Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR.

OBJECTIVE: Most reports on serious infections (SI) in rheumatoid arthritis (RA) patients treated with biological disease-modifying antirheumatic drugs (bDMARDs) are from the USA and Western Europe. Data from other regions are largely missing. We report data from South American countries with different backgrounds and health-care systems but similar registries. METHODS: We merged 2010-2016 data from two registries, BIOBADABRASIL (Brazil) and BIOBADASAR (Argentina), which share the same protocol, online platform and data monitoring process. Patients with active RA were included when they began the first bDMARD or a conventional synthetic DMARD (csDMARD, control group). The SI incidence rate (IR) per 1000 patient/years and adjusted IR ratio (aIRR) were estimated for bDMARDs and csDMARDs. RESULTS: Data were analysed for 3717 RA patients with an exposure of 13,380 patient/years. The 2591 patients treated with bDMARDs (64% tumour necrosis factor-α inhibitors (TNFi)) had a follow-up of 9300 years, and the 1126 treated with csDMARDs had an exposure of 4081 patient/years. The SI IR was 30.54 (CI 27.18-34.30) for all bDMARDs and 5.15 (CI 3.36-7.89) for csDMARDs. The aIRR between the two groups was 2.03 ([1.05, 3.9] p = 0.034) for the first 6 months of treatment but subsequently increased to 8.26 ([4.32, 15.76] p < 0.001). The SI IR for bDMARDs decreased over time in both registries, dropping from 36.59 (28.41-47.12) in 2012 to 7.27 (4.79-11.05) in 2016. CONCLUSION: While SI remains a major concern in South American patients with RA treated with bDMARDs, a favourable trend toward a reduction was observed in the last years.Key Points• New comprehensive data on biologic drugs safety from international collaboration in South America.• First proposal for national registries data merging in South America.• Serious infections remain a major concern in RA patients treated with biologics.• A significant reduction of serious infections in RA patients exposed to biologics was observed over a 7 years period.

Glomerulonefritis ANCA asociada con biopsia renal atípica en paciente con artritis psoriásica: Reporte de caso y revisión / ANCA associated vasculitis with atypical kidney biopsy in context of psoriasic arthritis: Case report and review

Introducción: La glomerulonefritis rápidamente progresiva (GNRP) no se presenta como manifestación extraarticular de la Artritis Psoriasica (APs). Las GNRP son frecuentemente relacionadas a vasculitis ANCA asociadas (VAA). Según la bibliografía, no es inusual encontrar depósitos de inmunocomplejos (IC) en las lesiones glomerulares de VAA. Existen publicaciones de casos en donde la presencia de una VAA podría estar asociada a la terapia con anti-TNFα. Caso: Mujer de 56 años de edad con artritis psoriásica en tratamiento con metotrexato y etanercept. Debido a infección de vías aéreas suspende etanercept y, posterior a la suspensión, evoluciona con síndrome nefrítico con biopsia renal que evidencia GN con depósitos de IC poco característicos y ANCA c / PR3 (+) en altos títulos. Conclusiones: Presentamos una paciente en la cual la manifestación de dos entidades, aparentemente no relacionadas, representa un reto diagnóstico y terapéutico. La relación con el tratamiento anti-TNFα ha sido descripta aunque no pueda demostrarse su relación causal. La mayoría de las biopsias renales de las VAA no presentan depósitos inmunes en la IF; aunque en un porcentaje bajo pueden visualizarse grados variables de complemento e inmunocomplejos.

Introduction: Anti-TNFα has changed the evolution and prognosis in psoriatic arthritis (PsA). Among the adverse events (AD) of these treatments, rapidly progressive glomerulonephritis (GNRP) has been described. In 80% of cases of GNRP, vasculitis is associated to ANCA (AAV). According to the literature, it is not unusual to find immune complex deposits (IC) in glomerular AAV lesions. There are publications of cases in which the presence of an AAV could be associated with the anti-TNFα therapy. Case: A 56-year-old woman with psoriatic arthritis under treatment with methotrexate and etanercept. Due to airway infection, etanercept is suspended and after the suspension evolves with nephritic syndrome with renal biopsy, which shows GN with uncharacteristic IC deposits and ANCA c / PR3 (+) in high titers. Conclusions: We present a patient in whom the manifestation of two entities, apparently unrelated, represents a diagnostic and therapeutic challenge. The relationship with the anti-TNFα treatment has been described, although its causal relationship can not be demonstrated. Most renal biopsies of AAV do not have immune deposits in the IF; although in a low percentage variable degrees of complement and immune complex deposits can be visualized.