7848 - €31,378), followed by secukinumab (range: €9015 - €33,419). Ustekinumab (range: €11,689 – €39,280) and ixekizumab (range: €11,092 – €34,289) ranked respectively third and fourth, in terms of cost-effectiveness ratio. As concerns the cost per sustained response analysis, secukinumab showed the lowest value observed (€21,375) over the other options, because of its high response rate (86% vs. 60–80%), which was achieved early in time. Conclusion: Biologic therapy is a v

Published
2021

15. A Multicenter Study on the Prevalence of Clinical Patterns and Clinical Phenotypes in Adult Atopic Dermatitis

Author

Nettis, E, primary, Ortoncelli, M, additional, Pellacani, G, additional, Foti, C, additional, Di Leo, E, additional, Patruno, C, additional, Rongioletti, F, additional, Argenziano, G, additional, Ferrucci, SM, additional, Macchia, L, additional, Napolitano, M, additional, Ribero, S, additional, Bonzano, L, additional, Romita, P, additional, Di Bona, D, additional, Bennardo, L, additional, Piras, V, additional, Calabrese, G, additional, Tavecchio, S, additional, Detoraki, C, additional, Carbonara, M, additional, and Fabbrocini, G, additional

Published
2020
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16. Pruritus characteristics in a large Italian cohort of psoriatic patients

Author

Damiani, G., Cazzaniga, S., Conic, R. R. Z., Naldi, L., Griseta, V., Miracapillo, A., Azzini, M., Mocci, L., Michelini, M., Offidani, A., Bernardini, L., Campanati, A., Ricotti, G., Giacchetti, A., Norat, M., Gualco, F., Castelli, A., Cuccia, A., Diana, A., Roncarolo, G., Belli, M. A., Baldassarre, M. A., Santoro, G., Vena, G. A., Lo Console, F., Filotico, R., Mastrandrea, V., Brunetti, B., Musumeci, F., Carrabba, E., Dal Mas, P., Annicchiarico, F., Benvegnu, B., Spaziani, G., Cusano, F., Saletta Iannazzone, S., Galluccio, A., Pezza, M., Marchesi, L., Imberti, G., Reseghetti, A., Barbera, C., Reggiani, M., Lanzoni, A., Patrizi, A., Bardazzi, F., Antonucci, A., De Tommaso, S., Wallnofer, W., Ingannamorte, F., Calzavara-Pinton, P., Iannazzi, S., Zane, C., Capezzera, R., Bassisi, S., Rossi, M. T., Altamura, V., Vigl, W., Nobile, C., Aste, N., Murgia, S., Mugheddu, C., Scuderi, G., Baglieri, F., Di Dio, C., Cilioni Grilli, E., Mastronardi, C., Agnusdei, C. P., Antrilli, A., Aulisa, L., Raimondo, U., Scotto di Luzio, G., Battarra, V. C., Farro, P., Plaitano, R., Micali, G., Musumeci, M. L., Massimino, D., Li Calzi, M., La Greca, S., Pettinato, M., Sapienza, G., Valenti, G., De Giacomo, P. F., Amico, Arcangeli, F., Brunelli, D., Ghetti, E., Tulli, A., Assi, G., Amerio, P., Laria, G., Prestinari, F., Spadafora, S., Coppola, M., Caresana, G., Pezzarossa, E., Felisi, C., Donato, L., Bertero, M., Musso, L., Pa lazzini, S., Bruscino, P., Agozzino, U. C., Ottaviani, M., Simoncini, C., Virgili, A., Osti, F., Fabbri, P., Volpi, W., Caproni, M., Lotti, T., Prignano, F., Buggiani, G., Troiano, M., Fenizi, G., Altobella, A., Amoruso, A., Condello, M., Goffredo, A., Righini, M. G., Alessandrini, F., Satolli, F., Zampetti, M., Bertani, E., Fossati, S., Parodi, A., Burlando, M., Fiorucci, C., Nigro, A., Ghigliotti, G., Massone, L., Moise, G. M., Serrai, M., Cannata, G., Campagnoli, A. M., Daly, M., Leporati, C., Peila, R., Filosa, G., Bugatti, L., Nicolini, M., Nazzari, G., Cestari, R., Anastasio, F., Larussa, F. M., Pollice, N., De Francesco, F., Mazzocchetti, G., Peris, K., Fargnoli, M. C., Di Cesare, A., De Angelis, L., Flati, G., Biamonte, A. S., Quarta, G., Congedo, M., Carcaterra, A., Strippoli, D., Fideli, D., Marsili, F., Celli, M., Ceccarini, M., Bachini, L., D'Oria, M., Schirripa, V., De Filippi, C., Martini, P., Lapucci, E., Mazzatenta, C., Ghilardi, A., Simonacci, M., Bettacchi, A., Gasco, R., Zanca, A., Battistini, S., Dattola, S., Vernaci, R., Postorino, F., Zampieri, P. F., Padovan, C., Gonzalez Intchaurraga, M. A., Ladurner, J., Guarneri, B., Cannavo, S., Manfre, C., Borgia, F., Puglisi Guerra, A., Cattaneo, A., Carrera, C., Fracchiolla, C., Mozzanica, N., Prezzemolo, L., Menni, S., Lodi, A., Martino, P., Monti, M., Mancini, L., Sacrini, F., Altomare, G. F., Taglioni, M., Lovati, C., Mercuri, S. R., Schiesari, G., Giannetti, A., Conti, A., Lasagni, C., Greco, M., Ronsini, G., Schianchi, S., Fiorentini, C., Niglietta, S., Maglietta, R., Padalino, C., Crippa, D., Pini, M., Rossi, E., Tosi, D., Armas, M., Ruocco, V., Ayala, F., Balato, N., Gaudiello, F., Cimmino, G. F., Monfrecola, G., Gallo, L., Argenziano, G., Fulgione, E., Berruti, G., Ceparano, S., De Michele, I., Giorgiano, D., Leigheb, G., Deledda, S., Peserico, A., Alaibac, M., Piaserico, S., Schiesari, L., Dan, G., Mattei, I., Oro, E., Arico, M., Bongiorno, M. R., Angileri, R., Amato, S., Todaro, F., Milioto, M., Bellastro, R., Di Nuzzo, S., De Panfilis, G., Zanni, M., Borroni, G., Cananzi, R., Brazzelli, V., Lisi, P., Stingeni, L., Hansel, K., Pierfelice, V., Donelli, S., Rastelli, D., Gasperini, M., Barachini, P., Cecchi, R., Bartoli, L., Pavesi, M., De Paola, S., Corradin, M. T., Ricciuti, F., Piccirillo, A., Viola, L., Tataranni, M., Mautone, M. G., Lo Scocco, G., Niccoli, M. C., Brunasso Vernetti, A. M. G., Gaddoni, G., Resta, F., Casadio, M. C., Arcidiaco, M. C., Luvara, M. C., Albertini, G., Di Lernia, V., Guareschi, E., Catrani, S., Morri, M., De Simone, C., D'Agostino, M., Agostino, I., Calvieri, S., Cantoresi, F., Richetta, A., Sorgi, P., Carnevale, C., Nicolucci, F., Berardesca, E., Ardigo, M., De Felice, C., Gubinelli, E., Talamonti, M., Camplone, G., Cruciani, G., Riccardi, F., Barbati, R., Zumiani, G., Pagani, W., Malagoli, P. G., Pellicano, R., Donadio, D., Di Vito, C., Cottoni, F., Montesu, M. A., Pirodda, C., Addis, G., Marongiu, P., Farris, A., Cacciapuoti, M., Verrini, A., Desirello, G., Gnone, M., Fimiani, M., Pellegrino, M., Castelli, G., Zappala, L., Sesana, G., Ingordo, V., Vozza, E., Di Giuseppe, D., Fasciocco, D., Nespoli, P., Papini, M., Cicoletti, M., Bernengo, M. G., Ortoncelli, M., Bonvicino, A., Capella, G., Doveil, G. C., Forte, M., Peroni, A., Salomone, B., Savoia, P., Pippione, M., Zichichi, L., Frazzitta, M., De Luca, G., Tasin, L., Simonetto, D., Ros, S., Trevisan, G., Patamia, M., Miertusova, S., Patrone, P., Frattasio, A., Piccirillo, F., La Spina, S., Di Gaetano, L., Marzocchi, V., Motolese, A., Venturi, C., Gai, F., Pasquinucci, S., Bellazzi, R. M., Silvestri, T., Girolomoni, G., Gisondi, P., Veller Fornasa, C., Trevisan, G. P., Damiani G., Cazzaniga S., Conic R.R.Z., Naldi L., Griseta V., Miracapillo A., Azzini M., Mocci L., Michelini M., Offidani A., Bernardini L., Campanati A., Ricotti G., Giacchetti A., Norat M., Gualco F., Castelli A., Cuccia A., Diana A., Roncarolo G., Belli M.A., Baldassarre M.A., Santoro G., Vena G.A., Lo Console F., Filotico R., Mastrandrea V., Brunetti B., Musumeci F., Carrabba E., Dal Mas P., Annicchiarico F., Benvegnu B., Spaziani G., Cusano F., Saletta Iannazzone S., Galluccio A., Pezza M., Marchesi L., Imberti G., Reseghetti A., Barbera C., Reggiani M., Lanzoni A., Patrizi A., Bardazzi F., Antonucci A., De Tommaso S., Wallnofer W., Ingannamorte F., Calzavara-Pinton P., Iannazzi S., Zane C., Capezzera R., Bassisi S., Rossi M.T., Altamura V., Vigl W., Nobile C., Aste N., Murgia S., Mugheddu C., Scuderi G., Baglieri F., Di Dio C., Cilioni Grilli E., Mastronardi C., Agnusdei C.P., Antrilli A., Aulisa L., Raimondo U., Scotto di Luzio G., Battarra V.C., Farro P., Plaitano R., Micali G., Musumeci M.L., Massimino D., Li Calzi M., La Greca S., Pettinato M., Sapienza G., Valenti G., De Giacomo P.F., Amico, Arcangeli F., Brunelli D., Ghetti E., Tulli A., Assi G., Amerio P., Laria G., Prestinari F., Spadafora S., Coppola M., Caresana G., Pezzarossa E., Felisi C., Donato L., Bertero M., Musso L., Pa lazzini S., Bruscino P., Agozzino U.C., Ottaviani M., Simoncini C., Virgili A., Osti F., Fabbri P., Volpi W., Caproni M., Lotti T., Prignano F., Buggiani G., Troiano M., Fenizi G., Altobella A., Amoruso A., Condello M., Goffredo A., Righini M.G., Alessandrini F., Satolli F., Zampetti M., Bertani E., Fossati S., Parodi A., Burlando M., Fiorucci C., Nigro A., Ghigliotti G., Massone L., Moise G.M., Serrai M., Cannata G., Campagnoli A.M., Daly M., Leporati C., Peila R., Filosa G., Bugatti L., Nicolini M., Nazzari G., Cestari R., Anastasio F., Larussa F.M., Pollice N., De Francesco F., Mazzocchetti G., Peris K., Fargnoli M.C., Di Cesare A., De Angelis L., Flati G., Biamonte A.S., Quarta G., Congedo M., Carcaterra A., Strippoli D., Fideli D., Marsili F., Celli M., Ceccarini M., Bachini L., D'Oria M., Schirripa V., De Filippi C., Martini P., Lapucci E., Mazzatenta C., Ghilardi A., Simonacci M., Bettacchi A., Gasco R., Zanca A., Battistini S., Dattola S., Vernaci R., Postorino F., Zampieri P.F., Padovan C., Gonzalez Intchaurraga M.A., Ladurner J., Guarneri B., Cannavo S., Manfre C., Borgia F., Puglisi Guerra A., Cattaneo A., Carrera C., Fracchiolla C., Mozzanica N., Prezzemolo L., Menni S., Lodi A., Martino P., Monti M., Mancini L., Sacrini F., Altomare G.F., Taglioni M., Lovati C., Mercuri S.R., Schiesari G., Giannetti A., Conti A., Lasagni C., Greco M., Ronsini G., Schianchi S., Fiorentini C., Niglietta S., Maglietta R., Padalino C., Crippa D., Pini M., Rossi E., Tosi D., Armas M., Ruocco V., Ayala F., Balato N., Gaudiello F., Cimmino G.F., Monfrecola G., Gallo L., Argenziano G., Fulgione E., Berruti G., Ceparano S., De Michele I., Giorgiano D., Leigheb G., Deledda S., Peserico A., Alaibac M., Piaserico S., Schiesari L., Dan G., Mattei I., Oro E., Arico M., Bongiorno M.R., Angileri R., Amato S., Todaro F., Milioto M., Bellastro R., Di Nuzzo S., De Panfilis G., Zanni M., Borroni G., Cananzi R., Brazzelli V., Lisi P., Stingeni L., Hansel K., Pierfelice V., Donelli S., Rastelli D., Gasperini M., Barachini P., Cecchi R., Bartoli L., Pavesi M., De Paola S., Corradin M.T., Ricciuti F., Piccirillo A., Viola L., Tataranni M., Mautone M.G., Lo Scocco G., Niccoli M.C., Brunasso Vernetti A.M.G., Gaddoni G., Resta F., Casadio M.C., Arcidiaco M.C., Luvara M.C., Albertini G., Di Lernia V., Guareschi E., Catrani S., Morri M., De Simone C., D'Agostino M., Agostino I., Calvieri S., Cantoresi F., Richetta A., Sorgi P., Carnevale C., Nicolucci F., Berardesca E., Ardigo M., De Felice C., Gubinelli E., Talamonti M., Camplone G., Cruciani G., Riccardi F., Barbati R., Zumiani G., Pagani W., Malagoli P.G., Pellicano R., Donadio D., Di Vito C., Cottoni F., Montesu M.A., Pirodda C., Addis G., Marongiu P., Farris A., Cacciapuoti M., Verrini A., Desirello G., Gnone M., Fimiani M., Pellegrino M., Castelli G., Zappala L., Sesana G., Ingordo V., Vozza E., Di Giuseppe D., Fasciocco D., Nespoli P., Papini M., Cicoletti M., Bernengo M.G., Ortoncelli M., Bonvicino A., Capella G., Doveil G.C., Forte M., Peroni A., Salomone B., Savoia P., Pippione M., Zichichi L., Frazzitta M., De Luca G., Tasin L., Simonetto D., Ros S., Trevisan G., Patamia M., Miertusova S., Patrone P., Frattasio A., Piccirillo F., La Spina S., Di Gaetano L., Marzocchi V., Motolese A., Venturi C., Gai F., Pasquinucci S., Bellazzi R.M., Silvestri T., Girolomoni G., Gisondi P., Veller Fornasa C., and Trevisan G.P.

