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2. 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

3. Biosimilar infliximab: An expert view

Author

Genazzani, A., Altomare, G., Balato, N., Cusano, F., Depità, O., Loconsole, F., Giuseppe MICALI, Piaserico, S., Girolomoni, G., Genazzani, A, Altomare, G, Balato, Nicola, Cusano, F, De Pità, O, Loconsole, F, Micali, G, Piaserico, S, and Girolomoni, G.

Subjects
Ankylosing, Arthritis, Biosimilar pharmaceuticals, Dermatology, Infliximab, Rheumatoid, Spondylitis, 2708, Antibodies, Monoclonal, Molecular Weight, Italy, Humans, spondylitis, ankylosing, Drug Approval
Abstract

CT-P13, a biosimilar of infliximab, was the first biosimilar monoclonal antibody to be approved in both the European Union and Korea. As a monoclonal antibody, CT-P13 is a large molecule with a high molecular weight, and as such it differs from other biosimilars currently in the market. The comparability exercise for CT-P13, therefore, requires special consideration, as it was the first demonstration of biosimilarity between a biosimilar monoclonal antibody and its originator. This paper summarizes current regulations on the approval of biosimilars, describes the evidence leading to the approval of CT-P13, and discusses the potential role of this molecule in the Italian scenario on the basis of the view of a group of experts.

Published
2015

4. The Italian Euromelanoma Day: evaluation of results and implications for future prevention campaigns

Author

BONGIORNO, Maria Rita, Suppa, M, Altomare, G, Cannavò, SP, Capizzi, R, Catricalà, C, Colombo, E, Fargnoli, MC, Fossati, B, Frascione, P, Lisi, P, Santini, M, Scalvenzi, M, Peris, K, Italian investigators for the Euromelanoma prevention campaign, Suppa, M, Altomare, G, Cannavò, Sp, Capizzi, R, Catricalà, C, Colombo, E, Fargnoli, Mc, Fossati, B, Frascione, P, Lisi, P, Santini, M, Scalvenzi, Massimiliano, Peris, K, Italian investigators for the Euromelanoma prevention, c. a. m. p. a. i. g. n., Bongiorno, MR, Cannavò, SP, Fargnoli, MC, Scalvenzi, M, and Italian investigators for the Euromelanoma prevention campaign.

Subjects
Male, Questionnaires, Pediatrics, Skin Neoplasms, Health Behavior, Surveys and Questionnaires, inglese, 80 and over, Settore MED/35 - Malattie Cutanee E Veneree, Mass Screening, Medicine, Skin cancer, Young adult, Child, Melanoma, Early Detection of Cancer, Aged, 80 and over, integumentary system, Incidence (epidemiology), Middle Aged, Day screening campaign, Predictive value, Europe, Italy, Child, Preschool, Sunlight, Female, Risk assessment, Cutaneous malignant melanoma, Adult, medicine.medical_specialty, Adolescent, Dermoscopy, Health Promotion, Dermatology, Risk Assessment, Young Adult, Humans, Preschool, Mass screening, Aged, business.industry, medicine.disease, Surgery, Melanoma detection, Anniversaries and Special Events, Health promotion, business, Program Evaluation
Abstract

Background Melanoma incidence/mortality is increasing worldwide. “Euromelanoma Day” is a pan-European campaign for skin cancer prevention. Results of the 2010 Euromelanoma Day in Italy are reported herein. Materials and methods A questionnaire was used to collect data on participants' characteristics and suspected skin cancers. Result A total of 1085 participants was screened (64.1% females, median age 44 years). Suspicion rate, detection rate, and positive predictive values for melanoma were 1.3, 0.28 and 21.4%, respectively. Poorly educated, ≥35 years old, pale-skinned males were at higher risk for skin cancer than highly educated

Published
2014

5. Differential management of mild-to-severe psoriasis with biologic drugs: An Italian Delphi consensus expert panel

Author

Girolomoni, Giampiero, Altomare, G, Ayala, F, Berardesca, E, Calzavara Pinton, P, Chimenti, S, Martini, P, Peserico, A, Puglisi Guerra, A, Antonio Vena, G, on behalf on the Delphi working group, Girolomoni, Giampiero, Altomare, Gianfranco, Ayala, Fabio, Berardesca, Enzo, Calzavara Pinton, Piergiacomo, Chimenti, Sergio, Martini, Patrizia, Peserico, Andrea, Puglisi Guerra, Antonio, and Antonio Vena, Gino

