Publications by authors named "Daljit Tatla"
Article Synopsis
- Bimekizumab is a monoclonal antibody that targets interleukin-17A and IL-17F to help reduce chronic inflammation in patients with psoriatic arthritis, requiring self-injection methods like a syringe or auto-injector.
- A study (DV0004) trained patients to self-inject the drug, measuring safety and efficacy, including pain levels and overall user experience after injections at Baseline and Week 4.
- Results showed all patients successfully self-injected without serious issues, reported low pain levels, and had a positive experience with both injection devices, indicating good tolerance and effectiveness.
Article Synopsis
- Bimekizumab, an IgG1 monoclonal antibody, targets interleukin (IL)-17F and IL-17A, and is administered subcutaneously for treating moderate to severe plaque psoriasis.* -
- In a phase 3 study, patients were trained to self-inject bimekizumab using either a safety syringe or auto-injector, with assessments of their self-injection capability at 8 weeks and after initial training.* -
- Results showed that all participants were able to safely self-inject the drug, reported minimal pain, and had positive self-injection experiences, demonstrating both devices' effectiveness for patient use.*
Background: ava® is a new reusable electromechanical auto-injector (e-Device) with disposable, single-use certolizumab pegol (CZP) dispensing cartridges.
Methods: RA0098 (NCT03357471) was a US, multicenter, open-label, phase 3 study designed to assess whether the e-Device can be used safely and effectively by self-injecting patients. CZP pre-filled syringe (PFS) self-injecting patients (≥18 years) diagnosed with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, plaque psoriasis, and Crohn's disease received training and self-injected CZP using the e-Device at 2 visits.
Introduction: Clinical assessment of motor symptoms in Parkinson's disease (PD) is subjective and may not reflect patient real-world experience. This two-part pilot study evaluated the accuracy of the NIMBLE wearable biosensor patch (containing an accelerometer and electromyography sensor) to record body movements in clinic and home environments versus clinical measurement of motor symptoms.
Methods: Patients (Hoehn & Yahr 2-3) had motor symptom fluctuations and were on a stable levodopa dose.
Although stapling is an alternative to hand-suturing in gastrointestinal surgery, recent trials specifically designed to evaluate differences between the two in surgery time, anastomosis time, and return to bowel activity are lacking. This trial compared the outcomes of the two in subjects undergoing open gastrointestinal surgery. Adult subjects undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis were enrolled into this open-label, prospective, randomized, interventional, parallel, multicenter, controlled trial.
View Article and Find Full Text PDFAims: The purpose of this study was to assess the incidence, features, and clinical sequelae of 'electrical storm' (ES).
Methods And Results: This study is a prospectively designed secondary analysis of SHIELD; a randomized trial of azimilide for suppression of ventricular tachycardia/fibrillation (VT/VF) leading to implanted cardioverter defibrillator (ICD) therapies. Systematic and rigorous follow-up and blinded adjudication of ICD therapy allowed identification of all ESs (>/=3 separate VT/VF episodes leading to ICD therapies within 24 h).
This report presents the rationale and study design details of the SHock Inhibition Evaluation with Azimilide study, which is recruiting 624 patients with implantable cardioverter-defibrillators (ICDs) who are at risk for life-threatening ventricular arrhythmia, randomized to azimilide 75 mg, azimilide 125 mg, or placebo and followed for 1 year. The objective of this study is to determine the effect of azimilide versus placebo on the symptomatic ventricular arrhythmia burden using a unique statistical analysis based on the unusual temporal distribution of symptomatic ICD therapies. The primary efficacy end points are time to all-cause shocks and time to all-cause shocks plus symptomatic ventricular arrhythmic events triggering antitachycardia pacing measured from randomization.
View Article and Find Full Text PDFBackground: Although implanted cardioverter defibrillators (ICDs) effectively treat sustained ventricular tachyarrhythmias, up to 50% of ICD recipients eventually require concomitant antiarrhythmic drug therapy to prevent symptomatic arrhythmia recurrences and hence reduce the number of device therapies.
Methods And Results: A total of 633 ICD recipients were enrolled in a randomized, double-blind, placebo-controlled study to evaluate the effect of daily doses of 75 or 125 mg of azimilide on recurrent symptomatic ventricular tachyarrhythmias and ICD therapies. Total all-cause shocks plus symptomatic ventricular tachycardia (VT) terminated by antitachycardia pacing (ATP) were significantly reduced by azimilide, with relative risk reductions of 57% (hazard ratio [HR]=0.