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Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials.
Br J Dermatol. 2023 02 22; 188(3):330-340.BJ

Abstract

BACKGROUND

Discontinuation of biologics is common among patients with psoriasis due to treatment failure or adverse events. To achieve improvements in disease management, patients and clinicians may choose to switch biologics.

OBJECTIVES

To evaluate the efficacy and safety of switching to bimekizumab from adalimumab, ustekinumab and secukinumab.

METHODS

Data are reported for up to 80 weeks after patients switched to bimekizumab from adalimumab at week 24 in BE SURE, ustekinumab at week 52 in BE VIVID [upon entry into the BE BRIGHT open-label extension (OLE)] and secukinumab at week 48 in BE RADIANT (upon entry into the BE RADIANT OLE). Efficacy outcomes are reported by number of weeks after switching to bimekizumab and were split based on whether patients had achieved a ≥ 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at the time of switch. Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rates (EAIRs) per 100 patient-years. Trial registration: BE SURE (NCT03412747), BE VIVID (NCT03370133), BE BRIGHT (NCT03598790), BE RADIANT (NCT03536884).

RESULTS

Rapid and durable improvements in clinical responses and benefits in health-related quality of life were observed among PASI 90 nonresponders who switched to bimekizumab. Most PASI 90 nonresponders achieved PASI 90 4 weeks after switching to bimekizumab from adalimumab (67%), ustekinumab (79%) and secukinumab (53%). After 48 weeks of bimekizumab, 91%, 90% and 79% of PASI 90 nonresponders had achieved PASI 90 after switching from adalimumab, ustekinumab or secukinumab, respectively. Durable improvements were also observed for PASI 100, Investigator's Global Assessment score 0/1, body surface area affected by psoriasis ≤ 1%, absolute PASI ≤ 2, and Dermatology Life Quality Index 0/1. Among PASI 90 responders, existing treatment responses were maintained or improved after switching to bimekizumab. The majority of TEAEs were mild or moderate. EAIRs were generally similar between active-comparator treatment periods and after switching to bimekizumab. EAIRs typically decreased with a longer duration of bimekizumab exposure.

CONCLUSIONS

High proportions of patients who did not adequately respond to adalimumab, ustekinumab or secukinumab achieved high levels of skin clearance after switching to bimekizumab. Bimekizumab was well tolerated and there were no new safety findings.

Authors+Show Affiliations

Psoriasis Research and Treatment Center, Department of Dermatology, Venereology and Allergology, Charité-Universitätsmedizin Berlin, Berlin, Germany. Freie Universität Berlin, Berlin, Germany. Humboldt-Universität zu Berlin, Berlin, Germany.Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.Yale University, New Haven, CT, USA. Central Connecticut Dermatology Research, Cromwell, CT, USA.Oregon Medical Research Center, Portland, OR, USA.Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.SKiN Centre for Dermatology, Probity Medical Research, Peterborough, ON, Canada. Queen's University, Kingston, ON, Canada.Hautaerzte Rue143, Essen, Germany.UCB Pharma, Brussels, Belgium.UCB Pharma, Morrisville, NC, USA.UCB Pharma, Brussels, Belgium.UCB Pharma, Morrisville, NC, USA.UCB Pharma, Monheim, Germany.Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article

Language

eng

PubMed ID

36751950

Citation

Kokolakis, Georgios, et al. "Bimekizumab Efficacy and Safety in Patients With Moderate-to-severe Plaque Psoriasis Who Switched From Adalimumab, Ustekinumab or Secukinumab: Results From Phase III/IIIb Trials." The British Journal of Dermatology, vol. 188, no. 3, 2023, pp. 330-340.
Kokolakis G, Warren RB, Strober B, et al. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. Br J Dermatol. 2023;188(3):330-340.
Kokolakis, G., Warren, R. B., Strober, B., Blauvelt, A., Puig, L., Morita, A., Gooderham, M., Körber, A., Vanvoorden, V., Wang, M., de Cuyper, D., Madden, C., Nunez Gomez, N., & Lebwohl, M. (2023). Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. The British Journal of Dermatology, 188(3), 330-340. https://doi.org/10.1093/bjd/ljac089
Kokolakis G, et al. Bimekizumab Efficacy and Safety in Patients With Moderate-to-severe Plaque Psoriasis Who Switched From Adalimumab, Ustekinumab or Secukinumab: Results From Phase III/IIIb Trials. Br J Dermatol. 2023 02 22;188(3):330-340. PubMed PMID: 36751950.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. AU - Kokolakis,Georgios, AU - Warren,Richard B, AU - Strober,Bruce, AU - Blauvelt,Andrew, AU - Puig,Luis, AU - Morita,Akimichi, AU - Gooderham,Melinda, AU - Körber,Andreas, AU - Vanvoorden,Veerle, AU - Wang,Maggie, AU - de Cuyper,Dirk, AU - Madden,Cynthia, AU - Nunez Gomez,Natalie, AU - Lebwohl,Mark, PY - 2023/2/9/pubmed PY - 2023/2/25/medline PY - 2023/2/8/entrez SP - 330 EP - 340 JF - The British journal of dermatology JO - Br J Dermatol VL - 188 IS - 3 N2 - BACKGROUND: Discontinuation of biologics is common among patients with psoriasis due to treatment failure or adverse events. To achieve improvements in disease management, patients and clinicians may choose to switch biologics. OBJECTIVES: To evaluate the efficacy and safety of switching to bimekizumab from adalimumab, ustekinumab and secukinumab. METHODS: Data are reported for up to 80 weeks after patients switched to bimekizumab from adalimumab at week 24 in BE SURE, ustekinumab at week 52 in BE VIVID [upon entry into the BE BRIGHT open-label extension (OLE)] and secukinumab at week 48 in BE RADIANT (upon entry into the BE RADIANT OLE). Efficacy outcomes are reported by number of weeks after switching to bimekizumab and were split based on whether patients had achieved a ≥ 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at the time of switch. Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rates (EAIRs) per 100 patient-years. Trial registration: BE SURE (NCT03412747), BE VIVID (NCT03370133), BE BRIGHT (NCT03598790), BE RADIANT (NCT03536884). RESULTS: Rapid and durable improvements in clinical responses and benefits in health-related quality of life were observed among PASI 90 nonresponders who switched to bimekizumab. Most PASI 90 nonresponders achieved PASI 90 4 weeks after switching to bimekizumab from adalimumab (67%), ustekinumab (79%) and secukinumab (53%). After 48 weeks of bimekizumab, 91%, 90% and 79% of PASI 90 nonresponders had achieved PASI 90 after switching from adalimumab, ustekinumab or secukinumab, respectively. Durable improvements were also observed for PASI 100, Investigator's Global Assessment score 0/1, body surface area affected by psoriasis ≤ 1%, absolute PASI ≤ 2, and Dermatology Life Quality Index 0/1. Among PASI 90 responders, existing treatment responses were maintained or improved after switching to bimekizumab. The majority of TEAEs were mild or moderate. EAIRs were generally similar between active-comparator treatment periods and after switching to bimekizumab. EAIRs typically decreased with a longer duration of bimekizumab exposure. CONCLUSIONS: High proportions of patients who did not adequately respond to adalimumab, ustekinumab or secukinumab achieved high levels of skin clearance after switching to bimekizumab. Bimekizumab was well tolerated and there were no new safety findings. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/36751950/Bimekizumab_efficacy_and_safety_in_patients_with_moderate_to_severe_plaque_psoriasis_who_switched_from_adalimumab_ustekinumab_or_secukinumab:_results_from_phase_III/IIIb_trials_ DB - PRIME DP - Unbound Medicine ER -