Subjects
medicine.medical_specialty, Pathology, Special populations, Consensus, Discoid lupus erythematosus, Alternative medicine, Consensu, Dermatology, Etanercept, Psoriasis, Surveys and Questionnaires, medicine, Humans, Surveys and Questionnaire, survey, Severe psoriasis, computer.programming_language, Psoriasi, Biological Products, clinical recommendations, treatment choice, business.industry, medicine.disease, Biological Therapy, Family medicine, Biological Product, business, computer, Delphi, Clinical recommendation, Human
Abstract

In the management of moderate-to-severe psoriasis, increasingly complex clinical scenarios necessitate practical tools for appropriate biologic therapy selection in individual patients. An Italian Delphi consensus panel provided guidance on biologic use in selected clinical scenarios. Methods: Ten experts defined statements under consideration, which were distributed as an online survey to a dermatologist panel. Plenary discussions of contentious statements were held to achieve consensus. Results: The survey was sent to 30 clinicians. After plenary discussions, consensus was reached on all 20 statements on the following topics: special populations; infections; comorbidities; immunogenicity; extra-cutaneous involvement; pregnancy; and adherence. Three statements required further discussion in order to gain consensus: use of subcutaneous biologics in mild liver impairment (final 94% agreement), use of any biologic in discoid lupus erythematosus (final 100% disagreement), and use of etanercept in patients with history of hypersensitivity reactions to drugs and/or food (final 75% disagreement). Conclusions: This Delphi expert consensus on the use of biologics in psoriasis provides practical recommendations for dermatologists to use when choosing an appropriate biologic in challenging but common clinical scenarios. More data are required to clarify clinical differences of biologic drugs used to treat psoriasis. © 2014 Informa UK Ltd.

Published
2015

6. 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

7. Transition to ustekinumab in patients with moderate-to-severe psoriasis and inadequate response to methotrexate:a randomized clinical trial (TRANSIT)

Author

Adamski, Z, Altomare, G, Aricò, M, Aste, N, Aubin, F, Augustin, M, Ayala, F, Bachelez, H, Baran, E, Barker, J, Belinchón, I, Berbis, P, Bernengo, Mg, Bessis, D, Beylot Barry, M, Bordas Orpinell, Fj, Burden, D, Bylaite, M, Cambazard, F, Carazo, S, Carrascosa, Jm, Carretero, G, Cerio, R, Chimenti, S, David, M, Duval Modeste, Ab, Eedy, D, Estebaranz, L, Filipe, P, Flytström, I, Fonseca, E, Gamanya, R, Ghislain, Pd, Giannetti, A, Girolomoni, G, Gospodinov, D, Griffiths, C, Grob, Jj, Guillet, G, Hernanz Hermosa, Jm, Hoffmann, M, Ioannidis, D, Jacobi, A, Jemec, G, Kadurina, M, Kaszuba, K, Katsambas, A, Kemeny, L, Kerkhof, P, Kragballe, K, Kuzmina, N, Lambert, K, Lázaro, P, Lotti, T, Luger, T, Matz, H, Modiano, P, Moessner, R, Moreno, D, Moreno Jímenez, Jc, Mørk, Nj, Mrowietz, U, Murphy, R, Nicolas, Jf, Nikkels, A, Oliveira, H, Ormerod, A, Ortonne, Jp, Parodi, A, Pasternack, R, Paul, C, Pec, J, PESERICO STECCHINI NEGRI DE SALVI, Andrea, Philipp, S, Piquet, L, Plantin, P, Puig, L, Reich, K, Reményik, E, Riedl, E, Röcken, M, Rustin, M, Saari, S, Saiag, P, Salmhofer, W, Schadendorf, D, Sebastian, M, Simaljakova, M, Simon, Jc, Spirén, A, Stalder, Jf, Stavrianeas, N, Sticherling, M, Ternowitz, T, Thaci, D, Thio, B, Uhlig, D, Valiukeviciene, S, Vanaclocha Sebastián, Fj, and Wozel, G.

Subjects
Male, medicine.medical_specialty, Dermatology, Antibodies, Monoclonal, Humanized, ustekinumab, methotrexate, law.invention, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Psoriasis Area and Severity Index, law, Psoriasis, Internal medicine, Ustekinumab, Clinical endpoint, Medicine, Humans, 030212 general & internal medicine, Dose-Response Relationship, Drug, business.industry, Drug Substitution, digestive, oral, and skin physiology, Dermatology Life Quality Index, psoriasis, Middle Aged, medicine.disease, 3. Good health, Discontinuation, Surgery, Clinical trial, Treatment Outcome, Female, Dermatologic Agents, business, medicine.drug
Abstract

