Objectives: To assess immunogenicity and safety in patients with active rheumatoid arthritis (RA) transitioning from rituximab [US-licensed rituximab: Reference Product (RP); EU-approved rituximab: Reference Medicinal Product (RMP)] to DRL_RI (proposed rituximab biosimilar), in comparison to those continuing on RP/RMP.
Methods: This double-blind, randomized, Phase 3 study included 140 RA patients having prior exposure to RP/RMP; transitioned to DRL_RI (n = 70) or continued with RP/RMP (n = 70) for two 1000 mg infusions on Days 1 and 15. Assessments included Time-matched Rituximab Concentration (TMRC), anti-drug antibodies (ADAs), neutralizing antibodies (NAbs) and ADA titre over 12 weeks, and safety follow-up till 26 weeks.
Zh Vopr Neirokhir Im N N Burdenko
October 2024
Background: Growing skull fracture (GSF) of the orbital roof is a rare complication of head injury in infancy and early childhood. Analysis of the Medline database between 1983 and 2023 identified 17 articles describing 63 children after surgical treatment of GSF of the orbital roof.
Material And Methods: We present a 2-year-old child with moderate traumatic brain injury (TBI) complicated by GSF of the orbital roof.
In our recent research, we have effectively demonstrated the feasibility of classifying magnetic resonance images (MRI) of glial tumors into four histological types utilizing standardized volume of interest (VOI), radiomics and machine learning. This research aims to determine the reproducibility of our approach when the locations of VOI are changed. We were able to demonstrate high reproducibility of ML results when the same feature selection methodology was employed across different VOIs.
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