Publications by authors named "R Bhore"
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.
Background: A high-dose formulation of intravitreal aflibercept (8 mg) could improve treatment outcomes in diabetic macular oedema (DMO) by requiring fewer injections than the standard comparator, aflibercept 2 mg. We report efficacy and safety results of aflibercept 8 mg versus 2 mg in patients with DMO.
Methods: PHOTON was a randomised, double-masked, non-inferiority, phase 2/3 trial performed at 138 hospitals and specialty retina clinics in seven countries.
Background: Intravitreal aflibercept 8 mg could improve treatment outcomes and provide sustained disease control in patients with neovascular age-related macular degeneration (nAMD), with extended dosing compared with aflibercept 2 mg.
Methods: PULSAR is a phase 3, randomised, three-group, double-masked, non-inferiority, 96-week trial conducted across 223 sites worldwide. Adults with nAMD were randomised 1:1:1 to aflibercept 8 mg every 12 weeks (8q12), aflibercept 8 mg every 16 weeks (8q16), or aflibercept 2 mg every 8 weeks (2q8), following three initial monthly doses in all groups.
Monoclonal antibodies against GFRα3 are efficacious against evoked hyperalgesic and allodynic responses in mouse join pain models but, one of these, REGN5069, was not effective against pain in a randomized, placebo-controlled clinical trial in patients with osteoarthritis pain.
Neurobiol Pain
June 2023
The artemin-GFRα3 signaling pathway has been implicated in various painful conditions including migraine, cold allodynia, hyperalgesia, inflammatory bone pain, and mouse knees contain GFRα3-immunoreactive nerve endings. We developed high affinity mouse (REGN1967) and human (REGN5069) GFRα3-blocking monoclonal antibodies and, following evaluations in mouse models of chronic joint pain (osteoarthritic-like and inflammatory), conducted a first-in-human phase 1 pharmacokinetics (PK) and safety trial of REGN5069 (NCT03645746) in healthy volunteers, and a phase 2 randomized placebo-controlled efficacy and safety trial of REGN5069 (NCT03956550) in patients with knee osteoarthritis (OA) pain. In three commonly used mouse models of chronic joint pain (destabilization of the medial meniscus, intra-articular monoiodoacetate, or Complete Freund's Adjuvant), REGN1967 and REGN5069 attenuated evoked behaviors including tactile allodynia and thermal hyperalgesia without discernably impacting joint pathology or inflammation, prompting us to further evaluate REGN5069 in humans.
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