Clinical efficacy of efalizumab in patients with chronic plaque psoriasis: results from three randomized placebo-controlled Phase III trials: part I.

Background: Effective psoriasis therapies are needed for long-term symptom control.

Objective: Assess efalizumab (Raptiva) efficacy in a large cohort of psoriasis patients.

Methods: Data from three Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter studies were pooled.

Efalizumab retreatment in patients with moderate to severe chronic plaque psoriasis.

Background: Efalizumab targets T cell-mediated steps important in psoriasis immunopathogenesis.

Objective: We sought to evaluate the efficacy and safety of efalizumab retreatment in patients with moderate to severe plaque psoriasis.

Methods: In this open-label, phase III study, 365 patients who received efalizumab therapy during an earlier clinical trial were retreated with 12 weeks of subcutaneous efalizumab (1 mg/kg/wk) 35 days or more after their last dose of efalizumab.

Long-term continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: updated results from an ongoing trial.

Background: Efalizumab is a T cell-targeted therapy for psoriasis.

Objective: We sought to evaluate the efficacy and safety of long-term, continuous efalizumab therapy.

Methods: Of 339 patients enrolled in this ongoing, open-label, phase III study, after 3 months 290 qualified for and entered the maintenance treatment phase.

Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized phase III trial.

Background: Efalizumab inhibits multiple T-cell-mediated processes.

Objective: To evaluate 12- and 24-week efalizumab therapy for psoriasis.

Methods: In this phase III, randomized, double-blind trial, 498 patients received subcutaneous 1 or 2 mg/kg/wk efalizumab or placebo for 12 weeks.

Cotherapy with recombinant human insulin-like growth factor I and insulin improves glycemic control in type 1 diabetes. RhIGF-I in IDDM Study Group.

Objective: To study the effects of 12 weeks of cotherapy with recombinant human IGF-I (rhIGF-I) and insulin on glycemic control in patients with type 1 diabetes.

Research Design And Methods: The study population consisted of 223 patients who ranged in age from 11-66 years and were randomized in a double-blind study to receive 12 weeks of treatment with twice-daily subcutaneous injections of placebo (n = 54), or rhIGF-I at a dose (A.M/P.

Behavior change after growth hormone treatment of children with short stature.

Objectives: To measure the prevalence of behavioral and learning problems among children with short stature and to assess the effect of growth hormone (GH) treatment on such problems.

Study Design: A total of 195 children with short stature (age range 5 to 16 years, mean age 11.2 years) were tested for intelligence, academic achievement, social competence, and behavior problems before beginning GH therapy and yearly during 3 years of treatment.

Reduced concentration of serum growth hormone-binding protein in children with idiopathic short stature. National Cooperative Growth Study.

One possible explanation for the growth failure in children with idiopathic short stature (ISS) is reduced peripheral responsiveness to GH. In Laron syndrome, growth retardation is caused by GH resistance due to GH receptor (GH-R) defects, which are associated in most cases with absent or low serum concentrations of the GH-R-related GH-binding protein (GHBP). We tested the hypothesis that some children with ISS have reduced serum concentrations of GHBP and that this may reflect decreased sensitivity to GH.

Academic achievement and psychological adjustment in short children. The National Cooperative Growth Study.

Limited information is available on the educational and behavioral functioning of short children. Through 27 participating medical centers, we administered a battery of psychologic tests to 166 children referred for growth hormone (GH) treatment (5 to 16 years) who were below the third percentile for height (mean height = -2.7 SD).

Effects of recombinant human insulin-like growth factor-I (rhIGF-I) on total and free IGF-I concentrations, IGF-binding proteins, and glycemic response in humans.

To examine the effects of repeated administration of recombinant human insulin-like growth factor-I (rhIGF-I) on IGF-I levels, free IGF-I pharmacokinetics, glycemic response, and IGF-binding proteins (IGFBP), we administered rhIGF-I (0.03 mg/kg iv bolus) to 12 healthy males each morning for 5 consecutive days. Serum was collected over 24 h on days 1 and 5 for measurement of total and free IGF-I, glucose, insulin, and IGFBP.

Effects of acute right ventricular ischemia on ventricular interactions during prosthetic left ventricular support.

Systolic ventricular interactions may be partially responsible for right ventricular failure that sometimes occurs during clinical use of prosthetic left ventricular assist devices. In this hypothesis, it is proposed that the left ventricular assist device reduces left ventricular pressure and its contribution to right ventricular performance, thus impairing right ventricular output. On the other hand, these effects may be small compared with other causes of right ventricular failure such as ischemia.

Growth hormone treatment in the United States: demographic and diagnostic features of 2331 children.

Demographic, diagnostic, and baseline clinical data were collected for a large cohort (N = 2331) of children who started treatment with biosynthetic human growth hormone (GH) between October 1985 and October 1987. Eighty-one percent met classic criteria for GH deficiency and were classified as having idiopathic GH deficiency (59%), organic GH deficiency (18%), or septo-optic dysplasia (4%). The remaining 19.

Bridge to cardiac transplantation: successful use of prosthetic biventricular support in a patient awaiting a donor heart.

A 33-year-old man with dilated cardiomyopathy was successfully "bridged" to cardiac transplantation, with the use of left and right prosthetic ventricles. The prostheses supported the pulmonary and systemic circulations for 87 h, at which time they were removed and orthotopic transplantation was performed. Heart transplantation is the only viable long-term therapy for end-stage dilated cardiomyopathy.

Right ventricular function in an operating room model of mechanical left ventricular assistance and its effects in patients with depressed left ventricular function.

Approximately 20% of patients who receive left ventricular assist devices (LVADs) for refractory cardiac failure after open heart surgery have had complications of right ventricular failure. To evaluate this problem in the diseased heart we simulated an LVAD in the operating room by bypassing and unloading the left ventricle with the heart-lung machine before routine open heart surgery. Right ventricular function was assessed in 12 patients with preoperative left ventricular ejection fractions of less than 0.

Right heart function during left heart assist and the effects of volume loading in a canine preparation.

A significant fraction of patients in whom mechanical left ventricular assist devices are implanted for refractory cardiac failure after open heart surgery have had the complication of right heart failure. To evaluate the effects of left ventricular assistance and pressure unloading on right ventricular function, we performed experiments in the normal hearts of open-chest, anesthetized, large mongrel dogs. We compared right ventricular function before and after left ventricular-to-aortic bypass with a roller pump at right atrial pressure levels of 1, 3, 5, and 7 mm Hg produced by volume loading.