Publications by authors named "Julia Jauch-Lembach"
Introduction: Primary membranous nephropathy (PMN) is most often caused by autoantibodies to phospholipase A2 receptor (PLA2R). M-PLACE (NCT04145440) is an open-label, phase 1b/2a study that assessed the safety and efficacy of the fully human anti-CD38 monoclonal antibody felzartamab in high-risk anti-PLA2R+ PMN.
Methods: Patients with newly diagnosed or relapsed PMN (cohort 1 [C1]; = 18) or PMN refractory to immunosuppressive therapy (IST) (cohort 2 [C2]; = 13) received 9 infusions of felzartamab 16 mg/kg in the 24-week treatment period, followed by a 28-week follow-up.
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.
Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study.
BioDrugs
December 2020
Background: Sandoz adalimumab SDZ-ADL (GP-2017) is an approved adalimumab biosimilar with similar efficacy and comparable safety and immunogenicity to reference adalimumab (ref-ADL) as confirmed by analytical, pharmacokinetic and confirmatory studies. ADMYRA, a phase III double-blind study, was conducted with an aim to generate efficacy, safety and immunogenicity comparability data in patients with moderate-to-severe rheumatoid arthritis (RA) having inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX). The study also evaluated an aspect of 'switching' reference product to the biosimilar in terms of efficacy, safety and immunogenicity up to Week 48.
View Article and Find Full Text PDFDifferences in immunogenicity associated with non-product related variability: insights from two pharmacokinetic studies using GP2017, an adalimumab biosimilar.
Expert Opin Biol Ther
October 2019
: 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.
View Article and Find Full Text PDFArticle Synopsis
- 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