Incidence of tuberculosis infection in spondyloarthritis patients treated with biological and conventional diseasemodifying anti-rheumatic drugs in an endemic area

Introduction: Registries of spondyloarthritis (SpA) patients’ follow-up provided evidence that tumor necrosis factor inhibitors (TNFi) increase the incidence of active tuberculosis infection (TB). However, most of these registries are from low burden TB areas. Few studies evaluated the safety of biologic agents in TB endemic areas. This study compares the TB incidence rate (TB IR) in anti-TNF-naïve and anti-TNFexperienced subjects with SpA in a high TB incidence setting. Methods: In this retrospective cohort study, medical records from patients attending a SpA clinic during 13 years (2004 to 2016) in a university hospital were reviewed. The TB IR was calculated and expressed as number of events per 105 patients/year; the incidence rate ratio (IRR) associated with the use of TNFi was calculated. Results: A total of 277 patients, 173 anti-TNF-naïve and 104 anti-TNF-experienced subjects, were evaluated; 35.7% (N = 35) of patients who were prescribed an antiTNF drug were diagnosed with latent tuberculosis infection (LTBI). Total follow-up time (person-years) was 1667.8 for anti-TNF-naïve and 394.9 for anti-TNF-experienced patients. TB IR (95% CI) was 299.8 (37.4-562.2) for anti-TNF naïve and 1012.9 (25.3-2000.5) for anti-TNF experienced subjects. The IRR associated with the use of TNFi was 10.4 (2.3- 47.9). Conclusions: In this high TB incidence setting, SpA patients exposed to anti-TNF therapy had a higher incidence of TB compared to anti-TNF-naïve subjects, although the TB incidence in the control group was significant

Incidence of tuberculosis infection in spondyloarthritis patients treated with biological and conventional diseasemodifying anti-rheumatic drugs in an endemic area

Introduction: Registries of spondyloarthritis (SpA) patients’ follow-up provided evidence that tumor necrosis factor inhibitors (TNFi) increase the incidence of active tuberculosis infection (TB). However, most of these registries are from low burden TB areas. Few studies evaluated the safety of biologic agents in TB endemic areas. This study compares the TB incidence rate (TB IR) in anti-TNF-naïve and anti-TNFexperienced subjects with SpA in a high TB incidence setting. Methods: In this retrospective cohort study, medical records from patients attending a SpA clinic during 13 years (2004 to 2016) in a university hospital were reviewed. The TB IR was calculated and expressed as number of events per 105 patients/year; the incidence rate ratio (IRR) associated with the use of TNFi was calculated. Results: A total of 277 patients, 173 anti-TNF-naïve and 104 anti-TNF-experienced subjects, were evaluated; 35.7% (N = 35) of patients who were prescribed an antiTNF drug were diagnosed with latent tuberculosis infection (LTBI). Total follow-up time (person-years) was 1667.8 for anti-TNF-naïve and 394.9 for anti-TNF-experienced patients. TB IR (95% CI) was 299.8 (37.4-562.2) for anti-TNF naïve and 1012.9 (25.3-2000.5) for anti-TNF experienced subjects. The IRR associated with the use of TNFi was 10.4 (2.3- 47.9). Conclusions: In this high TB incidence setting, SpA patients exposed to anti-TNF therapy had a higher incidence of TB compared to anti-TNF-naïve subjects, although the TB incidence in the control group was significant

Incidence of tuberculosis infection in spondyloarthritis patients treated with biological and conventional disease-modifying anti-rheumatic drugs in an endemic area

Antecedentes : Os registros de acompanhamento de pacientes com espondiloartrite (SpA) forneceram evidências de que os inibidores do fator de necrose tumoral (TNFi) aumentam a incidência de infecção tuberculosa ativa (TB). No entanto, a maioria desses registros é de áreas de baixo peso da TB. Poucos estudos avaliaram a segurança de agentes biológicos em áreas endêmicas da tuberculose. Este trabalho compara a taxa de incidência de TB (TB IR) em indivíduos com experiência em anti-TNF e anti-TNF com SpA em um cenário de alta incidência de TB. Métodos : neste estudo de coorte retrospectivo, foram revisados os prontuários médicos de pacientes atendidos na Clínica SpA durante 13 anos (2004 a 2016) em um hospital universitário. O IR da TB foi calculado e expresso como número de eventos por 10 5 pacientes / ano;foi calculada a razão da taxa de incidência (TIR) associada ao uso de TNFi. Resultados : Foram avaliados 277 pacientes, 173 indivíduos com anti-TNF e 104 com experiência em anti-TNF; 35,7% (N = 35) dos pacientes que receberam um medicamento anti-TNF foram diagnosticados com infecção tuberculosa latente (ILTB). O tempo total de acompanhamento (pessoa / ano) foi 1667,8 e 394,9, respectivamente. O IR da TB (IC 95%) foi de 299,8 (37,4- 562,2) para os anti-TNF e 1012,9 (25,3- 2000,5) para os anti-TNF. A TIR associada ao uso de TNFi foi de 10,4 (2,3- 47,9). Conclusões : nesse cenário de alta incidência de TB, os pacientes com SpA expostos à terapia anti-TNF apresentaram uma incidência maior de TB em comparação aos indivíduos que não receberam anti-TNF, embora a incidência de TB no grupo controle tenha sido significativa