BIMZELX® (bimekizumab-bkzx) Five-Year Data at AAD 2025 Showed Sustained Skin Clearance and Long-Term Efficacy in Moderate-to-Severe Plaque Psoriasis

• Sustained complete skin clearance over five years: In a subset of 153 patients from the second extension of BE BRIGHT, 67.7% of patients with moderate-to-severe plaque psoriasis (PSO) treated with BIMZELX^® (bimekizumab-bkzx) achieved PASI100⁺ at five years
• Durable and broad efficacy across patient subgroups at four years: Consistently high rates of complete or near-complete skin clearance seen at four years regardless of baseline weight or baseline cardiometabolic comorbidities such as hypertension, hyperglycemia, or elevated BMI
• High response rates in patients at risk of psoriatic arthritis at three years: Data showed 68.7–71.6% of PSO patients at risk of developing psoriatic arthritis (PsA) achieved complete skin clearance, generally consistent with the overall treated group. Similar results were seen in all patients with PSO, including those with PsA at baseline
• Dual inhibition: BIMZELX^® is the first and only approved medicine designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)

ATLANTA, March 7, 2025 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced further long-term data from the Phase 3 trials, and their open-label extensions, investigating BIMZELX^® (bimekizumab-bkzx) in adults with moderate-to-severe plaque psoriasis (PSO). Dual inhibition with BIMZELX demonstrated high efficacy and sustained clinical benefits across different adult patient populations living with this common inflammatory skin condition.^1-4

"A primary treatment goal for people living with psoriasis is durable, high rates of complete skin clearance. These five-year bimekizumab-bkzx results provide valuable evidence for clinical decision-making," said Andrew Blauvelt, MD, MBA, Chair, Medical Board, National Psoriasis Foundation. "The sustained complete skin clearance offers important insights into the potential of bimekizumab-bkzx's dual inhibition to provide long-term management of this chronic inflammatory condition."

Among patients with PSO only at baseline, who were at risk of progression to psoriatic arthritis (PsA), 68.7–71.6% achieved complete skin clearance (Psoriasis Area and Severity Index [PASI]100) at three years, generally consistent with the overall treated group, who achieved 72%.⁴ Similar results were seen in all patients with PSO, including those with PsA at baseline. Among the 153 US/Canadian patients who completed an open-label extension period to five years,^* 67.7% achieved PASI100, while 84.9% achieved PASI90.¹ In this subgroup over the five-year period, BIMZELX was generally well tolerated with no unexpected safety findings.¹

"Psoriasis is a chronic condition that increases the risk of developing other serious health issues," said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB. "These five-year results highlight the robust potential of bimekizumab-bkzx in transforming patient outcomes by offering the possibility of lasting, complete skin clearance. Bimekizumab-bkzx is aiming to set a new standard for treatment success, and our belief in its innovative dual inhibition approach is reflected in our dedication to head-to-head trials, including the BE BOLD Phase 3 trial in psoriatic arthritis."

UCB's data for BIMZELX in moderate-to-severe PSO will be presented as six posters at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, U.S., March 7–11.^1-6 These abstracts complement other BIMZELX data presented at AAD in hidradenitis suppurativa,^7-13 psoriatic arthritis,^14-16 ankylosing spondylitis, and non-radiographic axial spondyloarthritis,^17-18 emphasizing UCB's leadership in addressing unmet health needs for people living with immune-mediated inflammatory diseases.

⁺PASI100: 100% improvement from baseline in Psoriasis Area and Severity Index, indicating complete skin clearance.^1,4

^*All patients received BIMZELX every four weeks (Q4W) to Week 16, then received either Q4W or Q8W depending upon response to treatment. Receiving Q4W to Week 16, then Q8W thereafter is the approved dosing regimen (Q4W/Q8W). Results included patients receiving both Q4W/Q8W and Q4W/Q4W.

Notes to Editors:
Further detail on selected BIMZELX data in PSO presented at AAD 2025: 

