- Responder analyses demonstrated that approximately nine out of 10 patients treated with BIMZELX who achieved PASI90 at Year 1, and over seven out of 10 patients who achieved complete skin clearance (PASI100) at Year 1, maintained this response to Year 4
- Switching adalimumab, secukinumab, or ustekinumab PASI90 non-responders to BIMZELX led to most patients (over 70 percent) rapidly achieving and maintaining PASI90 for up to four years, and a large proportion (over 40 percent) achieved complete skin clearance based on a post-hoc analysis
ATLANTA, GA, USA I September 25, 2024 I UCB, a global biopharmaceutical company, today announced the presentation of new four-year data in patients with moderate-to-severe plaque psoriasis treated with BIMZELX® (bimekizumab-bkzx), an interleukin (IL)-17A and IL-17F inhibitor. These post-hoc analyses include maintenance of response through four years in BIMZELX patients who achieved near-complete or complete skin clearance after one year, and the clinical response up to four years in patients switching to BIMZELX following an inadequate response to either adalimumab, ustekinumab, or secukinumab.1,2 These data are presented at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, the Netherlands, September 25–28, 2024. In addition, the design and rationale behind the exploratory, multicenter, open-label Phase 3b BIMZELX study, BE UNIQUE, that is exploring the fast onset, high level, and durability of clinical and molecular responses in patients with psoriatic disease are also shared.3
“Given the chronic nature of psoriasis, it is critically important to evaluate long-term response of treatments. Achieving completely clear skin is a key goal for people living with moderate-to-severe plaque psoriasis, and results presented at EADV 2024 showed that over 7 out of 10 patients who achieved complete skin clearance after one year maintained this response at four years,” said Professor Richard Warren, Northern Care Alliance NHS Foundation Trust and The University of Manchester, United Kingdom.
“The four-year data presented at EADV 2024 demonstrate maintenance of complete skin clearance for patients continuing treatment with bimekizumab,” said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB. “We are also proud to share the design of BE UNIQUE, a Phase 3b study investigating whether the durability of clinical response with bimekizumab is associated with molecular and cellular changes in skin, blood, and joints of patients with psoriatic disease.”
Highlights from the BIMZELX abstracts presented at EADV 2024:
Maintenance of response from end of pivotal trials through four years (post-hoc analysis): Data were pooled from the 52-week BE VIVID and 56-week BE SURE and BE READY pivotal Phase 3 trials, and their open-label extension (OLE), BE BRIGHT.1 Included patients were randomized to BIMZELX 320 mg every four weeks (Q4W) to Week 16, then BIMZELX Q4W or every eight weeks (Q8W) until OLE entry.1 Data are reported here for the combined BIMZELX dose group.1
- Of the 771 patients forming this group, 89.6 percent (n=691) and 75.1 percent (n=579) were PASI90 and PASI100 responders at Year 1, respectively.1†
- Of the PASI90 responders at Year 1, 87.9 percent maintained PASI90 response at Year 4.1‡
- Of the PASI100 responders at Year 1, 74.2 percent maintained PASI100 response at Year 4.1‡
Four-year analysis of patients switching after inadequate response to adalimumab, ustekinumab, and secukinumab (post-hoc analysis): Included patients from the 56-week BE SURE (BIMZELX versus adalimumab) and 52-week BE VIVID (BIMZELX versus ustekinumab) who then entered the BE BRIGHT OLE, and also patients from the 48-week BE RADIANT (BIMZELX versus secukinumab) who then entered its OLE.2 All patients received BIMZELX Q8W from OLE Week 16/48 (BE RADIANT/BE BRIGHT) or the next scheduled visit.2
- Of patients randomized to receive adalimumab at baseline who entered the OLE, 41.9 percent (n=54/129) did not have a PASI90 response at the time of switch to BIMZELX (Week 24).2*
- Following switch from adalimumab and after 176 weeks of BIMZELX, 92.2 percent achieved PASI90 and 74.4 achieved PASI100.2‡
- Of patients randomized to receive ustekinumab at baseline who entered the OLE, 33.3 percent (n=44/132) did not achieve PASI90 at the time of switch to BIMZELX (Week 52).2*
- Following switch from ustekinumab and after 144 weeks of BIMZELX, 82.0 percent achieved PASI90 and 58.8 percent achieved PASI100.2‡
- Of patients randomized to receive secukinumab at baseline who entered the OLE, 18.5 percent (n=58/314) did not achieve PASI90 at the time of switch to BIMZELX (Week 48).2*
- Following switch from secukinumab and after 96 weeks of BIMZELX, 71.7 percent achieved PASI90 and 39.8 percent achieved PASI100.2‡
Design and rationale behind the Phase 3b BE UNIQUE study: BE UNIQUE is an ongoing multicenter Phase 3b study designed to investigate molecular and cellular changes associated with BIMZELX responses in patients with psoriasis and psoriatic arthritis.3 The primary objective is to assess change in gene expression score on skin biopsies, using preselected genes based on BIMZELX’s mechanism of action and psoriatic disease pathways.3
UCB previously shared four-year safety data on BIMZELX for the treatment of moderate-to-severe plaque psoriasis. Data showed that treatment-emergent adverse events were consistent with longer BIMZELX exposure, with no new safety signals.
