B. Samuels - Academia.edu (original) (raw)

Papers by B. Samuels

The Journal of Rheumatology, 2014

To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with act... more To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with active systemic lupus erythematosus (SLE) treated up to 7 years (n = 177 currently ongoing). Patients (n = 345) who completed a double-blind, placebo-controlled, 52-week study of belimumab 1, 4, or 10 mg/kg and 24-week extension of belimumab (placebo switched to 10 mg/kg; belimumab same dose or switched to 10 mg/kg) could receive belimumab 10 mg/kg in an open-label continuation study (n = 296). Disease activity was analyzed in patients with active SLE at baseline of the initial study. Biomarker and SLE medication changes were evaluated, and adverse events (AE) were monitored throughout the study. Total belimumab exposure over 7 years (double-blind and open-label periods): 1746 patient-years. SLE Responder Index (SRI) response rates at Week 52 in autoantibody-positive patients: placebo, 29%; belimumab, 46% (p < 0.05). In the continuation study, 57% of auto-antibody-positive patients had an SRI response by Year 2 and 65% by Year 7; severe flares occurred in 19% with placebo and 17% with belimumab during the first year, with the annual rate declining to 2%-9% during years 2-7. Anti-dsDNA autoantibodies in patients positive for them at baseline had a progressive decline of 40%-60% from baseline over 2-7 years with belimumab. Corticosteroid use decreased over time with ≥ 50-55% reduction in median dose during years 5-7. Serious and overall annual AE rates, including infections, were generally stable or decreased during 7-year treatment. Disease control and safety profile were maintained in patients with active SLE taking belimumab plus standard therapy for up to 7 years. [ClinicalTrials.gov numbers: NCT00071487 and NCT00583362].

Investigative Radiology, 1988

From 95 subjects imaged with both speed of sound and attenuation ultrasonic computed tomography (... more From 95 subjects imaged with both speed of sound and attenuation ultrasonic computed tomography (UCT), analyses were performed on 40 cases for which unequivocal clinical diagnoses were available for correlation. This paper describes the UCT image characteristics and addresses the hypothesis that carcinomas and other lesions can be detected and localized by means of simple visual criteria or lesion characteristics that are quantitative relative to those of other breast tissues in the same patient. The most useful within-patient criterion was selection of the solid mass with the highest speed of sound in either breast (12 of 12 carcinomas). Architectural asymmetry between breasts in the three types of images was a significant contributing factor in visual image interpretation in seven of the eight cancer patients in whom there were comparable images of both breasts. Solid masses were discriminated by attenuation coefficient and pulse echo criteria. Our results did not substantiate the hypothesis that the average speed of sound throughout the cancer containing breast would be higher than in the contralateral breast. These results are better than might be expected from pulse echo imaging alone on this population. However, clinical implementation probably should be deferred until the technique is made more convenient and less expensive, or more accurate with a greater promise for diagnosis of minimal cancers.

Archives of Ophthalmology, 1929

Ocean Modelling, 2011

A parameterization for the restratification by finite-amplitude, submesoscale, mixed layer eddies... more A parameterization for the restratification by finite-amplitude, submesoscale, mixed layer eddies, formulated as an overturning streamfunction, has been recently proposed to approximate eddy fluxes of density and other tracers. Here, the technicalities of implementing the parameterization in the coarseresolution ocean component of global climate models are made explicit, and the primary impacts on model solutions of implementing the parameterization are discussed. Three global ocean general circulation models including this parameterization are contrasted with control simulations lacking the parameterization. The MLE parameterization behaves as expected and fairly consistently in models differing in discretization, boundary layer mixing, resolution, and other parameterizations. The primary impact of the parameterization is a shoaling of the mixed layer, with the largest effect in polar winter regions. Secondary impacts include strengthening the Atlantic meridional overturning while reducing its variability, reducing CFC and tracer ventilation, modest changes to sea surface temperature and air-sea fluxes, and an apparent reduction of sea ice basal melting.