Subjects
Male, Cross-sectional study, Severity of Illness Index, Cohort Studies, 030207 dermatology & venereal diseases, 0302 clinical medicine, Risk Factors, education, itch, pruritus, psoriasis, pustular psoriasis, treatment, Adolescent, Adult, Cross-Sectional Studies, Educational Status, Facial Dermatoses, Female, Foot Dermatoses, Genitalia, Hand Dermatoses, Humans, Italy, Middle Aged, Pruritus, Psoriasis, Registries, Sex Factors, Young Adult, Epidemiology, Young adult, skin and connective tissue diseases, Settore MED/33 - MALATTIE APPARATO LOCOMOTORE, Infectious Diseases, 030220 oncology & carcinogenesis, Cohort, PRURITIS EPIDEMIOLOGY, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Cohort study, medicine.medical_specialty, PSORIAS, Dermatology, Article, 03 medical and health sciences, Pharmacotherapy, Settore MED/35, Severity of illness, medicine, business.industry, medicine.disease, Pruritus,Itch sensation, business
Abstract

Background: Psoriasis (Ps) is a chronic systemic autoimmune disease associated with pruritus in 64–98% of patients. However, few modestly sized studies assess factors associated with psoriatic pruritus. Objective: To investigate factors associated with Ps pruritus intensity. Methods: Psoriasis patients 18years or older seen in one of 155 centres in Italy between September 2005 and 2009 were identified from the Italian PsoCare registry. Patients without cutaneous psoriasis and those with missed information on pruritus were excluded. Results: We identified 10802 patients, with a mean age 48.8±14.3years. Mild itch was present in 33.2% of patients, moderate in 34.4%, severe in 18.7% and very severe in 13.7%. Higher itch intensity was associated with female gender, lower educational attainment compared to university degree, pustular psoriasis, psoriasis on the head, face, palmoplantar areas, folds and genitalia, more severe disease, disease duration

Published
2019

17. Dupilumab therapy of atopic dermatitis of the elderly: a multicentre, real-life study

Author

Patruno, C., Napolitano, M., Argenziano, G., Peris, Ketty, Ortoncelli, M., Girolomoni, G., Offidani, A., Ferrucci, S. M., Amoruso, G. F., Rossi, M., Stingeni, L., Malara, G., Grieco, T., Foti, C., Gattoni, M., Loi, C., Iannone, Maria Teresa, Talamonti, M., Stinco, G., Rongioletti, F., Pigatto, P. D., Cristaudo, A., Nettis, E., Corazza, M., Guarneri, F., Amerio, P., Esposito, M., Belloni Fortina, A., Potenza, C., Fabbrocini, G., Angileri, L., Bianchelli, T., Borghi, A., Buligan, C., Calabrese, G., Calzavara Pinton, P., Caroppo, F., Chello, C., Dal Bello, G., Damiani, G., Fargnoli, Maria Concetta, Ferrillo, M., Galluzzo, M., Gori, Niccolo', Gualdi, G., Hansel, K., Macchia, L., Mariano, M., Nistico, S. P., Pertusi, G., Piras, V., Provenzano, Katia Elisabetta, Ravaioli, G. M., Ribero, S., Romanelli, Margherita, Romita, P., Tolino, E., Trifiro, C., Peris K. (ORCID:0000-0002-5237-0463), Iannone M., Fargnoli M. C., Gori N., Provenzano E., Romanelli M., Patruno, C., Napolitano, M., Argenziano, G., Peris, Ketty, Ortoncelli, M., Girolomoni, G., Offidani, A., Ferrucci, S. M., Amoruso, G. F., Rossi, M., Stingeni, L., Malara, G., Grieco, T., Foti, C., Gattoni, M., Loi, C., Iannone, Maria Teresa, Talamonti, M., Stinco, G., Rongioletti, F., Pigatto, P. D., Cristaudo, A., Nettis, E., Corazza, M., Guarneri, F., Amerio, P., Esposito, M., Belloni Fortina, A., Potenza, C., Fabbrocini, G., Angileri, L., Bianchelli, T., Borghi, A., Buligan, C., Calabrese, G., Calzavara Pinton, P., Caroppo, F., Chello, C., Dal Bello, G., Damiani, G., Fargnoli, Maria Concetta, Ferrillo, M., Galluzzo, M., Gori, Niccolo', Gualdi, G., Hansel, K., Macchia, L., Mariano, M., Nistico, S. P., Pertusi, G., Piras, V., Provenzano, Katia Elisabetta, Ravaioli, G. M., Ribero, S., Romanelli, Margherita, Romita, P., Tolino, E., Trifiro, C., Peris K. (ORCID:0000-0002-5237-0463), Iannone M., Fargnoli M. C., Gori N., Provenzano E., and Romanelli M.

Abstract

Background: Treatment of moderate-to-severe atopic dermatitis (AD) in the elderly may be challenging, due to side-effects of traditional anti-inflammatory drugs and to comorbidities often found in this age group. Furthermore, efficacy and safety of innovative drugs such as dupilumab are not yet well known. Objectives: A multicentre retrospective, observational, real-life study on the efficacy and safety of dupilumab was conducted in a group of patients aged ≥65 years and affected by severe AD. Their main clinical features were also examined. Methods: Data of elderly patients with severe (EASI ≥24) AD treated with dupilumab at label dosage for 16 weeks were retrospectively collected. Treatment outcome was assessed by comparing objective (EASI) and subjective (P-NRS, S-NRS and DLQI) scores at baseline and after 16 weeks of treatment. Results: Two hundred and seventy-six patients were enrolled in the study. They represented 11.37% of all patients with severe AD. Flexural eczema was the most frequent clinical phenotype, followed by prurigo nodularis. The coexistence of more than one phenotype was found in 63/276 (22.82%) subjects. Data on the 16-week treatment with dupilumab were available for 253 (91.67%) patients. Efficacy of dupilumab was demonstrated by a significant reduction of all the scores. No statistically significant difference regarding efficacy was found in elderly patients when compared to the group of our AD patients aged 18–64 years, treated with dupilumab over the same period. Furthermore, only 18 (6.52%) patients discontinued the drug due to inefficacy. Sixty-one (22.51%) patients reported adverse events, conjunctivitis and flushing being the most frequent. One (0.36%) patient only discontinued dupilumab due to an adverse event. Conclusions: Therapy with dupilumab led to a significant improvement of AD over a 16-week treatment period, with a good safety profile. Therefore, dupilumab could be considered as an efficacious and safe tre

Published
2020

18. Efficacy of switching between tumor necrosis factor-alfa inhibitors in psoriasis: results from the Italian Psocare registry