Background: limited data exist on transitioning patients with psoriasis from conventional systemic agents to biologics. Objectives: the TRANSIT study aimed to assess the efficacy and safety of two methotrexate-to-ustekinumab transition strategies. Methods: patients with moderate-to-severe psoriasis and inadequate methotrexate response were randomized 1 : 1 to receive ustekinumab with immediate (arm 1) or 4-week gradual (arm 2) methotrexate withdrawal. Patients weighing ≤ 100 kg or > 100 kg received ustekinumab 45 mg or 90 mg, respectively. The primary endpoint was the frequency of adverse events (AEs) at week 12. Secondary endpoints included additional safety, efficacy and patient-reported outcomes. We report the 12-week efficacy and safety results. Results: overall, 244 patients in arm 1 and 245 in arm 2 were randomized and received ustekinumab. Four patients per arm discontinued the trial by week 12. At week 12 in arms 1 and 2, respectively, 61% and 65% of patients experienced an AE, 2·9% and 2·4% had a serious AE, and 1·2% and 0·4% had an AE leading to ustekinumab discontinuation. In arms 1 and 2, respectively, median Psoriasis Area and Severity Index (PASI) score decreased from 15·2 and 15·4 at baseline to 2·9 and 2·8 at week 12; 58% and 62% of patients achieved a 75% reduction from baseline in PASI score (PASI 75) at week 12; median baseline Dermatology Life Quality Index fell from 8 and 9 at baseline to 1 (both arms) at week 16. Conclusions: ustekinumab was well tolerated and effective in patients who had an inadequate response to methotrexate. Both transition strategies resulted in similar week 12 safety and efficacy outcomes.

Published
2013
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8. One-year safety and efficacy of ustekinumab and results of dose adjustment after switching from inadequate methotrexate treatment: the TRANSIT randomized trial in moderate-to-severe plaque psoriasis

Author

Adamski, Z, Altomare, G, Aricò, M, Aste, N, Aubin, F, Augustin, M, Ayala, F, Bachelez, H, Baran, E, Barker, J, Belinchón, I, Berbis, P, Bernengo, Mg, Bessis, D, Beylot Barry, M, Bordas Orpinell, Fj, Burden, D, Bylaite, M, Cambazard, F, Carazo, S, Carrascosa, Jm, Carretero, G, Cerio, R, Chimenti, S, David, M, Duval Modeste, Ab, Eedy, D, Estebaranz, L, Filipe, P, Flytström, I, Fonseca, E, Gamanya, R, Ghislain, Pd, Giannetti, A, Girolomoni, G, Gospodinov, D, Griffiths, C, Grob, Jj, Guillet, G, Hernanz Hermosa, Jm, Hoffmann, M, Ioannidis, D, Jacobi, A, Jemec, G, Kadurina, M, Kaszuba, K, Katsambas, A, Kemeny, L, Kerkhof, P, Kragballe, K, Kuzmina, N, Lambert, K, Lázaro, P, Lotti, T, Luger, T, Matz, H, Modiano, P, Moessner, R, Moreno, D, Moreno Jímenez, Jc, Mørk, Nj, Mrowietz, U, Murphy, R, Nicolas, Jf, Nikkels, A, Oliveira, H, Ormerod, A, Ortonne, Jp, Parodi, A, Pasternack, R, Paul, C, Pec, J, PESERICO STECCHINI NEGRI DE SALVI, Andrea, Philipp, S, Piquet, L, Plantin, P, Puig, L, Reich, K, Reményik, E, Riedl, E, Röcken, M, Rustin, M, Saari, S, Saiag, P, Salmhofer, W, Schadendorf, D, Sebastian, M, Simaljakova, M, Simon, Jc, Spirén, A, Stalder, Jf, Stavrianeas, N, Sticherling, M, Ternowitz, T, Thaci, D, Thio, B, Uhlig, D, Valiukeviciene, S, Vanaclocha Sebastián, Fj, and Wozel, G.

Subjects
Male, medicine.medical_specialty, Population, Dermatology, Antibodies, Monoclonal, Humanized, law.invention, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Psoriasis Area and Severity Index, Internal medicine, Psoriasis, Ustekinumab, Clinical endpoint, medicine, Humans, 030212 general & internal medicine, Adverse effect, education, education.field_of_study, Dose-Response Relationship, Drug, business.industry, Drug Substitution, Middle Aged, medicine.disease, 3. Good health, Surgery, Regimen, Methotrexate, Treatment Outcome, Female, Dermatologic Agents, business, psoriasis, ustekinumab, methotrexate, medicine.drug
Abstract

