Publications by authors named "Sigrid Balser"
Article Synopsis
- The RUSTIC trial evaluated the pharmacokinetic (PK) similarity of the proposed ustekinumab biosimilar FYB202 with the EU-approved and US-licensed versions after a single 45-mg injection to 491 healthy adults.
- Results showed that all comparisons of PK characteristics were similar, as the concentration measurements fell within the accepted range of 80%-125%.
- Safety analyses indicated that FYB202 had a lower rate of positive antidrug antibody results compared to reference drugs, supporting its marketing authorization alongside further studies in plaque psoriasis patients.
Introduction: Biological therapies such as bevacizumab have improved survival in patients with NSCLC. This study was conducted to confirm the equivalent efficacy of the biosimilar candidate BI 695502 to the bevacizumab reference product (RP).
Methods: In this phase 3, multicenter, randomized, double-blind trial of adult patients with recurrent or metastatic NSCLC received up to 18 weeks of induction treatment with BI 695502 or bevacizumab RP 15 mg/kg plus paclitaxel and carboplatin.
Article Synopsis
- BI 695501 is a biosimilar to adalimumab, showing similar effectiveness and safety in treating rheumatoid arthritis and psoriasis, and the VOLTAIRE-CD study specifically investigates its efficacy in patients with Crohn's disease.
- The study was a phase 3, randomized, double-blind trial conducted at 92 centers across Europe and the USA, involving patients aged 18-80 with moderately to severely active Crohn's disease, comparing BI 695501 to the adalimumab reference product.
- The primary goal was to measure clinical response at week 4, assessing efficacy through a reduced Crohn's Disease Activity Index score, with patients also monitored for safety throughout the trial.
Article Synopsis
- BI 695501 is a biosimilar to Humira® and was tested in a Phase III trial (VOLTAIRE-PSO) for patients with moderate-to-severe chronic plaque psoriasis.
- The trial measured effectiveness based on the number of patients achieving at least a 75% reduction in psoriasis severity (PASI 75) after 16 and 24 weeks of treatment, finding similar response rates between BI 695501 and adalimumab.
- Safety results showed that both treatments had comparable rates of treatment-emergent adverse events and similar rates of anti-drug antibody positivity, indicating that BI 695501 is as safe and effective as the adalimumab reference product.
The aim of this study was to develop an integrated pharmacokinetic and pharmacodynamic (PK/PD) model and assess the comparability between epoetin alfa HEXAL/Binocrit (HX575) and a comparator epoetin alfa by a model-based approach. PK/PD data-including serum drug concentrations, reticulocyte counts, red blood cells, and hemoglobin levels-were obtained from 2 clinical studies. In sum, 149 healthy men received multiple intravenous or subcutaneous doses of HX575 (100 IU/kg) and the comparator 3 times a week for 4 weeks.
View Article and Find Full Text PDFIntroduction: Recombinant human growth hormone (rhGH) is effective and safe when used to treat growth hormone deficiency (GHD) in children. However, it has been suggested that switching between different types of rhGH can have a detrimental effect on patients.
Methods: The current analysis assessed the efficacy and safety of rhGH in children who received continuous Omnitrope® (Sandoz GmbH, Kundl, Austria) therapy either with lyophilized powder for solution or ready-to-use solution, with children who received 9 months of treatment with Genotropin® (Pfizer Limited, Sandwich, UK) followed by Omnitrope solution thereafter.
Filgrastim is a recombinant human granulocyte colony stimulating factor (G-CSF) that stimulates production of neutrophils. The objective of this analysis was to develop a pharmacokinetic (PK) and pharmacodynamic (PD) model to account for an increase in G-CSF clearance on multiple dosing because of an increase of the G-CSF receptor-mediated endocytosis. Data from 4 randomized studies involving healthy volunteers were used for analysis.
View Article and Find Full Text PDFObjective: Two strengths of a novel ready-to-use liquid preparation of the recombinant human GH (rhGH) Omnitrope were developed to increase the convenience for the patients.
Design: Omnitrope 3.3 mg/ml solution or Omnitrope 6.
Background And Objective: Filgrastim is a human granulocyte-colony stimulating factor (G-CSF). The biological activity of filgrastim is identical to that of endogenous G-CSF. It controls neutrophil production within the bone marrow by stimulating the proliferation, differentiation and survival of myeloid progenitor cells and some end-cell function activation.
View Article and Find Full Text PDFThe objective of this study was to establish and validate an ex vivo human cervical tissue model appropriate for transport studies of molecular and especially nucleic acid based drugs. For that purpose conditions had to be established for a standardized tissue handling and preparation following hysterectomy to allow an immediate experimental use of fresh tissue samples. Samples of the ectocervical, endocervical and the transition zone representing the entire cervix organ were characterized in Franz diffusion cells by the determination of the in vitro permeation of low and high molecular weight markers (propanolol, mannitol, dextran 4000, 10,000, 20,000 and 40,000Da).
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