Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Herpes zoster virus (HZV) reactivation disproportionately affects patients with systemic rheumatic diseases and it is commonly described in short- and long-term use of anti-Tumor Necrosis Factor (TNF) drugs. However, it is unclear whether anti-TNF therapy elevates herpes zoster risk in patients with spondyloarthritis (SpA). The aim of this study was to evaluate the incidence of HZV infections in the TNF-inhibitors-treated SpA patients in the Gruppo Italiano Studio Early Arthritis (GISEA) Registry, and assess the predictors of their occurrence.
Methods: The Registry, which is designed to collect real-world clinical data concerning RA and SpA patients receiving biological drugs as part of routine care, was approved by local Ethics Committees, and enrols patients aged ≥18 years who have given their written informed consent. The baseline information includes demographics, disease duration, HAQ, DAS28, BASDAI, BASFI and BASMI scores, steroid use (defined as actively receiving oral steroids at the time of recruitment), smoking history and comorbidities.
Results: The analysis involved 3321 SpA patients (1731 males, 52.2%; mean age 47±13 years; median disease duration three years, interquartile range [IQR] 0, 8 years): 1065 (32%) treated with infliximab (IFN), 1052 (32%) with adalimumab (ADA), and 1204 (36%) with etanercept (ETN). Two thousand, one hundred and five (63.4%) had a median of one comorbity (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) 12 years. Herpes zoster involed 21 patients (0.6%). Crude incidence rates among anti-TNF users were 2.4 per 1000 patient years (95% CI, 1.5-3.6). Univariate analysis showed that female gender (p=0.512) and comorbidities (p=0.861) were not associated with a high risk of HVZ reactivation, and that the use of IFN rather than the use of ETN and ADA (p=.133 and p=00.129) was not associated with a higher risk of HVZ reactivaction. Furthermore, univariate models showed that the HAQ (HR 3.71 p=0.012) and BASFI (HR=1.39 p=0.004) were statistically significant predictors of HVZ infections.
Conclusion: These data add to currently available evidence suggesting that anti-TNF therapy is not associated with a increased risk of HZV infections in SpA patients.
To cite this abstract in AMA style:Atzeni F, Sebastiani M, Panetta V, Salaffi F, Iannone F, Gremese E, Carletto A, Marchesoni A, Gorla R, Govoni M, Foti R, Favalli EG, Ramonda R, Sarzi-Puttini PC, Lapadula G, Ferraccioli G. Anti-TNF Drugs Are Not Associated with Increasead Risk of Hzv Infections in Patients with Spondyloarthritis (SpA): Results from the GISEA Registry [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/anti-tnf-drugs-are-not-associated-with-increasead-risk-of-hzv-infections-in-patients-with-spondyloarthritis-spa-results-from-the-gisea-registry/. Accessed December 1, 2020.
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