Background: There are limited long-term, ‘real-world’ data on ustekinumab, or the effect of dose adjustment in suboptimal responders. Objectives: We describe 52-week data from TRANSIT, which initiated ustekinumab by licensed regimen and investigated exploratory dose adjustment. Methods: Patients with moderate-to-severe psoriasis and inadequate methotrexate response received ustekinumab, with immediate or gradual methotrexate withdrawal. Outcomes were similar between treatment arms at week 12 (primary endpoint), so week 52 data were pooled. Patients weighing ≤ 100 kg or > 100 kg were administered ustekinumab 45 or 90 mg, respectively. Patients weighing ≤ 100 kg without 75% improvement in Psoriasis Area and Severity Index (PASI 75) response at weeks 28 or 40 received a dose adjustment to 90 mg. The primary analysis used observed data. Results: Overall, 391 and 98 patients received ustekinumab 45 and 90 mg, respectively. Forty-four patients (9%) discontinued before week 52 (0·4% due to adverse events). At week 52 (in the overall population), 369 patients (83%) achieved a PASI score ≤ 5, and 341 patients (77%) achieved PASI 75; the median PASI score decreased from 15 at baseline to 1·8. At weeks 28 and 40, 84 and 31 patients, respectively, did not achieve PASI 75 and received a dose adjustment; by week 52, 35/82 (43%) and 15/31 (48%) of these patients, respectively, achieved PASI 75 (two discontinued between weeks 28 and 40). Conclusions: Ustekinumab showed sustained 1-year efficacy and was well tolerated when initially administered according to label. Adjusting the ustekinumab dose to 90 mg may result in clinically meaningful improvement in response in patients weighing ≤ 100 kg with suboptimal initial response.

Published
2013
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9. Allergy to mercurochrome and rifamycin.

Author

Riboldl, A., Pigatto, P. D., Morelli, M., Altomare, G. F., and Polenghi, M. M.

Subjects
ALLERGIES, RIFAMYCINS, CONTACT dermatitis, MERCURIC chloride, PHENYLACETATES, DERMATOLOGY
Abstract

This article focuses on a study related to the allergy to medicines such as mercurochrome and rifamycin. In the present case, an 11-year-old boy had contact dermatitis to mercurochrome and rifamycin, but there was no personal or family history of allergy or intolerance to drugs or medicines. The use of mercurochrome and rifamycin were stopped and when the rash cleared, he was patch tested. There was positive reactions to mercurous ammonium chloride, mercurochrome, mercuric chloride and rifamycin, but no reaction to mercurous phenylacetate.

Published
1985
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10. Italian guidelines on the systemic treatments of moderate-to-severe plaque psoriasis

Author

Luca Bianchi, Francesca Prignano, Andrea Chiricozzi, Luigi Naldi, Fabio Ayala, Caterina Foti, Paolo Gisondi, Giampiero Girolomoni, Gianfranco Altomare, Luca Stingeni, Stefano Piaserico, Federico Bardazzi, A. Offidani, Andrea Parodi, Marina Talamonti, C. De Simone, Andrea Conti, Antonio Costanzo, Paolo Dapavo, Franco Rongioletti, Gisondi, P, Altomare, G, Ayala, Fabio, Bardazzi, F, Bianchi, L, Chiricozzi, A, Costanzo, A, Conti, A, Dapavo, P, De Simone, C, Foti, Lidia, Naldi, L, Offidani, A, Parodi Giusino, Ugo, Piaserico, S, Prignano, F, Rongioletti, F, Stingeni, L, Talamonti, M, Girolomoni, G., Ayala, F, Foti, C, Parodi, A, and Girolomoni, G

Subjects
medicine.medical_specialty, Pathology, MONOCLONAL-ANTIBODY, BIOLOGIC THERAPIES, LONG-TERM, HEPATITIS-B, Alternative medicine, MEDLINE, Italian guidelines, Dermatology, Severity of Illness Index, Italian guidelines, moderate-to-severe plaque psoriasis, law.invention, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Infectious Diseases, LATENT TUBERCULOSIS INFECTION, Psoriasis, Nominal group technique, Severity of illness, medicine, Humans, Evidence-Based Medicine, business.industry, Italy, 2708, RANDOMIZED CONTROLLED-TRIAL, INFLAMMATORY-BOWEL-DISEASE, DOUBLE-BLIND TRIAL, PHASE-III, ERYTHRODERMIC PSORIASIS, Evidence-based medicine, medicine.disease, moderate-to-severe plaque psoriasis, 030220 oncology & carcinogenesis, Facilitator, Family medicine, business, Settore MED/35 - MALATTIE CUTANEE E VENEREE
Abstract

Psoriasis is a common disease, which has a considerable impact on the healthcare system. Therefore, appropriate use of therapeutic resources is very important. Management of psoriasis in daily clinical practice is highly variable because many issues are still debated and not definitely addressed by the evidence-based medicine. Moreover, the different availability and reimbursability of drugs in each country justifies national guidelines. Expert consensus can provide helpful guidelines for optimizing patient care. A total of 20 dermatologists from different areas of Italy and with large experience in the treatment of psoriasis agreed to participate in the guidelines expert panel who aimed to reach consensus on the factors influencing psoriasis severity, the indications for systemic treatments, the parameters to be considered in the choice of treatment, and the factors to be considered in the choice of biological treatment. The recommendations for the use, screening and monitoring of systemic therapies were based on the 2015 S3 European Dermatology Forum/European Academy of Dermatology and Venereology psoriasis guidelines. Recommendations on the treatment of psoriasis in special patient populations were also agreed. The final document was discussed in a meeting moderated by a facilitator with participation of the entire group and adopting a nominal group technique to reach consensus. A statement was regarded as consented when agreement was achieved by at least 75% of the voting experts according to the Delphi procedure.

