Publications by authors named "N S Braunstein"
Background: Development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) to monoclonal antibodies may adversely impact pharmacokinetics, efficacy, and/or safety.
Objective: To describe incidence, titer, and persistence of dupilumab ADAs and NAbs, and their effects on pharmacokinetics, efficacy, and safety in patients with atopic dermatitis (AD).
Methods: This analysis included seven phase 3 randomized, placebo-controlled (N=2,992) and two long-term open-label extension (N=2,287) trials of subcutaneous dupilumab in adults and pediatric patients with moderate-to-severe AD.
Background: Pain associated with osteoarthritis (OA) is frequently disabling; treatments are often ineffective or intolerable. Fasinumab selectively inhibits nerve-growth factor and has shown efficacy for the management of OA pain.
Methods: In this randomized, double-blind, phase III safety study, patients with moderate-to-severe OA pain and history of inadequate pain relief received placebo or fasinumab (at 1, 3, 6, and 9 mg every 4 weeks [Q4W] and 1 and 6 mg every 8 weeks [Q8W] for 52 weeks).
Article Synopsis
- Pregnant women with COVID-19 are at higher risk for severe outcomes, and this study evaluated the safety and effectiveness of the monoclonal antibody treatment CAS+IMD in this population.* -
- The study, which involved 82 pregnant participants, found that CAS+IMD was well tolerated with minimal adverse reactions, and it effectively reduced viral loads without significantly affecting fetal development.* -
- Overall, the treatment showed promising safety and efficacy, suggesting it could be a viable option for managing COVID-19 in pregnant women, although conclusions about its effects are limited due to a small number of placebo recipients.*
Safety and Pharmacokinetics of Casirivimab and Imdevimab (CAS + IMD) in Pediatric Outpatients With COVID-19.
J Pediatric Infect Dis Soc
November 2024
Article Synopsis
- A clinical trial assessed the safety of the combination of casirivimab and imdevimab (CAS + IMD) in children with COVID-19.
- The results showed that the treatment was well tolerated, similar to findings in adults, with minimal immune response side effects.
- The study supports further development of advanced monoclonal antibodies for children at higher risk for COVID-19.
Article Synopsis
- This study aimed to analyze how common existing joint bone issues are in patients with hip or knee pain from osteoarthritis (OA) who were screened for fasinumab clinical trials.
- Out of 27,633 screened participants, 21,997 underwent imaging, and 5.5% were excluded due to severe articular bone problems noted in X-rays or MRIs, such as bone fragmentation and osteonecrosis.
- The results suggest that around 5% of OA patients who qualified for the clinical trials ended up being excluded because of serious preexisting joint conditions detected during imaging tests.