Impact of bimekizumab and certolizumab pegol on efficacy, safety and osteoblastic activity in radiographic axial spondyloarthritis: results from a phase IIa, multicentre, randomised, double-blind, exploratory study with PET-CT imaging.

ABSTRACT:

Background

The efficacy and safety of bimekizumab (BKZ), an inhibitor of interleukin (IL)-17F in addition to IL-17A, has been established in axial spondyloarthritis (axSpA). Early assessment of new bone formation is possible using ¹⁸F-fluoride positron emission tomography-computerised tomography (PET-CT) imaging to quantitatively monitor osteoblastic activity.

Objectives

This exploratory study, initiated before phase IIb/III studies, assessed the efficacy and safety of BKZ in patients with radiographic (r-)axSpA and its effect on new bone formation.

Design

Patients were randomised 2:1 to BKZ 160 mg every 2 weeks (Q2W; Weeks 0-10) then 320 mg Q4W (Weeks 12-44), or the reference drug: certolizumab pegol (CZP) 400 mg Q2W (Weeks 0-4), then 200 mg Q2W (Weeks 6-1

SUBMITTER: Baraliakos X 

PROVIDER: S-EPMC11605740 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature