PMID- 33141869 OWN - NLM STAT- MEDLINE DCOM- 20201224 LR - 20201224 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 15 IP - 11 DP - 2020 TI - Safety profile of biologic drugs for psoriasis in clinical practice: An Italian prospective pharmacovigilance study. PG - e0241575 LID - 10.1371/journal.pone.0241575 [doi] LID - e0241575 AB - Psoriasis is an inflammatory and chronic skin disorder associated with physical and psychological burden impairing patients' quality of life. In the last decade, biologic drugs have widely changed treatment of moderate-severe psoriasis and their number is increasing overtime. To early identify expected/unexpected adverse events (AEs) with biologic treatments, pharmacovigilance programs are needed. We designed a post-marketing active pharmacovigilance program to monitor and analyse AEs and/or serious adverse events (SAEs) reports. All consecutive patients treated with one biologic drug during a two-years period and satisfying inclusion criteria have been enrolled in five Dermatology tertiary units. Demographic and clinical features of patients, type of treatment used, therapy discontinuation, failures, switch/swap to another biologic, and possible onset of AEs were collected. Overall, 512 patients with a diagnosis of psoriasis (286; 55.9%) or arthropathic psoriasis (226; 44.1%) have been enrolled. Eighty-two (16%) patients with AEs and 5 (1%) with SAEs have been identified. Further, 59 (11.5%) had a primary/secondary failure (mainly on infliximab and etanercept). The adverse events and SAEs were reported with golimumab (4/12), adalimumab (32/167), infliximab (9/48), etanercept (31/175) and ustekinumab (11/73), no adverse events have occurred with secukinumab (0/37). Infliximab and etanercept were significantly associated with primary/secondary failures, whereas no differences have been highlighted for AEs insurgence. On the other hand, ustekinumab seems to be associated with a low rate of AEs (p = 0.01) and no adverse events or failures have been reported with secukinumab (p = 0.04 and 0.03, respectively). Our study, even though limited by a small sample size and a brief follow-up period, provide useful data on widely used biologic drugs and their tolerability, discontinuation rate and the incurrence of severe adverse events. Further studies are necessary to include the recently approved biologic drugs and to increase the sample size for more detailed analysis. FAU - Iannone, Luigi Francesco AU - Iannone LF AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - Bennardo, Luigi AU - Bennardo L AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - Palleria, Caterina AU - Palleria C AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - Roberti, Roberta AU - Roberti R AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - De Sarro, Caterina AU - De Sarro C AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - Naturale, Maria Diana AU - Naturale MD AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - Dastoli, Stefano AU - Dastoli S AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - Donato, Luca AU - Donato L AD - Dermatology Outpatient Clinic, Azienda Sanitaria Provinciale Crotone, Crotone, Italy. FAU - Manti, Antonia AU - Manti A AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - Valenti, Giancarlo AU - Valenti G AD - Division of Dermatology, "Ciaccio-Pugliese" Hospital, Catanzaro, Italy. FAU - D'Amico, Domenico AU - D'Amico D AD - Division of Dermatology, "Ciaccio-Pugliese" Hospital, Catanzaro, Italy. FAU - D'Attola, Santo AU - D'Attola S AD - Dermatologic Unit, Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli", Reggio Calabria, Italy. FAU - De Francesco, Adele Emanuela AU - De Francesco AE AD - UOC Pharmacy, "Mater domini" Hospital, Catanzaro, Italy. FAU - Bosco, Vincenzo AU - Bosco V AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - Donato Di Paola, Eugenio AU - Donato Di Paola E AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - Nistico, Steven Paul AU - Nistico SP AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - Citraro, Rita AU - Citraro R AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - Russo, Emilio AU - Russo E AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. FAU - De Sarro, Giovambattista AU - De Sarro G AD - Science of Health Department, School of Medicine, University Magna Graecia, Catanzaro, Italy. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20201103 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (Biological Products) SB - IM MH - Adult MH - Adverse Drug Reaction Reporting Systems/*statistics & numerical data MH - Aged MH - Biological Products/*adverse effects MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology/etiology MH - Female MH - Humans MH - Italy/epidemiology MH - Male MH - Middle Aged MH - Pharmacovigilance MH - Prospective Studies MH - Psoriasis/*drug therapy MH - Quality of Life PMC - PMC7608898 COIS- The authors have read the journal's policy and the authors of this manuscript have the following competing interests: ER has received speaker fees and participated at advisory boards for Eisai and has received research fundings by GW Pharmaceuticals, Pfizer, Italian Ministry of Health (MoH) and the Italian Medicine Agency (AIFA). This does not alter our adherence to PLOS ONE policies on sharing data and materials. All other authors have no conflicts to declare. EDAT- 2020/11/04 06:00 MHDA- 2020/12/29 06:00 PMCR- 2020/11/03 CRDT- 2020/11/03 17:11 PHST- 2020/08/11 00:00 [received] PHST- 2020/10/19 00:00 [accepted] PHST- 2020/11/03 17:11 [entrez] PHST- 2020/11/04 06:00 [pubmed] PHST- 2020/12/29 06:00 [medline] PHST- 2020/11/03 00:00 [pmc-release] AID - PONE-D-20-25117 [pii] AID - 10.1371/journal.pone.0241575 [doi] PST - epublish SO - PLoS One. 2020 Nov 3;15(11):e0241575. doi: 10.1371/journal.pone.0241575. eCollection 2020.