Anti-TNF Drugs Are Not Associated with Increasead Risk of Hzv Infections in Patients with Spondyloarthritis (SpA): Results from the GISEA Registry

Fabiola Atzeni¹, Marco Sebastiani², Valentina Panetta³, Fausto Salaffi⁴, Florenzo Iannone⁵, Elisa Gremese⁶, Antonio Carletto⁷, Antonio Marchesoni⁸, Roberto Gorla⁹, Marcello Govoni¹⁰, Rosario Foti¹¹, Ennio G. Favalli¹², Roberta Ramonda¹³, Pier Carlo Sarzi-Puttini¹⁴, Giovanni Lapadula¹⁵ and Gianfranco Ferraccioli¹⁶, ¹Rheumatology Unit, ASST Fatebenefratelli - Sacco, L. Sacco University Hospital, Milano, Italy, ²SC Reumatologia, Dipartimento di Medicine, Medicina d’Urgenza e Specialità Mediche, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy, ³L'altrastatistica -Consultancy & Training- Biostatistics office., Rome, Italy, ⁴Rheumatology Department, Polytechnic University of Marche, C. Urbani Hospital, Jesi,, Ancona, Italy, ⁵Interdisciplinary Department of Medicine (DIM), Rheumatology Unit, University of Bari, General Hospital, Bari, Italy, ⁶Division of Rheumatology, Institute of Rheumatology, Catholic University of the Sacred Heart, Rome, Italy, ⁷Rheumatology Unit, University of Verona, Verona, Italy, ⁸Department of Rheumatology, Gaetano Pini Institute, Milan, Italy, ⁹Rheumatology and Immunology Unit, Spedali Civili di Brescia, Brescia, Italy, ¹⁰Medical Sciences, UOC of Rheumatology, University Hospital S. Anna, Cona Ferrara, Italy, ¹¹Rheumatology Unit, Vittorio-Emanuele University Hospital of Catania, Catania, Italy, ¹²Department and Chair of Rheumatology, University of Milan, Gaetano Pini Institute, Milan, Italy, ¹³Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova, Italy, ¹⁴Rheumatology Unit, L. Sacco University Hospital, Milan, Italy, ¹⁵Rheumatology Unit, University of Bari, Bari, Italy, ¹⁶Division of Rheumatology, Catholic University of the Sacred Heart, Rome, Italy

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Anti-TNF therapy and infection

Session Information

Date: Sunday, November 13, 2016

Title: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment - Poster I: Axial and Peripheral Spondyloarthritis – Clinical Aspects, Imaging and Treatment

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.

Disclosure: F. Atzeni, None; M. Sebastiani, None; V. Panetta, None; F. Salaffi, None; F. Iannone, None; E. Gremese, None; A. Carletto, None; A. Marchesoni, None; R. Gorla, None; M. Govoni, None; R. Foti, None; E. G. Favalli, None; R. Ramonda, None; P. C. Sarzi-Puttini, None; G. Lapadula, None; G. Ferraccioli, None.

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 .

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