Published
2017

11. The impact of biologic therapy in chronic plaque psoriasis from a societal perspective: an analysis based on Italian actual clinical practice

Author

Giampiero Girolomoni, A. Puglisi Guerra, Sergio Chimenti, A. Vena Gino, Patrizia Martini, Barbara Polistena, Andrea Peserico, Piergiacomo Calzavara-Pinton, Federico Spandonaro, Enzo Berardesca, Fabrizio Ayala, Gianfranco Altomare, Polistena, B, Calzavara Pinton, P., Altomare, G., Berardesca, E., Girolomoni, G., Martini, P., Peserico, A., Puglisi Guerra, A., Spandonaro, F., Vena Gino, A., Chimenti, S., and Ayala, Fabio

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, chronic plaque psoriasis, Cost-Benefit Analysis, Dermatology, Settore SECS-P/06 - Economia Applicata, Drug Costs, Direct Service Costs, Etanercept, Growth hormone deficiency (GHD) Epidemiology Somatropin Device Efficiency, Young Adult, Indirect costs, Quality of life (healthcare), Cost of Illness, Infectious Diseases, Psoriasis, Adalimumab, Humans, Medicine, Prospective Studies, biologic therapy, Intensive care medicine, biologic therapy, chronic plaque psoriasis, Aged, Biological Products, Cost–benefit analysis, business.industry, Anti-Inflammatory Agents, Non-Steroidal, Middle Aged, medicine.disease, Infliximab, Quality-adjusted life year, Italy, Chronic Disease, Physical therapy, Female, Observational study, Quality-Adjusted Life Years, business, medicine.drug
Abstract

Objective Psoriasis is one of the most common forms of chronic dermatitis, affecting 2-3% of the worldwide population. It has a serious effect on the way patients perceive themselves and others, thereby prejudicing their quality of life and giving rise to a significant deterioration in their psycho-physical well-being; it also poses greater difficulties for them in leading a normal social life, including their ability to conduct a normal working life. All the above-mentioned issues imply a cost for the society. This study proposes to evaluate the impact on societal costs for the treatment of chronic plaque psoriasis with biologics (etanercept, infliximab and adalimumab) in the Italian clinical practice. Method A prospective observational study has been conducted in 12 specialized centres of the Psocare network, located throughout Italy. Direct and indirect costs (as well as the health-related quality of life of patients with plaque psoriasis undergoing biologic treatments) have been estimated, while the societal impact has been determined using a cost-utility approach. Results Non-medical and indirect costs account for as much as 44.97% of the total cost prior to treatment and to 6.59% after treatment, with an overall 71.38% decrease. Adopting a societal perspective in the actual clinical practice of the Italian participating centres, the ICER of biologic therapies for treating plaque psoriasis amounted to €18634.40 per QALY gained - a value far from the €28656.30 obtained by adopting a third-party payer perspective. Conclusion Our study confirms that chronic psoriasis subjects patients to a considerable burden, together with their families and caregivers, stressing how important it is to take the societal perspective into consideration during the appraisal process. Besides, using data derived from Italian actual practice, treatment with biologics shows a noteworthy benefit in social terms. © 2015 European Academy of Dermatology and Venereology.

Published
2015

12. PSOCUBE, a multidimensional assessment of psoriasis patients as a both clinically/practically sustainable and evidence-based algorithm

Author

Paolo Gisondi, Nicola Balato, Francesca Prignano, Paolo Amerio, Stefano Piaserico, Anna Campanati, Rosita Saraceno, Andrea Conti, S. Amato, Gianfranco Altomare, D. Linder, Linder, D, Altomare, G, Amato, S, Amerio, P, Balato, Nicola, Campanati, A, Conti, A, Gisondi, P, Prignano, F, Saraceno, R, and Piaserico, S.

