Présentation PowerPoint Acknowledgements and Disclosures The study was funded by UCB Pharma. This poster was originally presented as an e-poster at the 28th EADV congress, 9–13 October 2019, Madrid, Spain. The authors would like to acknowledge Jessica Gamage PhD CMPP, of iMed Comms, an Ashfield Company, for medical writing support that was funded by UCB Pharma in accordance with GPP3 guidelines. A Blauvelt reports consultant and investigator fees from AbbVie, Aclaris, Akros, Allergan, Almirall, Amgen, Arena, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermavant, Dermira Inc, Eli Lilly, FLX Bio, Galderma, Genentech/Roche, GlaxoSmithKline, Janssen, LEO, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Revance, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharmaceuticals, UCB Pharma, Valeant, Vidac; and speaker fees from Janssen, Regeneron, Sanofi Genzyme. KA Papp reports consultant honoraria from AbbVie, Akros, Amgen, Arcutis, Astellas, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, CanFite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Galderma, Genentech, Janssen, Kyowa Hakko Kirin, LEO, Merck (MSD), Merck-Serono, Mitsubishi Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi Aventis/Genzyme, Sun Pharma, Takeda, UCB Pharma, Valeant/Bausch Health; speaker fees from AbbVie, Amgen, Astellas, Celgene, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, LEO, Merck (MSD), Novartis, Pfizer, Sanofi Aventis/Genzyme, Sun Pharma, Valeant/Bausch Health; investigator grants from AbbVie, Akros, Allergan, Amgen, Anacor, Arcutis, Astellas, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, CanFite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Galderma, Genentech, Gilead, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, LEO, MedImmune, Merck (MSD), Merck-Serono, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi Aventis/Genzyme, Sun Pharma, Takeda, UCB Pharma, Valeant/Bausch Health; advisory board honoraria from AbbVie, Amgen, Astellas, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dow Pharma, Eli Lilly, Galderma, Janssen, Merck (MSD), Novartis, Pfizer, Regeneron, Sanofi Aventis/Genzyme, Sun Pharma, UCB Pharma, Valeant/Bausch Health; and other fees from AbbVie, Akros, Amgen, Anacor, Boehringer Ingelheim, Celgene, Coherus, Eli Lilly, Janssen, Kyowa Hakko Kirin, Merck (MSD), Merck-Serono, Novartis, Pfizer, Regeneron, Sanofi Aventis/Genzyme, Sun Pharma, Valeant/Bausch Health. JF Merola reports consultant honoraria from AbbVie, Almirall, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, Merck, Novartis, Samumed, Sanofi Regeneron, Sun Pharma, UCB Pharma; investigator honoraria from Biogen IDEC, Celgene, Incyte, Novartis, Pfizer, Sanofi Regeneron; and other financial benefit from AbbVie. A Gottlieb reports consultant/advisory board agreements/or speakers bureau agreements with AbbVie, Allergan, Avotres Therapeutics, Beiersdorf, Bristol-Myers Squibb, Celgene, Dermira, Eli Lilly, Incyte, Janssen, LEO, Novartis, Reddy Labs, Sun Pharmaceutical Industries, UCB Pharma, Valeant, Xbiotech; and research/educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis, Xbiotech, UCB Pharma. N Cross and C Madden are employees of UCB Pharma. L Peterson and C Cioffi are employees and stockholders of UCB Pharma. CEM Griffiths reports advisory board honoraria from AbbVie, Almirall, Celgene, Eli Lilly, Galderma, Janssen, Novartis, Pfizer, Sandoz, UCB Pharma; speaker honoraria from AbbVie, Almirall, Bristol-Meyers Squibb, Celgene, Eli Lilly, Galderma, Janssen, Novartis, Pfizer, Sandoz, UCB Pharma; and other grants from AbbVie, Celgene, Eli