New BIMZELX[®]▼ (bimekizumab) two-year data in moderate to severe plaque psoriasis presented at the 30th European Academy of Dermatology and Venereology (EADV) Congress

Brussels, Belgium – 29th September 2021 – 07:30 CEST – UCB, a global biopharmaceutical company, today announced new interim results from the BE BRIGHT open-label extension (OLE) study evaluating the long-term safety, tolerability and efficacy of BIMZELX^® (bimekizumab) through to two years in adult patients with moderate to severe plaque psoriasis who completed one of the three Phase 3 pivotal studies. These data, together with additional findings from the Phase 3/3b clinical program for bimekizumab in psoriasis, were presented today across nine UCB-supported abstracts at the 30th European Academy of Dermatology and Venereology (EADV) Congress. 

Bimekizumab is the first selective IL-17A and IL-17F inhibitor to be approved in the European Union for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.¹   

“Following the recent approval of bimekizumab in Europe, we are pleased to share new two-year data at EADV supporting the clinical value of bimekizumab in the treatment of moderate to severe psoriasis. The range of longer-term efficacy and safety data presented offer important new insights for the dermatology community and reflect our commitment to improving the standard of care for people with psoriasis,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. 

Interim data from the BE BRIGHT study presented at EADV showed that patients treated with bimekizumab achieved sustained levels of skin clearance (PASI 90 and PASI 100) through to two years with continuous maintenance dosing*, and that bimekizumab was generally well tolerated, with no new safety signals identified.^2,3,4 Switching to bimekizumab following 24 weeks of adalimumab treatment (BE SURE) resulted in a sustained increase in PASI 90 and PASI 100 responder rates up to two years.^2,5 In addition, switching to bimekizumab following 52 weeks of ustekinumab treatment (BE VIVID) resulted in a sustained increase in PASI 100 responder rates up to week 100.^3,6 Patients switching to bimekizumab after an inadequate response to ustekinumab at week 52 also showed sustained improvements in levels of skin clearance (PASI 90 and PASI 100).³ 

“In clinical practice, patients with moderate to severe plaque psoriasis may need to transition between biologics to optimally control their disease. Longer-term results from the BE SURE study and the BE BRIGHT open-label extension study shared at EADV 2021 demonstrated that switching from adalimumab to bimekizumab helped more patients with moderate to severe psoriasis to achieve and maintain completely clear skin, as measured by PASI 100, through two years of treatment,” said Professor Diamant Thaçi, Institute and Comprehensive Center for Inflammation Medicine, University Hospital of Lübeck, Lübeck, Germany. 

Longer-term results from BE SURE and BE BRIGHT open-label extension trial¥  

After completing the phase 3 BE SURE trial, patients could enrol in the OLE study.^2,5 In bimekizumab-randomized patients (320 mg every four weeks [Q4W] through two years), PASI 90 response rates were 91.2 percent at both weeks 16 and 104.^2,5 PASI 100 response rates in this group were 61.6 percent at week 16 and 72.3 percent at week 104.^2,5 In bimekizumab-randomized patients (320 mg Q4W for 16 weeks, and then every eight weeks [Q8W] through two years), the percentage of patients reaching PASI 90 was 89.4 percent at week 16 and 89.7 percent at week 104.^2,5 Levels of PASI 100 response in this group were 62.8 percent at week 16 and 68.1 percent at week 104.^2,5 

Switching from adalimumab to bimekizumab 320 mg Q4W resulted in sustained response rates (PASI 90 and PASI 100) through to two years (week 104), which were comparable to the response rates seen in patients receiving continuous bimekizumab treatment.² Bimekizumab was well tolerated over two years, with no new safety signals.² 

Bimekizumab data up to two years in patients switching from ustekinumab^± 
This analysis included adult patients from BE VIVID who were initially randomized to ustekinumab 45 mg / 90 mg (by weight) at weeks 0 / four, then every 12 weeks, or bimekizumab 320 mg Q4W through week 52.^3,6  Based on the PASI 90 response at week 52, patients entering the OLE were re-randomized to bimekizumab 320 mg Q4W or Q8W.³

At entry to the OLE study, 44.9 percent of ustekinumab-treated patients and 73.6 percent of bimekizumab-treated patients had achieved PASI 100.³ For all patients who switched from ustekinumab to bimekizumab the PASI 100 response increased to 65.4 percent at week 56, 78.7 percent at week 68 and 69.9 percent at week 100, which was comparable to the response rate seen in patients receiving continuous bimekizumab treatment at week 68 (75.4 percent) through week 100 (68.8 percent).³ For patients who switched to bimekizumab following an inadequate response to ustekinumab at week 52, high levels of response were achieved. At week 56, after one dose of bimekizumab, 77.3 percent of these patients achieved PASI 90 and 40.9 percent achieved PASI 100. These responses were sustained and further improved at week 100, with 84.1 percent and 54.5 percent of patients achieving PASI 90 and PASI 100, respectively. There were no unexpected safety findings in patients who switched from ustekinumab to bimekizumab during the OLE.³

