UCB Announces Late-Breaking Two-Year Data for BIMZELX® (bimekizumab-bkzx) in Moderate-to-Severe Hidradenitis Suppurativa at EADV 2024

Rhea-AI Summary

UCB announced two-year data from Phase 3 studies BE HEARD I and II, evaluating BIMZELX® (bimekizumab-bkzx) in adults with moderate-to-severe hidradenitis suppurativa (HS). Results showed maintained improvements over two years:

- At Week 96, 85.4% of patients achieved HiSCR50, 77.1% achieved HiSCR75, and 44.2% achieved HiSCR100

- Improvements in disease severity, reductions in draining tunnel count, and quality of life were maintained

- Approximately 1 in 3 patients reported minimal or no impact on health-related quality of life

BIMZELX was generally well-tolerated with no new safety signals. The data was presented at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam.

Positive

• 85.4% of patients achieved HiSCR50 at Week 96, up from 79.9% at Week 48
• 77.1% of patients achieved HiSCR75 at Week 96, up from 64.0% at Week 48
• 44.2% of patients achieved HiSCR100 at Week 96, up from 30.2% at Week 48
• Maintained improvements in disease severity, draining tunnel count, and quality of life over two years
• 33.9% of patients reported minimal or no impact on health-related quality of life at Week 96

Negative

• None.

• Clinically meaningful improvements observed with BIMZELX over one year of treatment were maintained up to two years (Week 96)
• At Week 96, over eight in 10 patients treated with BIMZELX achieved HiSCR50, over seven in 10 achieved HiSCR75, and over four in 10 achieved HiSCR100*
• Approximately one in three patients treated with BIMZELX reported minimal or no impact of the disease on their health-related quality of life over two years*

ATLANTA, Sept. 27, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced the first presentation of two-year data from the Phase 3 studies, BE HEARD I and BE HEARD II, and their open-label extension, evaluating the efficacy and safety of BIMZELX^® (bimekizumab-bkzx), an interleukin (IL)-17A and IL-17F inhibitor, in adults with moderate-to-severe hidradenitis suppurativa (HS).¹ These new data are presented today as a late-breaking platform presentation at the 33^rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, the Netherlands, September 25–28, 2024.

Results showed that the clinically meaningful improvements observed with BIMZELX treatment at one year were maintained over two years.^1* At Week 96, 85.4 percent (n=381/446) of patients treated with BIMZELX achieved HS Clinical Response 50 (HiSCR50). The more stringent endpoints, HiSCR75 and HiSCR100, were achieved by 77.1 percent (n=344/446) and 44.2 percent (n=197/446) of patients, respectively.^1* Improvements in the severity of disease, reductions in draining tunnel count, and improvements in health-related quality of life were also maintained over two years.^1* BIMZELX was generally well tolerated and no new safety signals were observed.¹ 

"Hidradenitis suppurativa is a chronic, relapsing, and painful inflammatory skin disease that significantly impacts patients' quality of life. The bimekizumab data presented at EADV 2024 showed maintained improvements in clinical response, symptoms, severity, and quality of life over two years. These findings are particularly encouraging given the need for new treatment options that offer sustained relief for patients," said Professor Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation (EHSF) e.V., Director of the Departments of Dermatology, Venereology, Allergology and Immunology, Städtisches Klinikum Dessau, and Founding Professor of Dermatology and Venereology at the Brandenburg Medical School, Germany.

"In moderate to severe hidradenitis suppurativa, healthcare professionals and patients value long-term data when they are making treatment decisions. We are proud to present, for the first time, the bimekizumab two-year results at EADV 2024," said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB. "These longer-term data build on the 48-week results, demonstrating maintained response over two years, which is highly relevant for the hidradenitis suppurativa community."

* Observed Case 

Summary of the BIMZELX two-year data in moderate-to-severe HS presented at EADV 2024:

Patients who completed Week 48 in BE HEARD I and BE HEARD II could enroll in the open-label extension study and received BIMZELX every two weeks (Q2W) or every four weeks (Q4W) based on ≥90 percent HiSCR averaged from Weeks 36, 40, and 44. Results are shared for the BIMZELX total patient group.

• HS Clinical Response:
  • HiSCR50 was achieved by 79.9 percent (n=444/556) of BIMZELX patients at Week 48 and 85.4 percent (n=381/446) at Week 96.^1*
  • HiSCR75 was achieved by 64.0 percent (n=356/556) of BIMZELX patients at Week 48 and 77.1 percent (n=344/446) at Week 96.^1*
  • HiSCR90 was achieved by 42.3 percent (n=235/556) of BIMZELX patients at Week 48 and 57.6 percent (n=257/446) at Week 96.^1*
  • HiSCR100 was achieved by 30.2 percent (n=168/556) of BIMZELX patients at Week 48 and 44.2 percent (n=197/446) at Week 96.^1*

• International HS Severity Score System (IHS4): Patients treated with BIMZELX saw a decrease in the severity of their HS symptoms as measured by the IHS4 score.^1* The mean IHS4 score at baseline was 35.6±31.5 among BIMZELX patients.^1* The percent change from baseline in IHS4 score at Week 48 among BIMZELX patients was maintained through Week 96 (-70.3±39.6 and -79.8±28.1 at Week 48 and Week 96, respectively).^1*
  