Subjects
Evidence-based practice, psoriasis, dermatology life quality index, quality of life, disease severity, Multidimensional assessment, Physical examination, Standardized test, Dermatology, Psoriasis, medicine, Humans, Medical history, Clinical significance, computer.programming_language, Evidence-Based Medicine, medicine.diagnostic_test, business.industry, Disease Management, medicine.disease, Infectious Diseases, business, computer, Algorithm, Algorithms, Delphi
Abstract

Background There is increasing awareness of the clinical relevance of psoriasis comorbidities and of the importance of timely and effective screening for such comorbidities in the management of psoriatic patients. Previous works have focused on assessing evidence for prevalence of comorbidities and on the best available evidence for sensitivity in diagnosing suspected comorbidities. No algorithms are available, which have been tested on large numbers of physicians concerning the acceptance of such algorithms both by practicing clinical dermatologists and by their consulting specialists from other fields. Objective To propose a multidimensional assessment algorithm for psoriasis comorbidities which may prove at the same time enough sensitive and practically sustainable in daily clinical practice. Methods After an exhaustive literature search, we performed a Delphi procedure involving 50 dedicated dermatological centres to obtain a standardized assessment algorithm, which would meet requirements of sustainability and acceptability both from the point of view of Evidence-Based Medicine as well as from the point of view of practical and clinical feasibility: to meet both requirements, results from the Delphi procedure were elaborated and modified by a restricted panel of experts. Results The procedure has yielded PSOCUBE, a three-dimensional table comprising 14 clinical examination and history taking items, 32 screening laboratory and instrumental exams and 11 clinimetric scores. Conclusion PSOCUBE, a simple algorithm, may be employed by practising dermatologists to perform standardized assessment procedures on psoriatic patients raising the chances of early recognition of patients at risk for comorbidities, thus fostering more effective prevention; PSOCUBE may therefore contribute to reduce the overall impact of this chronic, widespread disease.

Published
2014

13. Anti-adalimumab antibodies in psoriasis: lack of clinical utility and laboratory evidence

Author

Silvia Perego, Gianfranco Altomare, Marco Diani, Giovanna Lombardi, Giuseppe Banfi, Veronica Sansoni, Lombardi, G., Perego, S., Sansoni, V., Diani, M., Banfi, G., and Altomare, G.

Subjects
Adult, Male, musculoskeletal diseases, medicine.medical_specialty, Group ii, Anti-Inflammatory Agents, Dermatology, Severity of Illness Index, Antibodies, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Psoriasis, medicine, Adalimumab, Humans, In patient, Treatment Failure, skin and connective tissue diseases, 030203 arthritis & rheumatology, High prevalence, biology, Tumor Necrosis Factor-alpha, business.industry, Research, Immunogenicity, General Medicine, Middle Aged, medicine.disease, humanities, anti-drug antibodies, Case-Control Studies, Immunology, biology.protein, Female, ELISA, Tumor necrosis factor alpha, Antibody, business, Biomarkers, medicine.drug
Abstract

Objective Adalimumab has proven effective in psoriasis; however, secondary failure may result from the drug9s immunogenicity. Prevalence data on the immunogenicity of biologicals, and of adalimumab in particular, are highly variable. We investigated the prevalence of anti-adalimumab antibodies and the association with clinical indexes and tumour necrosis factor α (TNFα) serum levels in psoriatic patients. Design Case–control, longitudinal. Setting Single centre. Participants Patient groups: I (n=20) receiving biological therapies after switching from adalimumab; II (n=30) ongoing adalimumab therapy; III (n=30) novel adalimumab therapy; IV (n=15) biological therapies other than adalimumab. Healthy subjects : (group V; n=15) never treated with immunosuppressants or biologicals. Interventions All groups were tested at enrolment. Group II was also tested at 12 months, and group III at 1, 3, and 6 months. Primary and secondary outcome measures Standard clinical evaluations (Psoriasis Area Severity Index (PASI)), blood samples and two-site ELISA-based measurement of serum adalimumab trough levels, anti-adalimumab antibodies and TNFα. Results The false-positive rate was 23% for adalimumab detection and 22% for anti-adalimumab antibodies in patients naive to adalimumab. Spurious positivity for anti-adalimumab antibodies (one-time-point positivity in group III during follow-up) accounted for 33% of the total. The prevalence of anti-drug antibodies was highest (87%) in group I patients. No correlations were found between the presence of anti-adalimumab antibodies or adalimumab levels and changes in PASI scores. Conclusions High variability of results, high prevalence of false-positives and lack of association between anti-adalimumab antibodies and TNFα level/PASI score limit this assay9s usefulness. Accurate clinical evaluation is key to early identification of treatment failures.

