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Safety Profile of Biologics Used in Rheumatology: An Italian Prospective Pharmacovigilance Study.

Authors :
Barbieri, Maria Antonietta
Cicala, Giuseppe
Cutroneo, Paola Maria
Gerratana, Elisabetta
Palleria, Caterina
De Sarro, Caterina
Vero, Ada
Iannone, Luigi
Manti, Antonia
Russo, Emilio
De Sarro, Giovambattista
Atzeni, Fabiola
Spina, Edoardo
Source :
Journal of Clinical Medicine. Apr2020, Vol. 9 Issue 4, p1227. 1p.
Publication Year :
2020

Abstract

Post-marketing surveillance activities are essential to detect the risk/benefit profile of biologic disease-modifying antirheumatic drugs (bDMARDs) in inflammatory arthritis. The aim of this study was to evaluate adverse events (AEs) in patients treated with bDMARDs in rheumatology during a prospective pharmacovigilance study from 2016 to 2018. Descriptive statistical analyses were performed to evaluate bDMARDs-related variables of patients without AEs/failures vs patients with AEs and failures. The risk profile among biologics was assessed by comparing patients treated with each bDMARD to patients treated with etanercept. A total of 1155 patients were enrolled, mostly affected by rheumatoid arthritis (46.0%). AEs and failures were experienced by 8.7% and 23.3%, respectively. The number of comorbidities significantly influenced the onset of AEs, while anxiety-depressive, gastrointestinal disease, and fibromyalgia influenced onset of failures. The probability of developing an AE was significantly lower in patients treated with secukinumab, while the probability of developing treatment failure was significantly lower in patients treated with golimumab, secukinumab and tocilizumab. A total of 216 AEs were reported (25.5% serious), mostly regarding infections (21.8%), musculoskeletal (17.6%) and skin (16.2%) disorders. Serious AEs included neutropenia (12.7%), lymphocytosis (9.1%) and uveitis (7.3%). The obtained results revealed known AEs but real-world data should be endorsed for undetected safety concerns. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
20770383
Volume :
9
Issue :
4
Database :
Academic Search Index
Journal :
Journal of Clinical Medicine
Publication Type :
Academic Journal
Accession number :
143079548
Full Text :
https://doi.org/10.3390/jcm9041227