  
• Draining tunnel (DT) count: The mean DTs at baseline was 3.8±4.3 among BIMZELX patients.^1* The percent change from baseline in draining tunnel count at Week 48 among BIMZELX patients was maintained through Week 96 (–57.5 ±72.9 and –73.7±45.7 percent, at Week 48 and Week 96, respectively).^1*
  
  
• Health-related quality of life: The proportion of BIMZELX patients who achieved Dermatology Life Quality Index (DLQI) 0/1 at Week 48 was maintained through Week 96. The Mean DLQI Total at baseline was 11.0±6.8 among bimekizumab patients. Approximately one in three patients reported minimal or no impact of the disease on their health-related quality of life over two years (27.4 percent [n=151/155] and 33.9 percent [n=149/439] at Week 48 and Week 96, respectively).^1*

BIMZELX was generally well-tolerated over two years with no new safety signals observed. Over two years, 917/995 patients who received ≥1 dose of BIMZELX experienced a treatment-emergent adverse event (TEAE). Serious TEAEs were reported in 122 patients.¹ Over two years, the most common TEAEs (exposure adjusted incidence rates) were hidradenitis (20.5), coronavirus infection (15.3), and oral candidiasis (10.5).¹

Notes to Editors:
* Observed Case

About Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic, painful, and debilitating inflammatory skin disease that is associated with systemic manifestations.^2,3 The main symptoms are nodules, abscesses, and pus-discharging draining tunnels (or sinus tracts leading out of the skin) which typically occur in the armpits, groin and buttocks.^2,3 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.^2,3 HS develops in early adulthood and affects approximately one percent of the population in most studied countries.^2,3

About BE HEARD I/BE HEARD II and the Open-Label Extension Study

The efficacy and safety profile of BIMZELX were evaluated in adult patients with moderate-to-severe hidradenitis suppurativa (HS) in two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (BE HEARD I and BE HEARD II).⁴ The two studies had a combined enrollment of 1,014 participants.⁴ In each study, patients were randomized 2:2:2:1 (initial [16-week]/maintenance [32-weeks]) to BIMZELX 320 mg every two weeks (Q2W/Q2W), every four weeks (Q4W/Q4W), or a combination (BIMZELX 320 mg every two weeks to Week 16 then every 4 weeks to Week 48 [Q2W/Q4W] or placebo to Week 16 then BIMZELX 320 mg every two weeks to Week 48 [PBO/Q2W]).¹ Patients who completed Week 48 could enroll in the open-label extension.¹ Of 1,014 total patients, 556 patients randomized at baseline to BIMZELX in BE HEARD I and II completed Week 48 and entered the open-label extension study; 446 patients in the open-label extension study completed Week 96.¹ The primary endpoint in both trials was HiSCR50 at Week 16.⁴ A key secondary endpoint was HiSCR75 at Week 16.⁴ HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.⁴

About BIMZELX (bimekizumab-bkzx)

Bimekizumab 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.⁵ Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.⁵

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.⁵ BIMZELX is not approved in the U.S. for the treatment of moderate-to-severe hidradenitis suppurativa (HS). In the U.S., the efficacy and safety profile of BIMZELX in HS have not been established.

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 INFORMATION⁵

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 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 (≥ 1%) adverse reactions in plaque psoriasis 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 infections.

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.

Forward looking statements

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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

1. Zouboulis C, Garg A, Sayed C, et al. Bimekizumab efficacy and safety through 2 years in patients with hidradenitis suppurativa: Results from the phase 3 BE HEARD I&II trials and open-label extension BE HEARD EXT. Abstract at EADV 2024. Amsterdam, Netherlands.
2. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-64.
3. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18.
4. Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48‑week, randomised, double‑blind, placebo‑controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504-19.
5. BIMZELX^® (bimekizumab-bkzx) U.S. Prescribing Information. https://www.ucb-usa.com/Innovation/Products/BIMZELX. Accessed September 2024.

US-BK-2401209 
Date of preparation: September 2024
BIMZELX® is a registered trademark of the UCB Group of Companies.  
©2024 UCB, Inc., Smyrna, GA 30080. All rights reserved.

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FAQ

What were the key results of BIMZELX (UCBJY) in the two-year hidradenitis suppurativa study?

At Week 96, 85.4% of patients achieved HiSCR50, 77.1% achieved HiSCR75, and 44.2% achieved HiSCR100. Improvements in disease severity, draining tunnel count, and quality of life were maintained over two years.

How did BIMZELX (UCBJY) affect patients' quality of life in the hidradenitis suppurativa study?

Approximately one in three patients (33.9%) reported minimal or no impact of the disease on their health-related quality of life over two years of treatment with BIMZELX.

What was the safety profile of BIMZELX (UCBJY) in the two-year hidradenitis suppurativa study?

BIMZELX was generally well-tolerated over two years with no new safety signals observed. The most common treatment-emergent adverse events were hidradenitis, coronavirus infection, and oral candidiasis.

Where were the two-year results of BIMZELX (UCBJY) for hidradenitis suppurativa presented?

The two-year data was presented as a late-breaking platform presentation at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, September 2024.