Published
2016
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14. Italian Euromelanoma Day Screening Campaign (2005-2007) and the planning of melanoma screening strategies

Author

Stefano Calvieri, Pietro Quaglino, Andrea Peserico, Franco Marsili, Biagio Guarneri, Paolo Valentini, Mara Lombardi, Giampiero Girolomoni, Chiara Ferrari, Giuseppe Micali, Gino A. Vena, Elisa Benati, Claudio Fracchiolla, Stefania Seidenari, Ketty Peris, Anna Lanzoni, Sergio Schiavon, Marcello Santini, Fabio Arcangeli, Giovanni Ponti, Torello Lotti, Paola Tribuzi, Giusto Trevisan, Giovanni Borroni, Annarosa Virgili, Gianfranco Altomare, Antonio Mariotti, Camillo Tonino, Giuseppe Albertini, Giuseppe Gaddoni, Maria Grazia Bernengo, Sergio Chimenti, Aurora Parodi, Stefania Borsari, Nicola Aste, Francesco Cusano, Maria Rita Bongiorno, Seidenari, S, Benati, E, Ponti, G, Borsari, S, Ferrari, C, Albertini, G, Altomare, G, Arcangeli, F, Aste, N, Bernengo, MG, Bongiorno, MR, Borroni, G, Calvieri, S, Chimenti, S, Cusano, F, Fracchiolla, C, Gaddoni, G, Girolomoni, G, Guarneri, B, Lanzoni, A, Lombardi, M, Lotti, T, Mariotti, A, Marsili, F, Micali, G, Parodi, A, Peris, K, Peserico, A, Quaglino, P, Santini, M, Schiavon, S, Tonino, C, Trevisan, G, Tribuzi, P, Valentini, P, Vena, GA, Virgili, A, S., Seidenari, E., Benati, G., Ponti, S., Borsari, C., Ferrari, G., Albertini, G., Altomare, F., Arcangeli, N., Aste, M. G., Bernengo, M. R., Bongiorno, G., Borroni, S., Calvieri, S., Chimenti, F., Cusano, C., Fracchiolla, G., Gaddoni, G., Girolomoni, B., Guarneri, A., Lanzoni, M., Lombardi, T., Lotti, A., Mariotti, F., Marsili, G., Micali, A., Parodi, K., Peri, A., Peserico, P., Quaglino, M., Santini, S., Schiavon, C., Tonino, Trevisan, Giusto, P., Tribuzi, P., Valentini, G., Vena, and A., Virgili

Subjects
Program evaluation, Male, Cancer Research, Skin Neoplasms, Time Factors, Epidemiology, Basal Cell, prevention, Risk Factors, self-surveillance, 80 and over, Settore MED/35 - Malattie Cutanee E Veneree, Medicine, Mass Screening, melanoma screening campaign, Melanoma prevention strategy, Melanoma risk factors, Melanoma screening campaign, Self-surveillance, Skin cancer, Family history, Young adult, Child, Melanoma, Aged, 80 and over, education.field_of_study, Nevus, Pigmented, skin cancer, Middle Aged, MALIGNANT MELANOMA, screening, Prognosis, Oncology, Italy, melanoma, risk factors, prognosis, Child, Preschool, Carcinoma, Squamous Cell, Female, Adult, medicine.medical_specialty, Adolescent, Population, melanoma prevention strategy, melanoma risk factors, Young Adult, Pigmented, Humans, Preschool, education, Nevus, Socioeconomic status, Mass screening, Aged, business.industry, Carcinoma, Public Health, Environmental and Occupational Health, melanoma risk factor, Infant, medicine.disease, Dermatology, Squamous Cell, Carcinoma, Basal Cell, Self-Examination, Skin cancer, business, Program Evaluation
Abstract

Although no study has definitively shown that unfocused screening of skin cancer is effective, many campaigns have been organized with the aim of increasing awareness on melanoma risk factors. The objective of this study was to analyse the results of the Skin Cancer Screening Day in Italy during the period 2005-2007, to determine the priorities for melanoma control plans in a Mediterranean country. A total of 5002 patients were screened by dermatologists in 31 cities. Individuals who considered themselves to have many naevi and those with a family history of melanoma showed a higher number of common and atypical naevi. Ten melanomas, 20 basal cell carcinomas and two squamous cell carcinomas were histopathologically confirmed. Our observations provide the following suggestions for melanoma prevention strategies: (a) an unfocused campaign is suitable to inform the public about the importance of self-examination of the skin, but is not useful to identify a larger number of melanomas; and (b) melanoma screening campaigns should focus on a selected population, which meets rigorous risk criteria to maintain higher cost-effectiveness. The financial support to effective melanoma screening programmes could be increased, especially in southern populations where lower levels of self-surveillance and socioeconomic conditions represent risk factors for late identification of melanoma.

