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THU0366 Gastrointestinal infections in patients with spondyloarthritis treated with anti-tnf drugs: results of gisea register
  1. F Atzeni1,
  2. V Panetta2,
  3. M Sebastiani3,
  4. F Salaffi4,
  5. A Carletto5,
  6. R Foti6,
  7. F Iannone7,
  8. G Elisa8,
  9. M Govoni9,
  10. A Marchesoni10,
  11. EG Favalli10,
  12. R Gorla11,
  13. R Ramonda12,
  14. P Sarzi-Puttini13,
  15. G Ferraccioli8,
  16. G Lapadula7,
  17. on behalf of GISEA group
  1. 1Rheumatology Unit, University Hospital L. Sacco, Milan, Italy, Milan
  2. 2L'altrastatistica Consultancy & Training, Biostatistics Office, Rome
  3. 3University Hospital of Modena, Modena
  4. 4Polytechnic University of Marche, C. Urbani Hospital, Jesi
  5. 5Rheumatology Unit, University of Verona, Verona
  6. 6Rheumatology Unit, Vittorio-Emanuele University Hospital of Catania, Catania
  7. 7University of Bari, Bari
  8. 8Division of Rheumatology, Institute of Rheumatology, Catholic University of the Sacred Heart, Rome
  9. 9Department of Medical Sciences, UOC of Rheumatology, Santa Anna University Hospital, Ferrara
  10. 10G. Pini Orthopedic Institute, Milan, Milan
  11. 11Rheumatology and Immunology Unit, Spedali Civili, Brescia
  12. 12University of Padua, Padua
  13. 13Rheumatology Unit, University Hospital L.Sacco, Milan, Italy


Background Tumour necrosis factor (TNF) plays a pivotal role in controlling intracellular of bacterial infection. The BSR Biologics Register (BSRBR) has reported an increase in the occurrence of listeria and salmonella infections in anti-TNF-treated rheumatoid arthritis patients in comparison with those patients treated with non-biological DMARDs.

Objectives The aim of this study was to determine the incidence of gastrointestinal infection in the anti-TNF-treated spondyloarthritis (SpA) patients in the GISEA registry, and identify the factors associated with its development.

Methods The prospective GISEA registry was designed to collect real-world clinical data concerning patients with RA or SpA treated with biological drugs. The baseline information includes demographics, disease duration, HAQ-DI, DAS-28, BASDAI, BASFI and BASMI scores, steroid use, smoking history and comorbidities.

Results Of the 3321 anti-TNF-treated SpA patients in the registry (1731 males, 52.2%; mean age 47±13 years; median disease duration three years, interquartile range [IQR] 0–8), 1065 (32%) were treated with infliximab (IFN), 1052 (32%) with adalimumab (ADA), and 1204 (36%) with etanercept (ETN). Two thousand, one hundred and five patients (63.4%) had a median of one comorbidity (IQR 0–2], the most frequent being hypertension (701), thyroid diseases (281), diabetes mellitus (207), cardiopathy (189), and osteoporosis (145). In combination with the biological drug, 919 patients (27.7%) received steroids and 2451 (79.9%) at least one DMARD. The median follow-up was three months (IQR 1–2 years). Twenty-two patients 0.7% experienced bacterial gastrointestinal infections, the most frequent being due to listeria, klebsilla and salmonella. The crude incidence rate was 2.5 per 1000 patient-years (95% CI 1.6–3.7). Univariate analysis showed that female gender (OR 3.9, 95% CI 1.5–10.0; p=0.004) and comorbidities (OR 3.4, 95% CI 1.0–3.5; p=0.049) were associated with a high risk of gastrointestinal infections, and that the use of IFN rather than ETN and ADA (p=0.712 and p=0.238) was not associated with a higher risk of gastrointestinal infections. Furthermore, univariate models showed that age (p=0.738), disease duration p=0.090, previous DMARDs (p=0.616), and HAQ (p=0.674) and BASFI (scores p=0.850) were not statistically significant predictors of gastrointestinal infections.

Conclusions The incidence rate of gastrointestinal infections in SpA patients treated with anti-TNF drugs is not increased. Being female and having comorbidities are predictive factors of gastrointestinal infections.

Disclosure of Interest None declared

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