Author

Piaserico, Stefano, Cazzaniga, Simone, Chimenti, Sergio, Giannetti, Alberto, Maccarone, Mara, Picardo, Mauro, Peserico, Andrea, Naldi, Luigi, Griseta, V., Miracapillo, A., Azzini, M., Mocci, L., Michelini, M., Offidani, A., Bernardini, L., Campanati, A., Ricotti, G., Giacchetti, A., Norat, M., Gualco, F., Castelli, A., Cuccia, A., Diana, A., Roncarolo, G., Belli, M. A., Baldassarre, M. A., Santoro, G., Vena, G. A., Lo Console, F., Filotico, R., Mastrandrea, V., Brunetti, B., Musumeci, F., Carrabba, E., Dal Mas, P., Annicchiarico, F., Benvegnã¹, B., Spaziani, G., Cusano, F., Saletta Iannazzone, S., Galluccio, A., Pezza, M., Marchesi, L., Imberti, G., Reseghetti, A., Barbera, C., Reggiani, M., Lanzoni, A., Patrizi, A., Bardazzi, F., Antonucci, A., De Tommaso, S., Balestri, R., Wallnofer, W., Ingannamorte, F., Calzavara-Pinton, P., Iannazzi, S., Zane, C., Capezzera, R., Bassisi, S., Rossi, M. T., Altamura, V., Vigl, W., Nobile, C., Aste, N., Murgia, S., Mugheddu, C., Scuderi, G., Baglieri, F., Di Dio, C., Cilioni Grilli, E., Mastronardi, C., Agnusdei, C. P., Antrilli, A., Aulisa, L., Raimondo, U., Scotto di Luzio, G., Battarra, V. C., Farro, P., Plaitano, R., Micali, G., Musumeci, M. L., Massimino, D., Li Calzi, M., La Greca, S., Pettinato, M., Sapienza, G., Valenti, G., De Giacomo, P. F., D’amico, D., Arcangeli, F., Brunelli, D., Ghetti, E., Tulli, A., Assi, G., Amerio, P., Laria, G., Prestinari, F., Spadafora, S., Coppola, M., Caresana, G., Pezzarossa, E., Domaneschi, E., Felisi, C., Donato, L., Bertero, M., Musso, L., Pa lazzini, S., Bruscino, P., Agozzino, U. C., Ottaviani, M., Simoncini, C., Virgili, A., Osti, F., Fabbri, P., Volpi, W., Caproni, M., Lotti, T., Prignano, F., Buggiani, G., Troiano, M., Fenizi, G., Altobella, A., Amoruso, A., Condello, M., Goffredo, A., Righini, M. G., Alessandrini, F., Satolli, F., Zampetti, M., Bertani, E., Fossati, S., Parodi, A., Burlando, M., Fiorucci, C., Nigro, A., Ghigliotti, G., Massone, L., Moise, G. M., Serrai, M., Cannata, G., Campagnoli, A. M., Daly, M., Leporati, C., Peila, R., Filosa, G., Bugatti, L., Nicolini, M., Nazzari, G., Cestari, R., Anastasio, F., Larussa, F. M., Pollice, N., De Francesco, F., Mazzocchetti, G., Peris, K., Fargnoli, M. C., Di Cesare, A., De Angelis, L., Flati, G., Biamonte, A. S., Quarta, G., Congedo, M., Carcaterra, A., Strippoli, D., Fideli, D., Marsili, F., Celli, M., Ceccarini, M., Bachini, L., D’oria, M., Schirripa, V., De Filippi, C., Martini, P., Lapucci, E., Mazzatenta, C., Ghilardi, A., Simonacci, M., Bettacchi, A., Gasco, R., Zanca, A., Battistini, S., Dattola, S., Vernaci, R., Postorino, F., Zampieri, P. F., Padovan, C., González Intchaurraga, M. A., Ladurner, J., Guarneri, B., Cannavo', S., Manfrã, C., Borgia, F., Puglisi Guerra, A., Sedona, P., Cattaneo, A., Carrera, C., Fracchiolla, C., Mozzanica, N., Prezzemolo, L., Menni, S., Lodi, A., Martino, P., Monti, M., Mancini, L., Sacrini, F., Altomare, G. F., Taglioni, M., Lovati, C., Mercuri, S. R., Schiesari, G., Giannetti, A., Conti, A., Lasagni, C., Greco, M., Ronsini, G., Schianchi, S., Fiorentini, C., Niglietta, S., Maglietta, R., Padalino, C., Crippa, D., Pini, M., Rossi, E., Tosi, D., Armas, M., Ruocco, V., Ayala, F., Balato, N., Gaudiello, F., Cimmino, G. F., Monfrecola, G., Gallo, L., Argenziano, G., Fulgione, E., Berruti, G., Ceparano, S., De Michele, I., Giorgiano, D., Leigheb, G., Deledda, S., Peserico, A., Alaibac, M., Piaserico, S., Schiesari, L., Dan, G., Mattei, I., Oro, E., Aricã², M., Bongiorno, M. R., Angileri, R., Amato, S., Todaro, F., Milioto, M., Bellastro, R., Di Nuzzo, S., De Panfilis, G., Zanni, M., Borroni, G., Cananzi, R., Brazzelli, V., Lisi, P., Stingeni, L., Hansel, K., Pierfelice, V., Donelli, S., Rastelli, D., Gasperini, M., Barachini, P., Cecchi, R., Bartoli, L., Pavesi, M., De Paola, S., Corradin, M. T., Ricciuti, F., Piccirillo, A., Viola, L., Tataranni, M., Mautone, M. G., Lo Scocco, G., Niccoli, M. C., Brunasso Vernetti, A. M. G., Gaddoni, G., Resta, F., Casadio, M. C., Arcidiaco, M. C., Luvarã , M. C., Albertini, G., Di Lernia, V., Guareschi, E., Catrani, S., Morri, M., De Simone, C., D’agostino, M., Agostino, I., Calvieri, S., Cantoresi, F., Richetta, A., Sorgi, P., Carnevale, C., Nicolucci, F., Berardesca, E., Ardigã², M., De Felice, C., Gubinelli, E., Chimenti, S., Talamonti, M., Camplone, G., Cruciani, G., Riccardi, F., Barbati, R., Zumiani, G., Pagani, W., Malagoli, P. G., Pellicano, R., Donadio, D., Di Vito, C., Cottoni, F., Montesu, M. A., Pirodda, C., Addis, G., Marongiu, P., Farris, A., Cacciapuoti, M., Verrini, A., Desirello, G., Gnone, M., Fimiani, M., Pellegrino, M., Castelli, G., Zappalã , L., Sesana, G., Ingordo, V., Vozza, E., Di Giuseppe, D., Fasciocco, D., Nespoli, P., Papini, M., Cicoletti, M., Bernengo, M. G., Ortoncelli, M., Bonvicino, A., Capella, G., Doveil, G. C., Forte, M., Peroni, A., Salomone, B., Savoia, P., Pippione, M., Zichichi, L., Frazzitta, M., De Luca, G., Tasin, L., Simonetto, D., Ros, S., Trevisan, G., Patamia, M., Miertusova, S., Patrone, P., Frattasio, A., Piccirillo, F., La Spina, S., Di Gaetano, L., Marzocchi, V., Motolese, A., Venturi, C., Gai, F., Pasquinucci, S., Bellazzi, R. M., Silvestri, T., Girolomoni, G., Gisondi, P., Veller Fornasa, C., Trevisan, G. P., Piaserico S, Cazzaniga S, Chimenti S, Giannetti A, Maccarone M, Picardo M, Peserico A, Naldi L, Psocare Study Group [.., Patrizi A, ], Piaserico, S, Cazzaniga, S, Chimenti, S, Giannetti, A, Maccarone, M, Picardo, M, Peserico, A, Naldi, L, Bongiorno, MR, Psocare Study Group, Monfrecola, Giuseppe, and Trevisan, Giusto

Subjects
Male, primary inefficacy, 75% improvement in the Psoriasis Area Severity Index score, PASI, PASI 75, Psoriasis Area Severity Index, TNF, biologics, efficacy, psoriasis, secondary loss of efficacy, switching, tumor necrosis factor, tumor necrosis factor-alfa inhibitors, Adult, Analysis of Variance, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Cohort Studies, Confidence Intervals, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Immunoglobulin G, Italy, Middle Aged, Multivariate Analysis, Predictive Value of Tests, Proportional Hazards Models, Psoriasis, Receptors, Tumor Necrosis Factor, Registries, Retrospective Studies, Risk Assessment, Severity of Illness Index, Treatment Outcome, Tumor Necrosis Factor-alpha, Young Adult, SWITHCES, psoriasis arthritis, pharmachological treatment, Etanercept, Monoclonal, Receptors, Settore MED/35 - Malattie Cutanee E Veneree, Humanized, Hazard ratio, Predictive value of tests, Drug, biologic, TNF-alpha, medicine.medical_specialty, Dermatology, Antibodies, Dose-Response Relationship, Settore MED/35, Internal medicine, Severity of illness, medicine, Adverse effect, psoriasi, Adalimumab, Infliximab, 2708, Proportional hazards model, business.industry, tumor necrosis factor-alfa inhibitor, Retrospective cohort study, medicine.disease, Confidence interval, Surgery, ANTI-TNFA, business
Abstract

Background: Some studies have shown that switching patients from one tumor necrosis factor (TNF)-alfa inhibitor to another may be beneficial when they have an inadequate response or an adverse event. Objective: We sought to assess the variables predicting the efficacy of the second TNF-alfa inhibitor in patients discontinuing the first TNF-alfa inhibitor. Methods: Data from all 5423 consecutive patients starting TNF-alfa inhibitor therapy for psoriasis between September 2005 and September 2010 who were included in the Italian Psocare registry were analyzed. Results: In 105 patients who switched to a second TNF-alfa inhibitor who had complete follow-up data, 75% improvement in the Psoriasis Area Severity Index score (PASI 75) was reached by 29% after 16 weeks and by 45.6% after 24 weeks. Patients who switched because of secondary loss of efficacy (loss of initial PASI 75 response) or adverse events/intolerance were more likely to reach PASI 75 than those who switched as a result of primary inefficacy (PASI 75 never achieved) (hazard ratio 2.7, 95% confidence interval 1.3-5.5 vs hazard ratio 2.0, 95% confidence interval 1.0-3.9 and 1, respectively). Limitations: There was a small number of patients with complete follow-up data. Conclusion: PASI 75 response in patients who switched from one antie-TNF-alfa agent to another was significantly reduced in patients who showed primary inefficacy of the first antie-TNF-alfa.

Published
2014

19. Metabolic abnormalities associated with initiation of systemic treatment for psoriasis: Evidence from the Italian Psocare Registry

Author

Gisondi, P., Cazzaniga, S., Chimenti, S., Giannetti, A., Maccarone, M, Picardo, M., Girolomoni, G., Naldi, L., Griseta, V, Miracapillo, A, Azzini, M, Mocci, L, Michelini, M, Offidani, A, Bernardini, L, Campanati, A, Ricotti, G, Giacchetti, A, Norat, M, Gualco, F, Castelli, A, Cuccia, A, Diana, A, Roncarolo, G, Belli, Ma, Baldassarre, Ma, Santoro, G, Vena, Ga, Lo Console, F, Filotico, R, Mastrandrea, V, Brunetti, B, Musumeci, F, Carrabba, E, Dal Mas, P, Annicchiarico, F, Benvegnù, B, Spaziani, G, Cusano, F, Saletta Iannazzone, S, Galluccio, A, Pezza, M, Marchesi, L, Imberti, G, Reseghetti, A, Barbera, C, Reggiani, M, Lanzoni, A, Patrizi, A, Bardazzi, F, Antonucci, A, De Tommaso, S, Balestri, R, Wallnofer, W, Ingannamorte, F, Calzavara-Pinton, P, Iannazzi, S, Zane, C, Capezzera, R, Bassisi, S, Rossi, Mt, Altamura, V, Vigl, W, Nobile, C, Aste, N, Murgia, S, Mugheddu, C, Scuderi, G, Baglieri, F, Di Dio, C, Cilioni Grilli, E, Mastronardi, C, Agnusdei, Cp, Antrilli, A, Aulisa, L, Raimondo, U, Scotto di Luzio, G, Battarra, Vc, Farro, P, Plaitano, R, Micali, G, Musumeci, Ml, Massimino, D, Li Calzi, M, La Greca, S, Pettinato, M, Sapienza, G, Valenti, G, De Giacomo PF, D'Amico, D, Arcangeli, F, Brunelli, D, Ghetti, E, Tulli, A, Assi, G, Amerio, P, Laria, G, Prestinari, F, Spadafora, S, Coppola, M, Caresana, G, Pezzarossa, E, Domaneschi, E, Felisi, C, Donato, L, Bertero, M, Musso, L, Pa lazzini, S, Bruscino, P, Agozzino, Uc, Ottaviani, M, Simoncini, C, Virgili, A, Osti, F, Fabbri, P, Volpi, W, Caproni, M, Lotti, T, Prignano, F, Buggiani, G, Troiano, M, Fenizi, G, Altobella, A, Amoruso, A, Condello, M, Goffredo, A, Righini, Mg, Alessandrini, F, Satolli, F, Zampetti, M, Bertani, E, Fossati, S, Parodi, A, Burlando, M, Fiorucci, C, Nigro, A, Ghigliotti, G, Massone, L, Moise, Gm, Serrai, M, Cannata, G, Campagnoli, Am, Daly, M, Leporati, C, Peila, R, Filosa, G, Bugatti, L, Nicolini, M, Nazzari, G, Cestari, R, Anastasio, F, Larussa, Fm, Pollice, N, De Francesco, F, Mazzocchetti, G, Peris, K, Fargnoli, Mc, Di Cesare, A, De Angelis, L, Flati, G, Biamonte, As, Quarta, G, Congedo, M, Carcaterra, A, Strippoli, D, Fideli, D, Marsili, F, Celli, M, Ceccarini, M, Bachini, L, D'Oria, M, Schirripa, V, De Filippi, C, Martini, P, Lapucci, E, Mazzatenta, C, Ghilardi, A, Simonacci, M, Bettacchi, A, Gasco, R, Zanca, A, Battistini, S, Dattola, S, Vernaci, R, Postorino, F, Zampieri, Pf, Padovan, C, González Intchaurraga MA, Ladurner, J, Guarneri, B, Cannavò, S, Manfrè, C, Borgia, F, Puglisi Guerra, A, Sedona, P, Cattaneo, A, Carrera, C, Fracchiolla, C, Mozzanica, N, Prezzemolo, L, Menni, S, Lodi, A, Martino, P, Monti, M, Mancini, L, Sacrini, F, Altomare, F, Taglioni, M, Lovati, C, Mercuri, Sr, Schiesari, G, Giannetti, A, Conti, A, Lasagni, C, Greco, M, Ronsini, G, Schianchi, S, Fiorentini, C, Niglietta, S, Maglietta, R, Padalino, C, Crippa, D, Pini, M, Rossi, E, Tosi, D, Armas, M, Ruocco, V, Ayala, F, Balato, N, Gaudiello, F, Cimmino, Gf, Monfrecola, G, Gallo, L, Argenziano, G, Fulgione, E, Berruti, G, Ceparano, I, De Michele, I, Giorgiano, D, Leigheb, G, Deledda, S, Peserico, A, Alaibac, M, Piaserico, S, Schiesari, L, Dan, G, Mattei, I, Oro, E, Aricò, M, Bongiorno, Mr, Angileri, R, Amato, S, Todaro, F, Milioto, M, Bellastro, R, Di Nuzzo, S, De Panfilis, G, Zanni, M, Borroni, G, Cananzi, R, Brazzelli, V, Lisi, P, Stingeni, L, Hansel, K, Pierfelice, V, Donelli, S, Rastelli, D, Gasperini, M, Barachini, P, Cecchi, R, Bartoli, L, Pavesi, M, De Paola, S, Corradin, Mt, Ricciuti, F, Piccirillo, A, Viola, L, Tataranni, M, Mautone, Mg, Lo Scocco, G, Niccoli, Mc, Brunasso Vernetti AM, Gaddoni, G, Resta, F, Casadio, Mc, Arcidiaco, Mc, Luvarà, Mc, Albertini, G, Di Lernia, V, Guareschi, E, Catrani, S, Morri, M, De Simone, C, D'Agostino, M, Agostino, I, Calvieri, S, Cantoresi, F, Richetta, A, Sorgi, P, Carnevale, C, Nicolucci, F, Berardesca, E, Gubinelli, E, Chimenti, S, Talamonti, M, Camplone, G, Cruciani, G, Riccardi, F, Barbati, R, Zumiani, G, Pagani, W, Malagoli, Pg, Pellicano, R, Donadio, D, Di Vito, C, Cottoni, F, Montesu, Ma, Pirodda, C, Addis, G, Marongiu, P, Farris, A, Cacciapuoti, M, Verrini, A, Desirello, G, Gnone, M, Fimiani, M, Pellegrino, M, Castelli, G, Zappalà, L, Sesana, G, Ingordo, V, Vozza, Dg, Di Giuseppe, D, Fasciocco, D, Nespoli, P, Papini, M, Cicoletti, M, Bernengo, Mg, Ortoncelli, M, Bonvicino, A, Capella, G, Doveil, Gc, Forte, M, Peroni, A, Salomone, B, Savoia, P, Pippione, M, Zichichi, L, Frazzitta, M, De Luca, G, Tasin, L, Simonetto, S, Ros, S, Trevisan, G, Patamia, M, Miertusova, S, Patrone, A, Frattasio, A, Piccirillo, F, La Spina, S, Di Gaetano, L, Udine, Marzocchi, V, Motolese, A, Venturi, C, Gai, F, Pasquinucci, S, Bellazzi, Rm, Silvestri, T, Girolomoni, G, Gisondi, P, Veller Fornasa, C, Trevisan, Gp., Gisondi, P, Cazzaniga, S, Chimenti, S, Giannetti, A, Maccarone, M, Picardo, M, Girolomoni, G, Naldi, L, Monfrecola, Giuseppe, Psocare Study, G. r. o. u. p., P., Gisondi, S., Cazzaniga, S., Chimenti, A., Giannetti, M., Maccarone, M., Picardo, G., Girolimoni, L., Naldi, Trevisan, Giusto, Psocare Study Group: [.., M. Reggiani, A. Lanzoni, A. Patrizi, F. Bardazzi, A. Antonucci, S. De Tommaso, R. Balestri, and ]

