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PURPOSE: To assess efficacy, safety, and cost-effectiveness of adalimumab (ADA) therapy optimization in a large series of patients with uveitis due to Behçet disease (BD) who achieved remission after the use of this biologic agent. DESIGN: Open-label multicenter study of ADA-treated patients with BD uveitis refractory to conventional immunosuppressants. SUBJECTS: Sixty-five of 74 patients with uveitis due to BD, who achieved remission after a median ADA duration of 6 (range, 3-12) months. ADA was optimized in 23 (35.4%) of them. This biologic agent was maintained at a dose of 40 mg/subcutaneously/2 weeks in the remaining 42 patients. METHODS: After remission, based on a shared decision between the patient and the treating physician, ADA was optimized. When agreement between patient and physician was reached, optimization was performed by prolonging the ADA dosing interval progressively. Comparison between optimized and nonoptimized patients was performed. MAIN OUTCOME MEASURES: Efficacy, safety, and cost-effectiveness in optimized and nonoptimized groups. To determine efficacy, intraocular inflammation (anterior chamber cells, vitritis, and retinal vasculitis), macular thickness, visual acuity, and the sparing effect of glucocorticoids were assessed. RESULTS: No demographic or ocular differences were found at the time of ADA onset between the optimized and the nonoptimized groups. Most ocular outcomes were similar after a mean ± standard deviation follow-up of 34.7±13.3 and 26±21.3 months in the optimized and nonoptimized groups, respectively. However, relevant adverse effects were only seen in the nonoptimized group (lymphoma, pneumonia, severe local reaction at the injection site, and bacteremia by Escherichia coli, 1 each). Moreover, the mean ADA treatment costs were lower in the optimized group than in the nonoptimized group (6101.25 euros/patient/year vs. 12 339.48; P < 0.01). CONCLUSION: ADA optimization in BD uveitis refractory to conventional therapy is effective, safe, and cost-effective.
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Adalimumab/administração & dosagem , Síndrome de Behçet/complicações , Uveíte/tratamento farmacológico , Acuidade Visual , Adulto , Anti-Inflamatórios/administração & dosagem , Síndrome de Behçet/tratamento farmacológico , Relação Dose-Resposta a Droga , Feminino , Angiofluoresceinografia , Fundo de Olho , Humanos , Imunossupressores/uso terapêutico , Masculino , Estudos Retrospectivos , Tomografia de Coerência Óptica , Resultado do Tratamento , Uveíte/diagnóstico , Uveíte/etiologiaRESUMO
OBJECTIVE: The aim of this study was to assess the efficacy of anti-TNF-α therapy in refractory uveitis due to Behçet's disease (BD). METHODS: We performed a multicentre study of 124 patients with BD uveitis refractory to conventional treatment including high-dose corticosteroids and at least one standard immunosuppressive agent. Patients were treated for at least 12 months with infliximab (IFX) (3-5 mg/kg at 0, 2 and 6 weeks and then every 4-8 weeks) or adalimumab (ADA) (usually 40 mg every 2 weeks). The main outcome measures were degree of anterior and posterior chamber inflammation, visual acuity, macular thickness and immunosuppression load. RESULTS: Sixty-eight men and 56 women (221 affected eyes) were studied. The mean age was 38.6 years (s.d. 10.4). HLA-B51 was positive in 66.1% of patients and uveitis was bilateral in 78.2%. IFX was the first biologic agent in 77 cases (62%) and ADA was first in 47 (38%). In most cases anti-TNF-α drugs were used in combination with conventional immunosuppressive drugs. At the onset of anti-TNF-α therapy, anterior chamber and vitreous inflammation was observed in 57% and 64.4% of patients, respectively. In both conditions the damage decreased significantly after 1 year. At baseline, 50 patients (80 eyes) had macular thickening [optical coherence tomography (OCT) >250 µm] and 35 (49 eyes) had cystoid macular oedema (OCT>300 µm) that improved from 420 µm (s.d. 119.5) at baseline to 271 µm (s.d. 45.6) at month 12 (P < 0.01). The best-corrected visual acuity and the suppression load also showed significant improvement. After 1 year of follow-up, 67.7% of patients were inactive. Biologic therapy was well tolerated in most cases. CONCLUSION: Anti-TNF-α therapy is effective and relatively safe in refractory BD uveitis.
