April 2024

Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal Phase 3 trial

https://pubmed.ncbi.nlm.nih.gov/33549192/

Bimekizumab therapy was associated with a rapid and sustained improvement in PASI response and IGA score in patients with moderate to severe plaque psoriasis. Dual inhibition of IL-17A/F with bimekizumab can affect a more durable response in PsO patients than sole IL-17A inhibition. Gordon et al. compared the safety and efficacy of two different maintenance dosing schedules, in addition to the effects of treatment withdrawal in the 52-week BE READY trial.

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Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): Efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled Phase 3 trial

Lancet 2021;397:487–98. doi: 10.1016/S0140-6736(21)00125-2

Bimekizumab was more efficacious than ustekinumab and placebo in the treatment of moderate to severe plaque psoriasis. Previous bimekizumab Phase 2 clinical studies have shown both rapid and durable clinical improvements in skin clearance, as well as a safety profile in line with expectations from this MoA. This study aimed to evaluate the efficacy and safety of bimekizumab in moderate to severe plaque PsO over 1 year compared with both placebo and ustekinumab.

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Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT Phase 3b trial

J Am Acad Dermatol 2023;89:486–95. doi: 10.1016/j.jaad.2023.04.063

High levels of clinical responses were seen throughout the first 48 weeks with bimekizumab treatment. These were maintained to Week 96 in patients with moderate-to-severe plaque PsO.

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Bimekizumab versus adalimumab in plaque psoriasis

N Engl J Med 2021; 385:130–41. doi: 10.1056/NEJMoa2102388

Bimekizumab was noninferior and superior to adalimumab with respect to PASI 90 response and IGA score at Week 16. Bimekizumab is a promising IL-17A/F inhibitor that has shown clinical improvement in PsO patients compared to placebo and other IL inhibitors. Warren et al. compared the safety and efficacy of bimekizumab with adalimumab in a 56-week double-blind trial.

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March 2024

Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL

RMD Open. 2024 Feb 22;10(1):e003855 doi: 10.1136/rmdopen-2023-003855

Bimekizumab was well tolerated in patients with PsA and TNFi-IR up to 52 weeks, with a safety profile consistent with that observed in prior studies. This study aimed to assess 52-week safety and efficacy of bimekizumab in patients with active PsA and prior IR/intolerance to TNFi.

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February 2024

Validity and Score Interpretation of the 12-item Psoriatic Arthritis Impact of Disease: An Analysis of Pooled Data from Two Phase 3 Trials of Bimekizumab in Patients with Psoriatic Arthritis

RMD Open 2024;10(1):e003548 doi: 10.1136/rmdopen-2023-003548

This study reports that the PsAID-12 total score and individual PsAID items capturing disease concepts important to patients with PsA demonstrated robust psychometric properties.

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December 2023

Comparative Efficacy and Safety of Bimekizumab in Axial Spondyloarthritis: A Systematic Literature Review and Network Meta-analysis

Rheumatology (Oxford). 2023 doi: 10.1093/rheumatology/kead598 Epub ahead of print

This systematic literature review and network meta-analysis provides evidence for bimekizumab being an efficacious option in the management of both b/tsDMARD-naïve and experienced patients across the axSpA spectrum, with similar safety and tolerability to existing treatments.

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November 2023

Bimekizumab Treatment in Patients With Active Axial Spondyloarthritis: 52-week Efficacy and Safety from the Randomised Parallel Phase 3 BE MOBILE 1 and BE MOBILE 2 Studies

Ann Rheum Dis. 2023;83(2):199–213 doi 10.1136/ard-2023-224803

Baraliakos, et al. present data from two Phase 3 studies, BE MOBILE 1 and BE MOBILE 2, that investigated the clinical efficacy and safety of bimekizumab in axSpA patients. They found that bimekizumab had sustained and consistent efficacy in patients with nr-axSpA and r-axSpA.

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October 2023

Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from the Phase III, Randomised, Placebo-Controlled, Active Reference BE OPTIMAL Study

Ann Rheum Dis. 2023;82(11):1404–1414 doi: 10.1136/ard-2023-224431

Data from this phase 3 RCT demonstrated that the efficacy of bimekizumab observed at 16 weeks remained consistent through to 52 weeks in the treatment of bDMARD-naïve patients with PsA. Patients who started the trial on placebo and switched to bimekizumab at week 16 showed similar improvements to those patients who were randomised to receive bimekizumab at the start of the trail. No new safety signals were identified.

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February 2023

Efficacy and Safety of Bimekizumab in Axial Spondyloarthritis: Results of Two Parallel Phase 3 Randomised Controlled Trials

Ann Rheum Dis. 2023 Jan 17 doi: 10.1136/ard-2022-223595

Bimekizumab may therefore offer patients with axSpA an effective treatment option with a novel mode of action.

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