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Diaz-Llopis M.,University of Valencia | Salom D.,University of Valencia | Garcia-De-Vicuna C.,Service of Ophthalmology | Cordero-Coma M.,Service of Ophthalmology | And 12 more authors.
Ophthalmology | Year: 2012

Objective: To evaluate adalimumab therapy in refractory uveitis. Design: Prospective case series. Participants: A total of 131 patients with refractory uveitis and intolerance or failure to respond to prednisone and at least 1 other systemic immunosuppressive drug participated. Intervention: Patients received a 40 mg adalimumab subcutaneous injection every other week for 6 months. The associated immunosuppressants were tapered after administering 3 adalimumab injections (week 6). Main Outcome Measures: Degree of anterior and posterior chamber inflammation (Standardization of Uveitis Nomenclature Working Group criteria), immunosuppression load (as defined by Nussenblatt et al), visual acuity (logarithm of the minimal angle of resolution [logMAR]), and macular thickness (optical coherence tomography). Results: There were 61 men and 70 women (mean age, 27.3 years). The most common causes were juvenile idiopathic arthritis in 39 patients, pars planitis in 16 patients, and Behçet's disease in 13 patients. Twenty-seven patients had uveitis of idiopathic origin. Inflammation in the anterior chamber was present in 82% of patients and in the vitreous cavity in 59% of patients. Anterior chamber inflammation and vitreous inflammation decreased significantly (P < 0.001) from a mean of 1.51 and 1.03 at baseline to 0.25 and 0.14, respectively, at 6 months. Macular thickness was 296 (102) μ at baseline versus 240 (36) μ at the 6-month visit (P < 0.001). Visual acuity improved by -0.3 logMAR in 32 of 150 eyes (21.3%) and worsened by +0.3 logMAR (-15 letters) in 5 eyes (3.3%). The dose of corticosteroids also decreased from 0.74 (3.50) to 0.20 (0.57) mg/kg/day (P < 0.001). Cystoid macular edema, which was present in 40 eyes at baseline, showed complete resolution in 28 eyes at 6 months. The mean suppression load decreased significantly (8.81 [5.05] vs 5.40 [4.43]; P < 0.001). Six months after the initiation of the study, 111 patients (85%) were able to reduce at least 50% of their baseline immunosuppression load. Only 9 patients (6.9%) had severe relapses during the 6 months of follow-up. Conclusions: Adalimumab seems to be well tolerated and helpful in decreasing inflammatory activity in refractory uveitis and may reduce steroid requirement. Further controlled studies of adalimumab for uveitis are warranted. Financial Disclosure(s): The authors have no proprietary or commercial interest in any materials discussed in this article. © 2012 American Academy of Ophthalmology.

Hernandez-Molina J.M.,Hospital Universitario Carlos Haya
Antimicrobial Agents and Chemotherapy | Year: 2013

We report the epidemiological impact of carbapenemase-producing Enterobacteriaceae (CPE) in Spain in 2012. Of the 237 carbapenemases detected, 163 were from the OXA-48 group, 60 were from VIM-1, 8 were from KPC-2, 5 were from IMP, and 1 was from NDM-1. Interhospital spread of carbapenemase-producing Klebsiella pneumoniae was due to a limited number of multilocus sequence types (MLST) and carbapenemase types, including ST15-VIM-1, ST11-OXA-48, ST405-OXA-48, ST101-KPC-2, and ST11-VIM-1. The number of CPE cases in Spain has increased sharply in recent years, due mainly to the emergence of OXA-48. Copyright © 2013, American Society for Microbiology. All Rights Reserved.

The new insights presented at the 5th Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) held in Amsterdam, the Netherlands, 19-22 October 2011, have been summarized at the fourth edition of Post-ECTRIMS meeting held in Madrid in November 2011. Regional grey-matter atrophy is more sensitive to cognitive impairment than global grey-matter atrophy measures. In patients with clinically isolated syndrome cognitive impairment does not predict conversion to multiple sclerosis (MS) after 5-years of follow-up. Focusing on central nervous system plasticity and functional reorganization in MS, an early intervention can improve clinical aspects and enhances brain plasticity. Preservation of a potential for plasticity provides a rationale for rehabilitation interventions even in later stages of disease. Therapeutical strategies have focused on stem cell-mediated remyelination and immunomodulation functions, on cellular infiltration into the brain, and on new ways for immuno-modulation for the development of future therapies in MS. Encouraging findings from clinical trials with current and emerging disease-modifying therapy being developed was also a key theme at this edition. Positive results have been reported for rituximab, ocrelizumab, ofatumumab, daclizumab, alemtuzumab, teriflunomide, BG-12, and laquinimod, including a favorable safety profile. Since armamentarium for the treatment of MS is fast increasing, concerns exist about the risk of severe adverse events with their use. This aspect reinforces the importance of disease registries as a proactive tool for monitoring drug safety in the post-approval setting.

