First Presentation of Year 4 BIMZELX ® (bimekizumab-bkzx) Data Showed Long-Term Maintenance of Complete Skin Clearance in Moderate-to-Severe Plaque Psoriasis

• Late-breaking platform presentation showed that BIMZELX ^® (bimekizumab-bkzx) rapidly achieved and maintained high rates of clinical and health-related quality-of-life responses through four years; six out of ten patients achieved complete skin clearance at Year 4
• Responder-analyses demonstrated that approximately nine out of ten patients treated with BIMZELX who achieved PASI90 at Week 16, and over seven out of ten patients who achieved complete skin clearance (PASI100) maintained their response to Year 4
• Four-year safety data showed that treatment-emergent adverse events were consistent or decreased with longer BIMZELX exposure, with no new safety signals

ATLANTA, March 9, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced  that the first presentations of BIMZELX ^® (bimekizumab-bkzx) four-year efficacy and safety data in the treatment of adults with moderate-to-severe plaque psoriasis are being shared this week at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California, March 8“12.

"We are proud to debut the BIMZELX ^® four-year psoriasis data at the world's largest dermatology meeting, showing that the majority of adult patients treated with BIMZELX achieved deep and durable clinical response through four years, with a consistent tolerability profile. These results, from the largest pool of Phase 3 data, closely follow the U.S. launch, and reinforce our belief that BIMZELX has the potential to transform the lives of people with moderate-to-severe plaque psoriasis," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.

"Moderate-to-severe plaque psoriasis is a chronic condition with physical skin manifestations that can place a significant burden on a patient's health-related quality-of-life. Analysis shows that through four years of bimekizumab treatment, over six out of ten patients achieved and maintained complete skin clearance, a clinically meaningful endpoint and outcome for patients. These long-term data will be highly welcomed by the dermatology community since they provide important considerations for clinical practice," said Dr. Bruce Strober, Clinical Professor of Dermatology at Yale University, and Central Connecticut Dermatology, Connecticut, U.S.

The late-breaking platform presentation shared BIMZELX pooled data from treatment initiation through four years, showing that high rates of clinical and health-related quality-of-life responses were rapidly achieved and were maintained in the long-term. ¹  Responder-analyses showed that approximately nine out of ten patients treated with BIMZELX who achieved ‰¥90 percent improvement from baseline in the Psoriasis Area Severity Index (PASI90) and over seven out of ten patients who achieved complete skin clearance (PASI100) at Week 16 maintained their responses to Year 4. ² Pooled analysis from five Phase 3/3b studies showed that BIMZELX demonstrated good tolerability and a consistent safety profile with no new safety findings identified up to four years in patients with moderate-to-severe plaque psoriasis. ³

Highlights from the four-year BIMZELX data in moderate-to-severe plaque psoriasis presented at the 2024 AAD:

Treatment initiation through four years:  Data were pooled across the 52-week BE VIVID study, the 56-week BE READY and BE SURE studies and their open-label extension (OLE Week 144) BE BRIGHT. ¹  Analyzed patients were randomized to BIMZELX 320 mg every four weeks (Q4W) to Week 16, then BIMZELX Q4W or Q8W until OLE entry. ¹  Clinical and health-related quality of life (PASI90 and PASI100, body surface area [BSA] ‰¤1 percent and Dermatology Life Quality Index [DLQI]0/1) responses were assessed through to Year 4 (OLE Week 144). ¹  Data are presented below for all patients who received BIMZELX continuously from baseline and entered the OLE (n=771): ¹

• 90.9 percent achieved PASI90 at Week 16, and 86.1 percent through to Year 4.^{1 ¥}
• 65.8 percent achieved PASI100 at Week 16, and 64.7 percent through to Year 4.^{1 ¥}
• 78.5 percent achieved BSA ‰¤1 percent at Week 16, and 79.8 percent through to Year 4.^{1 ¥}
• 71.5 percent achieved DLQI0/1 at Week 16, and 78.7 percent through to Year 4.^{1 ¥}

Responder analysis to Year 4: Patients who completed the BE VIVID, BE SURE, and BE READY Phase 3 studies could enter the BE BRIGHT OLE. ²  Analyzed patients were randomized to BIMZELX 320 mg Q4W to Week 16, then BIMZELX Q4W or Q8W until OLE entry, then BIMZELX Q4W or Q8W dependent on PASI response/prior dose. ²  Maintenance of PASI90 and PASI100 was assessed in Week 16 responders to Year 4 (OLE Week 144) and is presented below for all patients: ²

• 87.7 percent who achieved PASI90 at Week 16 (n=693) maintained their response to Year 4.^{2 ¥}
• 73.3 percent who achieved PASI100 at Week 16 (n=503) maintained their response to Year 4.^{2 ¥}

Safety and tolerability through four years:  Data were pooled across the 52-week BE VIVID study, the 56-week BE READY and BE SURE studies, and the OLE studies BE BRIGHT and BE RADIANT.³ The total BIMZELX exposure was 6,324.3 patient-years (PY) across the studies (n=2,186).³

• Exposure-adjusted incidence rates (EAIRs) of treatment-emergent adverse events (TEAEs) remained consistent or decreased with longer BIMZELX exposure. Overall, TEAEs occurred at an EAIR of 170.5/100 PY and serious TEAEs at 5.5/100 PY.³
• The most common TEAEs were nasopharyngitis (12.7/100 PY), oral candidiasis (8.9/100 PY), and upper respiratory tract infections (5.7/100 PY). Oral candidiasis decreased from 18.9/100 PY at Year 1 to 5.4/100 PY at Year 4.³ Throughout, fewer TEAEs occurred with BIMZELX every 8 weeks (Q8W) (115.4/100 PY) vs. every 4 weeks (Q4W) (224.4/100 PY).³

^¥ Modified non-responder imputation analyses

Notes to Editors:
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.⁴ Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.⁴

BIMZELX  is not approved in the U.S. for the treatment of psoriatic arthritis or axial spondyloarthritis and  these are investigational indications only.

Please see Important Safety Information below and full U.S. prescribing information at www.UCB-USA.com/Innovation/Products/BIMZELX.

BIMZELX  U.S.  IMPORTANT  SAFETY INFORMATION⁴

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 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, advise 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.  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 adverse  reactions  ( ‰¥1 percent)  are  upper  respiratory  infections,  oral  candidiasis,  headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.

For  further  information,  contact  UCB:

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

U.S.  Communications
Erica Puntel
T +1.770.970.8465
email  erica.puntel@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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References

1. Strober B. 2024 AAD. Oral Presentation.
2.  Blauvelt A, Foley P, Langley RG, et al. Bimekizumab 4-year maintenance of responses in Week 16 responders with moderate to severe plaque psoriasis: Results from the BE BRIGHT open label extension phase 3 trial. Abstract at the 2024 American Academy of Dermatology Annual Meeting, San Diego, CA, U.S., March 8“12, 2024.
3. Gordon KB,  Thaçi D, Gooderham M, et al. Bimekizumab safety and tolerability in moderate to severe plaque psoriasis: Pooled analysis from up to 4 years of treatment in 5 phase 3/3b clinical trials. Abstract at the 2024 American Academy of Dermatology Annual Meeting, San Diego, CA, U.S., March 8“12, 2024.
4. BIMZELX [prescribing information]. Smyrna, GA: UCB, Inc.