Subjects
Adult, Male, arterial hypertension, Adolescent, Antineoplastic Agents, Risk Assessment, Severity of Illness Index, Antibodies, Drug Administration Schedule, Cohort Studies, Dose-Response Relationship, Young Adult, Settore MED/35, Age Distribution, Metabolic Diseases, Monoclonal, metabolic disorders, Humans, Psoriasis, Prospective Studies, Registries, Sex Distribution, Antibodies, Monoclonal, Dose-Response Relationship, Drug, Evidence-Based Medicine, Female, Immunosuppressive Agents, Incidence, Italy, Treatment Outcome, 2708, Infectious Diseases, METABOLIC SYNDROME, psoriasis, metabolic abnormalities, Treatment, therapy, Metabolic abnormalitie, metabolic comorbidities, Metabolic abnormalities, Drug
Abstract

OBJECTIVE: To evaluate variations in laboratory parameters and diagnoses of selected clinical conditions up to 16 weeks after starting a new systemic psoriasis treatment for Psocare Registry enrollees. DESIGN: Prospective cohort study. SETTING: Italian public referral centres for psoriasis treatment. PATIENTS: First-time recipients (n = 10,539) of continuous systemic psoriasis treatment for at least 16 weeks. MAIN OUTCOME MEASURE: Mean variations in (weeks 8 and 16) and proportions of patients reaching a clinically meaningful increase in serum levels (week 16) of total and low-density lipoprotein cholesterol, triglycerides, aspartate amino transferase, alanine amino transferase and creatinine, as well as week-16 cumulative incidences of new diagnoses of diabetes mellitus and arterial hypertension. RESULTS: Mean cholesterol and triglyceride levels significantly increased in patients treated with acitretin or cyclosporine. Mean triglyceride levels also increased in efalizumab- and etanercept-treated patients. Mean transaminase values increased in methotrexate-treated patients, and mean aspartate amino transferase levels increased in infliximab-treated patients. The average serum creatinine value increased in cyclosporine-treated patients. Acitretin and cyclosporine were associated with risk of hypercholesterolaemia (odds ratios 1.51 and 1.34) and acitretin with risk of hypertriglyceridaemia (odds ratio 1.43). Methotrexate and infliximab were associated with risk of more than doubling the upper normal aspartate amino transferase (odds ratios 2.06 and 1.87) and alanine amino transferase (odds ratios 2.38 and 1.74) values. The relative risk of developing arterial hypertension and diabetes was increased for patients receiving cyclosporine (odds ratios 3.31 and 2.88). CONCLUSION: Systemic treatments for psoriasis resulted in heterogeneous effects on the parameters analysed.

Published
2013

22. Use of Dupilumab in 543 Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Retrospective Study

Author

Gabriella Fabbrocini, L Bonzano, Silvia Ferrucci, S Ribero, Simona Tavecchio, Giovanni Pellacani, Steven Paul Nisticò, C Detoraki, Franco Rongioletti, Cataldo Patruno, Paolo Romita, Eustachio Nettis, Viviana Piras, Michela Ortoncelli, M Carbonara, Giulia Calabrese, Danilo Di Bona, E. Di Leo, Luigi Macchia, Caterina Foti, G Argenziano, Maddalena Napolitano, Nettis, E, Ferrucci, S M, Ortoncelli, M, Pellacani, G, Foti, C, Di Leo, E, Patruno, C, Rongioletti, F, Argenziano, G, Macchia, L, Tavecchio, S, Napolitano, M, Ribero, S, Bonzano, L, Romita, P, Di Bona, D, Nisticò, S P, Piras, V, Calabrese, G, Detoraki, C, Carbonara, M, Fabbrocini, G, Nettis, E., Ferrucci, S. M., Ortoncelli, M., Pellacani, G., Foti, C., Di Leo, E., Patruno, C., Rongioletti, F., Argenziano, G., Macchia, L., Tavecchio, S., Napolitano, M., Ribero, S., Bonzano, L., Romita, P., Di Bona, D., Nistico, S. P., Piras, V., Calabrese, G., Detoraki, C., Carbonara, M., and Fabbrocini, G.

Subjects
Adult, medicine.medical_specialty, Immunology, Population, Dupilumab, Antibodies, Monoclonal, Humanized, Severity of Illness Index, Dermatitis, Atopic, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Retrospective Studie, Interquartile range, Internal medicine, Humans, Immunology and Allergy, Medicine, Eosinophilia, Multicenter real-life study, education, Retrospective Studies, Atopic dermatitis, education.field_of_study, business.industry, Conjunctiviti, Retrospective cohort study, Dermatology Life Quality Index, Immunoglobulin E, Conjunctivitis, Atopic dermatiti, medicine.disease, Clinical trial, Treatment Outcome, 030228 respiratory system, Multicentric real-life study, medicine.symptom, business, Human
Abstract

BACKGROUND Dupilumab has been demonstrated to be an effective treatment for patients with moderate-to-severe atopic dermatitis (AD) in clinical trials. However, evidence of real-world experience with dupilumab in a broader population is limited to date. METHODS Adult patients with moderate-to-severe AD, defined as an Eczema Area Severity Index (EASI) score of 24 or higher, treated with dupilumab at ten Italian academic centers, were included in the study. Physician-reported outcome measures (EASI), patient-reported outcome measures (pruritus and sleep score, Dermatology Life Quality Index, DLQI) and serological markers [immunoglobulin (Ig) E and eosinophil count] after 16 weeks were analyzed. RESULTS We enrolled 543 patients with moderate-to-severe AD. Two patients (0.4%) discontinued treatment. The median ± interquartile percentage change from baseline to 16 weeks of treatment in the EASI score was -87.5±22.0 (p

Published
2022
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23. A real-world economic analysis of biologic therapies for moderate-to-severe plaque psoriasis in Italy: results of the CANOVA observational longitudinal study

Author

Giovanni Pellacani, Annamaria Offidani, Aurora Parodi, Alina De Rosa, Martina Burlando, Maria Concetta Fargnoli, Alessandro Zullo, Emanuela Zagni, Federico Bardazzi, Eugenio Provenzano, Chiara Moltrasio, Lucia Simoni, Piergiorgio Malagoli, Delia Colombo, Andrea Conti, Luca Stingeni, Michela Ortoncelli, Giuseppe Argenziano, Salvatore Corrao, Annalisa Tonini, Francesca Gaiani, Katharina Hansel, Marina Talamonti, Matteo Megna, Ketty Peris, Matteo Paolinelli, Rosaria Fidanza, Gabriella Fabbrocini, Clara De Simone, Antonio Costanzo, Marco Adriano Chessa, Luca Bianchi, Alessandra Narcisi, Massimo Raspanti, Paolo Dapavo, Marco Romanelli, C. Carrera, M. Fiocchi, Silvana Ruffolo, Zagni, E., Bianchi, L., Fabbrocini, G., Corrao, S., Offidani, A., Stingeni, L., Costanzo, A., Pellacani, G., Peris, K., Bardazzi, F., Argenziano, G., Ruffolo, S., Dapavo, P., Carrera, C., Fargnoli, M. C., Parodi, A., Romanelli, M., Malagoli, P., Talamonti, M., Megna, M., Raspanti, M., Paolinelli, M., Hansel, K., Narcisi, A., Conti, A., De Simone, C., Chessa, M. A., De Rosa, A., Provenzano, E., Ortoncelli, M., Moltrasio, C., Fidanza, R., Burlando, M., Tonini, A., Gaiani, F. M., Simoni, L., Zullo, A., Fiocchi, M., Colombo, D., Zagni, Emanuela, Bianchi, Luca, Fabbrocini, Gabriella, Corrao, Salvatore, Offidani, Annamaria, Stingeni, Luca, Costanzo, Antonio, Pellacani, Giovanni, Peris, Ketty, Bardazzi, Federico, Argenziano, Giuseppe, Ruffolo, Silvana, Dapavo, Paolo, Carrera, Carlo, Fargnoli, Maria Concetta, Parodi, Aurora, Romanelli, Marco, Malagoli, Piergiorgio, Talamonti, Marina, Megna, Matteo, Raspanti, Massimo, Paolinelli, Matteo, Hansel, Katharina, Narcisi, Alessandra, Conti, Andrea, De Simone, Clara, Chessa, Marco Adriano, De Rosa, Alina, Provenzano, Eugenio, Ortoncelli, Michela, Moltrasio, Chiara, Fidanza, Rosaria, Burlando, Martina, Tonini, Annalisa, Gaiani, Francesca Maria, Simoni, Lucia, Zullo, Alessandro, Fiocchi, Martina, Colombo, Delia, Zagni E., Bianchi L., Fabbrocini G., Corrao S., Offidani A., Stingeni L., Costanzo A., Pellacani G., Peris K., Bardazzi F., Argenziano G., Ruffolo S., Dapavo P., Carrera C., Fargnoli M.C., Parodi A., Romanelli M., Malagoli P., Talamonti M., Megna M., Raspanti M., Paolinelli M., Hansel K., Narcisi A., Conti A., De Simone C., Chessa M.A., De Rosa A., Provenzano E., Ortoncelli M., Moltrasio C., Fidanza R., Burlando M., Tonini A., Gaiani F.M., Simoni L., Zullo A., Fiocchi M., and Colombo D.

