Publications by authors named "Lena Lemke"
Background: To support an interchangeability designation for Sandoz adalimumab biosimilar (GP2017), antidrug antibody (ADA) signal-to-noise (S/N) ratios were assessed in the GP2017 ADACCESS trial to directly assess potential changes in immunogenicity.
Research Design And Methods: ADACCESS was a 51-week trial in patients with moderate-to-severe plaque psoriasis that included patients treated continuously with reference adalimumab (cH), and patients who experienced four switches between reference adalimumab and GP2017 (H2H). ADAs were measured every 6 weeks during the switching phase using an electrochemiluminescence assay.
Article Synopsis
- Hyrimoz (SDZ-ADL) is a biosimilar to Humira, approved by the FDA and EMA in 2018 and has a new citrate-free formulation approved in 2023.
- Its approval was based on the Totality of Evidence approach, which included comprehensive data on its analytical, functional, pharmacokinetic, and clinical similarities to the reference medicine.
- Multiple studies demonstrated that SDZ-ADL and Humira have no significant differences in safety, efficacy, and immunogenicity, supporting its use in various patient groups.
Article Synopsis
- The study investigated the antidrug antibody (ADA) signal-to-noise (S/N) ratio as a new way to measure immune responses in healthy individuals after taking a single dose of the adalimumab biosimilar, GP2017.
- Validated bioanalytical methods were used to analyze ADA S/N ratios and titers, showing a strong correlation between the two measures.
- The ADA S/N ratio proved to be more sensitive and better correlated with the pharmacokinetics of the drug, indicating it could more effectively assess the immune response compared to traditional ADA titers.
Article Synopsis
- The 2022 study investigated a new biosimilar drug formulation, GP2017 (also known as SDZ-ADL or Hyrimoz), focusing on a high-concentration version (SDZ-ADL-HCF) aimed at treating inflammatory conditions.
- The study compared the behavior of both drug formulations in the body, looking at pharmacokinetics, immune system reactions, and side effects, using a random and double-blind method to ensure unbiased results.
- Findings indicated that the high-concentration formulation, SDZ-ADL-HCF, performed similarly to the original formulation in terms of absorption, immune response, and side effects, supporting its recent approval by health authorities.
Article Synopsis
- GP2017 is a biosimilar to adalimumab, and the study aimed to compare its pharmacokinetics (PK) between the standard formulation and a high-concentration formulation (HCF) in healthy male subjects.
- A total of 330 participants received either GP2017-HCF or the original GP2017, with PK data and safety monitored for 72 days.
- Results indicated that the PK profiles of GP2017-HCF and GP2017 were comparable, showing similar safety and tolerability, with no serious adverse events reported.
Article Synopsis
- - SDZ-ADL (GP2017) is a biosimilar to adalimumab that was studied in two phase III trials focusing on its impact on quality of life and patient-reported outcomes in chronic plaque psoriasis and rheumatoid arthritis.
- - Both studies confirmed that SDZ-ADL had similar efficacy, safety, and immunogenicity compared to the reference drug, with patients experiencing comparable improvements in quality of life metrics like the Dermatology Life Quality Index and EuroQol health status.
- - Results showed significant reductions in quality of life impact from baseline scores in both treatment groups, and improvements were maintained even after treatment switches over the study period.
: Antidrug antibody (ADA) development is known to occur with adalimumab treatment and impacts adalimumab exposure. Here, we compare the impact of immunogenicity on pharmacokinetics (PK) across two randomized PK studies of GP2017, an approved biosimilar adalimumab, in healthy subjects. : Healthy male subjects (= 107 in study GP17-104; = 90 in study GP17-103) received a single 40 mg subcutaneous injection of the same GP2017 drug product batch.
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- The study aimed to compare the pharmacokinetics (PK) of Sandoz biosimilar adalimumab (GP2017) to reference adalimumab (Humira) in healthy volunteers and evaluate the impact of different delivery methods (autoinjector vs. prefilled syringe).
- Healthy male subjects received either GP2017 or Humira, and their pharmacokinetics, safety, and immunogenicity were monitored for 72 days, showing similarity in PK profiles among the groups.
- Results confirmed that GP2017 is biosimilar to Humira, with consistent safety and immunogenicity, and equivalent tolerability regardless of whether the drug was administered via autoinjector or prefilled syringe
In suspected grade II gliomas, three distinct patterns of time-activity curves (TAC) on O-(2-[(18)F]fluoroethyl)-1-tyrosine ((18)F-FET) positron emission tomography (PET) have been delineated (i) increasing TAC homogeneously throughout the tumor, and decreasing TAC, (ii) either homogeneously throughout the tumor or (iii) only focally within otherwise increasing TAC patterns. Increasing TAC was associated with low-grade histology and decreasing TAC with high-grade histology. This prospective study analyzed whether these patterns correlate with distinct biological tumor subtypes and differential outcome.
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