Publications by authors named "Derrick Kaufman"
Article Synopsis
- Mosunetuzumab is a bispecific antibody that targets T cells to kill malignant B cells, showing promising results in a study of patients with relapsed/refractory follicular lymphoma (FL) over 37.4 months.
- In the study involving 90 patients, the complete response rate was 60.0%, while the objective response rate reached 77.8%, with significant durations of response reported.
- Safety concerns were minimal, with no serious adverse events noted, indicating that mosunetuzumab could be a safe and effective outpatient treatment option for FL patients, including those with high-risk conditions.
Protocol design and synopsis: Omalizumab as Monotherapy and as Adjunct Therapy to Multiallergen OIT in Children and Adults with Food Allergy (OUtMATCH).
J Allergy Clin Immunol Glob
November 2022
Background: Food allergy is common and causes substantial morbidity and even mortality. Safe and effective treatments for food allergy would therefore be highly desirable, especially for individuals with multiple food allergies.
Objectives: Our aim was to describe a phase 3 study on treatment of patients with multiple food allergies with omalizumab.
Importance: The port delivery system (PDS) with ranibizumab has demonstrated noninferior and equivalent efficacy compared with monthly intravitreal injections of ranibizumab, an anti-vascular endothelial growth factor (VEGF) agent, in patients with neovascular age-related macular degeneration (nAMD), but evaluating patient preference is important to help inform clinical decision-making.
Objective: Evaluate treatment satisfaction for ranibizumab delivered via PDS vs intravitreal injections as well as patient preference among those assigned to PDS.
Design, Setting, And Participants: Archway was a phase 3 randomized active-comparator open-label clinical trial conducted at 78 sites in the US.
Purpose: To evaluate the safety and efficacy of the Port Delivery System with ranibizumab (PDS) for the treatment of neovascular age-related macular degeneration (nAMD).
Design: Phase 3, open-label, randomized, visual acuity assessor-masked noninferiority and equivalence trial.
Participants: Patients with nAMD diagnosed within 9 months of screening previously treated with and responsive to anti-vascular endothelial growth factor therapy.
Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials.
J Allergy Clin Immunol
September 2020
Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by IgE hyperproduction and eosinophilic inflammation. The anti-IgE antibody, omalizumab, has demonstrated efficacy in patients with CRSwNP and comorbid asthma previously.
Objective: Our aim was to determine omalizumab safety and efficacy in CRSwNP in phase 3 trials (POLYP 1 and POLYP 2).
Article Synopsis
- The EXPECT study assessed the perinatal outcomes of pregnant women using omalizumab and compared these with outcomes from a matched cohort of untreated women with asthma.
- The study involved 250 women exposed to omalizumab and a comparison group of 1,153 women from Quebec, where results were adjusted for maternal age.
- Findings showed similar rates of major congenital anomalies and live births between the two groups, with some differences in premature births and growth measurements, but the overall risk assessment for omalizumab exposure remains inconclusive due to the study's observational design.
Clinical correlates of serum pigment epithelium-derived factor in type 2 diabetes patients.
J Diabetes Complications
February 2015
Aim: To determine if serum pigment epithelium-derived factor (PEDF) levels in Type 2 diabetes are related to vascular risk factors and renal function.
Methods: PEDF was quantified by ELISA in a cross-sectional study of 857 male Veterans Affairs Diabetes Trial (VADT) subjects, and associations with cardiovascular risk factors and renal function were determined. In a subset (n=246) in whom serum was obtained early in the VADT (2.
Aims: The VADT was a randomized clinical trial designed to assess the effect of intensive vs. standard glucose management on cardiovascular events in Type 2 diabetes. At the end of the study, intensive management failed to improve outcomes.
View Article and Find Full Text PDFObjective: The Veterans Affairs Diabetes Trial (VADT) was a randomized, prospective, controlled trial of 1,791 patients with type 2 diabetes to determine whether intensive glycemic control would reduce cardiovascular events compared with standard control. The effect of intensive glycemic control and selected baseline variables on renal outcomes is reported.
Research Design And Methods: Baseline mean age was 60.
Objective: Blood pressure ranges associated with cardiovascular disease (CVD) events in advanced type 2 diabetes are not clear. Our objective was to determine whether baseline and follow-up (On-Study) systolic blood pressure (SBP), diastolic blood pressure (DBP), and SBP combined with DBP predict CVD events in the Veterans Affairs Diabetes Trial (VADT).
Research Design And Methods: Participants in the VADT (n = 1,791) with hypertension received stepped treatment to maintain blood pressure below the target of 130/80 mmHg in standard and intensive glycemic treatment groups.
Background: Surgical site infection (SSI) after ventral incisional hernia repair (VIH) can result in serious consequences. We sought to identify patient, procedure, and/or hernia characteristics that are associated with SSI in VIH.
Methods: Between 2004 and 2006, patients were randomized in four Veteran Affairs (VA) hospitals to undergo laparoscopic or open VIH.