Conclusions Clinical and health-related quality of life responses observed during the first two years of treatment were sustained to three years of treatment, regardless of BKZ maintenance dose frequency prior to the third year. Additionally, responses were sustained in the third year, regardless of all patients switching to BKZ every 8 weeks. Increases in responses after the ADA to BKZ switch were also sustained to Week 152. BKZ was well-tolerated over three years, with no unexpected safety findings. Summary Presented at the 42nd Annual Fall Clinical Dermatology Conference | Las Vegas, NV | October 20–23, 2022 Objectives To evaluate the long-term efficacy and safety of bimekizumab (BKZ) over three years in patients with moderate to severe plaque psoriasis who enrolled in the BE SURE phase 3 trial and entered the BE BRIGHT open-label extension (OLE). Introduction • In BE SURE (NCT03412747), BKZ demonstrated superior efficacy compared with adalimumab (ADA) over 24 weeks. After patients switched from ADA to BKZ at Week 24, responses improved and were maintained over two years, with no unexpected safety findings.1 • Here, we consider long-term efficacy and safety over three years. Materials and Methods • Treatment in BE SURE was as shown in Figure 1. • Upon completion of BE SURE, patients could enrol in the BE BRIGHT OLE (NCT03598790; Figure 1).1–3 • Dose adjustments (to BKZ 320 mg every 4 weeks [Q4W] or every 8 weeks [Q8W]) could occur at Week 56 and Week 80 (OLE Week 24) based on the achievement of ≥90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90). All patients received BKZ Q8W from Week 104 (OLE Week 48; or next clinic visit). • Efficacy outcomes are reported for the intention-to-treat (ITT) population through Week 152 by initial randomisation group at BE SURE baseline. • Data are reported using modified non-responder imputation (mNRI), NRI, and observed case (OC). – For mNRI, patients who discontinued treatment due to lack of efficacy were considered non-responders at subsequent timepoints; multiple imputation was used for all other missing data. • Safety data are reported for Weeks 104–152 (data cut-off: 23 Oct 2021), and include treatment-emergent adverse events (TEAEs) reported using exposure-adjusted incidence rates (EAIRs). Two-year safety data have been reported previously (Weeks 0–104).1,2 – The overview of adverse events and the most common TEAEs is reported both by initial randomization group regardless of BKZ OLE dosing regimen, and for all patients pooled (BKZ Total). BKZ Total was only used for safety topics of interest. Results • In BE SURE, 478 patients were randomized 1:1:1 to: BKZ Q4W/Q4W (N=158), BKZ Q4W/Q8W (N=161), and ADA/BKZ Q4W (N=159) (Figure 1). Baseline demographics have been reported previously and were aligned across treatment arms.2 • BKZ-randomized patients maintained high levels of PASI 90 and PASI 100 responses to three years of treatment (Week 152/OLE Week 96; Figure 2; Table 1). • Among ADA-randomized patients, the rapid increases seen in PASI 90 and PASI 100 responses for after the Week 24 ADA to BKZ switch were durable to Week 152, reaching similar levels to BKZ-randomized patients (Figure 2; Table 1). • These trends were also reflected in DLQI 0/1 responses over three years (Figure 2; Table 1). • The most common TEAEs across BKZ-treated patients were coronavirus infection, oral candidiasis, and nasopharyngitis (Table 2). Rates of safety topics of interest were low (Table 3). • Two coronavirus infections were reported as serious; of which only one was confirmed by testing. Diamant Thaçi,1 Ron Vender,2 Menno de Rie,3 Curdin