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Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Síndrome de Behçet/tratamento farmacológico , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Uveíte/tratamento farmacológico , Adalimumab , Adolescente , Adulto , Idoso , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Síndrome de Behçet/complicações , Produtos Biológicos/efeitos adversos , Produtos Biológicos/uso terapêutico , Criança , Esquema de Medicação , Resistência a Medicamentos , Quimioterapia Combinada , Feminino , Seguimentos , Glucocorticoides/administração & dosagem , Glucocorticoides/uso terapêutico , Humanos , Imunossupressores/uso terapêutico , Infliximab , Masculino , Pessoa de Meia-Idade , Prednisona/administração & dosagem , Prednisona/uso terapêutico , Resultado do Tratamento , Uveíte/etiologia , Adulto JovemRESUMO
PURPOSE: To evaluate long-term visual and anatomical outcomes in neovascular age-related macular degeneration (nAMD) patients treated with anti-vascular endothelial growth factor (VEGF) agents depending on the time delay from confirmed diagnosis to treatment initiation. MATERIALS AND METHODS: Seventy-three nAMD patients (73 eyes) treated with anti-VEGF agents for 12 months using the pro re nata regimen were included in this retrospective longitudinal study. Patients were split into 3 groups according to the time from diagnosis to first anti-VEGF injection: < 48 h (group 1); 48 h-7 days (group 2); > 7 days (group 3). Decimal best-corrected visual acuity (VA) and macular thickness (MT) were recorded at baseline and 1-2-, 3-4-, 6- and 12-month later. Furthermore, age, gender as well as the applied treatment and number of injections after 12 months of treatment were also registered and compared. RESULTS: Long-term effect of the treatment demonstrated enhanced VA in group 1 patients compared with the rest of groups after 1-2-, 6-, and 12-month follow-up (P < 0.05). Positive effects of early treatment were additionally corroborated by the augmented percentage of patients with normal VA in the group 1 respect to the rest of groups over studied time points (P < 0.05). Moreover, the VA gain in nAMD at group 1 was obtained with a mean of 3.7 intravitreal injections over 1-year follow-up period. Regarding MT, non-significant difference was observed among groups. CONCLUSIONS: An early initial treatment with VEGF inhibitors is critical to achieve the best functional benefits of this therapy in new-onset nAMD patients.
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Inibidores da Angiogênese , Degeneração Macular , Humanos , Lactente , Inibidores da Angiogênese/uso terapêutico , Ranibizumab/uso terapêutico , Fator A de Crescimento do Endotélio Vascular , Estudos Retrospectivos , Estudos Longitudinais , Injeções Intravítreas , Degeneração Macular/diagnóstico , Degeneração Macular/tratamento farmacológico , Degeneração Macular/induzido quimicamente , Resultado do Tratamento , SeguimentosRESUMO
INTRODUCTION: Retinopathy of prematurity (ROP) is characterised by insufficient vascular development in the retina, and requires early treatment to avoid visual disability in severe cases. ROP is currently the second leading cause of preventable child blindness in the world. PATIENTS AND METHODS: This was an observational, retrospective, case-control study including 233 preterm infants examined between 1999 and 2019. RESULTS: Postnatal weight gain in the first 4 weeks of life, birth weight, gestational age, mechanical ventilation, transfusion, presence of sepsis, persistence of arterial ductus, necrotising enterocolitis, intraventricular haemorrhage, or periventricular leukomalacia were found to be significantly different between the ROP groups requiring and not requiring treatment. The mean postnatal weight gain in the ROP group not requiring treatment was 12.75⯱â¯5.99â¯g/day, whereas it was 9.50⯱â¯5.45â¯g/day in the ROP group requiring treatment. The risk of developing ROP that required treatment decreased with an increase in weight gain. The risk reduction was 2.76%-8.35% in preterm infants gaining 10â¯g/day, and 7.17%-12.76% in infants gaining 20â¯g/day. CONCLUSIONS: The risk of developing ROP requiring treatment decreased with increasing weight gain in the first 4 weeks of life. This was applicable in infants with postnatal weight gain ≥14â¯g/day. However, gestational age, birth weight, time of mechanical ventilation, and comorbidity should be taken into account when evaluating the risk of ROP requiring treatment.