Notes to Editors:
† Non-Responder Imputation
‡ Modified Non-Responder Imputation
* Observed Case
About Plaque Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin.4 This skin condition affects men and women of all ages and ethnicities.5 Psoriasis signs and symptoms can vary but may include red patches of skin covered with silvery-white scales; dry, cracked skin that may bleed; and thickened, pitted, or ridged nails.4 Psoriasis affects nearly three percent of the total population, or about 125 million people worldwide.6
About BIMZELX (bimekizumab-bkzx)
Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex.7 Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.7
In the U.S., BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, and adults with active ankylosing spondylitis.7
Please see Important Safety Information below and full U.S. prescribing information at UCB-USA.com/Innovation/Products/BIMZELX and http://www.BIMZELX.com.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
References
- Gordon KB, Cather J, Pariser D, et al. Bimekizumab maintenance of response from the end of pivotal trials through 4 years: Results in patients with moderate to severe plaque psoriasis from BE BRIGHT. Abstract at EADV 2024, Amsterdam, the Netherlands.
- Kokolakis G, Han G, Pariser G, et al. Bimekizumab long-term efficacy in patients with moderate to severe plaque psoriasis after switching from adalimumab, ustekinumab, or secukinumab: Results from up to 4 years of total treatment from BE BRIGHT and BE RADIANT. Abstract at EADV 2024, Amsterdam, the Netherlands.
- Gudjonsson J, Merola J, Warren R, et al. Bimekizumab: Exploring the fast onset, high level, and durability of clinical and molecular responses in patients with psoriatic disease – Design and rationale behind the exploratory, multicentre, open-label phase 3b BE UNIQUE study. Abstract at EADV 2024, Amsterdam, the Netherlands.
- Griffiths C, Armstrong A, Gudjonsson J, et al. Psoriasis. Lancet. 2021;397(10281):1301–15.
- Parisi R, Iskandar I, Kontopantelis E, et al. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ. 2020;369:m1590.doi:10.1136/bmj.m1590.
- Griffiths CEM, van der Walt JM, Ashcroft DM, et al. The global state of psoriasis disease epidemiology: a workshop report. Br J Dermatol. 2017;177(1):e4-e7.
- BIMZELX® (bimekizumab-bkzx) U.S. Prescribing Information. https://www.ucb-usa.com/Innovation/Products/BIMZELX. Accessed September 2024.
SOURCE: UCB
Post Views: 138
- Responder analyses demonstrated that approximately nine out of 10 patients treated with BIMZELX who achieved PASI90 at Year 1, and over seven out of 10 patients who achieved complete skin clearance (PASI100) at Year 1, maintained this response to Year 4
- Switching adalimumab, secukinumab, or ustekinumab PASI90 non-responders to BIMZELX led to most patients (over 70 percent) rapidly achieving and maintaining PASI90 for up to four years, and a large proportion (over 40 percent) achieved complete skin clearance based on a post-hoc analysis
ATLANTA, GA, USA I September 25, 2024 I UCB, a global biopharmaceutical company, today announced the presentation of new four-year data in patients with moderate-to-severe plaque psoriasis treated with BIMZELX® (bimekizumab-bkzx), an interleukin (IL)-17A and IL-17F inhibitor. These post-hoc analyses include maintenance of response through four years in BIMZELX patients who achieved near-complete or complete skin clearance after one year, and the clinical response up to four years in patients switching to BIMZELX following an inadequate response to either adalimumab, ustekinumab, or secukinumab.1,2 These data are presented at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, the Netherlands, September 25–28, 2024. In addition, the design and rationale behind the exploratory, multicenter, open-label Phase 3b BIMZELX study, BE UNIQUE, that is exploring the fast onset, high level, and durability of clinical and molecular responses in patients with psoriatic disease are also shared.3
“Given the chronic nature of psoriasis, it is critically important to evaluate long-term response of treatments. Achieving completely clear skin is a key goal for people living with moderate-to-severe plaque psoriasis, and results presented at EADV 2024 showed that over 7 out of 10 patients who achieved complete skin clearance after one year maintained this response at four years,” said Professor Richard Warren, Northern Care Alliance NHS Foundation Trust and The University of Manchester, United Kingdom.
“The four-year data presented at EADV 2024 demonstrate maintenance of complete skin clearance for patients continuing treatment with bimekizumab,” said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB. “We are also proud to share the design of BE UNIQUE, a Phase 3b study investigating whether the durability of clinical response with bimekizumab is associated with molecular and cellular changes in skin, blood, and joints of patients with psoriatic disease.”
