ABSTRACT
OBJECTIVE: To evaluate the safety of the methotrexate (MTX)-leflunomide (LEF) combination in rheumatoid arthritis (RA), comparing it with other therapeutic schemes involving conventional synthetic (cs-) and biologic (b-) disease-modifying antirheumatic drugs (DMARDs) or Janus kinase inhibitors (JAKi). METHODS: Patients with RA starting a treatment course with a csDMARD (without previous use of bDMARD or JAKi) or their first bDMARD/JAKi were followed up in a registry-based, multicentric cohort study in Brazil (BiobadaBrasil). The primary outcome was the incidence of serious adverse events (SAEs); secondary outcomes included serious infections. Multivariate Cox proportional hazards models and propensity score matching analysis (PSMA) were used for statistical comparisons. RESULTS: In total, 1671 patients (5349 patient-years [PY]) were enrolled; 452 patients (1537 PY) received MTX + LEF. The overall incidence of SAEs was 5.6 per 100 PY. The hazard of SAEs for MTX + LEF was not higher than for MTX or LEF (adjusted HR [aHR] 1.00, 95% CI 0.76-1.31, P = 0.98). MTX + LEF presented a lower hazard of SAEs (aHR 0.56, 95% CI 0.36-0.88, P = 0.01) and infectious SAEs (aHR 0.48, 95% CI 0.25-0.94, P = 0.03) than bDMARDs/JAKi with MTX or LEF. MTX + LEF presented lower hazard of SAEs than MTX + sulfasalazine (SSZ; aHR 0.33, 95% CI 0.16-0.65, P = 0.002). Analysis using PSMA confirmed the results obtained with traditional multivariate Cox analysis. CONCLUSION: In our study, MTX + LEF presented a relatively good overall safety profile in comparison to MTX + SSZ and schemes involving advanced therapies in RA.
Subject(s)
Arthritis, Rheumatoid , Methotrexate , Arthritis, Rheumatoid/drug therapy , Cohort Studies , Drug Therapy, Combination , Humans , Isoxazoles/therapeutic use , Leflunomide/therapeutic use , Methotrexate/adverse effects , RegistriesABSTRACT
OBJECTIVE: To evaluate the prevalence of hepatitis C virus (HCV) infection in high risk juvenile systemic lupus erythematosus (JSLE). STUDY DESIGN: Forty low income JSLE patients (6M:34F; mean age 19±4.4 yrs; mean disease duration 6±3.2 yrs) were studied. Twenty healthy children and adolescents matched for social economical level were included as controls. Anti-HCV tests were performed using a third generation microparticle enzyme immunoassay. Inclusion criterion was low social economical level. RESULTS: The frequencies of anti-HCV antibody were low and comparable between JSLE and control group (2.5% vs. 0, p=1.0). JSLE patients had significantly more risk factors for HCV infection compared to the control group, including immunosuppressive treatment (90% vs. 0, p<0.0001), hospitalization (50% vs. 12.5%, p=0.0006) and invasive procedures (47.5% vs. 12.5%, p=0.001). CONCLUSIONS: The observed low frequency of anti-HCV antibodies in high risk JSLE suggests that this virus does not seem to have a relevant role in the pathogenesis of this disease.
Subject(s)
Hepatitis C Antibodies/blood , Hepatitis C/epidemiology , Lupus Erythematosus, Systemic/epidemiology , Adolescent , Adult , Age of Onset , Case-Control Studies , Female , Humans , Male , Prevalence , Young AdultABSTRACT
Abstract Objective To evaluate the prevalence of hepatitis C virus (HCV) infection in high risk juvenile systemic lupus erythematosus (JSLE). Study design Forty low income JSLE patients (6M:34F; mean age 19 ± 4.4 yrs; mean disease duration 6 ± 3.2 yrs) were studied. Twenty healthy children and adolescents matched for social economical level were included as controls. Anti-HCV tests were performed using a third generation microparticle enzyme immunoassay. Inclusion criterion was low social economical level. Results The frequencies of anti-HCV antibody were low and comparable between JSLE and control group (2.5% vs. 0, p = 1.0). JSLE patients had significantly more risk factors for HCV infection compared to the control group, including immunosuppressive treatment (90% vs. 0, p < 0.0001), hospitalization (50% vs. 12.5%, p = 0.0006) and invasive procedures (47.5% vs. 12.5%, p = 0.001). Conclusions The observed low frequency of anti-HCV antibodies in high risk JSLE suggests that this virus does not seem to have a relevant role in the pathogenesis of this disease.
Resumo Objetivo Avaliar a prevalência de infecção pelo vírus da hepatite C (VHC) em pacientes de alto risco com lúpus eritematoso sistêmico de início juvenil (LESJ). Desenho do estudo Foram estudados 40 pacientes de baixa renda com LESJ (6 H: 34 M, com média de 19 ± 4,4 anos; duração média da doença de 6 ± 3,2 anos). Incluíram-se no grupo controle 20 crianças e adolescentes saudáveis pareados por nível socioeconômico. Fizeram-se testes anti-VHC com um ensaio imunoenzimático de micropartículas de terceira geração. O critério de inclusão foi o baixo nível socioeconômico. Resultados As frequências de anticorpos anti-VHC foram baixas e comparáveis entre os grupos LESJ e controle (2,5% versus 0, p = 1). Os pacientes com LESJ tinham significativamente mais fatores de risco para infecção por VHC em comparação com o grupo controle, incluindo tratamento imunossupressor (90% versus 0, p < 0,0001), internação (50% versus 12,5%, p = 0,0006) e procedimentos invasivos (47,5% versus 12,5%, p = 0,001). Conclusões A baixa frequência de anticorpos anti-VHC observada nos pacientes de alto risco com LESJ sugere que esse vírus não parece ter um papel relevante na patogênese dessa doença.
