UCB Announces Publication in The Lancet of Phase 3 BIMZELX® (bimekizumab-bkzx) Trials in Moderate-to-Severe Hidradenitis Suppurativa
UCB has announced that The Lancet has published results from the Phase 3 BE HEARD I and II trials evaluating BIMZELX® (bimekizumab-bkzx) in treating moderate-to-severe hidradenitis suppurativa (HS). These trials are the first to assess an IL-17A and IL-17F inhibitor for HS. The positive results support global regulatory submissions for BIMZELX. In April 2024, the FDA accepted a review of the supplemental biologics license application for BIMZELX, and the European Commission granted marketing authorization for the treatment of HS in adults who haven't responded to conventional therapy. Other regulatory submissions are ongoing worldwide.
- Publication in The Lancet, a prestigious medical journal, enhancing credibility.
- Positive Phase 3 trial results for BIMZELX in treating moderate-to-severe HS.
- FDA accepted supplemental biologics license application for review in April 2024.
- European Commission granted marketing authorization in April 2024.
- BIMZELX demonstrated sustained improvements in clinical and patient-reported outcomes.
- No specific revenue figures or financial data disclosed.
- Potential regulatory approval pending in other regions, creating uncertainty.
- Results based on Phase 3 trials; real-world effectiveness yet to be seen.
- BE HEARD I and BE HEARD II are the first Phase 3 trials to evaluate the efficacy and safety of an IL-17A and IL–17F inhibitor, BIMZELX® (bimekizumab-bkzx), in the treatment of adult patients with moderate-to-severe hidradenitis suppurativa
"Publication of results from the BE HEARD I and II trials in The Lancet, a world-leading medical journal, reflects the significance of these data to the dermatology community. People living with hidradenitis suppurativa face high unmet medical needs. The positive results from these trials support global regulatory submissions for BIMZELX in this chronic inflammatory skin disease," said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB.
"The Phase 3 studies with bimekizumab represent a significant milestone for the hidradenitis suppurativa community, and they include HiSCR75, a high threshold endpoint, as a key ranked secondary outcome. In these studies, bimekizumab consistently demonstrated sustained improvements in clinical- as well as patient-reported outcomes for people with moderate to severe disease. These findings provide strong support for targeting IL-17A and IL-17F as a new and promising therapeutic approach for the future," said Lead Investigator, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School,
In April 2024, UCB announced that the
Notes to editors:
About BE HEARD I and BE HEARD II
BE HEARD I and BE HEARD II were randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase 3 trials designed to evaluate the efficacy and safety of bimekizumab in adults with moderate-to-severe hidradenitis suppurativa (HS).1 The two trials had a combined enrolment of 1,014 participants with a diagnosis of moderate-to-severe HS.1 The primary endpoint in both trials was HiSCR50 at Week 16.1 A key secondary endpoint was HiSCR75 at Week 16.1 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 and inflammatory nodule count or draining tunnel count.1
Results from BE HEARD I and BE HEARD II showed that a significantly higher proportion of patients treated with bimekizumab versus placebo achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials. Bimekizumab treatment also resulted in clinically meaningful improvements in the ranked key secondary endpoint, HiSCR75 versus placebo at Week 16. Responses were maintained to Week 48.1 The safety profile of bimekizumab was consistent with safety data seen in previous trials with no new observed safety signals.1
About Hidradenitis Suppurativa (HS)
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease.2,3 The main symptoms are nodules, abscesses, and pus-discharging fistulas (channels 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 most commonly develops in early adulthood and affects approximately one percent of the population in most studied countries.2,3 Approximately one-third of people with HS have a family history of HS, and lifestyle factors such as smoking and obesity can also play a crucial role in the clinical course of HS.2,3
The symptoms of pain, discharge, and scarring are not only a physical burden.2,5 People with HS also experience stigma: worrying about, or directly experiencing, negative attitudes, and reactions from society in response to their symptoms.4 These feelings can lead to embarrassment, social isolation, low self-esteem, and sexual life impairment, and impact all areas of life, including interpersonal relationships, education, and work.2,5
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.6
In the
BIMZELX is not approved in HS by any regulatory authority worldwide.
Please see Important Safety Information below and full
BIMZELX
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
Nicole Herga
T +1.773.960.5349
email nicole.herga@ucb.com
About UCB
UCB,
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References
- 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. The Lancet. Published Online May 22, 2024. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00101-6/fulltext
- Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–64.
- Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18.
- Koumaki D, Efthymiou O, Bozi E, et al. Perspectives On Perceived Stigma And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Investig Dermatol. 2019;12(1):785–90.
- Kokolakis G, Wolk K, Schneider-Barrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236(5):421–30.
- BIMZELX® (bimekizumab-bkzx)
U.S. PI. Available at: https://www.ucb-usa.com/Innovation/Products/BIMZELX. Last accessed: May 2024.
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What is hidradenitis suppurativa (HS)?
