Background: Antibodies to infliximab (ATI) in serum are associated with secondary loss of
response (LOR) to infliximab (IFX) therapy in patients with inflammatory bowel disease …

This chapter describes the role of regulatory medical product review in furthering precision
medicine. Efficient data processing and appropriate analyses are needed to synthesize …

Accurate anti-drug antibody (ADA) measurements in patient sera requires dissociation of
ADA-drug complexes combined with sensitive and specific ADA detection. Bridging type …

Immune reactions to protein drugs present substantial challenges to protein replacement for
treating congenital diseases and metabolic deficiencies, due to the lack of endogenous …

Purpose To evaluate whether anti-drug antibodies (ADAs) are present in the ocular fluid of
patients with ranibizumab-recalcitrant neovascular age-related macular degeneration …

Introduction: Anti-tumor necrosis factor α (anti-TNFα) agents can potentially induce the anti-
nuclear antibodies (ANA) development over time. Evidence of the real impact of these …

Drug-induced kidney injury has historically been associated with renal tubule injury related
to small molecule pharmaceuticals such as nonsteroidal anti-inflammatory drugs …

Purpose: Licaminlimab is a new anti-TNFα antibody fragment for topical ocular application.
This phase II study assessed the tolerability, treatment effect, and pharmacokinetics of …

Objectives The aim of this work is to verify the non-inferior efficacy and safety of CMAB008
compared with innovator infliximab in rheumatoid arthritis patients combined with …

Background: The recommended infliximab (IFX) dose in (pediatric) rheumatology practice is
3–6 mg/kg every 4–8 weeks. Higher dosage regimens (> 10 mg/kg) of IFX are effective and …