Publications by authors named "Carol Cronenberger"
Article Synopsis
- Drug development teams look at how new medicines might interact with other drugs and whether the benefits of the medicine outweigh the risks.
- This study created a scoring system to predict how these drug interactions (DDIs) could affect people with conditions like diabetes, obesity, and migraines.
- The analysis showed that the most important interactions came from a specific type of drug, CYP3A, especially for people with diabetes.
Article Synopsis
- A study was conducted to evaluate the interchangeability of an adalimumab biosimilar, PF-06410293 (adalimumab-afzb), with the reference drug, to enhance patient access to effective rheumatoid arthritis treatment.
- The research involved a randomized, open-label design across 61 sites in ten countries, enrolling adults aged 18-70 with moderately to severely active rheumatoid arthritis who were stable on methotrexate.
- The primary outcomes measured were the maximum serum concentration and area under the plasma concentration-time curve, assessing whether the biosimilar can be considered equivalent to the reference drug based on specific pharmacokinetic criteria.
Article Synopsis
- The study aimed to assess how successful patients with rheumatoid arthritis (RA) were at self-administering a new adalimumab biosimilar using a prefilled pen during a specific treatment period in a clinical trial.
- A total of 50 participants, mostly women with a mean age of about 55, were included in the analysis, with nearly all successfully completing their injections and achieving a 100% delivery success rate across 294 attempts.
- Most participants preferred to continue using the prefilled pen for their injections instead of switching back to the older syringe option, indicating that the new method was well-received and effective.
Long-term efficacy, safety, and immunogenicity of the adalimumab biosimilar, PF-06410293, in patients with rheumatoid arthritis after switching from reference adalimumab (Humira®) or continuing biosimilar therapy: week 52-92 data from a randomized, double-blind, phase 3 trial.
Arthritis Res Ther
September 2021
Article Synopsis
- The REFLECTIONS B538-02 study evaluated the long-term safety and efficacy of the adalimumab biosimilar PF-06410293 compared to the reference adalimumab sourced from the EU in patients with active rheumatoid arthritis (RA).
- A total of 507 patients participated, with three groups: those who received the biosimilar from the start, those who switched to the biosimilar at week 26, and those who switched at week 52.
- ACR20 response rates were high and consistent throughout the study, with overall treatment-emergent adverse events reported as relatively low and generally well tolerated across the different groups.
Article Synopsis
- - The study aimed to assess the effectiveness and safety of a biosimilar adalimumab (ADL-PF) compared to the reference drug (ADL-EU) in patients with active rheumatoid arthritis over a longer treatment period.
- - Participants were initially randomized to receive either ADL-PF or ADL-EU, and after 26 weeks, those on ADL-EU were re-randomized to either continue with ADL-EU or switch to ADL-PF, while those on ADL-PF continued their treatment.
- - Results showed comparable improvement rates and safety profiles between treatments, indicating that switching from ADL-EU to ADL-PF did not affect treatment outcomes, with similar ant
Article Synopsis
- This study investigated PF-06410293 (ADL-PF), a biosimilar to adalimumab, to assess its pharmacokinetics, safety, and tolerability when administered via a prefilled syringe (PFS) or prefilled pen (PFP).
- A total of 164 healthy adults were randomly assigned to receive the drug, and results showed similar concentration-time profiles for both admin methods, meeting bioequivalence criteria.
- Adverse events were comparable across both groups, indicating that ADL-PF can be safely administered through either device without significant differences in patient experience.
A biosimilar is a biologic drug that is "highly similar to a reference (originator) product, with no clinically meaningful differences between the two products in safety, purity, and potency". Regulatory approval of a biosimilar is based on analytical, structural, and functional comparisons with the reference product, comparative nonclinical (in vivo) studies, clinical pharmacokinetics and/or pharmacodynamics, and immunogenicity. In addition, comparative clinical efficacy and safety assessments are usually conducted and, taken together, comprise the "totality of the evidence" supporting biosimilarity.
View Article and Find Full Text PDFObjective: Our objective was to evaluate the long-term efficacy, safety, and immunogenicity of the infliximab biosimilar, PF-06438179/GP1111 (PF-SZ-IFX), in patients with rheumatoid arthritis (RA) who continued biosimilar treatment throughout 78 weeks or who switched from reference infliximab (Remicade) sourced from the EU (IFX-EU) at week 30 or week 54 in the REFLECTIONS B537-02 study.
Methods: In this phase III, double-blind, active-controlled study, patients with moderate-to-severe active RA were initially randomized to PF-SZ-IFX or IFX-EU, each with methotrexate (treatment period [TP] 1; N = 650). At week 30, patients receiving PF-SZ-IFX continued PF-SZ-IFX; patients receiving IFX-EU were re-randomized to continue IFX-EU or switch to PF-SZ-IFX (TP2; n = 566).
