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25-05-2022 | Bimekizumab | Feature | Article

Updated June 2022

A quick guide to the phase 3 trials of bimekizumab in spondyloarthritis

Author: Claire Barnard

Bimekizumab – a monoclonal antibody that inhibits both interleukin (IL)-17A and IL-17F – is currently under investigation for a number of inflammatory conditions, including ankylosing spondylitis, nonradiographic axial spondyloarthritis (axSpA), and psoriatic arthritis (PsA). At phase 2, the BE AGILE trial showed that bimekizumab improved ASAS40 response rates in patients with ankylosing spondylitis, while the BE ACTIVE trial demonstrated improvements in musculoskeletal and skin symptoms among people with PsA. Following these positive results, the IL-17A/IL-17F inhibitor progressed to phase 3 trials, some of which were presented at the EULAR 2022 Congress in Copenhagen, Denmark. Read on for a summary of these phase 3 studies, including the patient populations, treatment groups, and key findings. The trials are all sponsored by the developer of bimekizumab, UCB.

BE MOBILE 1: Nonradiographic axSpA
 

Patient population

Treatment groups

Primary endpoint

Patients with active nonradiographic axSpA and objective inflammation defined by sacroiliitis on magnetic resonance imaging and/or elevated C-reactive protein

Bimekizumab 160 mg every 4 weeks or placebo

ASAS40 response at week 16

https://clinicaltrials.gov/ct2/show/NCT03928704

The results of BE MOBILE 1 were presented in a poster at the EULAR 2022 Congress by Xenofon Baraliakos, from Ruhr-University Bochum in Germany. The investigators found that ASAS40 response rates at week 16 were significantly higher among participants treated with bimekizumab versus placebo (47.7 vs 21.4%). There were also significant improvements in a range of secondary endpoints, including reductions from baseline in BASDAI and BASFI scores and sacroiliac joint inflammation, favoring the IL-17/IL-17F inhibitor. Improvements were seen irrespective of prior exposure to tumor necrosis factor (TNF) inhibitors. Baraliakos said that no new safety signals were seen for bimekizumab in BE MOBILE 1.

Related news story: BE MOBILE trials support bimekizumab for the treatment of axSpA

Video interview: Investigator Désirée van der Heijde discusses the BE MOBILE 1 and 2 trials

Video interview: Fabian Proft comments on the BE MOBILE 1 and 2 results

BE MOBILE 2: Ankylosing spondylitis
 

Patient population

Treatment groups

Primary endpoint

Patients with moderate-to-severe active ankylosing spondylitis

Bimekizumab 160 mg every 4 weeks or placebo

ASAS40 response at week 16

https://clinicaltrials.gov/ct2/show/NCT03928743

The BE MOBILE 2 findings were also presented at the EULAR 2022 Congress, and were similar to those seen in BE MOBILE 1. Désirée van der Heijde, from Leiden University Medical Center in the Netherlands, reported that ASAS40 response rates at week 16 were 44.8% in the bimekizumab arm compared with 22.5% in the placebo arm, a significant difference. Prior TNF inhibitor exposure did not impact response rates, and the safety profile of bimekizumab was similar to that seen previously.

Related news story: BE MOBILE trials support bimekizumab for the treatment of axSpA

Video interview: Investigator Désirée van der Heijde discusses the BE MOBILE 1 and 2 trials

Video interview: Fabian Proft comments on the BE MOBILE 1 and 2 results

BE COMPLETE: Psoriatic arthritis
 

Patient population

Treatment groups

Primary endpoint

Patients with active PsA and an inadequate response to TNF inhibitors

Bimekizumab 160 mg every 4 weeks or placebo

ACR50 response at week 16

https://clinicaltrials.gov/ct2/show/NCT03896581

Joseph Merola, from Brigham and Women’s Hospital in Boston, Massachusetts, USA, presented BE COMPLETE at the EULAR 2022 Congress. This study met its primary endpoint, with significantly higher ACR50 response rates at week 16 among people treated with bimekizumab versus placebo (43.4 vs 6.8%). The presenter emphasized strong skin responses with bimekizumab, and said that the agent had a favorable safety profile in line with previous observations.

Related news story: Bimekizumab beneficial for psoriatic arthritis in phase 3 trials

Video interview: Investigator Joseph Merola discusses the BE COMPLETE and BE OPTIMAL trials

Video interview: Philippe Carron comments on the BE COMPLETE and BE OPTIMAL results

BE OPTIMAL: Psoriatic arthritis
 

Patient population

Treatment groups

Primary endpoint

Biologic-naïve patients with active PsA

Bimekizumab 160 mg every 4 weeks, placebo, or adalimumab

ACR50 response at week 16

https://clinicaltrials.gov/ct2/show/NCT03895203

The findings from BE OPTIMAL were presented in the late-breaking abstract session at the EULAR 2022 Congress. Iain McInnes, from the University of Glasgow in the UK, and co-investigators demonstrated significantly higher ACR50 response rates at week 16 in the bimekizumab versus the placebo arm, at 43.9% versus 10.0%. The ACR50 response rate in the adalimumab reference arm was 45.7%. Similar to what was seen with the TNF inhibitor-experienced population in BE COMPLETE, the biologic-naïve patients in BE OPTIMAL achieved good skin responses with bimekizumab. McInnes noted that the safety profile of the IL-17A/IL-17F inhibitor was consistent with that seen in previous studies.

Related news story: Bimekizumab beneficial for psoriatic arthritis in phase 3 trials

Video interview: Investigator Joseph Merola discusses the BE COMPLETE and BE OPTIMAL trials

Video interview: Philippe Carron comments on the BE COMPLETE and BE OPTIMAL results

BE MOVING: Ankylosing spondylitis and nonradiographic axSpA
 

Patient population

Treatment groups

Primary endpoint

Patients with ankylosing spondylitis or nonradiographic axSpA who completed BE MOBILE 1 or BE MOBILE 2

Bimekizumab

Proportion of patients with treatment-emergent adverse events from baseline to week 128

https://clinicaltrials.gov/ct2/show/NCT04436640

BE MOVING is an open-label extension study that aims to evaluate the long-term safety profile of bimekizumab in patients with active axSpA (either ankylosing spondylitis or nonradiographic axSpA). All participants will receive bimekizumab throughout the study.

BE VITAL: Psoriatic arthritis
 

Patient population

Treatment groups

Primary endpoint

Patients with PsA who completed BE COMPLETE or BE OPTIMAL

Bimekizumab

Proportion of patients with treatment-emergent adverse events from baseline to week 160

https://clinicaltrials.gov/ct2/show/NCT04009499

BE VITAL is another extension study, with this trial investigating the long-term safety profile of bimekizumab in patients with active PsA who completed the BE COMPLETE or BE OPTIMAL studies. All participants will be treated with bimekizumab throughout the open-label extension study.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group

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