PMID- 30767865
OWN - NLM
STAT- MEDLINE
DCOM- 20190729
LR  - 20191210
IS  - 0392-856X (Print)
IS  - 0392-856X (Linking)
VI  - 37
IP  - 4
DP  - 2019 Jul-Aug
TI  - Rate of serious infections in spondyloarthropathy patients treated with 
      anti-tumour necrosis factor drugs: a survey from the Italian registry GISEA.
PG  - 649-655
AB  - OBJECTIVES: To determine the incidence of serious infections (SIs) among the 
      spondyloarthropathy (SpA) patients from the "Gruppo Italiano per lo Studio delle 
      Early Arthritis" (GISEA) registry and treated with tumour necrosis factor (TNF) 
      inhibitors (TNFIs), and to identify the factors associated with the development 
      of the infections. METHODS: This observational study on 3321 GISEA-registered SpA 
      patients collected real-world demographic and clinical data relating to their 
      biological drug treatments. The overall incidence of infections was analysed by 
      type of SpA. RESULTS: A total of 3321 SpA patients (1731 males, 52.2%; mean age 
      47+/-13 years; median disease duration 3 years, interquartile range [IQR] 0-8) were 
      eligible for inclusion in the analysis. Two hundred and fifty-nine patients 
      experienced at least one of 391 microbiologically diagnosed SIs, 32% of which 
      were recorded during the first 12 months of treatment. The overall incidence of 
      SIs was 43.9/1000 patient-years of follow-up (95% confidence interval [CI] 
      39.6-48.4): 29.9/1000 (95% CI 23.1-38.1) among those treated with adalimumab 
      (ADA); 36.1/1000 (95% CI 30.0-43.1) among those treated with etanercept (ETN); 
      and 61.4/1000 (95% CI 53.3-70.5) among those treated with infliximab (INF). The 
      highest incidence was observed among the patients with psoriatic arthritis (PsA), 
      but the difference was statistically significant only in comparison with the 
      patients with undifferentiated SpA (p=0.002), whose incidence of SIs was also 
      lower than in the patients with ankylosing spondylitis (AS) (p=0.034). 
      Multivariate models showed that the number of comorbidities (hazard ratio [HR] 
      1.29, 95%CI 1.2-1.4; p<0.001), age at the start of TNFi treatment (HR 0.99, 95%CI 
      0.97-0.99; p=0.030), steroid use (HR 1.40, 95%CI 1.1-1.8; p=0.012) and male sex 
      (HR 0.72, 95%CI 0.5-0.9; p=0.012) were all statistically significant predictors 
      of infection. The factors independently associated with a lower risk of SIs were 
      the use of ETN (HR 0.52, 95%CI 0.4-0.7; p<0.001) or ADA (HR 0.59, 95%CI 0.4-0.8; 
      p=0.002) rather than INF. CONCLUSIONS: The incidence of SIs was higher among 
      patients with PsA or AS than among those with undifferentiated SpA, and among 
      patients treated with INF than among those treated with ADA or ETN. Male sex, 
      steroid use and the number of comorbidities were all factors predictive of SIs.
FAU - Atzeni, Fabiola
AU  - Atzeni F
AD  - Rheumatology Unit, University of Messina, Italy. atzenifabiola@hotmail.com.
FAU - Sarzi-Puttini, Piercarlo
AU  - Sarzi-Puttini P
AD  - Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
FAU - Sebastiani, Marco
AU  - Sebastiani M
AD  - University Hospital of Modena, Italy.
FAU - Panetta, Valentina
AU  - Panetta V
AD  - L'Altrastatistica Consultancy & Training, Biostatistics Office, Rome, Italy.
FAU - Salaffi, Fausto
AU  - Salaffi F
AD  - Polytechnic University of Marche, C. Urbani Hospital, Jesi, Italy.
FAU - Iannone, Florenzo
AU  - Iannone F
AD  - Rheumatology Unit, University of Bari, Italy.
FAU - Carletto, Antonio
AU  - Carletto A
AD  - Rheumatology Unit, University of Verona, Italy.
FAU - Foti, Rosario
AU  - Foti R
AD  - Rheumatology Unit, Vittorio-Emanuele University Hospital of Catania, Italy.
FAU - Gremese, Elisa
AU  - Gremese E
AD  - Division of Rheumatology, Institute of Rheumatology, Catholic University of the 
      Sacred Heart, Rome, Italy.
FAU - Govoni, Marcello
AU  - Govoni M
AD  - Department of Medical Sciences, Division of Rheumatology, Santa Anna University 
      Hospital, Ferrara, Italy.
FAU - Marchesoni, Antonio
AU  - Marchesoni A
AD  - G. Pini Orthopaedic Hospital, Milan, Italy.
FAU - Favalli, Ennio
AU  - Favalli E
AD  - G. Pini Orthopaedic Hospital, Milan, Italy.
FAU - Gorla, Roberto
AU  - Gorla R
AD  - Rheumatology and Immunology Unit, Spedali Civili, Brescia, Italy.
FAU - Ramonda, Roberta
AU  - Ramonda R
AD  - University of Padova, Italy.
FAU - Ferraccioli, Gianfranco
AU  - Ferraccioli G
AD  - Division of Rheumatology, Institute of Rheumatology, Catholic University of the 
      Sacred Heart, Rome, Italy.
FAU - Lapadula, Giovanni
AU  - Lapadula G
AD  - Rheumatology Unit, University of Bari, Italy.
CN  - GISEA group.
LA  - eng
PT  - Journal Article
DEP - 20190211
PL  - Italy
TA  - Clin Exp Rheumatol
JT  - Clinical and experimental rheumatology
JID - 8308521
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - B72HH48FLU (Infliximab)
RN  - FYS6T7F842 (Adalimumab)
RN  - OP401G7OJC (Etanercept)
MH  - Adalimumab
MH  - Adult
MH  - Antirheumatic Agents/*adverse effects/therapeutic use
MH  - Etanercept
MH  - Female
MH  - Humans
MH  - Infections/epidemiology/*etiology
MH  - Infliximab
MH  - Italy
MH  - Male
MH  - Middle Aged
MH  - Registries
MH  - Spondylarthropathies/*complications/drug therapy/immunology
MH  - Surveys and Questionnaires
MH  - Tumor Necrosis Factor-alpha/*adverse effects/therapeutic use
EDAT- 2019/02/16 06:00
MHDA- 2019/07/30 06:00
CRDT- 2019/02/16 06:00
PHST- 2018/07/11 00:00 [received]
PHST- 2018/10/15 00:00 [accepted]
PHST- 2019/02/16 06:00 [pubmed]
PHST- 2019/07/30 06:00 [medline]
PHST- 2019/02/16 06:00 [entrez]
AID - 13134 [pii]
PST - ppublish
SO  - Clin Exp Rheumatol. 2019 Jul-Aug;37(4):649-655. Epub 2019 Feb 11.