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Retinopatia da Prematuridade , Aumento de Peso , Peso ao Nascer , Estudos de Casos e Controles , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Retinopatia da Prematuridade/epidemiologia , Estudos RetrospectivosRESUMO
Purpose: To assess the validity of the online WINROP algorithm in two Spanish populations of premature infants.Materials and methods: The study population consisted of 502 premature infants born in the San Cecilio University Hospital of Granada and the Regional University Hospital of Málaga in the years 2000-2015. The WINROP algorithm was used to determine an alarm threshold for retinopathy of prematurity (ROP). The results were compared with those obtained from serial examinations of premature infants.Results: The global WINROP algorithm showed a sensitivity of 62%, specificity of 74%, positive predictive value (PPV) of 59%, and negative predictive value (NPV) of 77%. This algorithm showed a greater sensitivity (76%) to identify severe ROP.Conclusions: The WINROP screening algorithm in this study showed moderate sensitivity, so many ROP cases amenable to treatment were not detected. Other criteria should be added to the algorithm to increase the sensitivity.
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Algoritmos , Triagem Neonatal/métodos , Retinopatia da Prematuridade/diagnóstico , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Recém-Nascido de muito Baixo Peso , Triagem Neonatal/normas , Valor Preditivo dos Testes , Gravidez , Estudos Retrospectivos , Medição de RiscoRESUMO
Importance: Vascular delay that occurs early in the development of retinopathy of prematurity (ROP) is a risk factor that can be compensated by ensuring a good rate of retinal vascularization to avoid ROP that requires treatment. Background: The objective of the present study was to determine the association between ROP that requires treatment and risk factors such as the extent of the temporal avascular area of the retina and the number of days of mechanical ventilation (MV). Design: Observational retrospective case-control study. Participants: Two hundred and twenty-eight premature newborns included in the screening protocol for retinopathy of prematurity. Methods: Subjects underwent retinal examination in the 4 and 6th postnatal weeks. Main Outcome Measures: The temporal avascular area was measured in disc diameters (DD), while the MV time was measured in days of treatment. Results: Patients with a longer MV time had a higher risk of treatment (R 2: 24.7, p < 0.0001; increase in risk of 8.1% for each additional day), as did those who showed greater avascular area (R 2: 24.7, p < 0.0001; increase in risk of 111% for each additional DD). An online calculator system and a table are presented for calculating the risk of ROP requiring treatment as a function of these two risk factors. Conclusions and Relevance: The temporal avascular area of the retina and MV time must be taken into account in the first examination of the newborn to predict the need for ROP treatment.
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We aimed to assess the efficacy of biologic therapy in refractory non-Multiple Sclerosis (MS) Optic Neuritis (ON), a condition more infrequent, chronic and severe than MS ON. This was an open-label multicenter study of patients with non-MS ON refractory to systemic corticosteroids and at least one conventional immunosuppressive drug. The main outcomes were Best Corrected Visual Acuity (BCVA) and both Macular Thickness (MT) and Retinal Nerve Fiber Layer (RNFL) using Optical Coherence Tomography (OCT). These outcome variables were assessed at baseline, 1 week, and 1, 3, 6 and 12 months after biologic therapy initiation. Remission was defined as the absence of ON symptoms and signs that lasted longer than 24 h, with or without an associated new lesion on magnetic resonance imaging with gadolinium contrast agents for at least 3 months. We studied 19 patients (11 women/8 men; mean age, 34.8 ± 13.9 years). The underlying diseases were Bechet's disease (n = 5), neuromyelitis optica (n = 3), systemic lupus erythematosus (n = 2), sarcoidosis (n = 1), relapsing polychondritis (n = 1) and anti-neutrophil cytoplasmic antibody -associated vasculitis (n = 1). It was idiopathic in 6 patients. The first biologic agent used in each patient was: adalimumab (n = 6), rituximab (n = 6), infliximab (n = 5) and tocilizumab (n = 2). A second immunosuppressive drug was simultaneously used in 11 patients: methotrexate (n = 11), azathioprine (n = 2), mycophenolate mofetil (n = 1) and hydroxychloroquine (n = 1). Improvement of the main outcomes was observed after 1 year of therapy when compared with baseline data: mean ± SD BCVA (0.8 ± 0.3 LogMAR vs. 0.6 ± 0.3 LogMAR; p = 0.03), mean ± SD RNFL (190.5 ± 175.4 µm vs. 183.4 ± 139.5 µm; p = 0.02), mean ± SD MT (270.7 ± 23.2 µm vs. 369.6 ± 137.4 µm; p = 0.03). Besides, the median (IQR) prednisone-dose was also reduced from 40 (10-61.5) mg/day at baseline to. 2.5 (0-5) mg/day after one year of follow-up; p = 0.001. After a mean ± SD follow-up of 35 months, 15 patients (78.9%) achieved ocular remission, and 2 (10.5%) experienced severe adverse events. Biologic therapy is effective in patients with refractory non-MS ON.