Purpose: The objectives of this analysis were to characterize the population pharmacokinetics (PK) of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin) sourced from the European Union (bevacizumab-EU) in patients with advanced non-squamous non-small cell lung cancer (NSCLC), and to quantify the difference in PK parameters between the two drug products via covariate analysis.
Methods: Pooled PF-06439535 and bevacizumab-EU serum concentration data from a comparative clinical efficacy and safety study (NCT02364999) in patients with NSCLC (N = 719) were analyzed using a non-linear mixed-effects modeling approach. Patients received PF-06439535 plus chemotherapy or bevacizumab-EU plus chemotherapy every 21 days for 4-6 cycles, followed by monotherapy with PF-06439535 or bevacizumab-EU.
Objective: To investigate the efficacy, safety and immunogenicity of PF-06438179/GP1111 (PF-SZ-IFX) compared with European reference infliximab (Remicade; ref-IFX) in patients with moderate-to-severe, active rheumatoid arthritis after continued long-term use of PF-SZ-IFX, and in patients who were switched from ref-IFX to PF-SZ-IFX.
Methods: REFLECTIONS B537-02 was a double-blind, active-controlled, multinational study in which patients (N=650) were initially randomised to PF-SZ-IFX or ref-IFX for 30 weeks (treatment period [TP] 1). During weeks 30-54 (TP2), the PF-SZ-IFX group (n=280) continued treatment with PF-SZ-IFX (PF-SZ-IFX/PF-SZ-IFX) and patients in the ref-IFX group (n=286) were rerandomised (1:1) to continue ref-IFX (ref-IFX/ref-IFX) (n=143) or switch to PF-SZ-IFX (ref-IFX/PF-SZ-IFX) (n=143) for a further 24 weeks.
Article Synopsis
- A 78-week study was conducted to compare the effectiveness and safety of PF-06410293, a biosimilar to adalimumab (Humira), in treating active rheumatoid arthritis (RA) in patients already on methotrexate.
- The study involved 597 patients who were randomized to receive either PF-06410293 or the reference adalimumab (adalimumab-EU), measuring outcomes using the American College of Rheumatology (ACR) criteria at 12 weeks.
- Results showed that the ACR20 response rates at week 12 were 68.7% for PF-06410293 and 72.7% for adalimumab-EU, indicating that the two
Objective: This extension study provided continued treatment to subjects with active rheumatoid arthritis who had participated for ≥16 weeks in a pharmacokinetic similarity study of PF-05280586 (potential rituximab biosimilar). Objectives were to evaluate overall pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of PF-05280586 after transition from rituximab reference products to PF-05280586, and follow-up of biomarker and efficacy assessments.
Methods: Subjects were offered ≤3 additional courses of treatment of PF-05280586, with or without a single transition from rituximab in Europe (rituximab-EU; MabThera) or the US (rituximab-US; Rituxan) to PF-05280586.
Ponezumab in mild-to-moderate Alzheimer's disease: Randomized phase II PET-PIB study.
Alzheimers Dement (N Y)
September 2017
Introduction: The safety, pharmacokinetics, and effect on peripheral and central amyloid β (Aβ) of multiple doses of ponezumab, an anti-Aβ monoclonal antibody, were characterized in subjects with mild-to-moderate Alzheimer's disease treated for 1 year.
Methods: Subjects were aged ≥50 years with Mini-Mental State Examination scores 16 to 26. Cohort Q was randomized to ponezumab 10 mg/kg ( = 12) or placebo ( = 6) quarterly.
Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy.
Alzheimers Dement (N Y)
September 2017
Introduction: Multiple intravenous doses of ponezumab, an anti-amyloid antibody, were evaluated in subjects with mild-to-moderate Alzheimer's disease (AD).
Methods: In part A, 77 subjects were randomized to ponezumab 0.1, 0.
Objective: PF-04360365 is a humanized IgG(2)Δa anti-amyloid β (Aβ) antibody designed to improve outcome in Alzheimer's disease (AD). Single doses of 0.1 - 10 mg/kg were safe and well tolerated in Western (mostly Caucasian) subjects with mild-to-moderate AD.
View Article and Find Full Text PDFArticle Synopsis
- More therapeutic proteins (TPs) are used when people take multiple medications, so it’s important to understand how they interact with each other to avoid side effects.
- Factors like patient types, other medicines they're taking, and how the body clears these proteins can change how TPs work or cause toxicity.
- Pfizer scientists review different ways TPs can interact with other drugs to make sure they are safe and effective during their development.
Aims: To develop a population-based model to describe and predict the pharmacokinetics of carboxyhaemoglobin (COHb) in adult smokers.
Methods: Data from smokers of different conventional cigarettes (CC) in three open-label, randomized studies were analysed using NONMEM (version V, Level 1.1).