• Five-year efficacy and safety: A US/Canadian subgroup of 153 patients* completing BE VIVID/BE SURE/BE READY and the BE BRIGHT open-label extension could enter a second 48-week extension (OLE2), where all patients received Q8W. BIMZELX demonstrated high rates of clinical and health-related quality of life responses, which were highly durable to Year 5.^† It was generally well tolerated in this patient subgroup, with no unexpected safety findings, over five years:¹
  • Of the 153* patients analyzed, 75.2% and 67.7% patients achieved PASI100 at one year and five years, respectively. Similarly, 92.8% and 84.9% achieved PASI90 at one year and five years, respectively
  • Over five years, in the subgroup of 153 patients*, the four most common treatment emergent adverse events (TEAEs) were: nasopharyngitis (9.7/100PY), oral candidiasis (7.6/100PY), coronavirus infection (6.1/100PY), and upper respiratory tract infection (5.8/100PY).
• Weight stratification: BIMZELX demonstrated long-term efficacy across four years regardless of patients' weight subgroup at baseline (either <90 kg or ≥90 kg):²*^†≠
  • Of the 420 patients analyzed who were <90 kg, 88.5%/67.4% achieved PASI90/PASI100 at four years
  • Of the 351 patients analyzed who were ≥90 kg, 83.0%/61.6% achieved PASI90/PASI100 at four years
• Skin clearance rates in patients with cardiometabolic comorbidities: High and durable levels of complete or near-complete skin clearance were achieved after four years of BIMZELX treatment in 771 patients with PSO, regardless of baseline hypertension, elevated BMI, or hyperglycemia:³*^†≠
  • Of the 375 patients with baseline hypertension, 82.8%/59.3%, respectively, achieved PASI90/PASI100 at four years
  • Of the 344 patients with baseline elevated BMI, 82.5%/60.7%, respectively, achieved PASI90/PASI100 at four years
  • Of the 62 patients with baseline hyperglycemia, 80.4%/56.9%, respectively, achieved PASI90/PASI100 at four years
• Patients at risk of progressing to psoriatic arthritis (PsA): The rates of complete skin clearance (PASI100) were high after three years in BIMZELX-treated patients with PSO and risk factors for progression to PsA or who screened PsA-positive, consistent with the overall BIMZELX-treated group. Outcomes were similar when the analysis was restricted to patients with only psoriasis at baseline.⁴*^†¥

^*All patients received BIMZELX every four weeks (Q4W) to Week 16, then received either Q4W or Q8W depending upon response to treatment. Receiving Q4W to Week 16, then Q8W thereafter is the approved dosing regimen (Q4W/Q8W). Results included patients receiving both Q4W/Q8W and Q4W/Q4W.

^†Modified non‑responder imputation.

^≠Data were pooled from the 52/56-week Phase 3 trials: BE VIVID, BE SURE, BE READY, and their open-label extension (OLE) BE BRIGHT.

^¥Data were pooled from BE VIVID, BE SURE, BE READY, the first 96 weeks of their open-label extension (OLE) BE BRIGHT, and BE RADIANT (48-week double-blinded period, plus 96-week OLE).

About Plaque Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin.¹⁹ This skin condition affects men and women of all ages and ethnicities.²⁰ 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.²¹ Psoriasis affects nearly three percent of the total population, or about 125 million people worldwide.²²

About Psoriatic Arthritis
Psoriatic arthritis is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin with a prevalence of 0.02 percent to 0.25 percent of the population.²³ Psoriatic arthritis affects approximately 30 percent of people living with psoriasis.²⁴ It manifests as joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis), and inflammation of the sites where tendons or ligaments insert into the bone (enthesitis).²⁵ The burden on those living with PsA extends beyond physical discomfort to reduced quality of life, with comorbidities including hypertension, cardiovascular disease, anxiety, and depression.²⁶

About BIMZELX^®(bimekizumab-bkzx) 
BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.²⁷ IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.^27-30 IL-17F is over-expressed in skin and highly elevated in the serum of patients with psoriasis (PSO), psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis (AS), and hidradenitis suppurativa (HS). ^27-31 

The approved indications for BIMZELX in the U.S. are:²⁷ 

• Plaque psoriasis: BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy  
• Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis 
• Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation 
• Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis 
• Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa 

BIMZELX U.S. IMPORTANT SAFETY INFORMATION 
 
IMPORTANT SAFETY INFORMATION 
 
Suicidal Ideation and Behavior 
BIMZELX (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment. 

Infections 
BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves. 

Tuberculosis 
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment. 

Liver Biochemical Abnormalities 
Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis. 

Inflammatory Bowel Disease 
Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.   

Immunizations 
Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.   

Most Common Adverse Reactions                                                                        
Most common (≥ 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue. 

Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections. 

Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections. 

Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infection. 

Please see Important Safety Information below and full U.S. Prescribing Information at http://www.ucb-usa.com/Innovation/Products/BIMZELX.   

For further information, contact UCB:

Investor Relations
Antje Witte
T +32.2.559.94.14
email antje.witte@ucb.com

Brand Communications
Nicole Herga
T +1.773.960.5349
email nicole.herga@ucb.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.

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Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. 

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. 

References

US-BK-2500314
Date of preparation: March 2025
BIMZELX^® is a registered trademark of the UCB Group of Companies.
©2025 UCB, Inc., Smyrna, GA 30080. All rights reserved.

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