Herpes Zoster Virus Infection in Patients Treated with Biological Therapies (BIOBADASAR)

Juan Pablo Pirola¹, Soledad Retamozo², Diego Baenas³, Alejandro Alvarellos⁴, Francisco Caeiro⁵, María Celina De La Vega⁶, Gustavo Casado⁷, Gimena Gomez⁸, Javier Roberti⁶, Osvaldo Luis Cerda⁹, Maria de los Angeles Gallardo¹⁰, Ana Quinteros¹¹, Ida Exeni¹², Juan Manuel Bande¹³, Pablo Astesana¹⁴, Analia Alvarez¹⁵, Amelia Granel¹⁶, Alejandra Peluzzon¹⁷, Ana Capuccio¹⁸, Romina Nieto¹⁹, Rossana Quintana²⁰, Eduardo Mussano²¹, Santiago Scarafia²², Carolina Costi²³, Mercedes De La Sota²⁴, Monica Patricia Diaz²⁵, Edson Javier Velozo²⁶, Santiago Aguero²⁷, Cristina Battagliotti²⁸, Sidney Soares de Souza²⁹, Emilia Cavillon³⁰, Analia Bohr³¹, Andrea Smichowski³², Alejandro Benitez³³, Daniela Vidal³⁴, Dora Pereira³⁵, Liliana Martinez³⁶, Luis Somma³⁷, Marta Zalazar³⁸, Pablo Finucci Curi³⁹, Leandro Carlevaris⁴⁰, Guillermo Berbotto⁴¹ and Veronica Saurit¹, ¹Rheumatology, Hospital Privado Centro Médico de Córdoba, Córdoba, Argentina, ²Rheumatology Unit, Hospital Privado Centro Médico de Córdoba, Argentina, Córdoba, Argentina, ³Hospital Privado Centro Médico de Córdoba, Córdoba, Argentina, ⁴Rheumatology, Hospital Privado Centro Médico de Córdoba, Cordoba, Argentina, ⁵Reumatología, Hospital Privado Centro Médico de Córdoba, Córdoba, Argentina, ⁶SAR, CABA, Argentina, ⁷Sociedad Argentina de Reumatologia, CABA, Argentina, ⁸Section of Rheumatology an, SAR, CABA, Argentina, ⁹IREP, CABA, Argentina, ¹⁰Hospital Italiano de Buenos Aires, CABA, Argentina, ¹¹Centro Integral Reumatológico, Tucuman, Argentina, ¹²Sanatorio Parque, Córdoba, Argentina, ¹³Hospital Tornú, CABA, Argentina, ¹⁴Sanatorio Allende, Cordoba, Argentina, ¹⁵Hospital Penna, Bahía Blanca, Argentina, ¹⁶Centro Platense de Reumatología, La Plata, Argentina, ¹⁷Hospital Clínica José de San Martín, CABA, Argentina, ¹⁸Hospital Cesar Milstein, CABA, Argentina, ¹⁹Hospital Provincial, Rosario, Argentina, ²⁰Sanatorio Parque, Rosario, Argentina, ²¹Córdoba, Hospital Nacional de Clínicas, Córdoba, Argentina, ²²Hospital Bernardino Rivadavia, CABA, Argentina, ²³Hospital San Martín, LaPlata, Argentina, ²⁴Consultorios, Bahia Blanca, Argentina, ²⁵Hospital Zonal Bariloche, Bariloche, Argentina, ²⁶Rheumatology, Sanatorio Adventista del Plata, Entre Rios, Argentina, ²⁷Sanatorio Pasteur, Catamarca, Argentina, ²⁸Hospital de Niños Dr Orlando Alasia, Santa Fé, Argentina, ²⁹Ramallo 1851, REUMAR, CABA, Argentina, ³⁰Consultorio, Cordoba, Argentina, ³¹Hospital de Rehabilitación Rocca, CABA, Argentina, ³²Atención Integral de Reumatología, CABA, Argentina, ³³CEIM, CABA, Argentina, ³⁴Hospital de Niños de Córdoba, Córdoba, Argentina, ³⁵Centro Raquis, Buenos Aires, Argentina, ³⁶Hospital Fernandez, CABA, Argentina, ³⁷SOMMA, Buenos Aires, Argentina, ³⁸Hospital Pirovano, CABA, Argentina, ³⁹Centro Médico Mitre, Entre Rios, Argentina, ⁴⁰IARI, CABA, Argentina, ⁴¹Sanatorio Británico, Rosario, Argentina

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Biologic drugs, infection and risk

Session Information

Date: Sunday, November 13, 2016

Title: Infection-related Rheumatic Disease

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: Biologic therapies (bDMARDs) have improved the treatment of rheumatic diseases; however, the risk of herpes zoster (HZ) virus infection or reactivation in patients treated with these drugs remains a concern. Objectives: We investigated the clinical characteristics and prognostic factors of HZ in an Argentine registry of rheumatic diseases patients treated with bDMARDs.