Conrad,4 Jennifer Soung,5 Bruce Strober,6,7 Maggie Wang,8 Nancy Cross,8 Delphine Deherder,9 Natalie Nunez Gomez,10 Alice B. Gottlieb11 Bimekizumab efficacy and safety through three years in patients with moderate to severe plaque psoriasis: Long-term results from the BE SURE randomized controlled trial and the BE BRIGHT open-label extension Previously presented at EADV 2022 Institutions: 1Institute and Comprehensive Center for Inflammation Medicine, University Hospital of Lübeck, Lübeck, Germany; 2Dermatrials Research Inc., Hamilton, Ontario, Canada; 3Department of Dermatology, Amsterdam University Medical Centres, Amsterdam, Netherlands; 4Department of Dermatology, Lausanne University Hospital, Switzerland; 5Southern California Dermatology, Inc., Santa Ana, California, USA; 6Yale University, New Haven, Connecticut, USA; 7Central Connecticut Dermatology Research, Cromwell, Connecticut, USA; 8UCB Pharma, Raleigh, North Carolina, USA; 9UCB Pharma, Braine-l’Alleud, Belgium; 10UCB Pharma, Monheim, Germany; 11Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York, USA. References: 1Thaçi D et al. Presented at EADV 2021, P1324; 2Warren RB et al. N Engl J Med 2021;385:130–41, NCT03412747; 3BE BRIGHT: clinicaltrials.gov/ct2/show/NCT03598790. Author Contributions: Substantial contributions to study conception/design, or acquisition/analysis/interpretation of data: DT, RV, MdR, CC, JS, BS, MW, NC, DD, NNG, ABG; Drafting of the publication, or revising it critically for important intellectual content: DT, RV, MdR, CC, JS, BS, MW, NC, DD, NNG, ABG; Final approval of the publication: DT, RV, MdR, CC, JS, BS, MW, NC, DD, NNG, ABG. Author Disclosures: DT: Honoraria for participation on advisory boards, as a speaker and for consultancy from AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Eli Lilly, Galapagos, Janssen, LEO Pharma, Morphosis, Novartis, Pfizer, Regeneron, Samsung, Sanofi Genzyme, Sun Pharma, and UCB Pharma; research grants received from Celgene, LEO Pharma, and Novartis. RV: Grants/Research Support: AbbVie, Amgen, Centocor, Dermira, Dermavant, Eli Lilly, Galderma, GSK, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Takeda, and UCB Pharma; speakers bureau/honoraria: AbbVie, Actelion, Amgen, Bausch Health, Celgene, Cipher, Eli Lilly, Galderma, GSK, Janssen, LEO Pharma, Merck, Novartis, Pfizer, and UCB Pharma; consulting fees: AbbVie, Actelion, Amgen, Bausch Health, Celgene, Cipher, Eli Lilly, Galderma, GSK, Janssen, LEO Pharma, Merck, Novartis, Palladin, Pfizer, and UCB Pharma. MdR: Honoraria for participation on advisory boards, as a speaker and for consultancy from AbbVie, Almirall, Artax Biopharma, Biogen, Celgene, Eli Lilly, Janssen-Cilag, Janssen, LEO Pharma, Novartis, and UCB Pharma. CC: Consultant and/or principal investigator in clinical trials for: AbbVie, Actelion, Amgen, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Incyte, Janssen-Cilag, LEO Pharma, MSD, Novartis, Pfizer, Samsung, Sanofi Genzyme, and UCB Pharma. JS: Honoraria and/or consulting fees from Amgen, Celgene, Dermavant, National Psoriasis Foundation, Ortho Dermatologics, and Regeneron; grants and consulting fees from Abbvie, Actelion, Boeringher Ingelheim, Dermira, Eli Lilly, Janssen, LEO Pharma, Novartis Pharma, and UCB Pharma; research grants from Cassiopeia, Galderma, and Pfizer. BS: Consultant (honoraria): AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli Lilly, EPI Health, Evelo Biosciences, Immunic Therapeutics, Janssen, LEO Pharma, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ono, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB Pharma, Union