Publications by authors named "Alison Balfour"
Importance: () is a coagulase-negative staphylococcus (CoNS), found commonly as skin flora in humans. While most species of CoNS are clinically benign, can exhibit a similar virulence to that of . However, there is scant data concerning infection in the pediatric population.
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- - SDZ-ADL (GP2017) is a biosimilar to adalimumab that was studied in two phase III trials focusing on its impact on quality of life and patient-reported outcomes in chronic plaque psoriasis and rheumatoid arthritis.
- - Both studies confirmed that SDZ-ADL had similar efficacy, safety, and immunogenicity compared to the reference drug, with patients experiencing comparable improvements in quality of life metrics like the Dermatology Life Quality Index and EuroQol health status.
- - Results showed significant reductions in quality of life impact from baseline scores in both treatment groups, and improvements were maintained even after treatment switches over the study period.
: Antidrug antibody (ADA) development is known to occur with adalimumab treatment and impacts adalimumab exposure. Here, we compare the impact of immunogenicity on pharmacokinetics (PK) across two randomized PK studies of GP2017, an approved biosimilar adalimumab, in healthy subjects. : Healthy male subjects (= 107 in study GP17-104; = 90 in study GP17-103) received a single 40 mg subcutaneous injection of the same GP2017 drug product batch.
View Article and Find Full Text PDFAim: SBR759 is a calcium-free, polymeric, iron(III)-based oral phosphate binder, in development for the treatment of hyperphosphatemia. The efficacy and safety of SBR759 was compared with sevelamer hydrochloride in chronic kidney dialysis patients on hemodialysis.
Methods: Japanese and Taiwanese hyperphosphatemic patients who were on hemodialysis (n = 203) received starting doses of 3.
Objective: This study assessed the efficacy and safety of canakinumab, a fully human anti-interleukin 1β monoclonal antibody, for prophylaxis against acute gouty arthritis flares in patients initiating urate-lowering treatment.
Methods: In this double-blind, double-dummy, dose-ranging study, 432 patients with gouty arthritis initiating allopurinol treatment were randomised 1:1:1:1:1:1:2 to receive: a single dose of canakinumab, 25, 50, 100, 200, or 300 mg subcutaneously; 4×4-weekly doses of canakinumab (50+50+25+25 mg subcutaneously); or daily colchicine 0.5 mg orally for 16 weeks.