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OBJECTIVE: To compare the efficacy of infliximab (IFX) versus adalimumab (ADA) as a first-line biologic drug over 1 year of treatment in a large series of patients with refractory uveitis due to Behçet's disease (BD). METHODS: We conducted an open-label multicenter study of IFX versus ADA for BD-related uveitis refractory to conventional nonbiologic treatment. IFX or ADA was chosen as the first-line biologic agent based on physician and patient agreement. Patients received 3-5 mg/kg intravenous IFX at 0, 2, and 6 weeks and every 4-8 weeks thereafter, or 40 mg subcutaneous ADA every other week without a loading dose. Ocular parameters were compared between the 2 groups. RESULTS: The study included 177 patients (316 affected eyes), of whom 103 received IFX and 74 received ADA. There were no significant baseline differences between treatment groups in main demographic features, previous therapy, or ocular sign severity. After 1 year of therapy, we observed an improvement in all ocular parameters in both groups. However, patients receiving ADA had significantly better outcomes in some parameters, including improvement in anterior chamber inflammation (92.31% versus 78.18% for IFX; P = 0.06), improvement in vitritis (93.33% versus 78.95% for IFX; P = 0.04), and best-corrected visual acuity (mean ± SD 0.81 ± 0.26 versus 0.67 ± 0.34 for IFX; P = 0.001). A nonsignificant difference was seen for macular thickness (mean ± SD 250.62 ± 36.85 for ADA versus 264.89 ± 59.74 for IFX; P = 0.15), and improvement in retinal vasculitis was similar between the 2 groups (95% for ADA versus 97% for IFX; P = 0.28). The drug retention rate was higher in the ADA group (95.24% versus 84.95% for IFX; P = 0.042). CONCLUSION: Although both IFX and ADA are efficacious in refractory BD-related uveitis, ADA appears to be associated with better outcomes than IFX after 1 year of follow-up.
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Adalimumab/uso terapêutico , Síndrome de Behçet/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Imunossupressores/uso terapêutico , Infliximab/uso terapêutico , Uveíte/tratamento farmacológico , Adulto , Síndrome de Behçet/complicações , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Uveíte/etiologiaRESUMO
PURPOSE: To analyse the speed of temporal retinal vascularisation in preterm infants included in the screening programme for retinopathy of prematurity. MATERIAL AND METHODS: A total of 185 premature infants were studied retrospectively between 2000 and 2017 in San Cecilio University Hospital of Granada, Spain. The method of binocular indirect ophthalmoscopy with indentation was used for the examination. The horizontal disc diameter was used as a unit of length. Speed of temporal retinal vascularisation (disc diameter/week) was calculated as the ratio between the extent of temporal retinal vascularisation (disc diameter) and the time in weeks. RESULTS: The weekly temporal retinal vascularisation (0-1.25 disc diameter/week, confidence interval) was significantly higher in no retinopathy of prematurity (0.73 ± 0.22 disc diameter/week) than in stage 1 retinopathy of prematurity (0.58 ± 0.22 disc diameter/week). It was also higher in stage 1 than in stages 2 (0.46 ± 0.14 disc diameter/week) and 3 of retinopathy of prematurity (0.36 ± 0.18 disc diameter/week). The rate of temporal retinal vascularisation (disc diameter/week) decreases when retinopathy of prematurity stage increases. The area under the receiver operating characteristic curve was 0.85 (95% confidence interval: 0.79-0.91) for retinopathy of prematurity requiring treatment versus not requiring treatment. The best discriminative cut-off point was a speed of retinal vascularisation <0.5 disc diameter/week, with a sensitivity and a specificity of 84.8% and 77%, respectively. CONCLUSION: The rate of temporal retinal vascularisation is a quantifiable observation that can help to alert a clinician that treatment of retinopathy of prematurity may be required. However, before becoming a new standard of care for treatment, it requires careful documentation, with agreement between several ophthalmologists.