Methods: Database included demographics of patients, type and duration of treatments and clinical information of adverse events. A control group was included for comparison consisting of patients not treated with bDMARDs but similar demographics. Values are expressed as mean±standard deviation, median (ranges), and frequencies (percentages), as appropriate. Multivariate logistic and regression analysis were used to identify variables associated with the occurrence of HZ; OR and 95% CI were calculated by exponentiation of regression coefficients.

Results: As of January 2016, 3483 patients, 4762 treatments and 2580 adverse events were studied. 2748 (78.9%) patients were women, mean age was 56.1±15.7 years. Patients were treated with non-bDMARDs in 2011 (57.7%) and 1472 (42.3%) with bDMARDs. BIOBADASAR included 2706 (77.7%) patients with rheumatoid arthritis (RA), 293 (8.4%) with psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA) and SLE with 117 (3.36%) each. Most frequent biological drugs were etanercept 1193 (41.4%), adalimumab 626 (21.7%), and abatacept with 282 (9.8%). Of 3483 patients, 25 (0.72%) developed HZ infection as an adverse event, their mean age was 59.44±19.31 years. The mean time between treatment and HZ infection was 10.5 (range 1.6 – 251.5) months. Twenty two (88%) patients with HZ received bDMARDs (5 patients developed HZ after more than one biological treatment) and 3 (12%) patients received only non-bDMARD treatments. Ten (40%) patients developed HZ infection during treatment with etanercept. Severities of HZ infections were: non-serious in 21 (84%) and serious in 4 (16%) cases. In comparison with patients treated with non-bDMARDs, patients with bDMARDs showed a high risk of development of HZ infection; incidence rate ratio (IRR) of HZ in the bDMARDs group was 9.084 (95% CI 2.72- 47.40; p<0.001). The risk was higher for those who used concomitant corticoids (HR 2.97, CI95% 1.55–8.66) and bDMARDs (HR 2.48, CI95% 1.37–15.5) than for those who used methotrexate (HR -3.42, CI95% 0.10–0.53); statistical differences were found in the univariate analysis, and confirmed by the multivariate models. The outcomes of HZ infection were: recovered without sequelae in 21 (84%), not recovered at time of report in 3 (12%) and recovered with sequelae in 1 (4%) case.

Conclusion:

A higher frequency of HZ was seen in patients treated with bDMARDs and concomitant corticoids whereas use of methotrexate has a protective effect. However, results should be interpreted cautiously because of registries inherent limitations.

Disclosure: J. P. Pirola, None; S. Retamozo, None; D. Baenas, None; A. Alvarellos, None; F. Caeiro, None; M. C. De La Vega, None; G. Casado, None; G. Gomez, None; J. Roberti, None; O. L. Cerda, None; M. D. L. A. Gallardo, None; A. Quinteros, None; I. Exeni, None; J. M. Bande, None; P. Astesana, None; A. Alvarez, None; A. Granel, None; A. Peluzzon, None; A. Capuccio, None; R. Nieto, None; R. Quintana, None; E. Mussano, None; S. Scarafia, None; C. Costi, None; M. De La Sota, None; M. P. Diaz, None; E. J. Velozo, None; S. Aguero, None; C. Battagliotti, None; S. Soares de Souza, None; E. Cavillon, None; A. Bohr, None; A. Smichowski, None; A. Benitez, None; D. Vidal, None; D. Pereira, None; L. Martinez, None; L. Somma, None; M. Zalazar, None; P. Finucci Curi, None; L. Carlevaris, None; G. Berbotto, None; V. Saurit, None.

To cite this abstract in AMA style:

Pirola JP, Retamozo S, Baenas D, Alvarellos A, Caeiro F, De La Vega MC, Casado G, Gomez G, Roberti J, Cerda OL, Gallardo MDLA, Quinteros A, Exeni I, Bande JM, Astesana P, Alvarez A, Granel A, Peluzzon A, Capuccio A, Nieto R, Quintana R, Mussano E, Scarafia S, Costi C, De La Sota M, Diaz MP, Velozo EJ, Aguero S, Battagliotti C, Soares de Souza S, Cavillon E, Bohr A, Smichowski A, Benitez A, Vidal D, Pereira D, Martinez L, Somma L, Zalazar M, Finucci Curi P, Carlevaris L, Berbotto G, Saurit V. Herpes Zoster Virus Infection in Patients Treated with Biological Therapies (BIOBADASAR) [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/herpes-zoster-virus-infection-in-patients-treated-with-biological-therapies-biobadasar/. Accessed .

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