Bioavailability, safety and immunogenicity of biosimilar infliximab (BOW015) compared to reference infliximab.

Objectives: To compare the single-dose pharmacokinetics (PK), safety, and immunogenicity of the biosimilar infliximab (BOW015) to reference infliximab (rIFX) in healthy volunteers and to establish bioequivalence.

Methods: In this randomized, double-blind, parallel-group, single-dose study, subjects received either BOW015 or rIFX. Both drugs were administered as a single IV 5 mg/kg dose over 2 hours on day 1.

Companion confidence in the balance of community-dwelling older adults: implications for physical activity promotion.

Background And Purpose: Positive social relationships may increase the intention of older adults to be physically active. In the presence of balance impairments, however, the potential influence of a familiar companion on an older adult's physical activity is not well understood. The purpose of this preliminary investigation was to explore companion confidence in the balance capability of an older adult as a potential determinant of older adult physical activity.

Randomized, double-blind, placebo-controlled, trial of transforaminal epidural etanercept for the treatment of symptomatic lumbar disc herniation.

Study Design: Multicenter, randomized, double-blind, placebo-controlled trial.

Objective: To examine the safety and efficacy of three different doses of the tumor necrosis factor alpha (TNF-α) inhibitor etanercept versus placebo for the treatment of symptomatic lumbar disc herniation (LDH).

Summary Of Background Data: TNF-α is considered to be a major cause of radicular leg pain associated with symptomatic LDH.

Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer.

Purpose: Therapeutic prostate-specific antigen (PSA) -targeted poxviral vaccines for prostate cancer have been well tolerated. PROSTVAC-VF treatment was evaluated for safety and for prolongation of progression-free survival (PFS) and overall survival (OS) in a randomized, controlled, and blinded phase II study.

Patients And Methods: In total, 125 patients were randomly assigned in a multicenter trial of vaccination series.