Similar Pharmacokinetics of the Adalimumab (Humira®) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE®-AI and VOLTAIRE®-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials

Introduction BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira ® . We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity of BI 695501 delivered via autoinjector (AI) vs. prefilled syringe (PFS). Methods Bo...

Full description

Saved in:
Bibliographic Details
Published in:Rheumatology and therapy. 2018-12, Vol.5 (2), p.403-421
Main Authors: Ramael, Steven, Van Hoorick, Benjamin, Tiessen, Renger, van Iersel, Thijs, Moschetti, Viktoria, Lang, Benjamin, Sonderegger, Ivo, Wiebe, Sabrina, Liedert, Bernd, Jayadeva, Girish
Format: Article
Language:English
Subjects:
Family Medicine
General Practice
Immunotherapy
Internal Medicine
Medicine
Medicine & Public Health
Monoclonal antibodies
Original Research
Orthopedics
Pharmacokinetics
Quality of Life Research
Rheumatology
TNF inhibitors
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Introduction BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira ® . We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity of BI 695501 delivered via autoinjector (AI) vs. prefilled syringe (PFS). Methods Both trials were randomized, open-label, parallel-group studies undertaken in subjects aged ≥ 18–65 years. VOLTAIRE ® -AI (NCT02606903) recruited healthy, Caucasian, male, non-athletic volunteers with BMI ≥ 18 to ≤ 30 kg/m 2 . VOLTAIRE ® -TAI (NCT02899338) recruited healthy men and women with BMI > 17.5 to 
ISSN:2198-6576
2198-6584
DOI:10.1007/s40744-018-0119-1