03/16/2023 | Press release | Distributed by Public on 03/16/2023 00:09
Brussels (Belgium), 16th March 2023 - 07:00 (CET) - UCB, a global biopharmaceutical company, today announced that it will present eight bimekizumab abstracts across a range of IL-17 mediated diseases1,2 - moderate to severe plaque psoriasis, active psoriatic arthritis (PsA) and moderate to severe hidradenitis suppurativa (HS) - at the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, U.S., 17-21 March. The abstracts have been accepted as one late-breaking oral platform presentation and seven posters including three with oral presentations. The platform presentation will share the first detailed data from the two Phase 3 studies, BE HEARD I and BE HEARD II, evaluating the efficacy and safety of bimekizumab compared with placebo in the treatment of adults with moderate to severe HS.3,4
"The Phase 3 results for hidradenitis suppurativa further demonstrate UCB's dedication to improving treatment options for patients with chronic diseases and reinforce our commitment to advancing dermatological care through cutting-edge science," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.
In the U.S., the efficacy and safety of bimekizumab have not been established for any indication and it is not approved by the U.S. Food and Drug Administration. In the European Union and Great Britain, bimekizumab is approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.5,6 UCB is investigating bimekizumab in PsA and HS. The efficacy and safety of bimekizumab in PsA and HS have not been established, and it is not approved for use in these indications by any regulatory authority worldwide.
Five of the eight abstracts at AAD 2023 will share data on bimekizumab in the treatment of moderate to severe plaque psoriasis including data evaluating bimekizumab in the treatment of nail psoriasis from the BE RADIANT phase 3b trial. Two abstracts evaluating bimekizumab for the treatment of active PsA will also be presented.
The following is a guide to the UCB-sponsored abstracts at AAD 2023:
Saturday March 18: 13:00-13:10
Sunday March 19: 13:00-13:05
Sunday March 19: 13:30-13-35
Sunday March 19: 15:10-15:15
Notes to editors:
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.5,7 In the U.S., the efficacy and safety of bimekizumab have not been established for any indication and it is not approved by the U.S. Food and Drug Administration.
In August 2021, bimekizumab was first approved in the European Union (EU)/European Economic Area (EEA) and in Great Britain, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.5,6 The label information may differ in other countries where approved. Please check local prescribing information.
About BIMZELX®▼(bimekizumab) in the EU/EEA In the EU/EEA, BIMZELX® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.5
BIMZELX®▼(bimekizumab) EU/EEA Important Safety Information in Psoriasis
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.
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
EU summary of product characteristics date of revision December 2022.
Last accessed: March 2023.
▼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
For further information, contact UCB:
email [email protected]
email [email protected]
email [email protected]
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 8,600 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.
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