Outcome following a short period of adalimumab dose escalation as rescue therapy in psoriatic patients

Background: Advances in biologic treatments have led to a new therapeutic frontier for moderate-to-severe psoriasis. Nevertheless, the efficacy of anti-TNFα decreases with time, requiring adjustments to maintain valuable Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) responses. Objectives: To evaluate the efficacy and safety of adalimumab dose escalation (40 mg, subcutaneous, once a week for 24 weeks) in psoriatic adult patients with secondary loss of response (PASI ≥50 to ≤75 or PASI≥75 and DLQI ≥5). Materials and Methods: A multicentre, observational study involving different Italian third-level referral centres for psoriasis enrolled a total of 64 adult patients with moderate-to-severe psoriasis who were treated with adalimumab and experienced a secondary loss of response. Primary end-points were PASI< 75 or PASI ≥50 to ≤ 75 with DLQI ≤ 5, and the secondary end-point was the ability to maintain a therapeutic response, resuming adalimumab every other week. Results: At Week 16 and Week 24, 29/64 (45.3%) and 35/64 (54.6%) responded based on PASI, and mean DLQI was 4.9 and 4.09, respectively. At Week 36 and Week 48, 45.3% and 28.1% patients achieved the second end-point, respectively. No adverse events were recorded except for one patient with recurrent tonsillitis. Conclusion: Adalimumab escalation could be considered in cases with loss of response before switching to alternative biologic therapy

Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection.

BACKGROUND: Long-acting injectable regimens may simplify therapy for patients with human immunodeficiency virus type 1 (HIV-1) infection. METHODS: We conducted a phase 3, randomized, open-label trial in which adults with HIV-1 infection who had not previously received antiretroviral therapy were given 20 weeks of daily oral induction therapy with dolutegravir-abacavir-lamivudine. Participants who had an HIV-1 RNA level of less than 50 copies per milliliter after 16 weeks were randomly assigned (1:1) to continue the current oral therapy or switch to oral cabotegravir plus rilpivirine for 1 month followed by monthly injections of long-acting cabotegravir plus rilpivirine. The primary end point was the percentage of participants who had an HIV-1 RNA level of 50 copies per milliliter or higher at week 48 (Food and Drug Administration snapshot algorithm). RESULTS: At week 48, an HIV-1 RNA level of 50 copies per milliliter or higher was found in 6 of 283 participants (2.1%) who received long-acting therapy and in 7 of 283 (2.5%) who received oral therapy (adjusted difference, -0.4 percentage points; 95% confidence interval [CI], -2.8 to 2.1), a result that met the criterion for noninferiority for the primary end point (margin, 6 percentage points). An HIV-1 RNA level of less than 50 copies per milliliter at week 48 was found in 93.6% who received long-acting therapy and in 93.3% who received oral therapy (adjusted difference, 0.4 percentage points; 95% CI, -3.7 to 4.5), a result that met the criterion for noninferiority for this end point (margin, -10 percentage points). Of the participants who received long-acting therapy, 86% reported injection-site reactions (median duration, 3 days; mild or moderate severity, 99% of cases); 4 participants withdrew from the trial for injection-related reasons. Grade 3 or higher adverse events and events that met liver-related stopping criteria occurred in 11% and 2%, respectively, who received long-acting therapy and in 4% and 1% who received oral therapy. Treatment satisfaction increased after participants switched to long-acting therapy; 91% preferred long-acting therapy at week 48. CONCLUSIONS: Therapy with long-acting cabotegravir plus rilpivirine was noninferior to oral therapy with dolutegravir-abacavir-lamivudine with regard to maintaining HIV-1 suppression. Injection-site reactions were common. (Funded by ViiV Healthcare and Janssen; FLAIR ClinicalTrials.gov number, NCT02938520.)

Outcome following a short period of adalimumab dose escalation as rescue therapy in psoriatic patients.

none14nononeBardazzi F, Bigi L, Campanati A, Conti A, Di Lernia V, Di Nuzzo S, Kaleci S, Lasagni C, Offidani AM, Giacchetti A, Nicolini M, Bettacchi A, Rosa L, Sacchelli L.Bardazzi, F; Bigi, L; Campanati, A; Conti, A; Di Lernia, V; Di Nuzzo, S; Kaleci, S; Lasagni, C; Offidani, Am; Giacchetti, A; Nicolini, M; Bettacchi, A; Rosa, L; Sacchelli, L

Detailed Performance Diagnosis Based on Production Timestamps: A Case Study

Part 11: Intelligent Diagnostics and Maintenance Solutions for Smart ManufacturingInternational audienceThis paper demonstrates a detailed performance diagnosis of a production process. With limited investment power for new technologies, managers want to diagnose the reason for system underperformance, i.e. diagnosing performance gaps. This paper found detailed performance measures for specific production orders by using event log data, i.e. a set of timestamps that denote the occurrence of an atomic event in production. Sequential time registrations for each production order give detailed insights in how the production process is behaving. The reported case study gave managers a web application that lets them zoom in and out of different characteristics to get an understanding how their production process results in a certain performance. Based on the background and case, a framework and way forward are proposed on how to perform detailed diagnosis to explain performance gaps in production

Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With HIV-1 Infection: ~5-Year Results From the LATTE-2 Study

Background. In the Long-Acting Antiretroviral Treatment Enabling Trial 2 (LATTE-2) phase 2b study, long-acting (LA) injectable cabotegravir + rilpivirine dosed every 8 weeks (Q8W) or every 4 weeks (Q4W) demonstrated comparable efficacy with daily oral antiretroviral therapy (ART) through 96 weeks in ART-naive adults with human immunodeficiency virus type 1 (HIV-1). Here we report efficacy, tolerability, and safety of cabotegravir + rilpivirine LA over approximately 5 years. Methods. After 20 weeks of oral cabotegravir + abacavir/lamivudine, participants were randomized to cabotegravir + rilpivirine LA Q8W or Q4W or continue oral ART through the 96-week maintenance period. In the extension period through week 256, participants continued their current LA regimen (randomized Q8W/Q4W groups) or switched from oral ART to Q8W or Q4W LA therapy (extension-switch groups). Endpoints assessed included proportion of participants with HIV-1 RNA 1 participant. Conclusions. Cabotegravir + rilpivirine LA exhibited long-term efficacy and tolerability, demonstrating its durability as maintenance therapy for HIV-1 infection

Efficacy of switching between tumor necrosis factor-alfa inhibitors in psoriasis: Results from the Italian Psocare Registry

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 anti-TNF-alfa agent to another was significantly reduced in patients who showed primary inefficacy of the first anti-TNF-alfa. © 2013 by the American Academy of Dermatology, Inc

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

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. \ua9 2012 European Academy of Dermatology and Venereology

Pruritus characteristics in a large Italian cohort of psoriatic patients

none368nononeDamiani, 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.; Benvegn_u, 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.; Gonz_alez Intchaurraga, M.A.; Ladurner, J.; Guarneri, B.; Cannav_o, S.; Manfr_e, 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.; Aric_o, 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.; Luvar_a, M.C.; Albertini, G.; Di Lernia, V.; Guareschi, E.; Catrani, S.; Morri, M.; Amerio, P.; De Simone, C.; D'Agostino, M.; Agostino, I.; Calvieri, S.; Cantoresi, F.; Richetta, A.; Sorgi, P.; Carnevale, C.; Nicolucci, F.; Berardesca, E.; Ardig_o, 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.; Zappal_a, 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.; Zumiani, 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, Giulia; 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.; Benvegn_u, 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, DIEGO ADRIAN; 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, Gianluca; 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, Marco; La Greca, S.; Pettinato, M.; Sapienza, G.; Valenti, G.; De Giacomo, P. F.; Amico, .; Arcangeli, F.; Brunelli, Donatella; Ghetti, E.; Tulli, A.; Assi, G.; Amerio, P.; Laria, G.; Prestinari, F.; Spadafora, S.; Coppola, M.; Caresana, G.; Pezzarossa, E.; Felisi, C.; DI DONATO, Luca; Bertero, M.; Musso, L.; Pa lazzini, S.; Bruscino, P.; Agozzino, U. C.; Ottaviani, M.; Simoncini, Claudia; Virgili, A.; Osti, F.; Fabbri, Paolo; 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, Gabriele; Peris, K.; Fargnoli, M. C.; Di Cesare, A.; DE ANGELIS, Luca; Flati, G.; Biamonte, A. S.; Quarta, G.; Congedo, M.; Carcaterra, A.; Strippoli, D.; Fideli, D.; Marsili, F.; Celli, Maria; 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.; Gonz_alez Intchaurraga, M. A.; Ladurner, J.; Guarneri, B.; Cannav_o, S.; Manfr_e, C.; Borgia, F.; Puglisi Guerra, A.; Cattaneo, A.; Carrera, C.; Fracchiolla, C.; Mozzanica, N.; Prezzemolo, L.; Menni, S.; Lodi, A.; Martino, P.; Monti, Marina; Mancini, L.; Sacrini, F.; Altomare, G. F.; Taglioni, M.; Lovati, C.; Mercuri, S. R.; Schiesari, G.; Giannetti, Anna; 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.; Aric_o, M.; Bongiorno, M. R.; Angileri, R.; D'Amato, Sonia; Todaro, F.; Milioto, M.; Bellastro, R.; Di Nuzzo, S.; De Panfilis, G.; Zanni, M.; Borroni, Giovanni Marco; 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.; Luvar_a, M. C.; Albertini, G.; Di Lernia, V.; Guareschi, E.; Catrani, S.; Morri, M.; Amerio, P.; De Simone, C.; D'Agostino, M.; Agostino, I.; Calvieri, S.; Cantoresi, F.; Richetta, A.; Sorgi, P.; Carnevale, C.; Nicolucci, F.; Berardesca, E.; Ardig_o, M.; De Felice, C.; Gubinelli, E.; Talamonti, Marco Claudio; 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.; Zappal_a, 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.; Zumiani, 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, Alfonso; Venturi, C.; Gai, F.; Pasquinucci, S.; Bellazzi, R. M.; Silvestri, T.; Girolomoni, G.; Gisondi, P.; Veller Fornasa, C.; Trevisan, G. P

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

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