Transverse Myelitis in Systemic Lupus Erythematosus: Clinical Features and Prognostic Factors in a Large Cohort of Latin American Patients.

BACKGROUND: Acute transverse myelitis (ATM) is an infrequent but severe complication of systemic lupus erythematosus (SLE). The purpose of study was to describe clinical features and prognostic factors of patients with SLE-related ATM. METHODS: In this medical records review study, data were collected from 60 patients from 16 centers seen between 1996 and 2017 who met diagnostic criteria for SLE and myelitis as defined by the American College of Rheumatology/Systemic International Collaborating Clinics and the Working Group of the Transverse Myelitis Consortium, respectively. Objective neurological impairment was measured with American Spinal Injury Association Impairment Scale (AIS) and European Database for Multiple Sclerosis Grade Scale (EGS). RESULTS: Among patients included, 95% (n = 57) were female, and the average age was 31.6 ± 9.6 years. Myelitis developed after diagnosis of SLE in 60% (n = 36). Symmetrical paraparesis with hypoesthesia, flaccidity, sphincter dysfunction, AIS = A/B, and EGS ≥ 8 was the most common presentation. Intravenous methylprednisolone was used in 95% (n = 57), and 78.3% (n = 47) received intravenous cyclophosphamide. Sensory/motor recovery at 6 months was observed in 75% (42 of 56), but only in 16.1% (9 of 56) was complete. Hypoglycorrhachia and EGS ≥ 7 in the nadir were associated with an unfavorable neurological outcome at 6 months (p < 0.05). A relapse rate during follow-up was observed in 30.4% (17 of 56). Hypoglycorrhachia and hypocomplementemia seem to be protective factors for relapse. Intravenous cyclophosphamide was associated with time delay to relapse. CONCLUSIONS: Systemic lupus erythematosus-related ATM may occur at any time of SLE course, leading to significant disability despite treatment. Relapses are infrequent and intravenous cyclophosphamide seems to delay it. Hypoglycorrhachia, hypocomplementemia, and EGS at nadir are the most important prognostic factors.

Seguridad y supervivencia de las terapias biológicas: primer informe del registro paraguayo-uruguayo de acontecimientos adversos con terapias biológicas Biobadaguay / Safety and survival associated with biologic therapies: first report of the biobadaguay on the Paraguayan-Uruguayan registry of adverse events with biologic therapies

OBJETIVOS: Analizar los acontecimientos adversos (AA) y la supervivencia de las terapias biológicas (TB) en el registro paraguayo-uruguayo de AA, Biobadaguay. MÉTODO: Estudio observacional, prospectivo de duración indeterminada. Se han incluido pacientes al inicio de la TB y controles. Se han registrado variables clínicas, biológicas y relacionadas con el tratamiento. RESULTADOS: Se realizaron 826 registros (650 TB y 176 controles). El 70,9% fueron mujeres y el diagnóstico más frecuente fue la artritis reumatoide (AR) (63,2%). La TB más utilizada fue el adalimumab (56,6%) y la causa más frecuente de interrupción, la ineficacia (42,1%). La incidencia de AA en pacientes con TB fue de 143,9 (128,8-160,8) por 1.000 pacientes/año. En el estudio comparativo de AA en función del diagnóstico, se observó que la artritis idiopática juvenil (AIJ) se asoció a más AA globales (RTI = 2,3; IC 95%: 1,6-3,4; p = 4,27×10−6), mientras que la AR se asoció a un mayor número de AA graves (RTI = 2,20; IC 95%: 1,2-4,1; p = 1,17×10−2). Por otro lado, el tratamiento con tocilizumab se asoció a una mayor tasa de AA (RTI = 2,69; IC 95%: 1,90-3,82; p = 3,13×10−8). El diagnóstico de AIJ, el tratamiento con corticoides y el número de TB previas se asociaron a la disminución de la supervivencia de las TB. CONCLUSIÓN: En este primer informe del registro Biobadaguay, la principal causa de interrupción de la TB fue la ineficacia. Con relación al diagnóstico, la AR y la AIJ se asociaron a un mayor riesgo de AA. En este registro, se identificaron variables relacionadas a una menor supervivencia de las TB

OBJECTIVE: Analyze adverse events (AE) and survival associated with biologic therapies (BT) in the Biobadaguay, the Paraguayan Uruguayan registry of adverse events. METHODS: Prospective, observational study of undetermined duration. Patients on BT at initiation and controls were included. Clinical, biological and treatment variables were registered. RESULTS: A total of 826 registers were entered (650 BT and 176 controls); 70.9% were women and rheumatoid arthritis (RA) was the most frequent diagnosis (63.2%). The BT most often used was adalimumab and the main cause of discontinuation was loss of efficacy (42.1%). The incidence of AE of patients on BT was 143.9 (128.8-160.8) per 1000 patients/year. In the comparative study of AE related to diagnosis, juvenile idiopathic arthrosis (JIA) was associated with a higher overall number of AE (RTI = 2.3; 95%CI: 1.6-3.4; P = 4.27 ×10−6), whereas RA was associated with a higher number of serious AE (RTI = 2.2; 95% CI: 1.2-4.1; P =1.17 ×10−2). On the other hand, treatment with tocilizumab was associated with a higher rate of AE (RTI = 2.69; 95% CI: 1.9-3.82; P = 3.13 ×10−8). In JIA, treatment with corticosteroids and number of previous BT was associated with a decrease in BT survival. CONCLUSION: In this first report of the Biobadaguay registry, the main cause of BT discontinuation was loss of efficacy. In terms of the diagnosis involved, RA and JIA were associated with a higher risk of AE. In this registry, variables related to a shorter survival of BT were identified

Safety and Survival Associated with Biologic Therapies: First Report of the Biobadaguay on the Paraguayan-Uruguayan Registry of Adverse Events with Biologic Therapies. / Seguridad y supervivencia de las terapias biológicas: primer informe del registro paraguayo-uruguayo de acontecimientos adversos con terapias biológicas Biobadaguay.

OBJECTIVE: Analyze adverse events (AE) and survival associated with biologic therapies (BT) in the Biobadaguay, the Paraguayan Uruguayan registry of adverse events. METHODS: Prospective, observational study of undetermined duration. Patients on BT at initiation and controls were included. Clinical, biological and treatment variables were registered. RESULTS: A total of 826 registers were entered (650 BT and 176 controls); 70.9% were women and rheumatoid arthritis (RA) was the most frequent diagnosis (63.2%). The BT most often used was adalimumab and the main cause of discontinuation was loss of efficacy (42.1%). The incidence of AE of patients on BT was 143.9 (128.8-160.8) per 1000 patients/year. In the comparative study of AE related to diagnosis, juvenile idiopathic arthrosis (JIA) was associated with a higher overall number of AE (RTI = 2.3; 95%CI: 1.6-3.4; P = 4.27 ×10-6), whereas RA was associated with a higher number of serious AE (RTI = 2.2; 95% CI: 1.2-4.1; P =1.17 ×10-2). On the other hand, treatment with tocilizumab was associated with a higher rate of AE (RTI = 2.69; 95% CI: 1.9-3.82; P = 3.13 ×10-8). In JIA, treatment with corticosteroids and number of previous BT was associated with a decrease in BT survival. CONCLUSION: In this first report of the Biobadaguay registry, the main cause of BT discontinuation was loss of efficacy. In terms of the diagnosis involved, RA and JIA were associated with a higher risk of AE. In this registry, variables related to a shorter survival of BT were identified.