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Velocidade do Fluxo Sanguíneo/fisiologia , Recém-Nascido Prematuro , Oftalmoscopia/métodos , Vasos Retinianos/fisiopatologia , Retinopatia da Prematuridade/fisiopatologia , Feminino , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Masculino , Curva ROC , Vasos Retinianos/diagnóstico por imagem , Retinopatia da Prematuridade/diagnóstico , Retinopatia da Prematuridade/terapia , Estudos RetrospectivosRESUMO
Introducción: La retinopatía del prematuro (ROP) se caracteriza por el desarrollo vascular insuficiente en la retina que, en los casos severos precisa tratamiento precoz para evitar secuelas visuales. Es actualmente la segunda causa mundial de ceguera infantil prevenible.Pacientes y métodos: Estudio observacional, retrospectivo, de casos-controles sobre 233 recién nacidos prematuros explorados entre 1999-2019.Resultados: La ganancia de peso posnatal en las primeras 4 semanas, el peso al nacer, la edad gestacional, la ventilación mecánica, las transfusiones recibidas y la presencia de sepsis, ductus arteriovenoso persistente, enterocolitis necrosante, hemorragia intraventricular o leucomalacia periventricular, mostraron diferencias significativas entre el grupo de ROP no susceptible de tratamiento frente al grupo candidato a tratamiento. La ganancia ponderal media fue 12,75±5,99g/día en el grupo no susceptible de tratamiento y 9,50±5,45g/día en el susceptible de tratamiento. El riesgo de ROP candidata a tratamiento se redujo progresivamente con el aumento de ganancia ponderal. La reducción del riesgo fue de 2,76 - 8,35% en ganancias de 10g/día, y alcanza el 7,17 - 12,76% en ganancias de 20g/día.Conclusiones: El riesgo de presentar ROP severa candidata a tratamiento disminuye con el aumento de la ganancia de peso posnatal en las primeras 4 semanas. Esta relación se mantiene en ganancias de peso >14g/día. Sin embargo, se deben tener en cuenta la edad gestacional y peso al nacer del recién nacido, la duración de la ventilación mecánica y su comorbilidad para la evaluación global del riesgo de ROP que precisa tratamiento. (AU)
Introduction: Retinopathy of prematurity (ROP) is characterised by insufficient vascular development in the retina, and requires early treatment to avoid visual disability in severe cases. ROP is currently the second leading cause of preventable child blindness in the world.Patients and methods: This was an observational, retrospective, case-control study including 233 preterm infants examined between 1999 and 2019.Results: Postnatal weight gain in the first 4 weeks of life, birth weight, gestational age, mechanical ventilation, transfusion, presence of sepsis, persistence of arterial ductus, necrotising enterocolitis, intraventricular haemorrhage, or periventricular leukomalacia were found to be significantly different between the ROP groups requiring and not requiring treatment. The mean postnatal weight gain in the ROP group not requiring treatment was 12.75±5.99g/day, whereas it was 9.50±5.45g/day in the ROP group requiring treatment. The risk of developing ROP that required treatment decreased with an increase in weight gain. The risk reduction was 2.76 - 8.35% in preterm infants gaining 10g/day, and 7.17 - 12.76% in infants gaining 20g/day.Conclusions: The risk of developing ROP requiring treatment decreased with increasing weight gain in the first 4 weeks of life. This was applicable in infants with postnatal weight gain ≥ 14g/day. However, gestational age, birth weight, time of mechanical ventilation, and comorbidity should be taken into account when evaluating the risk of ROP requiring treatment. (AU)
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Humanos , Recém-Nascido , Retinopatia da Prematuridade/dietoterapia , Retinopatia da Prematuridade/tratamento farmacológico , Retinopatia da Prematuridade/prevenção & controle , Recém-Nascido Prematuro , Cegueira , Estudos Retrospectivos , Aumento de Peso , Peso ao NascerRESUMO
PURPOSE: In recent years, we have seen an increase in the use of laser systems in the field of aesthetics (mainly depigmentation and hair removal). Alexandrite laser is the most widely used.Case report. METHODS: Case report. RESULTS: We describe a case of retinal injury (foveal photocoagulation) directly related to an alexandrite laser hair removal procedure. CONCLUSIONS: Hair removal by laser systems is a fast and efficient method. The use of lasers without adequate protective measures or by unqualified personnel increases the risk of ocular adverse effects.