Abstract
Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A and has demonstrated rapid and clinically meaningful improvements in disease activity in patients across the full spectrum of axial spondyloarthritis (axSpA) in two parallel phase 3 studies. Results from BE MOBILE 1 (active non-radiographic axSpA [nr-axSpA]) and BE MOBILE 2 (radiographic axSpA [r-axSpA]) have been reported; here we report health-related quality of life (QoL) outcomes (ASQoL, SF-36 and EQ-5D-3L) from these studies and their open-label extension study (BE MOVING) up to week (Wk)104.
Both BE MOBILE 1 and 2 started with a 16-Wk, double-blind, placebo (PBO)-controlled period where patients were randomised (1:1 in BE MOBILE 1 and 2:1 in BE MOBILE 2) to receive BKZ 160 mg every 4 Wks (Q4W) or PBO, followed by a 36-Wk maintenance period. All patients received BKZ from Wk16 and were invited to enrol in BE MOVING at Wk52. Change from baseline in ASQoL, SF-36-physical component summary (PCS) scores and mean component score in each of the five EQ-5D-3L domains (mobility, selfcare, usual activity, pain/discomfort and anxiety/depression) are reported up to Wk104. Clinically meaningful improvement (≥4-point) in ASQoL is also reported. Data are presented using multiple imputation, non-responder imputation (NRI) and observed cases.
In total, 254 patients with nr-axSpA (BKZ: 128; PBO: 126) and 332 patients with r-axSpA (BKZ: 221; PBO: 111) were randomised with 189 (74.4%) and 267 (80.4%) completing to Wk104, respectively. Patients treated with BKZ reported greater improvements in ASQoL and SF-36 PCS compared with PBO (p < 0.001, using Analysis of Covariance [ANCOVA]) at Wk16. By Wk104, these improvements were sustained or improved in patients treated with BKZ, including those who switched from PBO at Wk16 (Table). The scores across all five EQ-5D-3L domains improved up to Wk104. In patients with ASQoL ≥4 at baseline, 59.7% (NRI) had a clinically meaningful improvement in ASQoL at Wk104.
The significant improvement in QoL outcomes (measured by EQ-5D-3L, ASQoL and SF-36 PCS scores) observed in patients treated with BKZ at Wk16 was sustained or improved up to Wk104, across the axSpA disease spectrum.
N. D McKay: Member of speakers’ bureau; Gilead. Other; Travel fees from UCB and Gilead. A. Bennett: Honoraria; AbbVie Ltd, Pfizer, UCB, Novartis, Biogen. Grants/research support; Pfizer. Other; Advisory board fees from AbbVie Ltd, Pfizer, UCB, MSD, Novartis, Lilly. N. Goodson: Honoraria; UCB and Novartis. D. Voiniciuc: Other; Contractor for UCB and employee of Veramed. C. de la Loge: Other; Consultant to UCB, Brussels, Belgium. U. Massow: Other; Employee of UCB. V. Taieb: Other; Employee of UCB. H. Marzo-Ortega: Consultancies; AbbVie, Biogen, Celgene, Janssen, Eli-Lilly, Moonlake, Novartis, Pfizer and UCB. Honoraria; AbbVie, Biogen, Celgene, Janssen, Eli-Lilly, Moonlake, Novartis, Pfizer and UCB. Grants/research support; Janssen, Novartis and UCB. Other; Speaker fees from AbbVie, Biogen, Celgene, Janssen, Eli-Lilly, Moonlake, Novartis, Pfizer and UCB. K. Gaffney: Consultancies; Novartis, AbbVie, UCB, Lilly and Pfizer. Shareholder/stock ownership; Rheumatology events. Honoraria; Novartis, AbbVie, UCB, Lilly and Pfizer. Member of speakers’ bureau; Novartis, UCB, AbbVie and Lilly. Grants/research support; NASS, Versus Arthritis, AbbVie, Pfizer, UCB, Novartis, Lilly, Cellgene, Celltrion, Janssen, Gilead and Biogen. Other; Meeting expenses from AbbVie, Lilly, Roche, Novartis, Pfizer and UCB.
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