Publications by authors named "Christina Soubrane"
Background: Patients with diffuse cutaneous systemic sclerosis (dcSSc) have a poor prognosis. The importance of monitoring subjective measures of functioning and disability, such as the Health Assessment Questionnaire-Disability Index (HAQ-DI), is important as dcSSc is rated by patients as worse than diabetes or hemodialysis for quality of life impairment. This European Scleroderma Trials and Research (EUSTAR) database analysis was undertaken to examine the importance of impaired functionality in dcSSc prognosis.
View Article and Find Full Text PDFObjectives: Recent advances in systemic sclerosis (SSc) show that it involves a T-helper type-2-oriented immune response with interleukin (IL)-4 and IL-13. Romilkimab is an engineered, humanised, bispecific immunoglobulin-G4 antibody that binds and neutralises IL-4/IL-13 making it ideal for exploration in fibrosis.
Methods: Patients aged ≥18 years diagnosed with diffuse cutaneous SSc (dcSSc), and with or without immunosuppressive background therapy, were randomised (1:1) to subcutaneous romilkimab 200 mg or placebo one time per week for 24 weeks in this double-blind, proof-of-concept, phase II study.
Article Synopsis
- Idiopathic pulmonary fibrosis (IPF) is a serious lung disease with a short survival rate, and researchers conducted a study to find blood biomarkers that could predict disease progression and inform treatment strategies.
- In a 52-week study involving 211 participants, including 154 IPF patients and 57 control subjects, certain biomarkers were identified that distinguished IPF patients but did not predict individual disease progression.
- The study found no significant differences in the biomarker CCL18 between patients who progressed and those who did not, but two new biomarkers, HE4 and prostasin, showed potential for further exploration.
A phase 2b trial (NCT02345070) was conducted to evaluate the efficacy and safety of two dose levels/regimens of SAR156597 (a bispecific IgG4 antibody that binds and neutralises both circulating interleukin-4 and interleukin-13), in comparison with placebo, administered to patients with idiopathic pulmonary fibrosis (IPF) over 52 weeks.DRI11772 was a multinational randomised double-blind placebo-controlled phase 2b trial. Patients aged >40 years with a documented diagnosis of IPF received SAR156597 200 mg once every week (QW), SAR156597 200 mg once every 2 weeks (Q2W) or placebo, over 52 weeks.
View Article and Find Full Text PDFObjective: The goal was to evaluate the hypnotic efficacy of zolpidem at 0.25 mg/kg per day (maximum of 10 mg/day), compared with placebo, in children 6 through 17 years of age who were experiencing insomnia associated with attention-deficit/hyperactivity disorder.
Methods: An 8-week, North American, multicenter, double-blind, placebo-controlled, parallel-group study was conducted.
Efficacy and safety of zolpidem extended release in elderly primary insomnia patients.
Am J Geriatr Psychiatry
January 2008
Objectives: To evaluate the clinical efficacy and safety of zolpidem extended release for the treatment of primary insomnia in elderly patients.
Methods: A randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted. A total of 205 (117 women, 88 men; mean age 70.
Background And Purpose: To evaluate the clinical efficacy and safety of modified-release zolpidem (zolpidem-MR 12.5mg) for the treatment of primary insomnia in adults.
Patients And Methods: Two hundred and twelve (123 women, 89 men; mean age 44.