Pooled safety data from up to two years of treatment in Phase 2 and 3 clinical trials
Across Phase 2 and 3 trials, the total bimekizumab exposure was 3109.7 patient-years (N=1789).⁴ Treatment emergent adverse events (TEAEs) occurred at an exposure-adjusted incidence rate (EAIR) of 202.4 per 100 patient-years, serious TEAEs were seen at an EAIR of 5.9 new cases per 100 patient-years and TEAEs leading to discontinuation at 3.8 new cases per 100 patient-years.⁴ The most common TEAEs in the Phase 2 and 3 trials with bimekizumab were nasopharyngitis (EAIR: 19.1 new cases per 100 patient-years), oral candidiasis (12.6 new cases per 100 patient-years) and upper respiratory tract infection (8.9 new cases per 100 patient-years).⁴  The EAIR for oral candidiasis showed a decrease compared with one year of bimekizumab treatment (12.6 new cases per 100 patient-years versus 16.4 new cases per 100 patient-years) and was lower with bimekizumab dosed Q8W (9.6 per 100 patient-years) compared with Q4W (16.4 per 100 patient-years).⁴ The majority of cases (98.5 percent of patients experiencing oral candidiasis) were mild or moderate and rarely led to study discontinuation.⁴

*The recommended bimekizumab dose for adult patients with plaque psoriasis is 320 mg (given as two subcutaneous injections of 160 mg) at week 0, four, eight, 12, 16 and every eight weeks thereafter.1 For some patients with a body weight ≥ 120 kg who did not achieve complete skin clearance at week 16, 320 mg every four weeks after week 16 may further improve treatment response.1 In the studies reported at EADV 2021, patients received maintenance dosing of bimekizumab 320 mg Q4W or Q8W. 

¥ Modified non-responder imputation analyses

±Non-responder imputation analyses 

About BE BRIGHT⁷ 

BE BRIGHT (NCT03598790) is an ongoing, multicentre, open-label extension study assessing the long-term safety, tolerability and efficacy of bimekizumab in adult patients with moderate to severe plaque psoriasis. Patients who completed one of three bimekizumab Phase 3 studies, BE READY, BE VIVID and BE SURE, were eligible to enroll in the BE BRIGHT study. More details can be found at ClinicalTrials.gov. 

About BIMZELX (bimekizumab) in the EU
Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds with high affinity to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex.¹ Elevated concentrations of IL-17A and IL-17F have been implicated in the pathogenesis of several immune-mediated inflammatory diseases including plaque psoriasis.¹ Bimekizumab inhibits these proinflammatory cytokines, resulting in the normalization of skin inflammation and as a consequence improvement in clinical symptoms associated with psoriasis.¹ 

Bimzelx^®▼ (bimekizumab) EU/EEA* Important Safety Information

The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%) (most frequently nasopharyngitis) and oral candidiasis (7.3%). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headache, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab.

*EU/EEA means European Union/European Economic Area

Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis). 

Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be administered in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB and patients receiving bimekizumab should be monitored for signs and symptoms of active TB. 

Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated. 

Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated. 

Live vaccines should not be given in patients treated with bimekizumab.

Please consult the summary of product characteristics in relation to other side effects, full safety and prescribing information. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf

European summary of product characteristics date of revision August 2021

Last accessed: September 2021.   

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions 

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 8,400 people in nearly 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

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References

1. BIMZELX (bimekizumab) EU Summary of Product Characteristics, August 2021. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf.  
2. Thaçi D, Vender R, de Rie M, et al. Safety and efficacy of bimekizumab through 2 years in patients with moderate to severe plaque psoriasis: Longer-term results from the BE SURE randomised controlled trial and the BE BRIGHT open-label extension trial. Presented at EADV 2021.
3. Leonardi C, Sator PG, Morita A, et al. Bimekizumab efficacy and safety up to two years in patients with moderate to severe plaque psoriasis switching from ustekinumab: Interim results from the BE BRIGHT open-label extension trial. Presented at EADV 2021.
4. Reich K, Ståhle M, Okubo Y, et al. Bimekizumab safety in patients with moderate to severe plaque psoriasis: Analysis of pooled data from up to two years of treatment in phase 2 and 3 clinical trials. Presented at EADV 2021. 
5. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.
6. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
7. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE BRIGHT). Available at: https://clinicaltrials.gov/ct2/show/NCT03598790?term=NCT03598790&draw=2&rank=1. Last accessed September 2021.