PMID- 32344563
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 9
IP  - 4
DP  - 2020 Apr 24
TI  - Safety Profile of Biologics Used in Rheumatology: An Italian Prospective 
      Pharmacovigilance Study.
LID - 10.3390/jcm9041227 [doi]
LID - 1227
AB  - 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.
FAU - Barbieri, Maria Antonietta
AU  - Barbieri MA
AUID- ORCID: 0000-0002-2019-4696
AD  - Department of Clinical and Experimental Medicine, University of Messina, 98125 
      Messina, Italy.
FAU - Cicala, Giuseppe
AU  - Cicala G
AUID- ORCID: 0000-0002-8345-8679
AD  - Department of Clinical and Experimental Medicine, University of Messina, 98125 
      Messina, Italy.
FAU - Cutroneo, Paola Maria
AU  - Cutroneo PM
AD  - Sicilian Regional Pharmacovigilance Centre, University Hospital of Messina, 98125 
      Messina, Italy.
FAU - Gerratana, Elisabetta
AU  - Gerratana E
AD  - Department of Clinical and Experimental Medicine, University of Messina, 98125 
      Messina, Italy.
FAU - Palleria, Caterina
AU  - Palleria C
AD  - Department of Health Science, School of Medicine, University of Catanzaro, 
      Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini Hospital, 88100 
      Catanzaro, Italy.
FAU - De Sarro, Caterina
AU  - De Sarro C
AD  - Department of Health Science, School of Medicine, University of Catanzaro, 
      Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini Hospital, 88100 
      Catanzaro, Italy.
FAU - Vero, Ada
AU  - Vero A
AD  - Department of Health Science, School of Medicine, University of Catanzaro, 
      Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini Hospital, 88100 
      Catanzaro, Italy.
FAU - Iannone, Luigi
AU  - Iannone L
AD  - Department of Health Science, School of Medicine, University of Catanzaro, 
      Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini Hospital, 88100 
      Catanzaro, Italy.
FAU - Manti, Antonia
AU  - Manti A
AD  - Department of Health Science, School of Medicine, University of Catanzaro, 
      Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini Hospital, 88100 
      Catanzaro, Italy.
FAU - Russo, Emilio
AU  - Russo E
AUID- ORCID: 0000-0002-1279-8123
AD  - Department of Health Science, School of Medicine, University of Catanzaro, 
      Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini Hospital, 88100 
      Catanzaro, Italy.
FAU - De Sarro, Giovambattista
AU  - De Sarro G
AD  - Department of Health Science, School of Medicine, University of Catanzaro, 
      Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini Hospital, 88100 
      Catanzaro, Italy.
FAU - Atzeni, Fabiola
AU  - Atzeni F
AD  - Department of Clinical and Experimental Medicine, University of Messina, 98125 
      Messina, Italy.
FAU - Spina, Edoardo
AU  - Spina E
AUID- ORCID: 0000-0002-2509-7449
AD  - Department of Clinical and Experimental Medicine, University of Messina, 98125 
      Messina, Italy.
LA  - eng
GR  - multiregional active pharmacovigilance project AIFA 2010/2011 "valutazione di 
      sicurezza ed appropriatezza prescrittiva ed aderenza alla Terapia di farmaci 
      biologici impiegati in Centri Regionali di Dermatologia, Gastroenterologia e 
      Reumatologia"/Agenzia Italiana del Farmaco, Ministero della Salute/
PT  - Journal Article
DEP - 20200424
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC7230621
OTO - NOTNLM
OT  - adverse events
OT  - biologic drugs
OT  - inflammatory arthritis
OT  - pharmacovigilance
OT  - real-world data
OT  - treatment failure
COIS- The authors declare no conflict of interest.
EDAT- 2020/04/30 06:00
MHDA- 2020/04/30 06:01
PMCR- 2020/04/24
CRDT- 2020/04/30 06:00
PHST- 2020/04/03 00:00 [received]
PHST- 2020/04/15 00:00 [revised]
PHST- 2020/04/21 00:00 [accepted]
PHST- 2020/04/30 06:00 [entrez]
PHST- 2020/04/30 06:00 [pubmed]
PHST- 2020/04/30 06:01 [medline]
PHST- 2020/04/24 00:00 [pmc-release]
AID - jcm9041227 [pii]
AID - jcm-09-01227 [pii]
AID - 10.3390/jcm9041227 [doi]
PST - epublish
SO  - J Clin Med. 2020 Apr 24;9(4):1227. doi: 10.3390/jcm9041227.