Subjects
Response rate, medicine.medical_specialty, Cost per responder, Biologic, Cost, Ixekizumab, Longitudinal Studie, Context (language use), Secukinumab, Severity of Illness Index, Antibodies, Indirect costs, Settore MED/35, Quality of life, Internal medicine, Psoriasis, Ustekinumab, Monoclonal, Adalimumab, Antibodies, Monoclonal, Longitudinal Studies, Quality of Life, Treatment Outcome, Italy, Humans, Biological Therapy, Real-world, medicine, health care economics and organizations, Psoriasi, Costs, business.industry, Health Policy, Research, medicine.disease, Public aspects of medicine, RA1-1270, Settore MED/35 - MALATTIE CUTANEE E VENEREE, business, Human, medicine.drug
Abstract

BackgroundPsoriasis is a chronic immune-mediated inflammatory skin disease which can also involve joints. It is often associated with burdensome comorbidities which negatively impact prognosis and quality of life (QoL). Biologic agents have been shown to be effective in controlling disease progression, but their use is associated with higher costs compared with traditional systemic treatments. The economic analysis of the CANOVA (EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: an obserVAtional longitudinal study of real-life clinical practice) study aims to assess the costs and cost-effectiveness of biologics in a real-world context in Italy.MethodsThe annualised overall direct costs of moderate-to-severe plaque psoriasis management, the annualised cost of biologic drugs and the cost per responder in the Italian National Health System perspective were assessed. More specifically, the cost per response and cost per sustained response of the most prescribed biologic therapies for the treatment of moderate-to-severe plaque psoriasis within the CANOVA study were assessed using the Psoriasis Area Severity Index (PASI) at several score levels (75, 90 and 100%).ResultsThe most frequently used biologic therapies for plaque psoriasis were secukinumab, ustekinumab, adalimumab originator, and ixekizumab. Cost of biologics was the driver of expenditure, accounting for about 98% of total costs. Adalimumab originator was the biologic with the lowest cost per responder ratio (range: €7848 - €31,378), followed by secukinumab (range: €9015 - €33,419). Ustekinumab (range: €11,689 – €39,280) and ixekizumab (range: €11,092 – €34,289) ranked respectively third and fourth, in terms of cost-effectiveness ratio. As concerns the cost per sustained response analysis, secukinumab showed the lowest value observed (€21,375) over the other options, because of its high response rate (86% vs. 60–80%), which was achieved early in time.ConclusionBiologic therapy is a valuable asset for the treatment of moderate-to-severe plaque psoriasis. Concomitant assessment of treatment costs against the expected therapeutic response over time can provide physicians and payers additional insights which can complement the traditional risk-benefit profile assessment and drive treatment decisions.

Published
2021

24. Management of patients with atopic dermatitis undergoing systemic therapy during COVID-19 pandemic in Italy: Data from the DA-COVID-19 registry

Author

Chiricozzi, Andrea, Talamonti, Marina, De Simone, Clara, Galluzzo, Marco, Gori, Niccolò, Fabbrocini, Gabriella, Marzano, Angelo Valerio, Girolomoni, Giampiero, Offidani, Annamaria, Rossi, Maria Teresa, Bianchi, Luca, Cristaudo, Antonio, Fierro, Maria Teresa, Stingeni, Luca, Pellacani, Giovanni, Argenziano, Giuseppe, Patrizi, Annalisa, Pigatto, Paolo, Romanelli, Marco, Savoia, Paola, Rubegni, Pietro, Foti, Caterina, Milanesi, Nicola, Belloni Fortina, Anna, Bongiorno, Maria Rita, Grieco, Teresa, Di Nuzzo, Sergio, Fargnoli, Maria Concetta, Carugno, Andrea, Motolese, Alberico, Rongioletti, Franco, Amerio, Paolo, Balestri, Riccardo, Potenza, Concetta, Micali, Giuseppe, Patruno, Cataldo, Zalaudek, Iris, Lombardo, Maurizio, Feliciani, Claudio, Di Nardo, Lucia, Guarneri, Fabrizio, Peris, Ketty, Caldarola, Giacomo, Silvaggio, Dionisio, Dattola, Annunziata, Napolitano, Maddalena, Ferrucci, Silvia Mariel, Dal Bello, Giacomo, Bianchelli, Tommaso, Rovati, Chiara, Pigliacelli, Flavia, Ortoncelli, Michela, Hansel, Katharina, Calabrese, Giulia, Loi, Camilla, Iannone, Michela, Veronese, Federica, Romita, Paolo, Tronconi, Greta, Caroppo, Francesca, Tilotta, Giovanna, Sernicola, Alvise, Esposito, Maria, Raponi, Francesca, Gualdi, Giulio, Rech, Giulia, Musumeci, Maria Letizia, Nisticò, Steven Paul, Campitiello, Alessio, Bonzano, Laura, Piras, Viviana, Chiricozzi, A., Talamonti, M., De Simone, C., Galluzzo, M., Gori, N., Fabbrocini, G., Marzano, A. V., Girolomoni, G., Offidani, A., Rossi, M. T., Bianchi, L., Cristaudo, A., Fierro, M. T., Stingeni, L., Pellacani, G., Argenziano, G., Patrizi, A., Pigatto, P., Romanelli, M., Savoia, P., Rubegni, P., Foti, C., Milanesi, N., Belloni Fortina, A., Bongiorno, M. R., Grieco, T., Di Nuzzo, S., Fargnoli, M. C., Carugno, A., Motolese, A., Rongioletti, F., Amerio, P., Balestri, R., Potenza, C., Micali, G., Patruno, C., Zalaudek, I., Lombardo, M., Feliciani, C., Di Nardo, L., Guarneri, F., Peris, K., Caldarola, G., Silvaggio, D., Dattola, A., Napolitano, M., Ferrucci, S. M., Dal Bello, G., Bianchelli, T., Rovati, C., Pigliacelli, F., Ortoncelli, M., Hansel, K., Calabrese, G., Loi, C., Iannone, M., Veronese, F., Romita, P., Tronconi, G., Caroppo, F., Tilotta, G., Sernicola, A., Esposito, M., Raponi, F., Gualdi, G., Rech, G., Musumeci, M. L., Nistico, S. P., Campitiello, A., Bonzano, L., Piras, V., Chiricozzi, Andrea, Talamonti, Marina, De Simone, Clara, Galluzzo, Marco, Gori, Niccolò, Fabbrocini, Gabriella, Marzano, Angelo Valerio, Girolomoni, Giampiero, Offidani, Annamaria, Rossi, Maria Teresa, Bianchi, Luca, Cristaudo, Antonio, Fierro, Maria Teresa, Stingeni, Luca, Pellacani, Giovanni, Argenziano, Giuseppe, Patrizi, Annalisa, Pigatto, Paolo, Romanelli, Marco, Savoia, Paola, Rubegni, Pietro, Foti, Caterina, Milanesi, Nicola, Belloni Fortina, Anna, Bongiorno, Maria Rita, Grieco, Teresa, Di Nuzzo, Sergio, Fargnoli, Maria Concetta, Carugno, Andrea, Motolese, Alberico, Rongioletti, Franco, Amerio, Paolo, Balestri, Riccardo, Potenza, Concetta, Micali, Giuseppe, Patruno, Cataldo, Zalaudek, Iri, Lombardo, Maurizio, Feliciani, Claudio, Di Nardo, Lucia, Guarneri, Fabrizio, Peris, Ketty, Caldarola, Giacomo, Silvaggio, Dionisio, Dattola, Annunziata, Napolitano, Maddalena, Ferrucci, Silvia Mariel, Dal Bello, Giacomo, Bianchelli, Tommaso, Rovati, Chiara, Pigliacelli, Flavia, Ortoncelli, Michela, Hansel, Katharina, Calabrese, Giulia, Loi, Camilla, Iannone, Michela, Veronese, Federica, Romita, Paolo, Tronconi, Greta, Caroppo, Francesca, Tilotta, Giovanna, Sernicola, Alvise, Esposito, Maria, Raponi, Francesca, Gualdi, Giulio, Rech, Giulia, Musumeci, Maria Letizia, Nisticò, Steven Paul, Campitiello, Alessio, Bonzano, Laura, Piras, Viviana, Chiricozzi, A, Talamonti, M, De Simone, C, Galluzzo, M, Gori, N, Fabbrocini, G, Marzano, A, Girolomoni, G, Offidani, A, Rossi, M, Bianchi, L, Cristaudo, A, Fierro, M, Stingeni, L, Pellacani, G, Argenziano, G, Patrizi, A, Pigatto, P, Romanelli, M, Savoia, P, Rubegni, P, Foti, C, Milanesi, N, Belloni Fortina, A, Bongiorno, M, Grieco, T, Di Nuzzo, S, Fargnoli, M, Carugno, A, Motolese, A, Rongioletti, F, Amerio, P, Balestri, R, Potenza, C, Micali, G, Patruno, C, Zalaudek, I, Lombardo, M, Feliciani, C, Di Nardo, L, Guarneri, F, Peris, K, Caldarola, G, Silvaggio, D, Dattola, A, Napolitano, M, Ferrucci, S, Dal Bello, G, Bianchelli, T, Rovati, C, Pigliacelli, F, Ortoncelli, M, Hansel, K, Calabrese, G, Loi, C, Iannone, M, Veronese, F, Romita, P, Tronconi, G, Caroppo, F, Tilotta, G, Sernicola, A, Esposito, M, Raponi, F, Gualdi, G, Rech, G, Musumeci, M, Nistico, S, Campitiello, A, Bonzano, L, and Piras, V

Subjects
Registrie, 0301 basic medicine, Dermatitis, Systemic therapy, 0302 clinical medicine, Pandemic, Immunology and Allergy, Medicine, Registries, atopic dermatitis, COVID, SARS‐ CoV, treatment, SARS-CoV, Atopic dermatitis, Dupilumab, Italy, Original Article, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Human, atopic dermatiti, Adult, medicine.medical_specialty, Teledermatology, SARS‐CoV, atopic dermatitis, treatment, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Immunology, Communicable Disease Control, Humans, Pandemics, SARS-CoV-2, COVID-19, Dermatitis, Atopic, Atopic, 03 medical and health sciences, Settore MED/35, Disease severity, Internal medicine, business.industry, medicine.disease, 030104 developmental biology, 030228 respiratory system, atopic dermatitis, COVID, SARS-CoV, business
Abstract

Background Few and small studies have described the management of immunomodulant/immunosuppressive therapies or phototherapy in atopic dermatitis (AD) patients during coronavirus disease 2019 (COVID‐19) pandemic. Methods A national registry, named DA‐COVID‐19 and involving 35 Italian dermatology units, was established in order to evaluate the impact of COVID‐19 pandemic on the management of adult AD patients treated with systemic immunomodulant/immunosuppressive medications or phototherapy. Demographic and clinical data were obtained at different timepoints by teledermatology during COVID‐19 pandemic, when regular visits were not allowed due to sanitary restrictions. Disease severity was assessed by both physician‐ and patient‐reported assessment scores evaluating itch intensity, sleep disturbances, and AD severity. Results A total of 1831 patients were included, with 1580/1831 (86.3%) continuing therapy during pandemic. Most patients were treated with dupilumab (86.1%, 1576/1831) that was interrupted in only 9.9% (156/1576) of cases, while systemic immunosuppressive compounds were more frequently withdrawn. Treatment interruption was due to decision of the patient, general practitioner, or dermatologist in 39.9% (114/286), 5.6% (16/286), and 30.1% (86/286) of cases, respectively. Fear of increased susceptibility to SARS‐CoV‐2 infection (24.8%, 71/286) was one of the main causes of interruption. Sixteen patients (0.9%) resulted positive to SARS‐CoV‐2 infection; 3 of them (0.2%) were hospitalized but no cases of COVID‐related death occurred. Conclusions Most AD patients continued systemic treatments during COVID pandemic and lockdown period, without high impact on disease control, particularly dupilumab‐treated patients., Among 1831 studied AD patients, 86.1% were treated with dupilumab. Patients continuing therapy experienced a marked reduction of disease severity during pandemic. The causes of treatment interruption included: fear of increased susceptibility to SARS‐CoV‐2 infection (24.8%), occurrence of comorbidities (5.9%), age above 60 years (5.2%), SARS‐CoV‐2 infection (2.8%), close contact with SARS‐CoV‐2‐positive subject (2.4%), other reasons, for example, inability to maintain drug supply, non‐medical/unspecified causes (58.7%).

