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

Overview

Journal J Clin Med

Specialty General Medicine

Date 2020 Apr 30

PMID 32344563

Citations 7

Authors

Maria Antonietta Barbieri

Giuseppe Cicala

Paola Maria Cutroneo

Elisabetta Gerratana

Caterina Palleria

Caterina De Sarro

Ada Vero

Luigi Iannone

Antonia Manti

Emilio Russo

Giovambattista De Sarro

Fabiola Atzeni

Edoardo Spina

Affiliations

Soon will be listed here.

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.

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