Three‑year rheumatology data demonstrates sustained inflammation control in psoriatic arthritis and axial spondyloarthritis

UCB has announced new three-year data from phase 3 trials, and their open-label extensions, investigating BIMZELX^® (bimekizumab-bkzx) in adults with active psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) (non-radiographic [nr-]axSpA and radiographic [r-]axSpA).

Bimekizumab-bkzx, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),¹ continued to demonstrate sustained control of inflammation and deep efficacy in patients living with PsA and axSpA.^2,3,4,5,6

Sustained improvements across stringent measures of disease in patients with PsA²

In patients with PsA, one-year improvements were sustained to three years across the following GRAPPA domains:* peripheral arthritis, dactylitis, enthesitis, skin psoriasis and nail psoriasis.² 

Individual domain responses were consistent between bDMARD‑naïve and TNFi-IR patients.² 

Further, exposure-adjusted incidence rates per 100 patient years for uveitis and definite or probable adjudicated Inflammatory Bowel Disease (IBD) to Week 156 were 0.2 (95% confidence interval 0.1, 0.6) and 0.3 (0.1, 0.7) in BE OPTIMAL and 0 and 0.1 (0.0, 0.6) in BE COMPLETE, respectively.² (See Appendix for further details).

Sustained clinical response to highly stringent endpoints in half of patients with axial spondyloarthritis⁴

A high proportion of bimekizumab-bkzx-randomized patients who achieved clinical responses at Week 16 maintained these to Week 164 across the full disease spectrum of axSpA, including nr-axSpA and r-axSpA.⁴ 

From Week 16 through to Week 164, 50% of patients never lost their ASDAS LDA (<2.1) status at any assessed visit (MI), with a further 22.4% only losing their ASDAS LDA status at one visit, and 6.1% at two visits, respectively (MI).⁴ 

Of the 152 patients (43.6%; NRI) who achieved ASDAS LDA at Week 16, 78.8% still achieved ASDAS LDA at Week 164 (MI).⁴ (Proportion of patients who achieved ASDAS LDA at Week 16 and Week 164 in patients randomised to bimekizumab-bkzx 160 mg Q4W at baseline).⁴

Real-world findings demonstrate rapid HRQoL improvements in patients with PsA and axSpA^5,6

Interim, post-hoc data analysis (observed case, OC) of patient-reported outcomes from the SPEAK study in routine clinical practice showed that:^5,6 

For bimekizumab-bkzx-treated PsA patients, improvements in PsAID-12 total score were observed to 24 weeks, with mean (SD) change from baseline (CfB) at Week 24 of −1.9 (2.0).⁵ SF-36 PCS scores improved to Week 24 (mean [SD] CfB: +4.6 [7.9]), as did PGADA scores (Mean [SD] CfB: −17.5 [23.8]).⁵ 

At Week 2, mean (SD) change from baseline (CfB) in PsAID-12 total score and PGADA score were -0.8 (1.6) and -7.1 (19.3), respectively.⁵

For bimekizumab-bkzx-treated nr-axSpA and r-axSpA patients, improvements in ASAS HI score were observed to 24 weeks, with mean (SD) CfB at Week 24 of –1.6 (3.0).⁶ SF-36 PCS scores improved to Week 24 (mean [SD] CfB: +5.7 [7.3]), as did PGADA scores (mean [SD] CfB: –1.0 [2.5].⁶ 

At Week 2, mean (SD) change from baseline (CfB) in ASAS HI score and PGADA score were –0.7 (2.3) and –0.8 (2.1), respectively.⁶

References were supplied.