Published
2021

25. Long-term effectiveness of dupilumab up to 52 weeks in atopic dermatitis in 253 adult patients

Author

Silvia Ferrucci, Simona Tavecchio, L Bonzano, Luigi Macchia, Giulia Calabrese, Maddalena Napolitano, Steven Paul Nisticò, Caterina Foti, Aikaterini Detoraki, Katharina Hansel, Giuseppe Argenziano, Giovanni Pellacani, Paolo Romita, Michela Ortoncelli, Franco Rongioletti, Luca Stingeni, E. Di Leo, Gabriella Fabbrocini, Simone Ribero, M Carbonara, Cataldo Patruno, Eustachio Nettis, Viviana Piras, Danilo Di Bona, Nettis, E, Fabbrocini, G, Ortoncelli, M, Pellacani, G, Argenziano, G, Di Leo, E, Patruno, C, Stingeni, L, Foti, C, Rongioletti, F, Macchia, L, Tavecchio, S, Napolitano, M, Ribero, S, Bonzano, L, Calabrese, G, Di Bona, D, Nisticò, S P, Hansel, K, Romita, P, Piras, V, Carbonara, M, Detoraki, A, Ferrucci, S M, Nettis, E., Fabbrocini, G., Ortoncelli, M., Pellacani, G., Argenziano, G., Di Leo, E., Patruno, C., Stingeni, L., Foti, C., Rongioletti, F., Macchia, L., Tavecchio, S., Napolitano, M., Ribero, S., Bonzano, L., Calabrese, G., Di Bona, D., Nistico, S. P., Hansel, K., Romita, P., Piras, V., Carbonara, M., Detoraki, A., and Ferrucci, S. M.

Subjects
Adult, medicine.medical_specialty, Adult patients, business.industry, Eczema, Interleukin, Dermatology, Atopic dermatitis, medicine.disease, Antibodies, Monoclonal, Humanized, Dupilumab, Dermatitis, Atopic, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Monoclonal, Medicine, Humans, business
Abstract

Dupilumab, an inhibitor of interleukin (IL)-4/13 activity, is a biological agent approved for the treatment of moderate-to-severe atopic dermatitis (AD)1 . Our aim was to assess the long-term effectiveness and safety of dupilumab in a clinical real-life setting.

Published
2021

26. A multicentric study on prevalence of clinical patterns and clinical phenotypes in adult atopic dermatitis

Author

Cataldo Patruno, Silvia Ferrucci, L Bonzano, Eustachio Nettis, Viviana Piras, Giulia Calabrese, Gabriella Fabbrocini, Maddalena Napolitano, M Carbonara, C Detoraki, Caterina Foti, Simona Tavecchio, Franco Rongioletti, Simone Ribero, G Argenziano, Luigi Macchia, Danilo Di Bona, E. Di Leo, Luigi Bennardo, Giovanni Pellacani, Michela Ortoncelli, Paolo Romita, Nettis, E, Ortoncelli, M, Pellacani, G, Foti, C, Di Leo, E, Patruno, C, Rongioletti, F, Argenziano, G, Ferrucci, S M, Macchia, L, Napolitano, M, Ribero, S, Bonzano, L, Romita, P, Di Bona, D, Bennardo, L, Piras, V, Calabrese, G, Tavecchio, S, Detoraki, C, Carbonara, M, Fabbrocini, G, Nettis, E., Ortoncelli, M., Pellacani, G., Foti, C., Di Leo, E., Patruno, C., Rongioletti, F., Argenziano, G., Ferrucci, S. M., Macchia, L., Napolitano, M., Ribero, S., Bonzano, L., Romita, P., Di Bona, D., Bennardo, L., Piras, V., Calabrese, G., Tavecchio, S., Detoraki, C., Carbonara, M., and Fabbrocini, G.

Subjects
Adult, medicine.medical_specialty, Immunology, Atopic dermatitis, Clinical patterns, Clinical phenotypes, Dupilumab, MEDLINE, Dermatitis, Atopic, Clinical phenotype, medicine, Prevalence, Immunology and Allergy, Humans, Public Health Surveillance, Adult atopic dermatitis, business.industry, medicine.disease, Atopic dermatiti, Phenotype, Dermatology, Multicenter study, Clinical pattern, business
Published
2020

27. Median canaliform nail dystrophy of Heller in a patient with atopic dermatitis: ‘miraculous’ healing with dupilumab

Author

Simone Ribero, Riccardo Viola, Emi Dika, Michela Ortoncelli, Maria Teresa Giura, Giura M.T., Viola R., Dika E., Ribero S., and Ortoncelli M.

Subjects
medicine.medical_specialty, integumentary system, business.industry, Dupilumab, atopic dermatitis, healing, Dermatology, Atopic dermatitis, medicine.disease, Dupilumab, body regions, Monoclonal, medicine, business, Median nail dystrophy
Abstract

We report hereby a Median canaliform nail dystrophy of Heller in a patient with atopic dermatitis: ‘miraculous’ healing with dupilumab

Published
2020
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28. Short-term effectiveness and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis: results from a 16-week real-world multicenter retrospective study - il AD (Italian landscape atopic dermatitis).

Author

Gargiulo L, Ibba L, Alfano A, Malagoli P, Amoruso F, Balato A, Barei F, Burroni AG, Caccavale S, Calzavara-Pinton P, Esposito M, Fargnoli MC, Ferrucci SM, Foti C, Girolomoni G, Gola M, Guanti MB, Gurioli C, Magliulo M, Maurelli M, Morrone P, Musumeci ML, Napolitano M, Ortoncelli M, Patruno C, Piraccini BM, Pezzolo E, Ribero S, Rossi M, Savoia P, Sciarrone C, Tirone B, Vaccino M, Veronese F, Costanzo A, and Narcisi A

Subjects
Humans, Retrospective Studies, Female, Male, Adult, Middle Aged, Treatment Outcome, Italy, Pyrimidines adverse effects, Pyrimidines administration & dosage, Sulfonamides therapeutic use, Sulfonamides adverse effects, Aged, Young Adult, Dermatitis, Atopic drug therapy, Dermatitis, Atopic pathology, Severity of Illness Index
Abstract

Aim: Abrocitinib is a JAK-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD). We conducted a 16-week multicenter retrospective study to assess the short-term effectiveness and safety of abrocitinib in patients with moderate-to-severe AD., Our retrospective study included 85 adult patients from 14 Italian Dermatology Units affected by moderate-to-severe AD treated with abrocitinib 100/200 mg., Methods: Effectiveness of abrocitinib at weeks 4 and 16 was assessed by using the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA), the peak pruritus and sleep- Numerical Rating Scale (PP-NRS and S-NRS, respectively)., Results: At week 16, improvement of at least 90% in EASI (EASI90) and IGA 0/1 was observed in 49.4% and 61.2% of patients, respectively. A reduction of at least 4 points in PP-NRS and S-NRS compared with baseline was achieved by 70.6% of patients for both endpoints. No significant safety reports were observed during the study period. Naïve patients had better rates of EASI 90 compared to patients who previously failed dupilumab. Conclusion: Our data confirm the effectiveness of abrocitinib in a real-world setting with better clinical responses at weeks 4 and 16, compared with Phase-III clinical trials. Longer analyses are required to further establish the safety profile of abrocitinib.

Published
2024
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29. Drug Survival and Clinical Course of Patients with Cancer Treated with Biologic Therapy for Psoriasis.

Author

Macagno N, Mastorino L, Ortoncelli M, Borriello S, Astrua C, Verrone A, Stroppiana E, Dapavo P, Siliquini N, Ribero S, and Quaglino P

Abstract

Background/Objectives: Patients with treated solid tumors (TST) are a highly heterogeneous and difficult-to-treat population due to the risk of disease progression/recurrence or infection. Methods: We conducted an observational, retrospective, single-center study at the Dermatology Clinic of Turin with a focus on the special population of cancer patients with psoriasis treated with biologics. Results: As of July 2023, 52 psoriatic patients with a prior/concomitant history of malignancy had taken biologic drugs. The median age was 67 years, and the median age of cancer onset was 55 years. The most common tumors were gastrointestinal cancer and melanoma. After the tumor diagnosis, 61% received an anti-IL17 drug; 37 patients continued the initiated biologic therapy, while 12 switched drugs due to secondary inefficacy. The estimated biologic DS was 55.6% at 50 months. Evidence suggests that IL-17 is a key pathogenic factor involved in tumorigenesis, resulting in a lower risk of malignancies in subjects managed with IL-17 inhibitors. Similarly, IL-23 plays a role in suppressing innate immunity and promoting tumor and metastases development. This is a consistent real-life case series that support the use of biologic drugs in patients with TST. Conclusions : IL-23 and IL-17 inhibitors, being immunomodulators rather than immunosuppressants, may be a safe option for patients in an active oncological setting and for immune-correlated adverse events.

Published
2024
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30. Rapid Efficacy of riSankizumab in pretibial psoriasis invOLVEment: RESOLVE.

Author

Bernardini N, Skroza N, Atzori L, Mugheddu C, Megna M, Cacciapuoti S, Ortoncelli M, Montesu MA, Carpentieri A, Carriero M, Atzori MG, Addis G, Balestri R, Rech G, Bruni P, Papini M, and Potenza C

Abstract

Background: Despite extraordinary improvements in the management of psoriasis in recent times, some areas of the body, such as the pretibial area, still show an unsatisfactory response and a more significant impact on patient quality of life. This multicentre study focuses on psoriasis affecting sensitive areas (particularly the pretibial area), its impact on quality of life and the therapeutic response to risankizumab., Methods: This multicentre prospective observational study recruited patients with moderate-to-severe psoriasis with pretibial area involvement. All patients underwent treatment with risankizumab (150 mg every 3 weeks), and efficacy was assessed after 24 weeks., Results: The study included 128 patients with a mean age of 51 years, suffering from moderate-to-severe psoriasis with involvement of the pretibial area with median total Psoriasis Area Severity Index score of 17.05 and Dermatology Life Quality Index of 16.27. The group was further divided into two sub-groups: the 'mother patch' group, in whom the very first psoriatic plaque appeared in the pretibial region (45 patients), and the 'non-mother patch' group, in whom the psoriatic lesion in the pretibial region was present but not as the first manifestation (83 patients). In order to better assess the involvement of psoriasis in the pretibial area, the pretibial plaque lesion severity index was also calculated at baseline in all patients: extent 2.75, erythema 2.64, infiltration 2.45 and desquamation 2.38. All participants in this study showed a good therapeutic response, with a reduction in all scores., Conclusions: The pretibial area is becoming an object of therapeutic interest due to some resistance to clearance and the consequent impairment of patient quality of life. This study showed that risankizumab can give favourable therapeutic results not only in patients with moderate-to-severe psoriasis with involvement of the difficult-to-treat areas but particularly in patients with recalcitrant plaques in the pretibial area., Competing Interests: Disclosure and potential conflicts of interest: The authors declare that they have no conflicts of interest relevant to this manuscript. All other authors declare no conflict of interest. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2024/08/dic.2024-6-3-COI.pdf, (Copyright © 2024 Bernardini N, Skroza N, Atzori L, Mugheddu C, Megna M, Cacciapuoti S, Ortoncelli M, Montesu MA, Carpentieri A, Carriero M, Atzori MG, Addis G, Balestri R, Rech G, Bruni P, Papini M, Potenza C.)

Published
2024
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31. Drug Survival, Safety, and Effectiveness of Secukinumab for up to 5 Years in Patients with Psoriasis and Psoriatic Arthritis: A Long-Term Real-Life Experience.