Highlights from the BIMZELX abstracts presented at EADV 2024:
Maintenance of response from end of pivotal trials through four years (post-hoc analysis): Data were pooled from the 52-week BE VIVID and 56-week BE SURE and BE READY pivotal Phase 3 trials, and their open-label extension (OLE), BE BRIGHT.1 Included patients were randomized to BIMZELX 320 mg every four weeks (Q4W) to Week 16, then BIMZELX Q4W or every eight weeks (Q8W) until OLE entry.1 Data are reported here for the combined BIMZELX dose group.1
- Of the 771 patients forming this group, 89.6 percent (n=691) and 75.1 percent (n=579) were PASI90 and PASI100 responders at Year 1, respectively.1†
- Of the PASI90 responders at Year 1, 87.9 percent maintained PASI90 response at Year 4.1‡
- Of the PASI100 responders at Year 1, 74.2 percent maintained PASI100 response at Year 4.1‡
Four-year analysis of patients switching after inadequate response to adalimumab, ustekinumab, and secukinumab (post-hoc analysis): Included patients from the 56-week BE SURE (BIMZELX versus adalimumab) and 52-week BE VIVID (BIMZELX versus ustekinumab) who then entered the BE BRIGHT OLE, and also patients from the 48-week BE RADIANT (BIMZELX versus secukinumab) who then entered its OLE.2 All patients received BIMZELX Q8W from OLE Week 16/48 (BE RADIANT/BE BRIGHT) or the next scheduled visit.2
- Of patients randomized to receive adalimumab at baseline who entered the OLE, 41.9 percent (n=54/129) did not have a PASI90 response at the time of switch to BIMZELX (Week 24).2*
- Following switch from adalimumab and after 176 weeks of BIMZELX, 92.2 percent achieved PASI90 and 74.4 achieved PASI100.2‡
- Of patients randomized to receive ustekinumab at baseline who entered the OLE, 33.3 percent (n=44/132) did not achieve PASI90 at the time of switch to BIMZELX (Week 52).2*
- Following switch from ustekinumab and after 144 weeks of BIMZELX, 82.0 percent achieved PASI90 and 58.8 percent achieved PASI100.2‡
- Of patients randomized to receive secukinumab at baseline who entered the OLE, 18.5 percent (n=58/314) did not achieve PASI90 at the time of switch to BIMZELX (Week 48).2*
- Following switch from secukinumab and after 96 weeks of BIMZELX, 71.7 percent achieved PASI90 and 39.8 percent achieved PASI100.2‡
Design and rationale behind the Phase 3b BE UNIQUE study: BE UNIQUE is an ongoing multicenter Phase 3b study designed to investigate molecular and cellular changes associated with BIMZELX responses in patients with psoriasis and psoriatic arthritis.3 The primary objective is to assess change in gene expression score on skin biopsies, using preselected genes based on BIMZELX’s mechanism of action and psoriatic disease pathways.3
UCB previously shared four-year safety data on BIMZELX for the treatment of moderate-to-severe plaque psoriasis. Data showed that treatment-emergent adverse events were consistent with longer BIMZELX exposure, with no new safety signals.
Notes to Editors:
† Non-Responder Imputation
‡ Modified Non-Responder Imputation
* Observed Case
About Plaque Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin.4 This skin condition affects men and women of all ages and ethnicities.5 Psoriasis signs and symptoms can vary but may include red patches of skin covered with silvery-white scales; dry, cracked skin that may bleed; and thickened, pitted, or ridged nails.4 Psoriasis affects nearly three percent of the total population, or about 125 million people worldwide.6
About BIMZELX (bimekizumab-bkzx)
Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex.7 Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.7
In the U.S., BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, and adults with active ankylosing spondylitis.7
Please see Important Safety Information below and full U.S. prescribing information at UCB-USA.com/Innovation/Products/BIMZELX and http://www.BIMZELX.com.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
References
- Gordon KB, Cather J, Pariser D, et al. Bimekizumab maintenance of response from the end of pivotal trials through 4 years: Results in patients with moderate to severe plaque psoriasis from BE BRIGHT. Abstract at EADV 2024, Amsterdam, the Netherlands.
- Kokolakis G, Han G, Pariser G, et al. Bimekizumab long-term efficacy in patients with moderate to severe plaque psoriasis after switching from adalimumab, ustekinumab, or secukinumab: Results from up to 4 years of total treatment from BE BRIGHT and BE RADIANT. Abstract at EADV 2024, Amsterdam, the Netherlands.
- Gudjonsson J, Merola J, Warren R, et al. Bimekizumab: Exploring the fast onset, high level, and durability of clinical and molecular responses in patients with psoriatic disease – Design and rationale behind the exploratory, multicentre, open-label phase 3b BE UNIQUE study. Abstract at EADV 2024, Amsterdam, the Netherlands.
- Griffiths C, Armstrong A, Gudjonsson J, et al. Psoriasis. Lancet. 2021;397(10281):1301–15.
- Parisi R, Iskandar I, Kontopantelis E, et al. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ. 2020;369:m1590.doi:10.1136/bmj.m1590.
- Griffiths CEM, van der Walt JM, Ashcroft DM, et al. The global state of psoriasis disease epidemiology: a workshop report. Br J Dermatol. 2017;177(1):e4-e7.
- BIMZELX® (bimekizumab-bkzx) U.S. Prescribing Information. https://www.ucb-usa.com/Innovation/Products/BIMZELX. Accessed September 2024.
SOURCE: UCB
Post Views: 138