Perez-Ruiz E.,REDISSEC | Delgado M.,REDISSEC | Sanz A.,Hospital Universitario Carlos Haya | Gil A.M.S.,Clinic Croasa | Dominguez A.R.,REDISSEC
Journal of Medical Case Reports | Year: 2013

Introduction. Histiocytic sarcoma is a rare neoplasm with few cases reported in the literature of which some were diagnosed in animals. This neoplasm arises from abnormal reticuloendothelial system cell proliferation of histiocytes and has an aggressive behavior especially if located in the central nervous system. We present the first case of a patient with histiocytic sarcoma that involved the meninges and had a good course after multidisciplinary treatment. Case presentation. Our patient was a 41-year-old Caucasian woman with no previous history of disease who started with systemic symptoms such as headache and chills. Magnetic resonance imaging with gadolinium contrast of the brain suggested a mass 1.5×2cm in diameter in the temporal lobe with a non-uniform vasogenic edema. This lesion was implanted in the meninges and surgery was the first treatment. The histological findings revealed a histiocytic sarcoma. The patient received concomitant chemoradiotherapy after surgery with good tolerance and currently lives without disease. Conclusion: Although histiocytic sarcomas in the brain present an unusual location and have a poorer prognosis, we have identified the first primary leptomeningeal histiocytic sarcoma with a disease-free survival greater than 3 years following multidisciplinary treatment with surgery and chemotherapy and radiotherapy. © 2013 Pérez-Ruiz et al.; licensee BioMed Central Ltd.

Martin-Morales A.,Hospital Universitario Carlos Haya | Gutierrez-Hernandez P.,Hospital Universitario Of Canarias | Romero-Otero J.,Hospital Universitario 12 Of Octubre | Romero-Martin J.A.,Hospital de Mataro
Journal of Sexual Medicine | Year: 2014

Introduction: Stopwatch-assessed duration of erection has been proposed as an objective and reliable efficacy end point for erectile dysfunction (ED) treatments. Aim: The aim of this study is to assess vardenafil orodispersible tablets' (ODTs) efficacy in terms of duration of erection and (i) its correlation with other efficacy end points and male and female sexual quality of life (QoL) and (ii) its impact on intercourse duration. Methods: Randomized, double-blind, placebo-controlled, multicenter study comparing the efficacy and safety of vardenafil ODT 10mg on-demand over 12 weeks in 127 patients with ED was carried out. Main Outcome Measures: Primary efficacy end points were stopwatch-assessed duration of erection (min) at any attempt and when leading to successful intercourse, and the erectile function domain of the International Index of Erectile Function (EF-IIEF) score. Secondary end points were sexual encounter profile (SEP) 3 response rate and male sexual QoL. End points in participating women (N=46) were stopwatch-assessed duration of intercourse and sexual QoL. Results: At week 12/last observation carried forward, patients taking vardenafil ODT had longer duration of erections (at any attempt or leading to successful intercourse) vs. placebo (least square mean±standard error 10.2±0.9 minutes vs. 7.9±1.0 minutes, and 10.4±0.8 vs. 8.3±1.0 minutes, respectively), and significant increases in EF-IIEF scores, the SEP-3 response, and all sexual QoL items. An increased duration of intercourse was also observed. Female sexual QoL improved significantly. Both duration end points strongly correlated with EF-IIEF scores, and the three end points correlated well with SEP-3 response. Correlation was good with sexual QoL scores in men and women and with duration of intercourse, with differences between treatment groups only for duration end points. Safety was similar in both groups. Conclusion: This study provides further evidence for the consistency and reliability of the stopwatch-assessed duration of erection as an efficacy end point for ED treatments, with "duration of erection leading to successful intercourse" showing better properties than duration at any attempt. Martin-Morales A, Gutiérrez-Hernández P, Romero-Otero J, and Romero-Martín JA. Duration of erection: Does it really matter? A randomized, double-blind clinical trial to assess the impact of vardenafil ODT on duration of erection and its correlation with patients' and partners' sexual quality of life and duration of intercourse: The VADEOPEN study. J Sex Med 2014;11:1527-1538. © 2014 International Society for Sexual Medicine.

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