Author

Mastorino L, Dapavo P, Cariti C, Susca S, Siliquini N, Ortoncelli M, Stroppiana E, Verrone A, Giunipero di Corteranzo I, Leo F, Quaglino P, and Ribero S

Abstract

Introduction: the selective IL-17 inhibitor secukinumab has demonstrated efficacy and safety in the treatment of moderate-severe psoriasis in recent years., Objective: evaluate effectiveness and drug survival (DS) of secukinumab in patients with psoriasis for up to 5 years., Methods: This is a retrospective study on a monocentric cohort of patients with psoriasis on secukinumab evaluating the achievement of PASI100, PASI90, and PASI ≤ 3 and DS analysis up to 260 weeks. DS multivariate analysis was carried out considering sex, age, age of onset of the disease, obesity, cardiovascular comorbidities, diabetes, involvement of difficult-to-treat sites, psoriatic arthritis, treatment-naïve status, and mean baseline PASI., Results: At baseline, we evaluated 255 patients on secukinumab. PASI100 was reached by 41.7% and 70.6% of patients at weeks 16 and 260, respectively. PASI90 showed a similar trend with 46.5% of patients achieving it at week 16 and 88.2% at week 260. Non-obese patients showed a faster response than patients with obesity in achieving PASI100, PASI90, and PASI ≤ 3, with significant differences at 28 weeks [55% vs. 40% ( p = 0.033), 64% vs. 49% ( p = 0.038), and 76% vs. 62% ( p = 0.036), respectively]. The estimated DS for secukinumab was 84.3% at 12 and 48% at 60 months. Obesity and smoking habits were associated with a higher risk of discontinuation in multivariate models (HR 1.6 CI 1.05-2.45, p = 0.028; HR 1.48 CI 1.01-2.17, p = 0.043, respectively)., Conclusions: Secukinumab showed effectiveness for up to 5 years of treatment, with a high DS and achievement of PASI100, PASI90, and PASI < 3 at these time points. Only obesity reduced the response and maintenance of DS.

Published
2024
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32. Management of Patients Affected by Moderate-to-Severe Atopic Dermatitis with JAK Inhibitors in Real-World Clinical Practice: An Italian Delphi Consensus.

Author

Gargiulo L, Ibba L, Malagoli P, Burroni AG, Chiricozzi A, Dapavo P, Ferrucci SM, Gola M, Napolitano M, Ortoncelli M, Rossi MT, Sciarrone C, Costanzo A, and Narcisi A

Abstract

Introduction: Several systemic therapies have been approved for the treatment of severe AD. In particular, Janus kinase inhibitors (JAKi), including abrocitinib, baricitinib, and upadacitinib, recently received approval for the treatment of patients with severe AD after being evaluated in several clinical trials. However, a few concerns have been raised regarding their long-term safety and the management of these drugs in real-world clinical practice. In this article we described the results of a Delphi consensus aimed at describing the knowledge on JAKi and focusing, in particular, on providing clinical recommendations for dermatologists in daily practice regarding the use of these drugs., Methods: Twelve Italian dermatologists reviewed the most recent literature regarding the efficacy and safety profiles of JAKi and proposed 24 statements., Results: Agreement was reached for statements focusing on three main topics: (1) place in therapy of JAKi in patients with moderate-to-severe AD; (2) effectiveness and safety of JAK inhibitors in different phenotypes; (3) different approaches to the management of patients treated with JAKi in clinical practice. The panel proposed several recommendations regarding all the statements., Conclusion: Given the wide use of JAKi in clinical practice, it is crucial to establish a specific follow-up for each patient's phenotype in order to achieve the best possible clinical outcome and minimize potential adverse events., (© 2024. The Author(s).)

Published
2024
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33. Drug Survival of Upadacitinib and Predicting Factors of Discontinuation in Adult Patients Affected by Moderate-to-Severe Atopic Dermatitis: An Italian Multicenter Analysis.

Author

Pezzolo E, Ortoncelli M, Ferrucci SM, Guanti MB, Schena D, Napolitano M, Rossi M, Foti C, D'Amico D, Amoruso GF, Morrone P, Ribero S, Barei F, Biagi M, Pascucci E, Patruno C, Calzavara Pinton P, Romita P, Gargiulo L, Narcisi A, and Naldi L

Abstract

Background: Limited real-world data are available on upadacitinib drug survival in patients with atopic dermatitis (AD). Objectives: To investigate upadacitinib drug survival, and the reasons and predictors of drug discontinuation in AD patients. Methods: All consecutive patients aged 18-75 years, affected by moderate-to-severe AD, and treated with upadacitinib for more than 1 month at dermatological clinics were included during November 2020-August 2023. Upadacitinib survival was investigated through Kaplan-Meier survival analysis and the predictors through multivariable logistic regression analysis. Results: Overall, 325 adult AD patients (mean (SD) age, 38.6(15.6) years) had a 1-year and 1.5-year upadacitinib drug survival of 91.5% and 80.2%, respectively. The main reasons for drug discontinuation (25/325, 7.7%) were adverse events (4.9%), including cutaneous or infectious diseases (1.5%), such as acne and herpes zoster; blood test changes (1.2%), including hypercholesterolemia, creatine phosphokinase or liver enzyme elevation, and lymphopenia; urinary or respiratory infections (0.9%); deep venous thrombosis (0.3%); malignancies (0.3%); loss of consciousness (0.3%); and arthralgias (0.3%); followed by ineffectiveness (0.6%). No specific characteristic was significantly associated with an increased risk of upadacitinib discontinuation. Conclusions: Our findings show that upadacitinib was effective in moderate-to-severe AD after more than 1 year of continuous treatment but point to the need for clinical and laboratory monitoring of patients.

Published
2024
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34. Burden of Disease in the Real-Life Setting of Patients with Atopic Dermatitis: Italian Data From the MEASURE-AD Study.

Author

Argenziano G, Mercuri SR, Savoia P, Amerio P, Fortina AB, Bongiorno MR, De Felici Del Giudice MB, Parodi A, Pimpinelli N, Stingeni L, Ortoncelli M, Stinco G, Gualberti G, Levi A, Scuderi V, Bianchi L, and Malara G

Abstract

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease that negatively impacts the quality of life and work productivity of patients., Objectives: We sought to evaluate the real-world burden of AD patients in Italy., Methods: This sub-analysis of the MEASURE-AD multicountry study conducted between December 2019-2020 included patients diagnosed with moderate-to-severe AD eligible for or receiving systemic therapy in the previous 6 months. During a single visit, physician and patient-reported questionnaires were used., Results: A total of 118 adult patients were enrolled and 57.6% (N = 68) of patients had moderate-to-severe AD at the time of enrolment according to the Eczema Area and Severity Index. Sleep disorders interfered with daily function in the previous week in 58.5% (N = 69) of patients, pruritus was severe in 50% (N = 59) and 42.4% (N = 50) reported a flare lasting >7 days in the previous 6 months. According to the Dermatology Quality of Life Index, 37.3% (N = 44) of patients reported a severe impact of AD and approximately 10% had clinical depression/anxiety. Current drug therapy was considered inadequate in controlling AD in 26.3% (N=31) of patients. Work activity impairment was 38.6±31.7% and monthly AD-related expenses were 148.6±134.6 Euros per patient., Conclusions: This real-life study documents a high burden of disease in patients with moderate-severe AD in Italy.

Published
2024
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35. Interclass Switch between IL17 and IL23 Inhibitors in Psoriasis: A Real-Life, Long-Term, Single-Center Experience.

Author

Giordano S, Dapavo P, Ortoncelli M, Stroppiana E, Verrone A, Quaglino P, Ribero S, and Mastorino L

Abstract

Background: Interleukin 23 (IL-23) inhibitors, such as guselkumab, risankziumab, and tildrakizumab, have proved to be highly effective and safe for psoriasis treatment either in bio-naïve or bio-experienced patients. A substantial proportion of patients show a primary or secondary inefficacy to IL-17 inhibitors and can benefit from an alternative line of treatment, like IL-23 inhibitors. To date, no sufficient data are available on the effectiveness of IL-23 inhibitors after an anti-IL-17 agent., Methods: Our study includes 48 patients with moderate to severe psoriasis undergoing a switch from IL-17 to IL-23 inhibitors. This trial is registered with SS&#95;DERMO&#95;20., Results: The mean PASI (Psoriasis Area Severity Index) decreases from 11.6 to 3.3 at week 16, with responses maintained at weeks 28 and 52 (2 and 1.4, respectively), and a PASI100 achievement in more than 24% of patients at 16 weeks and 61.9 at 48 weeks, with no occurrence of serious adverse events. However, almost one in six patients interrupted the IL-23 inhibitors mainly due to primary ineffectivenss., Conclusions: Our data support the evidence that an interclass switch among IL-17 inhibitors is a safe and effective therapeutic option for these patients.

Published
2023
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36. A 52-week multicenter retrospective real-world study on effectiveness and safety of dupilumab in children with atopic dermatitis aged from 6 to 11 years.

Author

Patruno C, Fabbrocini G, Lauletta G, Boccaletti V, Colonna C, Cavalli R, Neri I, Ortoncelli M, Schena D, Stingeni L, Hansel K, Piccolo V, Di Brizzi V, Potenza C, Tolino E, Bianchi L, Manti S, De Pasquale R, Di Lernia V, Caminiti L, Galli E, Coppo P, Chiricozzi A, De Simone C, Guerriero C, Amoruso FG, Provenzano E, Leonardi S, Licari A, Marseglia GL, Palermo A, Di Pillo S, Russo D, Moschese V, Patella V, Peduto T, Ferreli C, Zangari P, Veronese F, Berti SF, Gruber M, Pezzolo E, Termine S, Satta R, Dragoni F, Esposito M, Fargnoli MC, Chiodini P, Vallone Y, di Vico F, Picone V, and Napolitano M

Subjects
Humans, Child, Retrospective Studies, Double-Blind Method, Treatment Outcome, Severity of Illness Index, Dermatitis, Atopic drug therapy, Dermatitis, Atopic diagnosis
Abstract

Background: Dupilumab has been shown to be a safe and effective drug for the treatment of atopic dermatitis (AD) in children from 6 months to 11 years in randomized clinical trials. Aim: The aim of this real-life study was to determine the effectiveness in disease control and safety of dupilumab at W52 in moderate-to-severe AD children aged 6-11 years. Methods: All data were collected from 36 Italian dermatological or paediatric referral centres. Dupilumab was administered at label dosage with an induction dose of 300 mg on day 1 (D1), followed by 300 mg on D15 and 300 mg every 4 weeks (Q4W). Treatment effect was determined as overall disease severity, using EASI, P-NRS, S-NRS and c-DLQI at baseline, W16, W24, and W52. Ninety-six AD children diagnosed with moderate-to-severe AD and treated with dupilumab were enrolled. Results: Ninety-one (94.8%) patients completed the 52-week treatment period and were included in the study. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to weeks 16, 24 and 52. Conclusions: Our real-life data seem to confirm dupilumab effectiveness and safety in paediatric patients. Moreover, our experience highlighted that patients achieving clinical improvement at W16 preserved this condition over time.

Published
2023
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37. Aging Impact in Response to Different Classes of Biological Treatment in Psoriatic Patients: A Real-Life Observational Study.

Author

Rosset F, Mastorino L, Dapavo P, Ortoncelli M, Quaglino P, and Ribero S

Abstract

Over the last decade, the treatment landscape for moderate to severe psoriasis has undergone transformative changes with the advent of biotechnological drugs. Monoclonal antibodies targeting the IL-17 and IL-23 pathways have displayed remarkable clinical efficacy and safety, even among patients with complex comorbidities. These innovations have extended across various age groups within the psoriatic population. However, a scarcity of age-specific data remains regarding the efficacy and safety of these medications. Our study tries to bridge this gap by systematically presenting data obtained from the analysis of 1055 patients treated for psoriasis with anti-IL17 and anti-IL23 drugs during a 1-year period. The effectiveness and safety of anti-IL-17 and anti-IL23 drugs for moderate to severe psoriasis were assessed across four different age groups ranging from patients less than 26 years old to patients older than 65 years, divided in four year ranges. In the studied population, baseline PASI score was significantly higher in the age group of individuals over 65 years compared to those under 26 years old. Patients over 65 years also exhibited a slower rate of improvement in PASI-90 and PASI < 3 at the 16-week mark compared to other age groups. However, no clinically significant differences in treatment response were found when comparing overall responses among different age groups. In age groups older than 26 years, anti-IL17 drugs seems faster in the achievement of PASI-100 when compared to anti-IL23 drugs. This trend became more pronounced with increasing age. The investigation provides insights into treatment responses and patient characteristics, highlighting the influence of age as a significant variable in patient management.

