Objective To evaluate the efficacy and safety of sarilumab in combination with methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). Methods Adults with moderate‐to‐severe RA and an inadequate response to MTX were randomized (1:1:1) to receive sarilumab (doses of 150 mg or 200 mg) or placebo every 2 weeks in conjunction with weekly MTX for 52 weeks. Co–primary end points were the proportion of patients achieving American College of Rheumatology 20% (ACR20) improvement responses at week 24, change from baseline in the Health Assessment Questionnaire (HAQ) disability index (DI) at week 16, and change from baseline in the modified Sharp/van der Heijde score (SHS) of radiographic damage at week 52. Results Baseline characteristics were similar among the groups. For all 3 co–primary end points, the sarilumab 150 mg and 200 mg groups demonstrated statistically significant improvements as compared with the placebo group (ACR20 response rate at week 24, 58.0%, 66.4%, and 33.4%, respectively [P < 0.0001]; least squares mean change in HAQ DI at week 16, −0.53, −0.55, and −0.29, respectively [P < 0.0001]; and mean change in SHS at week 52, 0.90, 0.25, and 2.78, respectively [P < 0.0001]). The most common treatment‐emergent adverse event was infection. In the sarilumab 150 mg, sarilumab 200 mg, and placebo groups, the incidence of serious infections was 2.6%, 4.0%, and 2.3%, respectively. Elevations in alanine aminotransferase levels >3‐fold the upper limit of normal occurred in 9.5%, 8.0%, and 2.1% of patients, respectively; in 24 patients, this led to discontinuation of treatment. Elevated total cholesterol levels were observed in 36.8%, 43.0%, and 18.3% of patients, respectively. In patients receiving 150 mg and 200 mg sarilumab, neutrophil counts of 0.5 to <1.0 × 109/liter were observed in 5.1% and 7.8% of patients, respectively, while neutrophil counts of <0.5 × 109/liter were observed in 0.9% and 0.7% of patients, respectively; none of the patients receiving placebo experienced changes in neutrophil counts. Conclusion In RA patients treated with sarilumab (150 mg or 200 mg every 2 weeks) in combination with MTX, both doses provided sustained clinical efficacy, as shown by significant improvements in symptomatic, functional, and radiographic outcomes. Sarilumab was generally well tolerated. The adverse events observed in this study were consistent with the effects of interleukin‐6 signaling blockade.
Tubercular involvement of the sternum, leading to osteomyelitis, is a rarely described entity even in countries where tuberculosis is endemic. Presentation in pediatric age group is even more uncommon. We describe a 12 year old girl who presented with a mass over the manubruim sterni and fever. CT chest demonstrated a soft tissue mass in the anterior mediastinum, eroding the cortex of the manubrium. Tubercular etiology was suggested by presence of epithelioid granulomas and acid fast bacilli in the Ziehl-Neelsen staining of the aspirate from the lesion. The patient responded well to antitubercular treatment.
ObjectiveTo describe the spectrum of magnetic resonance imaging (MRI) findings in patients with neurological manifestations of dengue.Materials and MethodsWe included nine patients with dengue fever (three females and six males; age range, 9–30 years), all of whom presented with neurological manifestations. The MRI examinations, performed in 1.5 T or 3 T scanners, included T1-weighted, T2-weighted, and fluid-attenuated inversion recovery (FLAIR) sequences. Diffusion-weighted imaging with apparent diffusion coefficient mapping was also employed. Fast low-angle shot and susceptibility-weighted gradient-recalled echo sequences, as well as contrast-enhanced T1-weighted scans, were also obtained in order to assess parenchymal enhancement. MRI scans were analyzed for lesion distribution and imaging features.ResultsAll patients showed areas of altered signal intensity that appeared as hyperintensity on T2-weighted and FLAIR sequences. The most commonly affected site was the basal ganglia-thalamus complex. Other affected sites were the cerebellum, cerebral cortex, white matter, and brainstem. In all cases, we observed patchy areas of restricted diffusion and focal areas of hemorrhage.ConclusionDengue encephalitis commonly affects the basal ganglia, thalamus, cerebellum, cerebral cortex, and white matter. Therefore, MRI should be an indispensable part of the evaluation of patients with neurological complications of dengue fever.
This study prospectively evaluates clinical course of pyogenic empyema thoracis in 25 children (2 mo to 12 y) treated with injectable antibiotics and chest tube drainage, and followed for 6 weeks. The median (range) age at presentation was 3 y (4 mo to 11 y). The pleural fluid culture was positive in 24% of patients. Staphylococcus aureus was the most commonly isolated organism. The median (range) duration of injectable antibiotics was 14(14-52) d; median duration of total antibiotics (injectable and oral) was 4 weeks. The median (range) duration of chest tube insertion and hospital stay was 8(5-45) and 14(14-56) days, respectively. All patients were discharged without any surgical intervention besides chest tube drainage. At discharge, pleural thickening was present in 84% and crowding of ribs was seen in 60% of the subjects on radiological examination. All these patients were asymptomatic at discharge. Chest deformity was present in 20% of the patients at 6-weeks follow up. Antibiotics and chest tube drainage is an effective method of treating pyogenic empyema thoracis in children in resource-poor settings.
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