Published
2012

15. Isotretinoin plus clindamycin seem highly effective against severe erlotinib-induced skin rash in advanced non-small cell lung cancer

Author

Marina Cazzaniga, Alessandra Crippa, F. Villa, Ilaria Colombo, Federica Cicchiello, Paolo Bidoli, Diego Cortinovis, Gianfranco Altomare, Bidoli, P, Cortinovis, D, Colombo, I, Crippa, A, Cicchiello, F, Villa, F, Cazzaniga, M, and Altomare, G

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Lung Neoplasms, Erlotinib Hydrochloride, Non-small cell lung cancer, Carcinoma, Non-Small-Cell Lung, medicine, Humans, Lung cancer, Adverse effect, Isotretinoin, Survival rate, Protein Kinase Inhibitors, Skin rash, business.industry, Nonsmall cell lung cancer, Clindamycin, Exanthema, medicine.disease, Rash, Dermatology, Anti-Bacterial Agents, ErbB Receptors, Survival Rate, Treatment Outcome, Erlotinib, Oncology, Quinazolines, Dermatologic Agents, medicine.symptom, business, medicine.drug
Abstract

Introduction: Erlotinib is useful in advanced non-small cell lung cancer although compliance and efficacy are diminished by skin rash in a high proportion of patients, often necessitating dose reduction or drug withdrawal. No effective treatment for the rash is available. Methods: We carried out a preliminary investigation on isotretinoin and clindamycin. Among 56 advanced lung cancer patients treated with erlotinib, 31 (53%) developed rash. Seven (35%) of the 20 G2/G3 cases agreed to treatment with clindamycin (450 mg/d, days 1–10; 300 mg/d, days 11–20) plus isotretinoin (20 mg/d, days 11–20) after being informed of the experimental nature of the combination. Results: In 6 of 7 (86%) patients, the rash resolved (G1/G0) without dose reduction; in the other patient (G3), the erlotinib dose also had to be reduced. Median time to resolution was 14 days (range 7–20 days). No rash-treatment adverse events occurred during 20 days of administration. Conclusions: Isotretinoin plus clindamycin promises to be the first effective treatment for erlotinib rash and is being tested further.

Published
2010

16. Risk factors of hypertension, diabetes and obesity, in Italian psoriasis patients: a survey on socio-demographic characteristics, smoking habit and alcohol consumption

Author

Emma Altobelli, R Petrocelli, Alberto Giannetti, Sergio Tiberti, Ketty Peris, Sergio Chimenti, Gino A. Vena, Andrea Peserico, Gianfranco Altomare, Mara Maccarone, Giuseppe Argenziano, Altobelli, E, Petrocelli, R, Maccarone, M, Altomare, G, Argenziano, Giuseppe, Giannetti, A, Peserico, A, Vena, Ga, Tiberti, S, Chimenti, S, and Peris, K.

Subjects
Adult, Male, medicine.medical_specialty, obesity, hypertension, Adolescent, Alcohol Drinking, Population, Dermatology, Type 2 diabetes, Comorbidity, smoking, Young Adult, risk factors, diabetes, psoriasis, alcohol, Risk Factors, Environmental health, Diabetes mellitus, Surveys and Questionnaires, medicine, Humans, Psoriasis, Obesity, Risk factor, education, Child, Aged, Demography, Aged, 80 and over, education.field_of_study, business.industry, Smoking, Middle Aged, medicine.disease, Surgery, Diabetes Mellitus, Type 2, Italy, Hypertension, Population study, Health education, Female, business
Abstract

We evaluated risk factors such as socio-demographic characteristics, smoking habits and alcohol consumption, associated with hypertension, diabetes and obesity in psoriasis patients, in order to plan health education programs that could prevent the onset or progression of co-morbidities. The study population consisted of 1376 patients with psoriasis who were consecutively recruited at 21 Italian Departments of Dermatology. Information concerning socio-demographic variables, smoking and alcohol consumption, and the presence of chronic disorders such as hypertension, type 2 diabetes and obesity was collected. The risk of co-morbidities according to the various exposure variables was calculated using logistic regression models. Psoriasis patients living in extremely urban areas showed the highest risk of diabetes (OR = 1.99, 95% CI 1.06-5.23) and obesity (OR = 2.60, 95% CI 1.10-16.12), as compared to patients living in rural areas. The OR for hypertension was higher for smokers (> 15 cigarettes per day, OR = 1.37, 95% CI 1.01-2.03) and drinkers (> 2 glasses/day of wine, OR = 2.11, 95% CI 1.31-3.40). The OR for diabetes or obesity was higher for drinkers: 1 drink/day (OR = 1.93, 95% CI 1.01-3.67) and > 1 drink/day of spirits (OR = 2.90, 95% CI 1.43-5.82), respectively. The results of our survey highlight the need to detect psoriasis patients with different susceptibilities to co-morbidities in order to plan specific health campaigns aimed at changing people's lifestyles with respect to smoking, drinking and diet.

Published
2009

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