Published
2023
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38. Is Dupilumab as Effective in Intrinsic Atopic Dermatitis as It Is in Extrinsic Atopic Dermatitis?

Author

Gelato F, Mastorino L, Stepkina E, Cavaliere G, Ribero S, Quaglino P, and Ortoncelli M

Abstract

Atopic dermatitis (AD) can be subclassified into the more frequent extrinsic type (EAD), with elevated serum IgE levels and frequent association with other atopic conditions, and the less frequent intrinsic type (IAD), with normal IgE levels and no history of atopy. This retrospective study has the objective to compare the efficacy of dupilumab therapy in patients with IAD versus EAD in a real-life setting. We studied a group of 360 patients treated with dupilumab for moderate-to-severe AD of whom 49 had IAD (IgE < 200 kU/L and no history of other atopic conditions) and 311 had EAD (IgE ≥ 200 kU/L and/or history of atopy). There were no statistically significant differences in the achievement of EASI75 between IAD and EAD patients either at 16, 32, or 48 weeks (61% vs. 50%; 66% vs. 60%; and 53% vs. 65%, respectively). Similarly, there were no statistically significant differences in the achievement of EASI90 or the reduction in NRSpp, NRSsd, and DLQI at each timepoint. Additionally, mean absolute eosinophils and IgE values were significantly higher in the EAD group at all timepoints. This study confirms that dupilumab, targeting the Th2 pathway, which is known to be overexpressed in all AD phenotypes, appears to be equally effective in the two populations regardless of IgE levels.

Published
2023
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39. Effectiveness and Safety of Upadacitinib in the Treatment of Moderate-Severe Atopic Dermatitis: A Multicentric, Prospective, Real-World, Cohort Study.

Author

Chiricozzi A, Gori N, Narcisi A, Balato A, Gambardella A, Ortoncelli M, Marzano AV, Balestri R, Palazzo G, Pellegrino M, Romanelli M, Tripepi G, Peris K, and Costanzo A

Subjects
Adult, Cohort Studies, Heterocyclic Compounds, 3-Ring, Humans, Prospective Studies, Quality of Life, Severity of Illness Index, Treatment Outcome, Dermatitis, Atopic drug therapy
Abstract

Background: The efficacy and safety of upadacitinib in atopic dermatitis (AD) have been defined in clinical trials, but no real-world data are currently available. We aimed to assess the safety and effectiveness of upadacitinib in a real-world AD patient cohort that mostly included patients who failed the available systemic therapies, including dupilumab., Methods: Prospective cohort study collecting data on upadacitinib-treated AD adult patients completing at least 16 weeks of therapy., Results: Forty-three patients showed rapid and marked response to upadacitinib with significant reduction of all disease severity scores since the first follow-up visit. At week 16, Eczema Area and Severity Index (EASI) 75, EASI 90, and EASI 100 response was observed in 97.5%, 82.1%, and 69.2% of patients, respectively. EASI 90 response reflected the achievement of a clear or almost clear condition (POEM 0-2), self-evaluated by 79.5% of patients. Patients' quality of life improved as suggested by the achievement of DLQI 0/1 by 38.5% of patients at week 4, and by 76.9% at week 16., Conclusion: Elevated effectiveness and favorable safety of upadacitinib were confirmed in patients unresponsive to dupilumab, who were not included in upadacitinib trials., (© 2022. The Author(s).)

Published
2022
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40. Chronic Pruritus in Atopic Patients Treated with Dupilumab: Real Life Response and Related Parameters in 354 Patients.

Author

Mastorino L, Rosset F, Gelato F, Ortoncelli M, Cavaliere G, Quaglino P, and Ribero S

Abstract

Chronic pruritus is a major symptom of atopic dermatitis (AD). Its etiopathogenesis is complex, and an understanding of the driving factors of its pathogenesis allows for the development of new molecule-targeted therapies. Dupilumab, targeting and blocking interleukin-4 (IL-4) and interleukin-13 (IL-13) molecules, has shown great efficacy in treating AD symptoms such chronic itching. We performed a retrospective observational study to evaluate possible chronic-itch-related characteristics and parameters in 356 AD patients who received dupilumab. The objective of the study was to evaluate the factors associated with the level of pruritus reported by patients at each of the 1575 detections in the form of the peak pruritus numerical rating scale (NRSpp) and sleep disturbance numerical rating scale (NRSsd). We focused on: the eczema area and severity index (EASI), dermatology life quality index (DLQI), patient-oriented eczema measure (POEMS), eosinophilia, L-lactate dehydrogenase (LDH), immunoglobulin E (IgE) and the time from the start of dupilumab therapy. NRSpp fell from 8.6 (sd 1.7) at baseline to 1.7 (sd 2.3) at 36 months and NRSsd from 7 (sd 3) to 0. Regarding the parameters that correlate with NRSpp, all the parameters analysed were significantly correlated except for eosinophils (p = 0.136). In the multivariate analysis, both considering and not considering treatment duration, the parameters were correlated (p < 0.001); EASI, DLQI, POEM, and LDH significantly correlated with NRSpp (p < 0.001 for each, except for LDH p = 0.003); while IgE tot lost significance (p = 0.337). Similar results were obtained for the parameters correlating with NRSsd. Our results confirm the efficacy of dupilumab on pruritus. The use of questionnaires such as DLQI and POEM is advisable in clinical practice and is adequate for assessing the impact of itching on AD. The low correlation of IgE and eosinophils, the ambiguity of LDH levels with the level of pruritus, and a poor clinical validity and unclear correlation with disease severity suggest a progressive abandonment of monitoring of these values.

Published
2022
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42. Real-life Effectiveness and Safety of Risankizumab in Moderate-to-severe Plaque Psoriasis: A 40-week Multicentric Retrospective Study.

Author

Borroni RG, Malagoli P, Gargiulo L, Valenti M, Pavia G, Facheris P, Morenghi E, Di Corteranzo IG, Narcisi A, Ortoncelli M, Dapavo P, and Costanzo A

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

Risankizumab is a humanized monoclonal antibody that binds the p19 subunit of interleukin-23. It is approved for treatment of moderate-severe chronic plaque psoriasis. This retrospective study included 66 consecutive adults with moderate-to-severe psoriasis vulgaris treated with risankizumab in monotherapy up to week 40 in a "real-life" setting. At week 40, 98.7%, 85.7% and 62.3% of patients achieved a Psoriasis Area and Severity Index (PASI) reduction ≥ 75% (PASI 75), PASI 90 and PASI 100, respectively. Patients who had not responded to 2 or more previous biologic treatments were significantly less likely to achieve PASI 75/90 at week 16 and PASI 90/100 at week 40 compared with those who had been previously treated with only 1 biologic, and compared with those treated with risankizumab as a first-line biologic. Increasing body mass index decreased the chances of reaching PASI 90 at week 40. No significant safety findings were recorded throughout the study, and none of the patients had to interrupt the treatment. These data suggest that the efficacy of risankizumab for plaque psoriasis in "real-life" clinical practice could differ from pivotal clinical trials data.

Published
2021
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43. A real-world economic analysis of biologic therapies for moderate-to-severe plaque psoriasis in Italy: results of the CANOVA observational longitudinal study.

Author

Zagni E, Bianchi L, Fabbrocini G, Corrao S, Offidani A, Stingeni L, Costanzo A, Pellacani G, Peris K, Bardazzi F, Argenziano G, Ruffolo S, Dapavo P, Carrera C, Fargnoli MC, Parodi A, Romanelli M, Malagoli P, Talamonti M, Megna M, Raspanti M, Paolinelli M, Hansel K, Narcisi A, Conti A, De Simone C, Chessa MA, De Rosa A, Provenzano E, Ortoncelli M, Moltrasio C, Fidanza R, Burlando M, Tonini A, Gaiani FM, Simoni L, Zullo A, Fiocchi M, and Colombo D

Subjects
Antibodies, Monoclonal therapeutic use, Biological Therapy, Humans, Italy, Longitudinal Studies, Severity of Illness Index, Treatment Outcome, Psoriasis drug therapy, Quality of Life
Abstract

Background: Psoriasis is a chronic immune-mediated inflammatory skin disease which can also involve joints. It is often associated with burdensome comorbidities which negatively impact prognosis and quality of life (QoL). Biologic agents have been shown to be effective in controlling disease progression, but their use is associated with higher costs compared with traditional systemic treatments. The economic analysis of the CANOVA (EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: an obserVAtional longitudinal study of real-life clinical practice) study aims to assess the costs and cost-effectiveness of biologics in a real-world context in Italy., Methods: The annualised overall direct costs of moderate-to-severe plaque psoriasis management, the annualised cost of biologic drugs and the cost per responder in the Italian National Health System perspective were assessed. More specifically, the cost per response and cost per sustained response of the most prescribed biologic therapies for the treatment of moderate-to-severe plaque psoriasis within the CANOVA study were assessed using the Psoriasis Area Severity Index (PASI) at several score levels (75, 90 and 100%)., Results: The most frequently used biologic therapies for plaque psoriasis were secukinumab, ustekinumab, adalimumab originator, and ixekizumab. Cost of biologics was the driver of expenditure, accounting for about 98% of total costs. Adalimumab originator was the biologic with the lowest cost per responder ratio (range: €7848 - €31,378), followed by secukinumab (range: €9015 - €33,419). Ustekinumab (range: €11,689 - €39,280) and ixekizumab (range: €11,092 - €34,289) ranked respectively third and fourth, in terms of cost-effectiveness ratio. As concerns the cost per sustained response analysis, secukinumab showed the lowest value observed (€21,375) over the other options, because of its high response rate (86% vs. 60-80%), which was achieved early in time., Conclusion: Biologic therapy is a valuable asset for the treatment of moderate-to-severe plaque psoriasis. Concomitant assessment of treatment costs against the expected therapeutic response over time can provide physicians and payers additional insights which can complement the traditional risk-benefit profile assessment and drive treatment decisions., (© 2021. The Author(s).)

Published
2021
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44. Dupilumab in HIV-positive patients with atopic dermatitis: a long-term follow-up patient and a literature review.

Author

Avallone G, Trunfio M, Giura MT, Siliquini N, Viola R, Orofino G, Mastorino L, Ortoncelli M, Quaglino P, and Ribero S

Subjects
Antibodies, Monoclonal, Humanized adverse effects, CD4 Lymphocyte Count, Dermatitis, Atopic complications, Female, Follow-Up Studies, HIV Seropositivity complications, Humans, Male, Middle Aged, Antibodies, Monoclonal, Humanized therapeutic use, Dermatitis, Atopic drug therapy, HIV Seropositivity drug therapy
Abstract

Dupilumab is an IgG4 human monoclonal antibody licensed for the treatment of moderate-to-severe atopic dermatitis. Despite evidence suggesting that T helper type two cytokines can modulate HIV-1 replication and anti-HIV-specific immune responses, impacting on viral reservoirs, HIV-positive patients under immunomodulating therapy have been excluded from clinical trials. We report a 47-year-old HIV-positive man with late-onset severe atopic dermatitis, treated with dupilumab and followed up for 27 months. Improvements in skin lesions and quality of life were observed after four months. Blood tests showed normalization of IgE levels, with the clinical condition remaining stable at a 27- month follow-up. We gathered 16 other cases reported in the literature of HIV-positive patients treated with dupilumab, with no, or few adverse reactions, for which it is unclear if dupilumab should be held accountable. With our case and literature review, we aim to shed light on dupilumab efficacy, safety, and tolerability among HIV-positive patients suffering from atopic dermatitis. In this regard, future research should focus on the effective role, underlying mechanisms, and efficacy of dupilumab in HIV-positive patients and HIV-positivity could be questioned as a valid exclusion criterion for clinical trials.

Published
2021
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