The Journal of Rheumatology, 2014

To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with act... more To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with active systemic lupus erythematosus (SLE) treated up to 7 years (n = 177 currently ongoing). Patients (n = 345) who completed a double-blind, placebo-controlled, 52-week study of belimumab 1, 4, or 10 mg/kg and 24-week extension of belimumab (placebo switched to 10 mg/kg; belimumab same dose or switched to 10 mg/kg) could receive belimumab 10 mg/kg in an open-label continuation study (n = 296). Disease activity was analyzed in patients with active SLE at baseline of the initial study. Biomarker and SLE medication changes were evaluated, and adverse events (AE) were monitored throughout the study. Total belimumab exposure over 7 years (double-blind and open-label periods): 1746 patient-years. SLE Responder Index (SRI) response rates at Week 52 in autoantibody-positive patients: placebo, 29%; belimumab, 46% (p < 0.05). In the continuation study, 57% of auto-antibody-positive patients had an SRI response by Year 2 and 65% by Year 7; severe flares occurred in 19% with placebo and 17% with belimumab during the first year, with the annual rate declining to 2%-9% during years 2-7. Anti-dsDNA autoantibodies in patients positive for them at baseline had a progressive decline of 40%-60% from baseline over 2-7 years with belimumab. Corticosteroid use decreased over time with ≥ 50-55% reduction in median dose during years 5-7. Serious and overall annual AE rates, including infections, were generally stable or decreased during 7-year treatment. Disease control and safety profile were maintained in patients with active SLE taking belimumab plus standard therapy for up to 7 years. [ClinicalTrials.gov numbers: NCT00071487 and NCT00583362].

Investigative Radiology, 1988

From 95 subjects imaged with both speed of sound and attenuation ultrasonic computed tomography (... more From 95 subjects imaged with both speed of sound and attenuation ultrasonic computed tomography (UCT), analyses were performed on 40 cases for which unequivocal clinical diagnoses were available for correlation. This paper describes the UCT image characteristics and addresses the hypothesis that carcinomas and other lesions can be detected and localized by means of simple visual criteria or lesion characteristics that are quantitative relative to those of other breast tissues in the same patient. The most useful within-patient criterion was selection of the solid mass with the highest speed of sound in either breast (12 of 12 carcinomas). Architectural asymmetry between breasts in the three types of images was a significant contributing factor in visual image interpretation in seven of the eight cancer patients in whom there were comparable images of both breasts. Solid masses were discriminated by attenuation coefficient and pulse echo criteria. Our results did not substantiate the hypothesis that the average speed of sound throughout the cancer containing breast would be higher than in the contralateral breast. These results are better than might be expected from pulse echo imaging alone on this population. However, clinical implementation probably should be deferred until the technique is made more convenient and less expensive, or more accurate with a greater promise for diagnosis of minimal cancers.

Archives of Ophthalmology, 1929

Ocean Modelling, 2011

A parameterization for the restratification by finite-amplitude, submesoscale, mixed layer eddies... more A parameterization for the restratification by finite-amplitude, submesoscale, mixed layer eddies, formulated as an overturning streamfunction, has been recently proposed to approximate eddy fluxes of density and other tracers. Here, the technicalities of implementing the parameterization in the coarseresolution ocean component of global climate models are made explicit, and the primary impacts on model solutions of implementing the parameterization are discussed. Three global ocean general circulation models including this parameterization are contrasted with control simulations lacking the parameterization. The MLE parameterization behaves as expected and fairly consistently in models differing in discretization, boundary layer mixing, resolution, and other parameterizations. The primary impact of the parameterization is a shoaling of the mixed layer, with the largest effect in polar winter regions. Secondary impacts include strengthening the Atlantic meridional overturning while reducing its variability, reducing CFC and tracer ventilation, modest changes to sea surface temperature and air-sea fluxes, and an apparent reduction of sea ice basal melting.