Lilly, Janssen, LEO, Novartis, Pfizer, Sandoz, UCB Pharma. Bimekizumab provides rapid and sustained improvements in scalp and nail outcomes in patients with moderate-to-severe plaque psoriasis: 60-week results from a randomized, double- blinded, Phase 2b extension study Andrew Blauvelt,1 Kim A Papp,2 Joseph F Merola,3 Alice B Gottlieb,4 Nancy Cross,5 Cindy Madden,5 Luke Peterson,5 Christopher Cioffi,6 Christopher EM Griffiths7 Synopsis ● Psoriasis of the scalp and nails are associated with substantial physical, psychosocial and functional impairments affecting patients’ quality of life (QoL)1,2 ● Scalp and nail psoriasis are considered difficult-to- treat areas and can be challenging to manage effectively with current therapies3,4 ● Interleukin (IL)-17A and IL-17F are expressed in psoriasis lesional skin and synergize with other cytokines to amplify inflammation; preclinical data support neutralization of both IL-17A and IL-17F as a novel targeting approach in psoriasis5 ● Bimekizumab is a monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F6 ● Bimekizumab was associated with rapid, substantial and durable clinical responses in patients with moderate-to-severe plaque psoriasis in the 12-week BE ABLE 1 (NCT02905006) and 48-week BE ABLE 2 extension (NCT03010527) Phase 2 studies, with no unexpected safety findings7,8 1Oregon Medical Research Center, Portland, OR, USA; 2Probity Medical Research and K Papp Clinical Research, Waterloo, ON, Canada; 3Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA; 4Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 5UCB Pharma, Raleigh, NC, USA; 6UCB Pharma, Brussels, Belgium; 7Dermatology Centre, University of Manchester, Manchester, UK Methods ● In BE ABLE 1, patients were randomized to placebo or bimekizumab 64 mg, 160 mg, 160 mg with a 320 mg loading dose (LD), 320 mg or 480 mg7 (Figure 1) ● In BE ABLE 2, BE ABLE 1 PASI90 responders remained on the same dose up to Week 60, except for those previously randomized to bimekizumab 480 mg, who received 320 mg from Week 128 (Figure 1) ● Presence of scalp or nail psoriasis at baseline (Week 0) was defined as a Psoriasis Scalp Severity Index (PSSI) score >0 or a modified Nail Psoriasis Severity Index (mNAPSI) score of >0, respectively ● The following outcomes were assessed in Week 12 responders: – Resolution of scalp psoriasis (defined as PSSI of 0) – Resolution of nail psoriasis (defined as mNAPSI of 0) – Complete skin clearance (defined as a score of 0 on both absolute PASI and the Investigator’s Global Assessment [IGA]) – Dermatology Life Quality Index (DLQI) of 0 or 1 (representing no impact of psoriasis on health- related QoL) ● Non-responder imputation and observed data are presented Results PATIENTS ● At the start of BE ABLE 2 (Week 12), across all treatment groups, 133 of 217 patients (61.3%) were PASI90 responders ● Of these 133 BE ABLE 1 responders, 125 (94.0%) had scalp psoriasis and 80 (60.2%) had nail psoriasis at baseline (Week 0) SCALP AND NAIL OUTCOMES ● Bimekizumab treatment provided considerable improvements in both scalp and nail psoriasis – The proportion of patients with scalp psoriasis at baseline who achieved resolution increased rapidly with bimekizumab treatment; responses were generally maintained up to Week 60 (Figure 2A) – The percentage of BE ABLE 1 responders with nail psoriasis at baseline achieving resolution increased over time across all bimekizumab dose groups, reaching 73–89% at Week 60 (Figure 2B) ● Among PASI90 responders with both scalp and nail psoriasis at baseline, the majority (60–73%) achieved complete skin and nail clearance