Open AccessSafety profile of biologic drugs for psoriasis in clinical practice: An Italian prospective pharmacovigilance study
Author(s) -
Luigi Francesco Ian,
Luigi Bennardo,
Caterina Palleria,
Roberta Roberti,
Caterina De Sarro,
Maria Diaturale,
Stefano Dastoli,
L. Donato,
Antonia Manti,
Giancarlo Valenti,
Domenico D’Amico,
S. Dattola,
Adele Emanuela De Francesco,
Vincenzo Bosco,
Eugenio Donato Di Paola,
Steven Paul Nisticò,
Rita Citraro,
Emilio Russo,
Giovambattista De Sarro
Publication year - 2020
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0241575
Subject(s) - medicine , ustekinumab , etanercept , adverse effect , pharmacovigilance , adalimumab , infliximab , secukinumab , psoriasis , discontinuation , golimumab , dermatology , psoriatic arthritis , rheumatoid arthritis , disease
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.