Objective: To evaluate subcutaneous SBI-087 to treat rheumatoid arthritis (RA).
Methods: A total of 210 adult patients with active RA were randomized to receive either 200 mg SBI-087 or placebo (Pbo), according to one of these patterns: SBI/Pbo/Pbo (SBI on Day 1), SBI/SBI/Pbo (SBI days 1 and 15), SBI/Pbo/SBI (SBI days 1 and 84), SBI/SBI/SBI (SBI days 1, 15, and 84), or Pbo/Pbo/Pbo (Pbo all 3 days). All patients were seropositive and taking background methotrexate. The primary endpoint was proportion of patients achieving 20% improvement from baseline at Week 16 by American College of Rheumatology criteria (ACR20). Other outcomes included 28-joint Disease Activity Score (DAS28)-C-reactive protein (CRP), physician's and patient's global assessments of disease activity (PGA and PtGA, respectively) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Peripheral CD19+ B cells were measured by high-sensitivity flow cytometer. Statistical significance was set at 2-sided α 0.10 level.
Results: The SBI/SBI/SBI group demonstrated significant improvement in ACR20 and DAS28-CRP from Week 8 onward, sustained improvement in CRP levels from Week 12 onward, and significant improvements in PGA and PtGA in weeks 16 through 24, and in HAQ-DI at Week 24. The SBI/Pbo/Pbo and SBI/SBI/Pbo groups did not meet the primary endpoint but demonstrated improvements in several secondary endpoints. All treatment groups exhibited depletion of peripheral CD19+ B cells throughout the study. Overall, 61.5% of patients receiving SBI-087 and 55.0% of patients receiving Pbo reported adverse events.
Conclusion: SBI-087 effectively depleted peripheral CD20 B cells and was well tolerated. Improvements were consistently observed in the SBI/SBI/SBI group for the majority of efficacy and quality-of-life outcomes.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.3899/jrheum.160146 | DOI Listing |
J Physiol Investig
January 2025
Department of Emergency, Shijiazhuang Traditional Chinese Medicine Hospital, Shijiazhuang, China.
Sepsis is a life-threatening condition that often results in severe brain injury, primarily due to excessive inflammation and mitochondrial dysfunction. This study aims to investigate the neuroprotective effects of Apelin-13, a bioactive peptide, in a rat model of sepsis-induced brain injury (SBI). Specifically, we examined the role of Apelin-13 in regulating mitophagy through the phosphatase and tensin homolog-induced putative kinase 1 (PINK1)/Parkin pathway and its impact on nucleotide-binding oligomerization domain-like receptor pyrin domain-containing 3 (NLRP3) inflammasome-mediated pyroptosis and oxidative stress.
View Article and Find Full Text PDFBMC Infect Dis
December 2024
Faculty of Medicine, Department of Pediatrics, Division of Pediatric Emergency Medicine, Hacettepe University, Ankara, Türkiye, Turkey.
Background: The primary aim of this study was to compare the groups, SARS-CoV-2-positive and -negative patients, in terms of the frequency of SBI. The SARS-CoV-2-positive group was compared with the other-RVPs-positive group as a secondary evaluation in terms of serious bacterial infection (SBI).
Methods: This retrospective multicenter cohort study was conducted at four university hospitals from March 2020 to December 2021.
Adv Emerg Nurs J
December 2024
Author Affiliations: Mid-Atlantic Emergency Medical Associates, Charlotte, North Carolina (Dr Jordan, Dr Steelman, and Ms McInnis); and UNC Charlotte School of Nursing, Charlotte, North Carolina (Dr Jordan).
Fever is the most common complaint for children of all ages who present to an emergency department (ED) for evaluation and treatment. Although most children with fever have a self-limiting viral illness, the infant less than 60 days of age with fever poses a higher risk for an underlying serious bacterial illness (SBI) including urinary tract infections, bacteremia and bacterial meningitis, or an invasive bacterial infection (IBI) including bacteremia. This case is a discussion of a high-risk febrile infant that was evaluated in the emergency department and was ultimately diagnosed with Streptococcus B meningitis.
View Article and Find Full Text PDFJ Psychoactive Drugs
November 2024
Drug Deaddiction and Treatment Centre, Department of Psychiatry, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Alcohol misuse is common in persons on opioid agonist maintenance treatment (OAMT). We tested the efficacy of screening and brief intervention (SBI) for harmful/hazardous alcohol use in buprenorphine/naloxone (BNX)-assisted OAMT. It was a double-blind, parallel-group, randomized trial, where 150 participants with alcohol misuse (Alcohol Use Disorder Identification Test - AUDIT 8-19) on BNX were allocated equally to receive either a single session SBI or screening and brief advice (control).
View Article and Find Full Text PDFMaterials (Basel)
October 2024
School of Civil Engineering, Chongqing Jiaotong University, Chongqing 400074, China.
In this study, a wear-resistant ultra-thin wear layer was fabricated with polyurethane as an adhesive to investigate its durability for pavement applications. Its road performance was investigated based on indoor tests. First, the abrasion test was performed using a tire-pavement dynamic friction analyzer (TDFA), and the surface elevation information of the wear layer was obtained by laser profile scanning.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!