by Week 60 (Figure 3) ● Resolution of scalp and nail psoriasis was associated with improved health-related QoL, with 91% and 84% of patients, respectively, achieving DLQI of 0 or 1 by Week 60 (Figure 4) References 1. Klaassen KMG et al. J Eur Acad Dermatol Venereol 2014;28:1690–1695; 2. Sampogna F et al. Acta Derm Venereol 2014;94:411–414; 3. Aldredge LM et al. J Dermatol Nurs Assoc 2018;10:189–197; 4. Merola JF et al. Dermatol Ther 2018;31(3):e12589; 5. Glatt S et al. Ann Rheum Dis 2018;77:523–532; 6. Glatt S et al. Br J Clin Pharmacol 2017;83:991–1001; 7. Papp KA et al. J Am Acad Dermatol 2018;79:277–286; 8. Blauvelt A et al. AAD 2019 [OP11180]. Figure 1. BE ABLE 1 and BE ABLE 2 study design Figure 2A. Percentage of BE ABLE 1 responders with scalp psoriasis at baseline achieving resolution of scalp psoriasis over time (NRI) Q4W, every four weeks; TEAEs, treatment-emergent adverse events. 0 20 40 60 80 100 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 Bimekizumab 64 mg (n=15) Bimekizumab 160 mg (n=50) Bimekizumab 320 mg (n=31) Bimekizumab 480 mg/320 mg (n=29) 80.6 86.2 100 76.0 0 4 8 12 16 20 24 28 32 36 40 44 48 P a ti e n ts a c h ie v in g P S S I 0 ( % ) Weeks from BE ABLE 1 / BE ABLE 2 baseline 0 20 40 60 80 100 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 Bimekizumab 64 mg (n=9) Bimekizumab 160 mg (n=41) Bimekizumab 320 mg (n=13) Bimekizumab 480 mg/320 mg (n=17)P a ti e n ts a c h ie v in g m N A P S I 0 ( % ) Weeks from BE ABLE 1 / BE ABLE 2 baseline 84.6 76.5 88.9 73.2 0 4 8 12 16 20 24 28 32 36 40 44 48 The 160 mg treatment group includes patients who received 160 mg plus 320 mg loading dose. Non-responder imputation. mNAPSI, modified Nail Psoriasis Severity Index; PSSI, Psoriasis Scalp Severity Index. Figure 3. BE ABLE 1 responders with both scalp and nail psoriasis at baseline achieving complete skin and nail clearance (absolute PASI, IGA, mNAPSI and PSSI scores of 0) at Week 12 and Week 60 (NRI) The 160 mg treatment group includes patients who received 160 mg plus 320 mg loading dose. Non-responder imputation. IGA, Investigators Global Assessment; mNAPSI, modified Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; PSSI, Psoriasis Scalp Severity Index. 0.0 60.0 22.2 70.4 27.3 72.7 30.8 69.2 0 20 40 60 80 100 Week 12 (BE ABLE 2 Week 0) Week 60 (BE ABLE 2 Week 48) Bimekizumab 64 mg (n=5) Bimekizumab 160 mg (n=27) Bimekizumab 320 mg (n=11) Bimekizumab 480 mg/320 mg (n=13) Figure 4A. BE ABLE 1 responders with scalp psoriasis at baseline (n=125) achieving resolution of scalp psoriasis (PSSI=0) and DLQI score of 0 or 1 at Weeks 12, 24 and 60 (pooled bimekizumab groups, observed data) 8.0 2.4 3.7 68.8 87.0 90.7 0 20 40 60 80 100 Week 12 Week 24 Week 60 PSSI>0 PSSI=0 P a ti e n ts a c h ie v in g D L Q I 0 / 1 ( % ) n=10 n=86 n=3 n=107 n=4 n=98 56.3 28.2 8.8 23.8 60.3 83.8 0 20 40 60 80 100 Week 12 Week 24 Week 60 mNAPSI>0 mNAPSI=0 P a ti e n ts a c h ie v in g D L Q I 0 / 1 ( % ) n=45 n=19 n=22 n=47 n=6 n=57 Figure 4B. BE ABLE 1 responders with nail psoriasis at baseline (n=80) achieving resolution of nail psoriasis (mNAPSI=0) and DLQI score of 0 or 1 at Weeks 12, 24 and 60 (pooled bimekizumab groups, observed data) Observed data. DLQI, Dermatology Life Quality Index; mNAPSI, modified Nail Psoriasis Severity Index; PSSI, Psoriasis Scalp Severity Index. Bimekizumab 160 mg (responders)  160 mg; n=55 n=42 n=39 n=43 Bimekizumab 160 mg (non-responders)  320 mg; n=14 Bimekizumab 160 mg Q4W (with 320 mg loading dose) Bimekizumab 160 mg Q4W BE ABLE 1 treatment period BE ABLE 2 treatment period BE ABLE 1 Baseline BE ABLE 1 Week 12 N=250 If