Purpose: Lebrikizumab is a novel, high-affinity immunoglobulin G4 monoclonal antibody that targets interleukin-13, a central mediator in atopic dermatitis (AD). In previous studies in patients with moderate-to-severe AD, lebrikizumab, administered subcutaneously via a prefilled syringe with a needle safety device (PFS-NSD), demonstrated rapid and durable dose-dependent efficacy. We assessed the pharmacokinetics and safety of lebrikizumab using either a PFS-NSD or an investigational autoinjector.
View Article and Find Full Text PDFImportance: Safe and effective long-term treatments for moderate to severe plaque psoriasis are needed.
Objective: To evaluate the long-term safety and efficacy of deucravacitinib through 3 years (week 148) in the randomized POETYK PSO-1, PSO-2, and nonrandomized long-term extension (LTE) trials.
Design, Setting, And Participants: PSO-1/PSO-2 were global, 52-week, randomized, double-blinded phase 3 trials in patients with moderate to severe plaque psoriasis.
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.
Background: Amlitelimab, a fully human nondepleting mAb targeting OX40 ligand on antigen-presenting cells, could prevent T-cell-driven inflammation seen in atopic dermatitis (AD).
Objective: This trial evaluated the efficacy and safety of amlitelimab in adults with AD.
Methods: In this 2-part, phase 2b, randomized, double-blinded placebo-controlled trial (ClinicalTrials.