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.
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.
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 November 30, 2020.
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