Therapeutics, Ventyxbio, and vTv Therapeutics; Stock Options: Connect Biopharma, Mindera Health; Speaker: AbbVie, Eli Lilly, Janssen, Regeneron, and Sanofi Genzyme; Scientific Co-Director (consulting fee): CorEvitas (formerly Corrona) Psoriasis Registry; Investigator: AbbVie, Cara, CorEvitas Psoriasis Registry, Dermavant, Dermira, and Novartis; Editor-in-Chief (honorarium): Journal of Psoriasis and Psoriatic Arthritis. MW, NC, DD: Employees and shareholders of UCB Pharma. NNG: Former employee and shareholder of UCB Pharma, current employee of Boehringer Ingelheim. ABG: Honoraria as an advisory board member and consultant for: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Incyte, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options for an RA project); Research/educational grants from: AnaptysBio, Boehringer Ingelheim, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, and UCB Pharma: All funds go to Mount Sinai Medical School. Acknowledgements: These studies were funded by UCB Pharma. We thank the patients and their caregivers in addition to the investigators and their teams who contributed to these studies. The authors acknowledge Susanne Wiegratz, MSc, UCB Pharma, Monheim, Germany, for publication coordination, Poppy Wilson, MBiol, Costello Medical, London, UK, for medical writing and editorial assistance and the Design team at Costello Medical for graphic design assistance. All costs associated with development of this poster were funded by UCB Pharma. Figure 1 Study design Figure 2 Efficacy responses by randomized treatment group through Week 152 (mNRI) ADA: adalimumab; BKZ: bimekizumab; CI: confidence interval; DLQI: Dermatology Life Quality Index; EAIR: exposure-adjusted incidence rate; IBD: inflammatory bowel disease; ITT: intention-to-treat; MACE: major adverse cardiac event; mNRI: modified non-responder imputation; NMSC: non-melanoma skin cancer; NRI: non-responder imputation; OC: observed case; OLE: open-label extension; PASI 90/100: ≥90%/100% improvement from BE SURE baseline in Psoriasis Area and Severity Index; PY: patient-years; Q4W: every 4 weeks; Q8W: every 8 weeks; SIB: suicidal ideation and behavior; TEAE: treatment-emergent adverse event. Table 1 Overview of efficacy outcomes (mNRI, NRI, OC) Percentage of patients achieving PASI 90 at Weeks 56, 104, and 152 (mNRI) High initial PASI 90 response rates among BKZ-randomized patients were maintained to Week 152. Additionally, PASI 90 response rates in patients switching from ADA to BKZ rapidly increased and were sustained over three years of treatment. There were no unexpected safety findings. BKZ Q4W/Q4W; N=158 BKZ Q4W/Q8W; N=161 ADA/BKZ Q4W; N=159 0 100 80 60 40 20 Week 56 Week 104 Week 152 P ro p o rt io n o f p a ti e n ts a c h ie v in g P A S I 9 0 ( % ) 92.6% 89.6% 94.3% 85.5% 87.3% 96.1%90.2% 89.0% 97.1% Table 2 Overview of adverse events during BKZ treatment in patients from BE SURE who entered BE BRIGHT, Weeks 104–152 Data to Week 104 have been reported previously.1 Data are presented for the ITT population by initial randomization group. Week 104 corresponds to OLE Week 48, and Week 152 to OLE Week 96. BKZ Q4W/Q4W N=158 BKZ Q4W/Q8W N=161 ADA/BKZ Q4W N=159 mNRI, % NRI, n (%) OC, n/N (%) mNRI, % NRI, n (%) OC, n/N (%) mNRI, % NRI, n (%) OC, n/N (%) PASI 90 Week 56 92.6 134 (84.8) 134/140 (95.7) 89.6 133 (82.6) 133/143 (93.0) 94.3 130 (81.8) 130/133 (97.7) Week 104 90.2 121 (76.6) 121/129 (93.8) 89.0 119 (73.9) 119/126 (94.4) 97.1 121 (76.1) 121/123 (98.4) Week 152 85.5 113 (71.5) 113/123 (91.9) 87.3 110 (68.3) 110/115 (95.7) 96.1 112 (70.4) 112/114 (98.2) PASI 100 Week 56 78.3 114 (72.2) 114/140 (81.4) 75.8 113 (70.2) 113/143 (79.0) 74.0 106 (66.7) 106/133 (79.7) Week 104 72.0 102 (64.6) 102/129 (79.1) 67.5 101 (62.7) 101/126 (80.2) 71.3 98 (61.6) 98/123 (79.7) Week 152 65.8 95 (60.1) 95/123 (77.2) 62.3 89 (55.3) 89/115 (77.4) 69.2 92 (57.9) 92/114 (80.7) DLQI 0/1 Week 56 78.5 117 (74.1) 117/140 (83.6) 81.9 127 (78.9) 127/142 (89.4) 81.0 116 (73.0) 116/132 (87.9) Week 104 80.8 112 (70.9) 112/130 (86.2) 82.1 110 (68.3) 110/126 (87.3) 82.0 112 (70.4) 112/124 (90.3) Week 152 77.1 101 (63.9) 101/121 (83.5) 81.4 103 (64.0) 103/115 (89.6) 78.0 101 (63.5) 101/112 (90.2) Two-year safety data have been reported previously (Weeks 0–104).1,2 Data are presented as EAIRs of new cases per 100 patient-years from Weeks 104–152 for all patients who received ≥1 BKZ dose in the Week 104–152 period (data cut-off: 23 Oct 2021), both by initial randomization group regardless of BKZ OLE dosing regimen, and for all patients pooled (BKZ Total). All patients received BKZ Q8W from Week 104 (OLE Week 96; or next visit). aValues in bold are the three most common TEAEs for the treatment group. EAIR/100 PY (95% CI) BKZ Total N=380 BKZ Q4W/Q4W N=132 BKZ Q4W/Q8W N=124 ADA/BKZ Q4W N=124 Any TEAE 101.7 (88.7, 116.0) 108.0 (85.5, 134.6) 99.4 (77.6, 125.4) 97.6 (76.2, 123.1) Serious TEAEs 6.2 (3.9, 9.5) 5.1 (1.9, 11.1) 8.2 (3.7, 15.5) 5.5 (2.0, 11.9) Discontinuation due to TEAEs 2.9 (1.4, 5.4) 2.5 (0.5, 7.4) 3.5 (1.0, 9.1) 2.7 (0.6, 7.9) Severe TEAEs 5.0 (2.9, 8.0) 3.4 (0.9, 8.7) 8.2 (3.7, 15.5) 3.6 (1.0, 9.2) Deaths 1.2 (0.3, 3.0) 1.7 (0.2, 6.1) 0.9 (0.0, 4.9) 0.9 (0.0, 5.0) Most Common TEAEsa Coronavirus infection 6.6 (4.1, 10.0) 5.2 (1.9, 11.3) 8.3 (3.8, 15.8) 6.4 (2.6, 13.3) Nasopharyngitis 4.8 (2.7, 7.7) 4.3 (1.4, 10.1) 2.7 (0.6, 7.8) 7.4 (3.2, 14.6) Oral candidiasis 6.3 (3.9, 9.7) 6.1 (2.5, 12.6) 7.3 (3.2, 14.4) 5.6 (2.0, 12.1) Urinary tract infection 3.5 (1.8, 6.2) 3.4 (0.9, 8.8) 5.4 (2.0, 11.7) 1.8 (0.2, 6.6) EAIR/100 PY (95% CI) BKZ Total (N=380) Serious infections 1.8 (0.6, 3.8) Active tuberculosis 0.0 IBD 0.6 (0.1, 2.1) Malignancies 0.6 (0.1, 2.1) NMSC 0.0 Adjudicated SIB 0.0 Serious hypersensitivity reactions 0.0 Adjudicated MACE 0.9 (0.2, 2.6) Elevated liver enzymes 3.2 (1.6, 5.8) Two-year safety data have been reported previously (Weeks 0–104).1,2 Data are presented as EAIRs of new cases per 100 patient-years from Weeks 104–152 for all patients who received ≥1 BKZ dose in the Week 104–152 period (data cut-off: 23 Oct 2021) for all patients pooled (BKZ Total). All patients received BKZ Q8W from Week 104 (OLE Week 96; or next visit). In BE SURE, patients were randomized 1:1:1 to: BKZ 320 mg Q4W for 56 weeks; BKZ 320 mg Q4W for 16 weeks then Q8W through Weeks 16–56; or ADA 40 mg Q2W for 24 weeks followed by BKZ 320 mg Q4W to Week 56. At Week 56, dose adjustments (to BKZ 320 mg Q4W or Q8W) could occur based on whether patients achieved PASI 90. Patients receiving BKZ 320 mg Q4W at Week 56 who achieved PASI 90 were randomized 4:1 to BKZ 320 mg Q4W or Q8W. At Week 24 of BE BRIGHT, for patients receiving BKZ 320 mg Q4W, if PASI 90 was achieved, the investigator could change the patient’s dosing interval from 320 mg Q4W to 320 mg Q8W. All patients were switched to BKZ 320 mg Q8W at the next scheduled clinic visit on or after the Week 104 visit (OLE Week 48) following protocol amendment. BE SURE BE BRIGHT Screening Initial treatment period Maintenance period Open-label treatment period N=478 1:1:1 randomization BKZ 320 mg Q8W BKZ 320 mg Q4W BKZ 320 mg Q4W BKZ 320 mg Q4W BKZ 320 mg Q4W BKZ 320 mg Q4W BKZ 320 mg Q4W BKZ 320 mg Q8W BKZ 320 mg Q8W BKZ 320 mg Q8W ADA 40 mg Q2W N=158 N=161 N=159