Publications by authors named "D E McCabe"
Objective: This post hoc analysis compared the immunogenicity of the biosimilar adalimumab-adbm (Cyltezo) with the adalimumab reference product (RP; Humira) across indications, including rheumatoid arthritis (RA), Crohn's disease (CD) and plaque psoriasis (PsO), and by patient sex in the VOLTAIRE trials programme.
Methods: In each active-comparator randomised controlled trial (RCT), immunogenicity was assessed at various time points by the proportion of patients with antidrug antibodies (ADAs) and neutralising antibodies (nAbs), using acid dissociation followed by electrochemiluminescence assay. Assay sensitivity was 50 ng/mL, and drug tolerance was ≥30 µg/mL (free drug) at the low positive control level.
Objectives: This analysis reported the incidence of safety endpoints across five phase 3 randomized controlled clinical trials in patients with rheumatoid arthritis (RA), Crohn's disease (CD), and chronic plaque psoriasis (PsO) who received ≥ 1 dose of adalimumab-adbm or adalimumab reference product (RP).
Methods: Exposure-adjusted incidence rates for safety endpoints were calculated per 100 patient-years and reported by disease indication and treatment arm. Subgroup analyses by patient age and sex were also conducted.
Article Synopsis
- This analysis investigated the impact of two treatments for rheumatoid arthritis (RA): a biosimilar (adalimumab-adbm) and the reference product (adalimumab), focusing on health-related quality of life (HRQoL) before and after treatment.
- HRQoL was measured using the SF-36 survey at the start of treatment and at 12 and 24 weeks, looking for significant improvements in patient scores.
- Results showed no major differences between the two treatments in physical health scores, but both groups saw substantial improvements in mental health and physical scores, with similar proportions achieving clinically meaningful improvements by week 24.*